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Efficacy and safety of risperidone long-acting injection in elderly people with schizophrenia  

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Full Text Available Dhiren Singh1,2, Daniel W O’Connor11Department of Psychological Medicine, Monash University, Melbourne, Australia; 2Peninsula Mental Health Service, Melbourne, AustraliaAbstract: Antipsychotic medication is the mainstay of treatment in elderly patients with psychosis. In recent years, second generation antipsychotics have come to be preferred. Longacting risperidone is the first such antipsychotic available for use in this vulnerable group of patients and offers an attractive alternative to traditional medications. The available literature revealed that long-acting risperidone is generally well tolerated and is effective in treating both the positive and negative symptoms of schizophrenia. Despite a lack of randomized trials and head-to-head studies, it appears to be a useful addition to the treatment armory for patients with chronic psychosis who require a depot preparation. Further research into its endocrine and metabolic side effects is needed.Keywords: risperidone, long-acting injection, old age, efficacy, safety

Dhiren Singh; Daniel W O’Connor

2009-01-01

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Risperidone long-acting injection: a review of its long term safety and efficacy  

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Full Text Available Michael K RainerMemory-Clinic and Psychiatric Department, Donauspital, Vienna, AustriaAbstract: A long-acting form of the second-generation antipsychotic drug risperidone is now broadly available for the treatment of schizophrenia and closely related psychiatric conditions. It combines the advantage of previously available depot formulations for first-generation drugs with the favorable characteristics of the modern “atypical” antipsychotics, namely higher efficacy in the treatment of the negative symptoms of schizophrenia and reduced motor disturbances. Published clinical studies show an objective clinical efficacy (as per psychiatric symptom scores and relapse data) that exceeds that of oral atypical antipsychotics when patients are switched to the long-acting injectable form, a low incidence of treatment-emergent extrapyramidal side effects, and very good acceptance by patients. Available data for maintenance treatment of bipolar disorder show equivalence with the oral form instead of superiority, but are still limited. As it seems likely that efficacy benefits are mostly due to the fact that the injectable form reduces the demand for patient compliance to one physician visit every 2 weeks instead of self-administration on a daily or twice-daily basis, additional potential could exist in other psychiatric disorders where atypical antipsychotic drugs are of benefit but where patient adherence to treatment schedules is typically low.Keywords: risperidone, schizophrenia, psychotic disorders, patient compliance; delayed-action preparations, injections, intramuscular

Michael K Rainer

2008-01-01

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Safety and efficacy of long-acting injectable risperidone in patients with schizophrenia spectrum disorders: a 6-month open-label trial in Asian patients.  

UK PubMed Central (United Kingdom)

The study aimed to evaluate the efficacy of long-acting injectable risperidone (LAR) in Asian patients with schizophrenia spectrum disorders. Twenty-five patients enrolled in this 6-month open labelled study. They were switched from their current antipsychotic to LAR without a prior oral risperidone run-in phase. Efficacy was assessed by the positive and negative syndrome scale (PANSS) and clinical global impression (CGI) scales. Extra-pyramidal side effects (EPSE) was assessed using the Simpson Angus Scale (SAS), and weight and plasma levels of fasting blood glucose, lipids and prolactin were measured. Baseline and last visits differences were tested by paired t-test and Wilcoxon signed-rank test; ratings measured over time were analysed using repeated measures ANOVA. Participants' mean age was 30.3 (+/-6.6) years. Principal reason for switching to LAR was non-compliance (40.0%). Thirteen (52%) patients completed the trial. Over 6 months, there were significant reductions in total PANSS (p = 0.008) and CGI (p = 0.001) scores. There were significant increases in weight (p < 0.001), levels of plasma cholesterol and fasting glucose. LAR was effective in improving symptom severity within the first month of starting treatment. However, significant increases in weight and plasma levels of fasting glucose and cholesterol raise concern about metabolic side effects.

Verma S; Subramaniam M; Abdin E; Sim K; Su A; Lee N; Chong SA

2010-04-01

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Safety and efficacy of long-acting injectable risperidone in patients with schizophrenia spectrum disorders: a 6-month open-label trial in Asian patients.  

Science.gov (United States)

The study aimed to evaluate the efficacy of long-acting injectable risperidone (LAR) in Asian patients with schizophrenia spectrum disorders. Twenty-five patients enrolled in this 6-month open labelled study. They were switched from their current antipsychotic to LAR without a prior oral risperidone run-in phase. Efficacy was assessed by the positive and negative syndrome scale (PANSS) and clinical global impression (CGI) scales. Extra-pyramidal side effects (EPSE) was assessed using the Simpson Angus Scale (SAS), and weight and plasma levels of fasting blood glucose, lipids and prolactin were measured. Baseline and last visits differences were tested by paired t-test and Wilcoxon signed-rank test; ratings measured over time were analysed using repeated measures ANOVA. Participants' mean age was 30.3 (+/-6.6) years. Principal reason for switching to LAR was non-compliance (40.0%). Thirteen (52%) patients completed the trial. Over 6 months, there were significant reductions in total PANSS (p = 0.008) and CGI (p = 0.001) scores. There were significant increases in weight (p < 0.001), levels of plasma cholesterol and fasting glucose. LAR was effective in improving symptom severity within the first month of starting treatment. However, significant increases in weight and plasma levels of fasting glucose and cholesterol raise concern about metabolic side effects. PMID:20373474

Verma, Swapna; Subramaniam, Mythily; Abdin, Edimansyah; Sim, Kang; Su, Alex; Lee, Nelson; Chong, Siow Ann

2010-04-01

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78 FR 52777 - Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection...  

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...on Bioequivalence Recommendations for Risperidone Injection; Availability AGENCY: Food...industry entitled ``Draft Guidance on Risperidone.'' The guidance provides specific...new drug applications (ANDAs) for risperidone injection. DATES: Although you...

2013-08-26

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Efficacy of risperidone in children with disruptive behavioural disorders.  

UK PubMed Central (United Kingdom)

This study aims to review the evidence for the efficacy of risperidone in the treatment of disruptive behavioural disorders (DBDs) in children and adolescents. Established databases were searched using the terms 'Risperidone and efficacy and children' and 'Risperidone and efficacy and adolescents'. Randomised, double-blind controlled studies were retained for analysis. Janseen-Cilag was contacted to identify any unpublished studies. Quality of studies was measured using Jadad scores. Seven studies of 657 subjects with a mean age of 9.9 years (SD= 2.0) (range 4-18 years) were identified. Only one study was judged to use the highest quality of methodology according to the Jadad score. Patients with DBD who were treated with risperidone showed clinical improvement compared with placebo. Weight gain, somnolence and gastrointestinal complaints were common. Risperidone was found to be efficacious in reducing symptoms in children and adolescents with DBD. However, studies were mostly of short duration and had deficiencies in the descriptions of blinding and randomisation. Research using rigorous methodology examining the long-term outcomes of efficacy and safety are required to inform clinicians and families of the therapeutic benefits and risks of risperidone in this clinical population.

Duhig MJ; Saha S; Scott JG

2013-01-01

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Clinical experience with the long-acting injectable formulation of the atypical antipsychotic, risperidone.  

UK PubMed Central (United Kingdom)

BACKGROUND: To detail specific effects of long-acting risperidone on individuals with schizophrenia and their way of life in a series of four cases. METHOD: Four patients with schizophrenia were selected from four different psychiatric centres. Patients were established on an oral dose of risperidone (1-4 mg/day) for 2 weeks. Based on their oral dose, they then received intramuscular injections of 25 mg or 50 mg of long-acting risperidone every 2 weeks, which could be adjusted according to clinical response. Assessments of efficacy (Positive And Negative Syndrome Scale, Clinical Global Impression-Severity) and safety (Extrapyramidal Symptom Rating Scale) were made at intervals throughout a 1-year period. RESULTS: Patients demonstrated a variety of reasons for receiving a long-acting injectable antipsychotic drug, including insufficient control of symptoms, adverse events and convenience. After 1 year of treatment with long-acting risperidone, all patients showed improvements in their symptoms of schizophrenia over their original stable condition, and benefited from a considerable reduction or total disappearance of pre-existing extrapyramidal symptoms. Patients were more socially interactive, with no signs of sedation, fatigue, confusion, depression or anxiety, and none were considered to have relapsed or to require hospitalisation. Three of the four patients were considered to have had no signs of illness after 1 year, one of whom had returned to college and another to work. They demonstrate that patients can be switched from oral and depot medications without problems. There was little pain or discomfort and no inflammatory response experienced at the injection site. CONCLUSION: The cases demonstrate the suitability of long-acting risperidone in patients benefiting from long-term treatment and suggest its potential in all patients who are at risk of relapse.

Martin SD; Libretto SE; Pratt DJ; Brewin JS; Huq ZU; Saleh BT

2003-01-01

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Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects.  

UK PubMed Central (United Kingdom)

Objective: To examine onset of efficacy of two long-acting injectable atypical antipsychotics in markedly-to-severely ill schizophrenia subjects.Methods: This subgroup analysis included 292 subjects with baseline Clinical Global Impressions-Severity scores of markedly ill or worse from a 13-week, randomized, double-dummy noninferiority study (NCT00589914). Subjects received (a) paliperidone palmitate (PP; 234mg day 1 and 156mg day 8 [corresponding to 150 and 100 milligram equivalents of paliperidone, respectively], both administered in deltoid muscle, followed by once-monthly flexible dosing in deltoid or gluteal muscle) and risperidone long-acting injection (RLAI)-matched placebo injections or (b) RLAI (25mg, days 8 and 22; followed by biweekly flexible dosing) and PP-matched placebo injections. RLAI subjects received oral risperidone days 1-28; PP subjects received oral placebo. Because of RLAI's release profile, data through day 22 correspond to oral risperidone. Assessments included Positive and Negative Syndrome Scale (PANSS) and adverse event (AE) reports. Paired t-tests assessed within-group changes.Results: LS mean (SE) PANSS total scores improved significantly (both p<.001) with PP and oral risperidone by day 4 (-5.0 [0.6] and -3.4 [0.6], respectively) through day 22; and with PP and RLAI through end point (-21.5 [1.9] and -18.6 [1.9], respectively). The between-group difference was significant only at day 4 (p=.006). Proportion of subjects with a ?30% reduction in PANSS total score was not significantly different between the two groups at day 4 and significantly greater with paliperidone palmitate than oral risperidone at days 15 and 22 (26.1% versus 12.7%, p=.013; 41.6% versus 32.0%, p=.048, respectively).Most common AEs (?5% in either treatment group): headache (PP 6.3% and RLAI 14.0%), insomnia (10.6% and 10.7%), somnolence (7.8% and 1.3%), akathisia (7.0% and 5.3%), schizophrenia (8.4% and 5.3%), agitation (5.6% and 2.0%), and injection site pain (5.6% and 1.3%).Conclusions: Using the recommended dosing regimens for PP and RLAI, both PP and oral risperidone (used during RLAI initiation) improved symptoms of schizophrenia in markedly to severely ill subjects at days 4-22.

Fu DJ; Bossie CA; Sliwa JK; Ma YW; Alphs L

2013-02-01

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Paliperidone palmitate and risperidone long-acting injectable in subjects with schizophrenia recently treated with oral risperidone or other oral antipsychotics  

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Full Text Available Larry Alphs,1 Cynthia A Bossie,1 Jennifer Kern Sliwa,2 Dong-Jing Fu,1 Yi-Wen Ma,3 Joseph Hulihan11CNS Medical Affairs, 2Medical Information, Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 3Biostatistics, B&P, Janssen Research & Development LLC, Titusville, NJ, USABackground: This post hoc subgroup analysis of a randomized, double-blind trial evaluated the response to treatment with two long-acting injectable atypical antipsychotics, ie, paliperidone palmitate and risperidone long-acting injectable (RLAI), in subjects with schizophrenia experiencing clinically significant symptoms despite recent treatment with oral risperidone only or other oral antipsychotics.Methods: Adult subjects were eligible for the 13-week, double-blind, double-dummy trial (NCT00589914) if they had an established diagnosis of schizophrenia for at least one year and a Positive and Negative Syndrome Scale (PANSS) total score of 60–120 inclusive at screening. Subjects received either paliperidone palmitate (234 mg, day 1; 156 mg, day 8; then once-monthly flexible dosing) or RLAI (25–50 mg biweekly, with oral risperidone supplementation on days 1–28), plus matched placebo injections/tablets.Results: This post hoc analysis reports data on 747 subjects who, within 2 weeks of starting double-blind study medication, had reportedly received oral risperidone only (paliperidone palmitate group, n = 126; RLAI group, n = 107), other oral antipsychotics (paliperidone palmitate group, n = 199; RLAI group, n = 203), or no antipsychotic (paliperidone palmitate group, n = 56; RLAI group, n = 56). Mean PANSS total scores improved significantly at end point across all subgroups (mean change from baseline ranged from ?17.5 to ?19.5, all P < 0.0001). Clinical Global Impression-Severity and Personal and Social Performance scale measures also significantly improved from baseline (all P < 0.0001).Conclusion: Treatment with paliperidone palmitate or RLAI resulted in a significant reduction in the symptoms of schizophrenia irrespective of previous recent treatment with oral risperidone only or other oral antipsychotics. For subjects who had previously received oral risperidone only, the difference in formulation was the main change in the intervention because the molecule delivered remained the same or similar. These data support the contribution of a long-acting formulation to improving the treatment response and suggest that nonadherence may be a significant contributor to inadequate efficacy of oral formulations in subjects with schizophrenia.Keywords: paliperidone palmitate, risperidone long-acting injection, schizophrenia

Alphs L; Bossie CA; Sliwa JK; Fu DJ; Ma YW; Hulihan J

2013-01-01

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Risperidone long-acting injection: pharmacokinetics following administration in deltoid versus gluteal muscle in schizophrenic patients.  

UK PubMed Central (United Kingdom)

Long-acting injectable (LAI) risperidone for intramuscular injection into the gluteal muscle every 2 weeks is approved for schizophrenia. The deltoid muscle provides a more accessible injection site and could therefore facilitate patient acceptance of an injectable medication. Two studies in chronic schizophrenic subjects evaluated the pharmacokinetics and tolerability of LAI risperidone administered into the deltoid muscle. The pharmacokinetics following deltoid injection and bioequivalence between deltoid and gluteal administration were assessed in an open-label, single-dose, crossover, fully powered bioavailability study. Tolerability and safety of deltoid LAI risperidone were investigated in an open-label multiple-dose study in subjects who were previously being treated with gluteal injections of LAI risperidone. Patients received 4 sequential intramuscular injections of LAI risperidone, administered every 2 weeks into the deltoid muscle. Deltoid and gluteal injections of LAI risperidone were shown to be bioequivalent at equal doses with respect to peak and total plasma exposure and exhibited dose-proportional pharmacokinetics, independent of injection site. In addition, deltoid injection was safe and well tolerated. Injection of LAI risperidone into the deltoid muscle can be considered an alternative route of administration, because deltoid and gluteal injections are interchangeable in terms of drug exposure, with no additional safety or tolerability issues.

Thyssen A; Rusch S; Herben V; Quiroz J; Mannaert E

2010-09-01

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Risperidone long-acting injection: pharmacokinetics following administration in deltoid versus gluteal muscle in schizophrenic patients.  

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Long-acting injectable (LAI) risperidone for intramuscular injection into the gluteal muscle every 2 weeks is approved for schizophrenia. The deltoid muscle provides a more accessible injection site and could therefore facilitate patient acceptance of an injectable medication. Two studies in chronic schizophrenic subjects evaluated the pharmacokinetics and tolerability of LAI risperidone administered into the deltoid muscle. The pharmacokinetics following deltoid injection and bioequivalence between deltoid and gluteal administration were assessed in an open-label, single-dose, crossover, fully powered bioavailability study. Tolerability and safety of deltoid LAI risperidone were investigated in an open-label multiple-dose study in subjects who were previously being treated with gluteal injections of LAI risperidone. Patients received 4 sequential intramuscular injections of LAI risperidone, administered every 2 weeks into the deltoid muscle. Deltoid and gluteal injections of LAI risperidone were shown to be bioequivalent at equal doses with respect to peak and total plasma exposure and exhibited dose-proportional pharmacokinetics, independent of injection site. In addition, deltoid injection was safe and well tolerated. Injection of LAI risperidone into the deltoid muscle can be considered an alternative route of administration, because deltoid and gluteal injections are interchangeable in terms of drug exposure, with no additional safety or tolerability issues. PMID:20097933

Thyssen, An; Rusch, Sarah; Herben, Virginie; Quiroz, Jorge; Mannaert, Erik

2010-01-23

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[Rationale for the use of long-acting injectable risperidone: a survey of French psychiatrists].  

UK PubMed Central (United Kingdom)

INTRODUCTION: Poor adherence is a major concern for the effectiveness of antipsychotic treatment in patients with schizophrenia. In particular, compliance problems constitute a poor prognostic factor for this disorder due to increasing risk of relapse and hospitalization. As maintaining antipsychotic therapy is a key element to prevent relapse, the use of depot preparations is therefore considered as a useful therapeutic option since it prevents covert non-adherence. When compared with neuroleptics, novel antipsychotic agents are also better tolerated by patients. In this study, the rationale for the use of long-acting injectable risperidone combining the benefits of novel antipsychotic agent and depot preparation is investigated in patients with psychosis. A secondary objective of the study is to assess the level of therapeutic adherence and to confirm the role of its key determinants. METHODS: An observational survey assessed the time and reasons to switch to long-acting risperidone in 1887 hospitalized and community-dwelling patients with psychosis (61.6% schizophrenia) defined by the CIM-10, and treated by 399 psychiatrists with oral risperidone for a recent acute episode. In a cross-sectional study performed under real-life conditions, treatment adherence was assessed by patients themselves using the Medication Adherence Questionnaire (MAQ) and therapeutic alliance was assessed by the 4-Point Alliance Scale (4-PAS). Psychiatrists assessed treatment acceptance using the Compliance Rating Scale (CRS), disease severity using the CGI, and insight using the G12 item from the Positive and Negative Syndrome Scale (PANSS). RESULTS: In the population studied, disorder severity (CGI) was defined as "moderate to marked" in 67.7% and "severe or among the most severe" for 21.1%. Insight (PANSS G12) was defined as normal for 36.6% of patients, moderate for 34.8% and low for 28.6%. The mean time to medication switch was 8 weeks after the start of care of the acute episode. The two main reasons to start the long-acting injectable risperidone were related to non-compliance with oral antipsychotic treatment (92.4%) and intention to improve efficacy (86.4%). Maintenance of a good therapeutic alliance (70.3%) and treatment tolerability (54.6%) were also often cited. For psychiatrists, 41.6% of patients demonstrated reticence or active reluctance to treatment. Therapeutic compliance (MAQ) for oral medication before the long-acting injectable risperidone was started was estimated as "mild" for 53.1% (n=852) of patients. Poor adherence strongly correlated with low insight (P<0.001) and with a disorder estimated as "severe" (P<0.001). Therapeutic alliance was higher for patients with a better level of treatment acceptance assessed by psychiatrists (P<0.001) and with a higher compliance with MAQ estimated by patients (P<0.001). Therapeutic alliance was lower for patients with a disorder defined as "severe" (P<0.001) and with poor insight (P<0.001). CONCLUSION: In this French survey, the two main reasons for psychiatrists to start long-acting injectable risperidone were related to non-compliance with oral antipsychotic treatment and with the desire to improve therapeutic efficacy. In accordance with results of previous studies, insight and therapeutic alliance were found to be associated with poor compliance. The main goal in the treatment of psychotic disorders is to obtain a functional remission and to reduce the incidence of relapse. Considering its improved efficiency and reduced dependence on patient compliance, the use of long-acting injectable risperidone is recommended as a useful therapeutic strategy.

Misdrahi D; Delgado A; Bouju S; Comet D; Chiariny JF

2013-05-01

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Paliperidone palmitate and risperidone long-acting injectable in subjects with schizophrenia recently treated with oral risperidone or other oral antipsychotics.  

UK PubMed Central (United Kingdom)

BACKGROUND: This post hoc subgroup analysis of a randomized, double-blind trial evaluated the response to treatment with two long-acting injectable atypical antipsychotics, ie, paliperidone palmitate and risperidone long-acting injectable (RLAI), in subjects with schizophrenia experiencing clinically significant symptoms despite recent treatment with oral risperidone only or other oral antipsychotics. METHODS: Adult subjects were eligible for the 13-week, double-blind, double-dummy trial (NCT00589914) if they had an established diagnosis of schizophrenia for at least one year and a Positive and Negative Syndrome Scale (PANSS) total score of 60-120 inclusive at screening. Subjects received either paliperidone palmitate (234 mg, day 1; 156 mg, day 8; then once-monthly flexible dosing) or RLAI (25-50 mg biweekly, with oral risperidone supplementation on days 1-28), plus matched placebo injections/tablets. RESULTS: This post hoc analysis reports data on 747 subjects who, within 2 weeks of starting double-blind study medication, had reportedly received oral risperidone only (paliperidone palmitate group, n = 126; RLAI group, n = 107), other oral antipsychotics (paliperidone palmitate group, n = 199; RLAI group, n = 203), or no antipsychotic (paliperidone palmitate group, n = 56; RLAI group, n = 56). Mean PANSS total scores improved significantly at end point across all subgroups (mean change from baseline ranged from -17.5 to -19.5, all P < 0.0001). Clinical Global Impression-Severity and Personal and Social Performance scale measures also significantly improved from baseline (all P < 0.0001). CONCLUSION: Treatment with paliperidone palmitate or RLAI resulted in a significant reduction in the symptoms of schizophrenia irrespective of previous recent treatment with oral risperidone only or other oral antipsychotics. For subjects who had previously received oral risperidone only, the difference in formulation was the main change in the intervention because the molecule delivered remained the same or similar. These data support the contribution of a long-acting formulation to improving the treatment response and suggest that nonadherence may be a significant contributor to inadequate efficacy of oral formulations in subjects with schizophrenia.

Alphs L; Bossie CA; Sliwa JK; Fu DJ; Ma YW; Hulihan J

2013-01-01

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Patient perspectives on use of long-acting antipsychotics in bipolar disorder: focus on risperidone injection  

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Full Text Available L Samalin, T Charpeaud, O Lorabi, PM LlorcaCentre Hospitalier Universitaire, Clermont-Ferrand, FranceAbstract: In the last few years, oral second-generation antipsychotics have demonstrated mood-stabilizing properties and are now widely used in the treatment of bipolar disorder. Unfortunately, treatment of this chronic and complex illness is hampered with poor adherence on the part of patients. Long-acting injectable formulations of second-generation antipsychotics could combine the effect of oral second-generation antipsychotics in patients with bipolar disorder and the benefits of depot formulation with the assurance of steady medication delivery and thereby improve adherence. In this context, the efficacy and tolerance of risperidone long-acting injection (RLAI) for maintenance treatment in patients with bipolar disorder is assessed. The relevant studies found RLAI to be effective in preventive treatment of manic but not depressive recurrences in bipolar patients, with good tolerance. RLAI appeared to be particularly suitable for patients with known poor adherence to treatment or severe bipolar disorder (such as patients who relapse frequently). Lastly, if RLAI, unlike the first-generation antipsychotics, does not induce depressive symptoms, the different studies do not enable us to consider its use in monotherapy in the preventive treatment of patients with depressive polarity. Long-acting second-generation antipsychotics in bipolar patients are therefore associated with long-term benefits, but their use in clinical practice needs to be improved.Keywords: bipolar disorder, depot antipsychotics, long-acting risperidone injection, ­maintenance treatment, compliance

L Samalin; T Charpeaud; O Lorabi; et al

2010-01-01

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Efficacy and safety of combination of risperidone and haloperidol with divalproate in patients with acute mania.  

UK PubMed Central (United Kingdom)

OBJECTIVE: The current study evaluated the efficacy and safety of risperidone and haloperidol as an adjunctive agent in combination with divalproate in patients with an episode of acute mania. METHODS: This 6-week randomized, single-blind study was conducted in psychiatric wards of a mental hospital. A total of 41 patients were randomly assigned to the risperidone (risperidone plus divalproate) or haloperidol groups (haloperidol plus divalproate). Efficacy was assessed by changes in symptom rating scales [Young Mania Rating Scale (YMRS), Brief Psychiatric Rating Scale (BPRS), and Clinical Global Impression (CGI) scores]. Safety and tolerability were assessed by monitoring the Extrapyramidal Symptom Rating Scale (ESRS) and Hamilton Rating Scale for depression. RESULTS: Mean doses at baseline, and at weeks 4 and 6 were 3.77, 4.95 and 5.00 mg/day of risperidone and 5.89, 9.95 and 8.58 mg/day of haloperidol, respectively. Risperidone was shown to have significant anti-manic effects which was observed as early as week 1, following start of treatment. The BPRS scores were in favor of risperidone at week 2. Patients receiving risperidone exhibited significant greater global improvement on the CGI, as early as week 2 and over the entire treatment period, than haloperidol after 4 weeks of treatment. The ESRS at endpoint were significantly higher in the haloperidol patients. CONCLUSIONS: Risperidone plus divalproate was more efficacious than haloperidol plus divalproate for treatment of acute mania, and was well tolerated due to its evidence showing rapid anti-manic action, effective and sustained control of manic and psychotic symptoms and a favorable safety and tolerability profile in acute mania.

Ouyang WC; Hsu MC; Yeh IN; Kuo CC

2012-09-01

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The cost associated with administering risperidone long-acting injections in the Australian community  

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Full Text Available Abstract Background Risperidone long-acting injection (LAI) is mostly administered twice weekly to people with schizophrenia by nurses at community mental health centres (CMHC) or through mobile outreach visits. This study estimates the cost of resource utilisation associated with the administration of risperidone LAI and the potential savings from substituting two-weekly injections with a longer interval product of therapeutic equivalence. Methods A survey of mental health staff overseeing the administration of risperidone LAI at 253 distinct Australian CMHCs was undertaken in November 2009. For the two-week period prior to the survey, respondents were asked questions on injection time (and related tasks) and, for mobile outreach visits, distance and time travelled as well as reduction in visits. Results were stratified by Australian Standard Geographical Classification (ASGC) region. Resource use was quantified and valued in Australian dollars. Results Results are derived from 74 CMHCs, representing approximately 26% of the national average risperidone LAI unit two-week sales. Stratified average injection time (including related tasks) for risperidone LAI ranged from 18-29 minutes, with a national average of 20.12 minutes. For mobile outreach visits, average distance per patient ranged from 19.4 to 55.5 km for One Staff Visits and 15.2 to 218.1 km for More Than One Staff Visits, and average time travelled ranged from 34.1 to 54.5 minutes for One Staff Visits and 29.2 to 136.3 minutes for More Than One Staff visits. The upper range consistently reflected greater resource utilisation in rural areas compared to urban areas. If administration of risperidone LAI had not been required, 20% fewer mobile outreach visits would have occurred. Conclusions The national average saving per two-weekly risperidone long-acting injection avoided is $75.14. In 2009 in Australia, this would have saved ~$11 million for injection administration costs alone if all patients taking two-weekly risperidone LAI had instead been treated with a therapeutically equivalent long-acting injectable antipsychotic requiring one less injection per month.

Dalton Andrew; Lambert Tim; Schrover Rudolf; Hertel Judy; Smith Dell

2011-01-01

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Maintenance therapy with once-monthly administration of long-acting injectable risperidone in patients with schizophrenia or schizoaffective disorder: a pilot study of an extended dosing interval  

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Full Text Available Abstract Background Several clinical studies have established the efficacy, safety, and tolerability of long-acting risperidone administered once every 2 weeks in patients with schizophrenia or schizoaffective disorder. This report evaluates preliminary efficacy, safety, tolerability, and pharmacokinetic data for a novel (once-monthly) administration of long-acting injectable risperidone 50 mg in patients with schizophrenia or schizoaffective disorder. Methods Clinically stable patients participated in a 1-year, open-label, single-arm, multicenter pilot study. During the 4-week lead-in phase, patients received long-acting risperidone 50 mg injections every 2 weeks, with 2 weeks of oral risperidone supplementation. Injections of long-acting risperidone 50 mg every 4 weeks followed for up to 48 weeks, without oral supplementation. The primary endpoint was relapse; other assessments included PANSS, CGI-S, adverse event reports, and determination of risperidone and 9-hydroxyrisperidone plasma concentrations. Results Twelve patients in the intent-to-treat population (n = 67) met relapse criteria (17.9%). Relapse risk at 1 year was estimated as 22.4%. Non-statistically significant improvements in symptoms (PANSS) and clinical status (CGI-S) at endpoint were observed. The most common adverse events included schizophrenia aggravated not otherwise specified (19.5%), anxiety (16.1%), insomnia (16.1%), and headache (11.5%). There were no unexpected safety and tolerability findings. Mean plasma concentrations for risperidone and 9-hydroxyrisperidone were generally stable during the study. Conclusion Once-monthly dosing of long-acting risperidone was well tolerated, associated with a relatively low relapse rate (similar to that reported with other antipsychotics), and maintained the clinically stable baseline status of most patients. Although the results suggest that some symptomatically stable patients with schizophrenia or schizoaffective disorder might be safely managed with long-acting risperidone 50 mg once monthly, these findings alone do not identify which patients will have a sufficient therapeutic benefit nor do they quantify comparative effects of standard and altered dosing. Study limitations (the open-label pilot study design, small sample size, and lack of a concurrent biweekly treatment arm) prevent broad interpretations and extrapolations of results. Controlled studies would be required to support a recommendation for alternative dosing regimens.

Gharabawi Georges M; Gearhart Natalie C; Lasser Robert A; Mahmoud Ramy A; Zhu Young; Mannaert Erik; Naessens Ineke; Bossie Cynthia A; Kujawa Mary; Simpson George M

2007-01-01

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Long-acting injectable risperidone in partially adherent and nonadherent patients with schizophrenia  

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Full Text Available Mário Rodrigues Louzã1, Helio Elkis1, Sandra Ruschel2, Irismar Reis de Oliveira3, Rodrigo Affonseca Bressan4, Paulo Belmonte-de-Abreu5, Hamilton Grabowski6, José Carlos Appolinário71Universidade de São Paulo, São Paulo; 2Hospital Mário Kroeff, Rio de Janeiro; 3Universidade Federal da Bahia, Salvador; 4Universidade Federal de São Paulo, São Paulo; 5Universidade Federal do Rio Grande do Sul, Porto Alegre; 6Hospital Bom Retiro, Curitiba; 7Janssen-Cilag Farmaceutica Ltda, São Paulo, BrazilBackground: Long-acting injectable antipsychotics may improve medication adherence, thereby improving overall treatment effectiveness. This study aimed to evaluate the effectiveness, safety, and tolerability of risperidone long-acting injection in schizophrenic patients switched from oral antipsychotic medication.Methods: In a 12-month, multicenter, open-label, noncomparative study, symptomatically stable patients on oral antipsychotic medication with poor treatment adherence during the previous 12 months received intramuscular injections of risperidone long-acting injection (25 mg starting dose) every 2 weeks. The primary endpoint was the change in Positive and Negative Syndrome Scale (PANSS) total score.Results: Of the 60 patients who were screened, 53 received at least one injection (safety population), and 51 provided at least one postbaseline assessment. Mean PANSS total scores improved significantly throughout the study and at endpoint. Significant improvements were also observed in Clinical Global Impression of Severity, Personal and Social Performance, and Drug Attitude Inventory scales. Risperidone long-acting injection was safe and well-tolerated. Severity of movement disorders on the Extrapyramidal Symptom Rating Scale was reduced significantly. The most frequently reported adverse events were insomnia (22.6%), increased prolactin (17.0%), and weight gain (13.2%).Conclusion: Risperidone long-acting injection was associated with significant symptomatic improvements in stable patients with schizophrenia following a switch from previous antipsychotic medications.Keywords: patient compliance, adherence, risperidone, delayed-action preparations, schizophrenia

Louzã M; Elkis H; Ruschel S; de Oliveira IR; Bressan RA; Belmonte-de-Abreu P; Grabowski H; Appolinário JC

2011-01-01

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A pilot study of the safety and efficacy of amisulpride and risperidone in elderly psychotic patients.  

UK PubMed Central (United Kingdom)

OBJECTIVE: The primary objective of this randomised, active-controlled, parallel group, double-blind study was to evaluate the tolerability of treatment with either amisulpride or risperidone in elderly patients with schizophrenia aged over 65 years; evaluation of efficacy was a secondary objective. METHODS: The study included patients of either sex aged 65 years or older fulfilling DSM IV-diagnostic criteria for psychotic disorders and who presented psychotic symptoms severe enough to require antipsychotic medication. Subjects were randomly allocated to a flexible dose of either amisulpride (100-400mg/day) or risperidone (1-4 mg/day) for six weeks following a three- to six-day placebo wash-out period. Safety assessment involved adverse event reporting, physical examination, blood pressure, heart rate and ECG monitoring, and laboratory tests. Extrapyramidal symptoms were evaluated with the Simpson-Angus Scale, Barnes Akathisia Scale and the AIMS. Efficacy parameters were changes in score on the PANSS, BPRS, CDS and MMSE scores. RESULTS: Thirty-eight patients were randomised, 25 to amisulpride and 13 to risperidone. A total of 26 adverse events were experienced by 10 patients in the amisulpride group and five patients in the risperidone group. One patient in each group discontinued the study due to the emergence of a movement disorder. Changes in scores on the three measures of extrapyramidal symptoms were similar in the two groups. The PANSS total score decreased by 27.8% in the amisulpride group and by 29% in the risperidone group between inclusion and study end. CONCLUSION: Amisulpride and risperidone are generally well tolerated in elderly patients with schizophrenia. Both drugs appeared to be efficacious in this study population, with no differences in efficacy being observed. However, the sample size was too low to reveal potential inter-group differences. Both these atypical antipsychotics thus appear to be suitable for the treatment of schizophrenia in the elderly.

Riedel M; Eich FX; Möller HJ

2009-04-01

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Emerging treatments in the management of bipolar disorder – focus on risperidone long acting injection  

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Full Text Available Wissam El-Hage1, Simon A Surguladze21Inserm U930 ERL CNRS 3106, Université François Rabelais and Clinique Psychiatrique Universitaire, CHRU de Tours, Tours, France; 2Institute of Psychiatry, King’s College London, UKAbstract: Bipolar disorder is a life-long psychiatric illness characterized by a high frequency of relapses and substantial societal costs. Almost half of the patients are prescribed second generation antipsychotics for treatment of manic states, or as the maintenance therapy. ­Risperidone long acting injection (RLAI) as a monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder was approved by Food and Drug Administration (FDA) in United States in May 2009. In this review we will consider the aspects of pharmacology, pharmacokinetics, metabolism, safety and tolerability, and clinical trials focusing on the efficacy of RLAI in bipolar disorder. The patients’ perspective and attitudes to long-acting injections will also be discussed.Keywords: second generation, antipsychotics, patient attitudes, lithium, valproate, monotherapy

Wissam El-Hage; Simon A Surguladze

2010-01-01

 
 
 
 
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Histamine H4 receptor polymorphism: a potential predictor of risperidone efficacy.  

UK PubMed Central (United Kingdom)

Histamine interacts with histamine H4 receptor (HRH4) to impact antipsychotic response. Pharmacogenetic information about this receptor could therefore be useful in developing individualized therapy. The aim of this investigation was to clarify whether polymorphisms at human HRH4 gene alter risperidone efficacy. We genotyped 5 tag-single nucleotide polymorphisms of the HRH4 gene and analyzed their association with the reduction in Positive and Negative Syndrome Scale (PANSS) scores in a group of 113 Chinese Han patients with schizophrenia who were following an 8-week period of risperidone monotherapy. Using ?(2), analysis of variance, haplotype, and receiver operating characteristics analysis, we found that HRH4 common variant rs4483927 is significantly associated with risperidone efficacy and that its TT genotype predicts poor therapeutic response both on the positive, negative, and general subscales and on the total scale of PANSS scores (P = 0.017, 0.019, 0.021, and 0.002, respectively, in analysis of variance). Our results provide the first evidence that an HRH4 polymorphism may be a molecular marker for the prediction of risperidone efficacy and suggest novel pharmacologic links between HRH4 gene and treatment of schizophrenia.

Wei Z; Wang L; Yu T; Wang Y; Sun L; Wang T; Huo R; Li Y; Wu X; Qin S; Xu Y; Feng G; He L; Xing Q

2013-04-01

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Effect of the addition of aripiprazole on hyperprolactinemia associated with risperidone long-acting injection.  

Science.gov (United States)

We sought to assess the effect of the addition of a fixed dose of 5 mg daily of aripiprazole on hyperprolactinemia induced by risperidone long-acting injectable (RLAI) treatment in patients with chronic psychoses and the adverse events related to the addition of aripiprazole and its impact on the disease. This is an open uncontrolled clinical trial with 13 patients with a severe mental disorder (schizophrenia and other unspecified psychoses) treated with RLAI and with increased serum prolactin levels. Subjects received the addition of a fixed dose of 5 mg daily of aripiprazole for 3 months. The main efficacy outcome was the change in serum prolactin levels after 3 months of treatment. Twelve of the 13 patients showed a decrease in serum prolactin levels (81 ± 46 ?g/L at baseline vs 42 ± 21 ?g/L at month 1, P < 0.001, 52% mean reduction). In 2 patients, prolactin levels reverted normality. In 8 patients who continued treatment for 2 more months, the decrease in prolactin levels was maintained. Symptoms associated with hyperprolactinemia improved, and no worsening of the Clinical Global Impression Scale scores was observed. The adverse effects due to the addition of aripiprazole were mild and transient. The addition of aripiprazole 5 mg daily to RLAI was associated with a significant decrease in hyperprolactinemia levels and no major additional toxicity in patients with chronic psychosis. PMID:23775053

Trives, Mehdi Ziadi; Llácer, José-María Bonete; Escudero, Miguel-Alfonso García; Pastor, Carlos Jeremías Martínez

2013-08-01

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Quetiapine versus risperidone in elderly patients with behavioural and psychological symptoms of dementia: efficacy, safety and cognitive function.  

UK PubMed Central (United Kingdom)

OBJECTIVE: In this study we directly compared the efficacy and tolerability of the atypical antipsychotics quetiapine and risperidone in elderly patients with dementia and symptoms of disturbed perception, thought content, mood or behaviour (behavioural and psychological symptoms of dementia-BPSD). METHODS: We conducted an 8-week, rater-blinded, randomised study of 72 outpatients (55-85 years) with BPSD (assessed by NPI baseline score), who received flexibly-dosed quetiapine (50-400 mg/day) or risperidone (0.5-2 mg/day). Primary efficacy measure: Neuropsychiatric Inventory (NPI) Parts 1 and 2; secondary efficacy measures: Clinical Global Impression (CGI), Cohen-Mansfield Agitation Inventory (CMAI), Mini-Mental State Examination (MMSE), Age-adjusted concentration test (AKT). Safety evaluations included the incidence of extrapyramidal symptoms (EPS) and adverse events (AEs). RESULTS: Sixty-nine of 72 patients were evaluable for efficacy (72 were evaluated for safety), 4 patients discontinued (3 due to AEs: quetiapine 2, risperidone 1; 1 lost to follow-up). Sixty-five patients received quetiapine (n=34; mean dose 77+/-40 mg/day) or risperidone (n=31; mean dose 0.9+/-0.3 mg/day). There was no significant difference between treatments on NPI scores; within treatment groups, NPI scores decreased significantly from baseline to Week 8 (Prisperidone arm 71.0%) experienced clinical improvement (CGI-Improvement scores); both agents reduced agitation (CMAI scores); and there was no cognitive impairment (MMSE and AKT scores). There were no significant differences between treatments in any safety measures, including EPS. Four patients experienced serious AEs (quetiapine arm 3; risperidone arm 1); none were considered treatment-related by the study investigator. There were no cerebrovascular AEs or deaths. CONCLUSIONS: Quetiapine or risperidone, at low doses, were equally effective and generally well tolerated (including no cognitive impairment) in the treatment of BPSD in elderly patients.

Rainer M; Haushofer M; Pfolz H; Struhal C; Wick W

2007-09-01

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[Paliperidone, risperidone].  

UK PubMed Central (United Kingdom)

Risperidone, a serotonin-dopamine antagonist, is effective in preventing delusions and hallucinations by D2 receptor antagonism and treating negative symptoms by 5-HT2A receptor antagonism. It is less likely to produce extrapyramidal symptoms than conventional antipsychotics, enabling safe drug therapy for schizophrenia. Paliperidone, based on 9OH-risperidone(major metabolite of risperidone), was developed to make the best use of the high therapeutic efficacy of Risperdal and enable continued treatment with lower prevalence of adverse events. Its mechanism of action as an extended-release tablet ensures slow release of the active ingredient, contributing to the lower prevalence of adverse events. With these pharmacological characteristics in mind, the two drugs can serve as safe and effective drug therapy.

Takeuchi K; Sanjo K; Sakai A

2013-04-01

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Efficacy and safety of risperidone oral solution in agitation associated with dementia in the elderly  

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Full Text Available BACKGROUND: Behavioral and psychological symptoms in dementia (BPSD) contribute to caregiver burden and institutionalization of elderly. Neuroleptics are prescribed to control agitation. Side effects of typical neuroleptics are harmful, making atypical neuroleptics an indication. OBJECTIVES: To evaluate efficacy and tolerability of risperidone oral solution (ROS) given once daily to demented elderly outpatients with BPSD (agitation). METHOD: Patients (n=26), 76.35±8.63 years, Diagnostic and Statistical Manual of Mental Disorders 4th ed. (DSM-IV) criteria for dementia. RSO was given, starting dose of 0.25 mg and increments of 0.25 mg every week. Mini-Mental State Examination (MMSE) assessed cognitive status, Behavioral and Emotional Activities Manifested in Dementia (BEAM-D) and Clinical Global Impression (CGI) measured BPSD, Extrapiramidal Symptom Rating Scale (ESRS) evaluated extrapyramidal symptoms. Cardiovascular side effects were evaluated clinically. RESULTS: There was a 26% reduction in agitation and no cardiovascular side effects in the range from 1.0 to 1.25 mg. Side effects were more prevalent above 2.5 mg. CONCLUSION: Risperidone oral solution improved agitation with good tolerability from 0.5 to 1.25 mg. A single dose with increments of 0.25 mg may be more acceptable to patients and caregivers.

Laks Jerson; Engelhardt Eliasz; Marinho Valeska; Rozenthal Marcia; Souza Fernando de Castro e; Bacaltchuk Josué; Stoppe Jr. Alberto; Ferreira R.C.R.; Bottino Cassio; Scalco Mônica

2001-01-01

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An open-label, multicenter evaluation of the long-term safety and efficacy of risperidone in adolescents with schizophrenia  

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Full Text Available Abstract Background Data on the long-term efficacy, safety, and tolerability of risperidone in adolescents with schizophrenia are limited. The objective of this study was to evaluate the efficacy and safety of maintenance risperidone treatment in adolescents with schizophrenia. Methods This open-label study of adolescents aged 13 to 17 years with schizophrenia was a single extension study of two short-term double-blind risperidone studies and also enrolled subjects directly in open-label risperidone treatment. The risperidone dose was flexible and ranged from 2 to 6 mg/day. Most subjects enrolled for 6 months; a subset enrolled for 12 months. Assessment tools included the Positive and Negative Syndrome Scale total and factor scores, Clinical Global Impressions, Children’s Global Assessment Scale, adverse event (AE) monitoring, vital signs, laboratory testing, and extrapyramidal symptom rating scales. Results A total of 390 subjects were enrolled; 48 subjects had received placebo in a previous double-blind study; 292 subjects had received risperidone as part of their participation in one of two previous controlled studies; and 50 subjects were enrolled directly for this study. A total of 279 subjects enrolled for 6 months of treatment, and 111 subjects enrolled for 12 months of treatment. Overall, 264 (67.7%) subjects completed this study: 209 of the 279 subjects (75%) in the 6-month group and 55 of the 111 subjects (50%) in the 12-month group. The median mode dose was 3.8 mg/day. At 6 months, all three groups experienced improvement from open-label baseline in symptoms of schizophrenia as well as general assessments of global functioning. Improvements were generally maintained for the duration of treatment. The most common AEs (?10% of subjects) were somnolence, headache, weight increase, hypertonia, insomnia, tremor, and psychosis. Potentially prolactin-related AEs (PPAEs) were reported by 36 (9%) subjects. The AE profile in this study was qualitatively similar to those of other studies in adult subjects with schizophrenia and in other psychiatric studies of risperidone in pediatric populations. Conclusions Risperidone maintenance treatment in adolescents over 6 to 12 months was well tolerated, consistent with related studies in this clinical population, and associated with continued efficacy. Clinical trials ClinicalTrials.gov registration number: NCT00246285 http://clinicaltrials.gov/ct2/show/NCT00246285?term=NCT00246285&rank=1

Pandina Gahan; Kushner Stuart; Karcher Keith; Haas Magali

2012-01-01

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Long-term safety and efficacy of risperidone for the treatment of disruptive behavior disorders in children with subaverage IQs.  

UK PubMed Central (United Kingdom)

OBJECTIVE: The objective of this study was to investigate the long-term safety and efficacy of risperidone in disruptive behavior disorders in children with subaverage IQs. Disruptive behavior disorders were defined as oppositional defiant disorder, disruptive behavior disorder, and conduct disorder as per the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria. METHODS: This was a 48-week open-label (OL) extension study of risperidone in 77 children diagnosed with a disruptive behavior disorder, and either borderline intellectual function or mild or moderate mental retardation who had participated in a previous 6-week, double-blind (DB) study and completed at least 2 weeks of DB therapy. Children, aged 5 to 12 years inclusive, who had: 1) a DSM-IV Axis I diagnosis of conduct disorder, oppositional defiant disorder, or disruptive behavior disorder- not otherwise specified; 2) a parent-assessed rating of > or =24 in the Conduct Problem Subscale of the Nisonger-Child Behavior Rating Form(28); 3) a DSM-IV Axis II diagnosis of mild or moderate mental retardation or borderline intellectual functioning with an IQ > or =36 and < or =84; and 4) a score of < or =84 on the Vineland Adaptive Behavior Scale. Participants received oral solution risperidone given at a once daily dose of between 0.02 and 0.06 mg/kg for a maximum of 48 weeks. Participants in the DB study who had been randomized would have had a maximum of 54 weeks of risperidone therapy. Study visits were scheduled at entry, weekly for the first month, and monthly for the remaining 11 months. RESULTS: Baseline scores on the conduct problem subscale at the start of the previous DB study were similar for both treatment groups: mean values of 33.5 and 33.3 were recorded for placebo- and risperidone-treated participants, respectively. At the time of the OL baseline visit, mean Conduct Problem Subscale scores were lower in those who had been treated with risperidone than in those who remained risperidone-naïve (17.5 and 26.1, respectively). Within 1 week of receiving daily risperidone therapy (mean daily dose: 1.38 mg), those participants who had been risperidone-naïve at OL entry showed a rapid improvement in the Conduct Problem Subscale score. At the week 1 assessment, the mean change from baseline for those who had been risperidone-naïve at OL entry was similar in magnitude to the change from DB baseline recorded for participants who had received risperidone in the DB study. This mean improvement was sustained in both groups throughout the remainder of the OL study. At study endpoint, those participants who had been risperidone-naïve at OL entry experienced a highly significant mean decrease from OL baseline in the mean Conduct Problem Subscale score of 10.6 +/- 2.18. The response to risperidone in the OL trial remained stable in those participants who had been treated with risperidone in the previous DB trial; in this group, the mean change at study endpoint from OL baseline was a nonsignificant decrease of 1.26 +/- 1.45. At DB baseline, 68% of participants had a Clinical Global Impression assessment rated as marked, severe, or extremely severe. By DB study endpoint, only 17% of participants (15% of whom had received placebo and 19% of whom had been treated with risperidone in the previous study) had this severe an assessment; 63% of participants had symptoms rated as either none, very mild, or mild. Similarly, highly significant decreases from baseline in the Vineland Adaptive Behavior Scale rating of the most troublesome symptom (often identified as either aggression (hitting, fighting, or temper tantrums) were observed by study endpoint after 48 weeks of risperidone therapy. For those participants who had received placebo in the previous study, a mean decrease of 47.1 +/- 4.87 mm from a DB baseline of 79.4 +/- 2.69 mm was observed. In those who had received risperidone, a mean decrease of 43.5 +/- 4.57 mm from a DB baseline of 79.3 +/- 3.66 mm was observed. Five subgroup analyses of the primary efficacy outcome were

Turgay A; Binder C; Snyder R; Fisman S

2002-09-01

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Long-term remission in schizophrenia and schizoaffective disorder: results from the risperidone long-acting injectable versus quetiapine relapse prevention trial (ConstaTRE)  

Science.gov (United States)

Objective: The objective of this study was to report the long-term remission results from the ConstaTRE relapse prevention trial, in which clinically stable adults with schizophrenia or schizoaffective disorder treated with oral risperidone, olanzapine, or oral conventional antipsychotics were randomized to risperidone long-acting injectable (RLAI) or oral quetiapine, dosed according to package-insert recommendations. Methods: In the ConstaTRE trial, efficacy and tolerability were recorded for up to 24 months. This post hoc analysis presents remission data, defined, according to the Schizophrenia Working Group criteria, as achieving and maintaining eight core symptoms of schizophrenia that are mild or less over 6 months. Additional secondary outcome measures are also presented. Results: A total of 710 patients were randomized to RLAI (n = 355) or quetiapine (n = 355). Mean mode ± standard deviation (SD) drug doses were RLAI 33 ± 10 mg every 2 weeks and quetiapine 413 ± 159 mg daily. Full remission was achieved by 51.1% of patients with RLAI and 39.3% with quetiapine (p = 0.003). Mean ± SD of full remission durations were not significantly different with RLAI (540 ± 181 days) and quetiapine (508 ± 188 days). Overall tolerability was similar between treatment groups. Conclusions: Among stable patients with schizophrenia or schizoaffective disorder, remission was more likely after switching to RLAI than quetiapine.

Cavallaro, Roberto; Folnegovic-Smalc, Vera; Bidzan, Leszek; Emin Ceylan, Mehmet; Schreiner, Andreas

2013-01-01

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Study of the efficacy and safety of switching from risperidone to paliperidone in elderly patients with schizophrenia.  

UK PubMed Central (United Kingdom)

AIM: We investigated the clinical efficacy and safety of switching to paliperidone (PAL) in elderly schizophrenia patients receiving risperidone. METHODS: The subjects were 27 inpatients who had been diagnosed with schizophrenia according to the DSM-IV. The patient's clinical symptoms were assessed using the Positive and Negative Syndrome Scale and the Clinical Global Impression-Severity of Illness Scale, and their safety was assessed using the Drug-induced Extrapyramidal Symptoms Scale, bodyweight, body mass index, and laboratory tests. We also investigated patient satisfaction using the Drug Attitude Inventory, a subjective outcome measure. RESULTS: No significant differences in clinical symptom improvement efficacy were seen between the PAL-switching group and the control group. The mean changes from baseline on the Drug-induced Extrapyramidal Symptoms Scale total score, Drug Attitude Inventory score, and prolactin level were significantly greater in the PAL-switching group than in the control group. Furthermore, patients with PAL needed less biperiden, even though they had similar risperidone-equivalent daily dosages to the control group. CONCLUSIONS: The results of this study suggest that switching elderly patients from risperidone to PAL may result in superior safety and patient satisfaction, and may also make it possible to reduce the dosage of biperiden.

Suzuki H; Gen K; Otomo M; Inoue Y; Hibino H; Mikami A; Matsumoto H; Mikami K

2013-02-01

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Effectiveness of switching from long-acting injectable fluphenazine or haloperidol decanoate to long-acting injectable risperidone microspheres: an open-label, randomized controlled trial.  

UK PubMed Central (United Kingdom)

OBJECTIVE: This multisite randomized trial addressed risks and benefits of staying on long-acting injectable haloperidol or fluphenazine versus switching to long-acting injectable risperidone microspheres. METHOD: From December 2004 through March 2008, adult outpatients with a Structured Clinical Interview for DSM-IV Axis I Disorders-Patient Edition diagnosis of schizophrenia or schizoaffective disorder who were taking haloperidol decanoate (n = 40) or fluphenazine decanoate (n = 22) were randomly assigned to stay on current long-acting injectable medication or switch to risperidone microspheres and followed for 6 months under study protocol and an additional 6 months naturalistic follow-up. Kaplan-Meier and Cox regression analyses were used to examine the primary outcome (time to treatment discontinuation), and random regression models were used to examine secondary outcomes. RESULTS: Groups did not differ significantly in time to treatment discontinuation through 6 months of protocol-driven treatment. When the 6-month naturalistic follow-up period was included, time to treatment discontinuation was significantly shorter for individuals assigned to switch than for individuals assigned to stay (10% of stayers discontinued versus 31% of switchers; P = .01). Groups did not differ with respect to psychopathology, hospitalizations, sexual side effects, new-onset tardive dyskinesia, or new-onset extrapyramidal symptoms. However, those randomized to switch to long-acting injectable risperidone microspheres had greater increases in body mass (increase of 1.0 body mass index [BMI] versus decrease of -0.3 BMI; P = .00) and prolactin (maximum increase to 23.4 ng/mL versus decrease to 15.2 ng/mL, P = .01) compared to those randomized to stay. CONCLUSION: Switching from haloperidol decanoate or fluphenazine decanoate to risperidone microspheres resulted in more frequent treatment discontinuation as well as significant weight gain and increases in prolactin. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00044655.

Covell NH; McEvoy JP; Schooler NR; Stroup TS; Jackson CT; Rojas IA; Essock SM

2012-05-01

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Risperidone Long-Acting Injections: Successful Alternative Deltoid Muscle Injections for Refractory Schizophrenia  

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Treatment-resistant paranoid schizophrenia is often addressed with long-term intramuscular preparations of conventional antipsychotics (haloperidol and fluphenazine), which can be associated with the development of painful, lumpy nodules at the injection site. In this article, we present a case exam...

Saxena, Arjun; Grace, Jeffery; Olympia, Josie L.; Trigoboff, Eileen; Watson, Thomas; Cushman, Sharon; Newcomer, David

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Remission in patients with first-episode schizophrenia receiving assured antipsychotic medication: a study with risperidone long-acting injection.  

Science.gov (United States)

Recently proposed criteria for remission by a 'Remission in Schizophrenia Working Group' have generated considerable interest. We assessed rates, predictors, and correlates of remission in a sample of patients with first-episode schizophrenia treated with injectable, long-acting risperidone. This allowed us to examine remission among patients known to be receiving medication. This was a single-site open-label study in which 50 newly diagnosed cases of schizophreniform disorder or schizophrenia aged 16 to 43 years were treated with injectable, long-acting risperidone 25-50 mg every 2 weeks for 2 years. Remission, according to Remission in Schizophrenia Working Group criteria, was achieved in 64% of the patients. Of those achieving remission, 97% maintained this status until study completion. Remission was associated with greater improvements in other symptom domains, insight, and social and occupational functioning. Patients in remission received lower doses of antipsychotic medication, had fewer extrapyramidal symptoms, and a more favorable attitude toward medication. The results of this open-label study suggest that a majority of first-episode patients who receive long-acting injectable antipsychotic medication may achieve sustained remission. Double-blind-controlled studies using long-acting injectable antipsychotics in early psychosis are warranted to further test this. PMID:18854720

Emsley, Robin; Oosthuizen, Petrus; Koen, Liezl; Niehaus, Dana J H; Medori, Rossella; Rabinowitz, Jonathan

2008-11-01

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Clinical utility of the risperidone formulations in the management of schizophrenia  

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Full Text Available Vishal Madaan1, Durga P Bestha2, Venkata Kolli2, Saurabh Jauhari2, Roger C Burket1 1University of Virginia Health System, Charlottesville, VA, USA; 2Creighton University Medical Center, Omaha, NE, USA Abstract: Risperidone is one of the early second-generation antipsychotics that came into the limelight in the early 1990s. Both the oral and long-acting injectable formulations have been subject to numerous studies to assess their safety, efficacy, and tolerability. Risperidone is currently one of the most widely prescribed antipsychotic medications, used for both acute and long-term maintenance in schizophrenia. Risperidone has better efficacy in the treatment of psychotic symptoms than placebo and possibly many first-generation antipsychotics. Risperidone fares better than placebo and first-generation antipsychotics in the treatment of negative symptoms. Risperidone's long acting injectable preparation has been well tolerated and is often useful in patients with medication nonadherence. Risperidone has a higher risk of hyperprolactinemia comparable to first-generation antipsychotics (FGAs) but fares better than many second-generation antipsychotics with regards to metabolic side effects. In this article, we briefly review the recent literature exploring the role of risperidone formulations in schizophrenia, discuss clinical usage, and highlight the controversies and challenges associated with its use. Keywords: risperidone, schizophrenia, formulation, antipsychotic, side effects

Madaan V; Bestha DP; Kolli VB; Jauhari S; Burket RC

2011-01-01

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Clinical experience and management considerations with long-acting risperidone.  

UK PubMed Central (United Kingdom)

BACKGROUND: Risperidone is the first atypical anti-psychotic available in a long-acting injectable formulation. OBJECTIVE: To provide an overview of the initial clinical experience gained with long-acting risperidone during clinical trials and in general treatment, including specific case studies, as well as providing practical advice on how to initiate treatment with this new drug. METHODS: Studies published between January 2002 and June 2005 that evaluated the pharmacokinetics, efficacy and safety of long-acting risperidone for the treatment of schizophrenia were reviewed, as identified from literature searches using Medline and EMBASE. Although not peer-reviewed, abstracts and posters on long-acting risperidone presented at key psychiatry and schizophrenia congresses during this period were also reviewed where available in the public domain. RESULTS: Clinical studies have consistently demonstrated that long-acting risperidone, available in dosage strengths of 25, 37.5 or 50 mg, given once every 2 weeks, is both effective and well tolerated in patients with schizophrenia. Furthermore, significant and sustained clinical improvement has been reported in patients switched to long-acting risperidone from other oral and long-acting antipsychotic agents. Several patients groups, including the young, the elderly and patients with schizoaffective disorder, have also been shown to derive significant benefit from long-acting risperidone. CONCLUSION: A wide variety of patient groups may benefit from treatment with long-acting risperidone, including patients with suboptimal efficacy, particularly as a result of partial compliance, patients experiencing side-effects with another antipsychotic agent or those with a first episode of schizophrenia. Furthermore, long-acting risperidone, with its assured medication delivery, should improve patient compliance and assist patients in achieving remission, an important step towards functional recovery.

Parellada E

2006-02-01

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Preparation and in-vitro characterization of Risperidone-cyclodextrin inclusion complexes as a potential injectable product  

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Full Text Available "n  "n Background and the purpose of the study: This investigation deals with risperidone cyclodextrin (CD) complexation for parenteral administration to improve its aqueous solubility which would be beneficial over immediate and sustained release formulations available in market especially for agitated and non-cooperative psychotic patients. "nMethods: The phase solubility study of the drug with ?-CD, hydroxypropyl (HP)-?-CD and ?-CD was conducted and CDs with higher stability constants were selected for complexation. The complexes of Risperidone with ?-CD and HP-?-CD were prepared by precipitation and vacuum drying methods, respectively. Fourier transform-infrared, X-ray diffraction and differential scanning calorimetry techniques were used for characterization of complexes. Drug precipitation study of complex's solution in water for injection and 100 ml of 0.1 M pH 7.4 phosphate buffer saline and stability study in accelerated condition were also carried out. "nResults: The stability constants of the CD were in the following order: ?-CD (341.953±11.87 M-1) > HP-?-CD (170.817± 5.93 M-1) > ?-CD (93.716 ± 3.25 M-1). CDs with high stability constants were selected to prepare the drug CD complex. The complexation efficiencies of ?-CD and HP-?-CD were 95.23 ± 2.27% and 97.59 ±1.97%, respectively. Both types of CDs exhibited complexation at 1:2 molar stoichiometric ratio. The drug precipitation study indicated complete solubility (100% drug dissolution) without a trace of precipitate within 5 mins. The complexes were found to be stable for a period of 3 months under accelerated stability conditions. Major conclusion:Stable complexes of risperidone were successfully formulated using both ?-CD and HP-?-CD by simple and highly efficient methods of complexation for parenteral administration.

D Shukla; S Chakraborty; S Singh; B Mishra

2009-01-01

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Treatment-completion rates with olanzapine long-acting injection versus risperidone long-acting injection in a 12-month, open-label treatment of schizophrenia: indirect, exploratory comparisons  

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Full Text Available Haya Ascher-Svanum1, William S Montgomery2, David P McDonnell3, Kristina A Coleman4, Peter D Feldman11Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA; 2Eli Lilly Australia Pty Ltd, West Ryde, New South Wales, Australia; 3Eli Lilly and Company, Cork, Ireland; 4OptumInsight, Lilyfield, New South Wales, AustraliaBackground: Little is known about the comparative effectiveness of atypical antipsychotics in long-acting injection formulation. Due to the absence of head-to-head studies comparing olanzapine long-acting injection and risperidone long-acting injection, this study was intended to make exploratory, indirect, cross-study comparisons between the long-acting formulations of these two atypical antipsychotics in their effectiveness in treating patients with schizophrenia.Methods: Indirect, cross-study comparisons between olanzapine long-acting injection and risperidone long-acting injection used 12-month treatment-completion rates, because discontinuation of an antipsychotic for any cause is a recognized proxy measure of the medication's effectiveness in treating schizophrenia. Following a systematic review of the literature, two indirect comparisons were conducted using open-label, single-cohort studies in which subjects were stabilized on an antipsychotic medication before depot initiation. The first analysis compared olanzapine long-acting injection (one study) with pooled data from nine identified risperidone long-acting injection studies. The second analysis was a “sensitivity analysis,” using only the most similar studies, one for olanzapine long-acting injection and one for risperidone long-acting injection, which shared near-identical study designs and involved study cohorts with near-identical patient characteristics. Pearson Chi-square tests assessed group differences on treatment-completion rates.Results: Comparison of olanzapine long-acting injection data (931 patients) with the pooled data from the nine risperidone long-acting injection studies (3950 patients) provided almost identical 12-month treatment-completion rates (72.7% versus 72.4%; P = 0.87). When the two most similar studies were compared, the 12-month completion rate for olanzapine long-acting injection was significantly higher than for risperidone long-acting injection (81.3% versus 47.0%; P < 0.001). However, any conclusions drawn from this comparison may be limited by differences in the studies' geographic catchment areas.Conclusion: Using treatment-completion rates as a proxy measure of medication effectiveness, olanzapine long-acting injection did not differ significantly from risperidone long-acting injection when including all eligible studies. However, the findings of this exploratory analysis should be interpreted with caution, considering the methodological limitations of these indirect, cross-study comparisons.Keywords: antipsychotic drugs, intramuscular injection, olanzapine, risperidone, schizophrenia

Ascher-Svanum H; Montgomery WS; McDonnell DP; Coleman KA; Feldman PD

2012-01-01

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Efficacy and tolerability of risperidone, yokukansan, and fluvoxamine for the treatment of behavioral and psychological symptoms of dementia: a blinded, randomized trial.  

UK PubMed Central (United Kingdom)

The descriptive term behavioral and psychological symptoms of dementia (BPSD) is used to cover a range of noncognitive disturbances including anxiety, depression, irritability, aggression, agitation, eating disorders, and inappropriate social or sexual behaviors. Behavioral and psychological symptoms of dementia are seen in about 90% of patients with dementia. We aimed to compare the efficacy and tolerability of risperidone, yokukansan, and fluvoxamine used for BPSD in elderly patients with dementia. Ninety inpatients with dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria were investigated in Sato Hospital, Koutokukai. We conducted an 8-week, rater-blinded, randomized trial, administering flexibly dosed risperidone, yokukansan, or fluvoxamine. Primary outcome measures were Neuropsychiatric Inventory in Nursing Home Version total score and its items. Secondary outcome measures were cognitive function measured by Mini-Mental State Examination and daily life function measured by Functional Independence Measure (FIM). Neurological adverse effects were measured by the Drug-Induced Extra-Pyramidal Symptoms Scale. At the end of the study, we analyzed 76 patients (92.7%). Mean Neuropsychiatric Inventory in Nursing Home Version total score decreased in all 3 drug groups, with no significant between-group differences. Mini-Mental State Examination and Functional Independence Measure scores did not change significantly. Drug-Induced Extra-Pyramidal Symptoms Scale scores did not change in the yokukansan and fluvoxamine groups, but increased significantly in the risperidone group. Risperidone, yokukansan, and fluvoxamine were equally effective in the treatment of BPSD in elderly patients. However, yokukansan or fluvoxamine for BPSD showed a more favorable profile in tolerability compared with risperidone. This trial is registered at UMIN Clinical Trials Registry (identifier: UMIN000006146).

Teranishi M; Kurita M; Nishino S; Takeyoshi K; Numata Y; Sato T; Tateno A; Okubo Y

2013-10-01

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Efficacy and tolerability of risperidone, yokukansan, and fluvoxamine for the treatment of behavioral and psychological symptoms of dementia: a blinded, randomized trial.  

Science.gov (United States)

The descriptive term behavioral and psychological symptoms of dementia (BPSD) is used to cover a range of noncognitive disturbances including anxiety, depression, irritability, aggression, agitation, eating disorders, and inappropriate social or sexual behaviors. Behavioral and psychological symptoms of dementia are seen in about 90% of patients with dementia. We aimed to compare the efficacy and tolerability of risperidone, yokukansan, and fluvoxamine used for BPSD in elderly patients with dementia. Ninety inpatients with dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria were investigated in Sato Hospital, Koutokukai. We conducted an 8-week, rater-blinded, randomized trial, administering flexibly dosed risperidone, yokukansan, or fluvoxamine. Primary outcome measures were Neuropsychiatric Inventory in Nursing Home Version total score and its items. Secondary outcome measures were cognitive function measured by Mini-Mental State Examination and daily life function measured by Functional Independence Measure (FIM). Neurological adverse effects were measured by the Drug-Induced Extra-Pyramidal Symptoms Scale. At the end of the study, we analyzed 76 patients (92.7%). Mean Neuropsychiatric Inventory in Nursing Home Version total score decreased in all 3 drug groups, with no significant between-group differences. Mini-Mental State Examination and Functional Independence Measure scores did not change significantly. Drug-Induced Extra-Pyramidal Symptoms Scale scores did not change in the yokukansan and fluvoxamine groups, but increased significantly in the risperidone group. Risperidone, yokukansan, and fluvoxamine were equally effective in the treatment of BPSD in elderly patients. However, yokukansan or fluvoxamine for BPSD showed a more favorable profile in tolerability compared with risperidone. This trial is registered at UMIN Clinical Trials Registry (identifier: UMIN000006146). PMID:23948783

Teranishi, Mika; Kurita, Masatake; Nishino, Satoshi; Takeyoshi, Kenji; Numata, Yukio; Sato, Tadahiro; Tateno, Amane; Okubo, Yoshiro

2013-10-01

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Changes in prolactin levels and sexual functioning after switching from long-acting injectable risperidone to paliperidone palmitate in young psychotic patients: a case series  

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Full Text Available Statement of the problem : Long-acting injectable (LAI) antipsychotics have been developed to increase compliance in schizophrenia. Risperidone-LAI was the first LAI atypical antipsychotic, as a biweekly injection. Paliperidone Palmitate (PP) is a recently developed LAI atypical antipsychotic that is administered monthly. PP is hydrolized to paliperidone (9-hydroxyrisperidone), the primary active metabolite of risperidone. Although both risperidone and paliperidone are associated with increases in prolactin levels, there is limited information regarding whether there are differences in sexual functioning between both compounds. We aimed to study whether there are changes in prolactin levels and/or sexual function after switching from LAI-risperidone to LAI-paliperidone. Methods : We have studied 12 psychopathologically stable subjects with a psychotic disorder (n=10 schizophrenia, 1 schizoaffective, 1 psychosis N.O.S.) attending to the Early Psychosis Program from Reus (HPU Institut Pere Mata, Spain) treated with long-acting risperidone for at least 6 months. All participants were switched to LAI. Clinical assessment was conducted at baseline and 3 months after the switch with measures of psychopathological status (Positive and Negative Symptom Scale [PANSS], Calgary Depression Scale) and sexual dysfuncion (Arizona Sexual Experiences Scale [ASEX]). Two fasting blood samples (baseline and 3 months post-switch) were obtained to determine prolactin levels in plasma. SPSS version 17.0 was used to perform the statistical analyses. Wilcoxon test was used to explore changes in continuous variables (e.g. prolactin levels, ASEX scores) during the period of the study. A p-value?risperidone to paliperidone reduced prolactin levels during a 3-month period. However, changes in prolactin levels were not associated with a significant improvement in sexual functioning.

Itziar Montalvo; Laura Ortega; Xavi López; Montse Solé; Rosa Monseny; Joan Franch; Javier Labad

2012-01-01

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Effects of switching to long-acting injectable risperidone from oral atypical antipsychotics on cognitive function in patients with schizophrenia.  

UK PubMed Central (United Kingdom)

OBJECTIVE: To investigate changes in cognitive function and clinical features following a switch from oral atypical antipsychotics (AAPs) to long-acting injectable risperidone (LAIR) in patients with schizophrenia. METHODS: Thirty-six patients with schizophrenia treated with oral AAPs participated in this open-label, 26-week study. Cognitive functions were measured at baseline and at 12 and 26 weeks. The secondary outcome measures included the Positive and Negative Syndrome Scale (PANSS), Social and Occupational Functioning Assessment Scale (SOFAS), Scale for Unawareness of Mental Disorder (SUMD), and measurements for extrapyramidal symptoms. RESULTS: Significant improvements in cognitive function were observed in the backward Digit Span Test, Verbal Learning Test, Wisconsin Card Sorting Test, correct responses on the Continuous Performance Test, and Trail Making Test part B following a switch to LAIR. Scores on the PANSS, SOFAS, SUMD, and the Simpson-Angus Rating Scale also improved significantly. Most improvements in neurocognitive function were not correlated with clinical measures. Weight gain and hyperprolactinemia were the most common adverse events. CONCLUSIONS: Switching from oral AAPs to LAIR improved cognitive function including vigilance, verbal learning and memory, executive function, sustained attention, and visuomotor speed in patients with schizophrenia. It was also effective for improving psychotic symptoms, social functioning, and insight.

Kim SW; Shin IS; Kim JM; Lee SH; Lee YH; Yang SJ; Yoon JS

2009-10-01

 
 
 
 
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Pharmacogenetic study on risperidone long-acting injection: influence of cytochrome P450 2D6 and pregnane X receptor on risperidone exposure and drug-induced side-effects.  

UK PubMed Central (United Kingdom)

Risperidone is metabolized by polymorphic enzymes, and a large variability in plasma concentration and therapeutic response is observed. Risperidone long-acting injection (RLAI) avoids the first-pass effect, and little is known about the influence of gene polymorphisms involved in its pharmacokinetics. The influence on plasma concentrations of risperidone (RIS), its metabolite 9-hydroxy-risperidone, and on adverse effects were investigated for polymorphisms of cytochrome P450 2D6 (CYP2D6) (*3, *4, *5, *6), CYP3A (CYP3A4*1B, CYP3A4 rs4646437, CYP3A5*3, CYP3A7*1C), ABCB1 (1236C>T, 2677G>T, 3435C>T), NR1/2 coding for pregnane X receptor (rs1523130, rs2472677, rs7643645), and for CYP3A activity measured by a phenotyping test. Forty-two patients with at least 4 consecutive unchanged doses of RLAI were included in a multicenter cross-sectional study. A 55% lower dose-adjusted plasma levels of RIS were observed for CYP2D6 ultrarapid metabolizers (n = 5) as compared with CYP2D6 intermediate metabolizers (P < 0.007). NR1/2 polymorphism (rs7643645A>G) influenced RIS exposure with a 2.8-fold lower active moiety (P = 0.031) in GG compared with the AA genotype. This was confirmed in a second independent cohort (n = 16). Furthermore, high-density lipoprotein cholesterol was positively correlated with CYP3A activity (P = 0.01), and the NR1/2 (rs2472677) polymorphism was associated with different adverse effects including prolactin plasma levels adjusted for age and sex. In conclusion, our results confirmed the influence of CYP2D6 genotype on plasma levels of RIS. This is the first report on the influence of NR1/2 polymorphisms on RLAI exposure and on drug-induced adverse effects. These results should be validated in larger cohorts.

Choong E; Polari A; Kamdem RH; Gervasoni N; Spisla C; Jaquenoud Sirot E; Bickel GG; Bondolfi G; Conus P; Eap CB

2013-06-01

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Changes in prolactin levels and sexual function in young psychotic patients after switching from long-acting injectable risperidone to paliperidone palmitate.  

UK PubMed Central (United Kingdom)

Hyperprolactinaemia is a significant side effect of antipsychotic medications and may cause sexual dysfunction. The aim of our study was to assess the effect of switching from long-acting injectable (LAI) risperidone to paliperidone palmitate (PP) on sexual function and prolactin levels in patients with psychosis. We carried out a prospective observational study during a 3-month period that involved 11 patients with psychosis treated with risperidone-LAI who suffered from hyperprolactinaemia and who were then switched to PP. Two assessments were completed: the first one before the switch and the second one 3 months after the switch. These assessments measured sexual function using the Arizona Sexual Experience Scale and assessed prolactin levels. Our results showed a significant decrease in serum prolactin levels (P=0.041). We observed a four-fold reduction in clinically significant sexual dysfunction that is suggestive of benefit, although the sample size is too small to be sure. Our study suggests that prolactin levels seem to decrease after switching from risperidone-LAI to PP in patients with a psychotic disorder.

Montalvo I; Ortega L; López X; Solé M; Monseny R; Franch J; Vilella E; Labad J

2013-01-01

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A Prospective Study Comparing the Long-term Effectiveness of Injectable Risperidone Long-acting Therapy and Oral Aripiprazole in Patients with Schizophrenia.  

UK PubMed Central (United Kingdom)

Objective: To test the hypothesis that long-term maintenance with injectable risperidone long-acting therapy is superior to oral daily aripiprazole in stable patients with schizophrenia.Design: This two-year, rater-blinded, open-label, multicenter study (NCT00299702) randomized subjects to injectable risperidone long-acting therapy (25-50mg, injected every 2 weeks) or oral aripiprazole (5-30mg/day), with study visits every two weeks. Subjects who met relapse criteria or discontinued study drug could remain in the study.Setting: Clinical trial.Participants: Stable subjects with schizophrenia not adequately benefiting from current treatment who experienced two or more relapses in the past two years. If recently relapsed, subjects were stabilized (per clinician judgment) for two or more months before entry.Measurements:Primary endpoints: time to relapse and time in remission. Safety assessments included adverse event reporting.Results: Of 355 subjects randomized, 349 were in the intent-to-treat analysis set. Data inspection revealed that 53 (14.9%) randomized subjects deviated from inclusion/exclusion criteria, most commonly not meeting stability requirements. At baseline, mean (standard deviation [SD]) Positive and Negative Syndrome Scale total score was 68.9 (14.6); 115 (33.0%) intent-to-treat subjects met remission criteria. Approximately 29 percent in each group discontinued the study before completing two years. No significant between-group differences were noted in time to relapse or time in remission. No new tolerability issues were identified.Conclusion: Results failed to demonstrate superiority with injectable risperidone long-acting therapy versus oral aripiprazole. The study design did not allow for valid conclusions of equivalence or noninferiority. Although this study attempted to mimic a real-world treatment setting for stable patients, the broad study population, the lack of patient selection for nonadherence, biweekly visits, regular assessments, and other design issues limited generalizability and interpretation relative to the study hypothesis.

Macfadden W; Ma YW; Thomas Haskins J; Bossie CA; Alphs L

2010-11-01

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Effectiveness of injectable risperidone long-acting therapy for schizophrenia: data from the US, Spain, Australia, and Belgium  

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Full Text Available Abstract Background Because wide variations in mental health care utilization exist throughout the world, determining long-term effectiveness of psychotropic medications in a real-world setting would be beneficial to physicians and patients. The purpose of this analysis was to describe the effectiveness of injectable risperidone long-acting therapy (RLAT) for schizophrenia across countries. Methods This was a pragmatic analysis of data from two prospective observational studies conducted in the US (Schizophrenia Outcomes Utilization Relapse and Clinical Evaluation [SOURCE]; ClinicalTrials.gov registration number for the SOURCE study: NCT00246194) and Spain, Australia, and Belgium (electronic Schizophrenia Treatment Adherence Registry [eSTAR]). Two separate analyses were performed to assess clinical improvement during the study and estimate psychiatric hospitalization rates before and after RLAT initiation. Clinical improvement was evaluated using the Clinical Global Impressions-Severity (CGI-S) and Global Assessment of Functioning (GAF) scales, and change from baseline was evaluated using paired t tests. Psychiatric hospitalization rates were analyzed using incidence densities, and the bootstrap resampling method was used to examine differences between the pre-baseline and post-baseline periods. Results The initial sample comprised 3,069 patients (US, n = 532; Spain, n = 1,345; Australia, n = 784; and Belgium, n = 408). In all, 24 months of study participation, completed by 39.3% (n = 209), 62.7% (n = 843), 45.8% (n = 359), and 64.2% (n = 262) of patients from the US, Spain, Australia, and Belgium, respectively, were included in the clinical analysis. Improvements compared with baseline were observed on both clinical assessments across countries (P P P Conclusions RLAT in patients with schizophrenia was associated with improvements in clinical and functional outcomes and decreased hospitalization rates in the US, Spain, Australia, and Belgium, despite differences in health care delivery systems.

Lambert Tim; Olivares José M; Peuskens Joseph; DeSouza Cherilyn; Kozma Chris M; Otten Patrick; Crivera Concetta; Jacobs An; Macfadden Wayne; Mao Lian; Rodriguez Stephen C; Dirani Riad; Akhras Kasem S

2011-01-01

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Maintenance treatment with long-acting injectable risperidone in first-episode schizophrenia: a randomized effectiveness study.  

UK PubMed Central (United Kingdom)

BACKGROUND: Because long-acting injectable (LAI) antipsychotics are largely reserved for persistently ill patients, little is known about the use of LAIs early in the course of illness for first-episode outpatients. METHOD: A prospective, open-label, randomized controlled trial was conducted in which outpatients with first-episode DSM-IV schizophreniform disorder, schizophrenia, or schizoaffective disorder were enrolled from December 2004 to March 2007. Participants were randomly assigned at a 2:1 ratio to a recommendation of changing to LAI risperidone microspheres (RLAI) (n = 26) or continuing oral antipsychotic treatment (n = 11) for up to 104 weeks. Primary outcomes were time until initial nonadherence (medication gap of ? 14 days) and medication attitudes as assessed with the Rating of Medication Influences scale. Patients randomly assigned to an RLAI recommendation could decline the recommendation, so analysis defined treatment groups by intent-to-treat and as-actually-treated. RESULTS: Eighty-one percent of patients (30/37) stopped medication within 104 weeks. There was a trend toward an initial adherence benefit favoring RLAI acceptors at 12 weeks (P = .058), but no significant difference between RLAI and oral antipsychotic treatment in time to initial nonadherence during the overall study (P = .188). Medication attitudes did not differ between groups. CONCLUSIONS: Acceptance of RLAI was associated with an initial adherence benefit that was not sustained over time. Early introduction of LAI therapy did not adversely affect adherence attitudes. The small size of the study and low power limit interpretation, but the few patients who remained adherent into a second year were all receiving RLAI. Nonadherence was almost universal in our first-episode cohort, but nonadherence was more easily detected among first-episode patients treated with LAI therapy than it was with oral antipsychotics. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00220714.

Weiden PJ; Schooler NR; Weedon JC; Elmouchtari A; Sunakawa-McMillan A

2012-09-01

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Switching to aripiprazole in outpatients with schizophrenia experiencing insufficient efficacy and/or safety/tolerability issues with risperidone: a randomized, multicentre, open-label study.  

UK PubMed Central (United Kingdom)

INTRODUCTION: This study evaluated the safety/tolerability and effectiveness of aripiprazole titrated-dose versus fixed-dose switching strategies from risperidone in patients with schizophrenia experiencing insufficient efficacy and/or safety/tolerability issues. METHODS: Patients were randomized to an aripiprazole titrated-dose (starting dose 5 mg/day) or fixed-dose (dose 15 mg/day) switching strategy with risperidone down-tapering. Primary endpoint was rate of discontinuation due to adverse events (AEs) during the 12-week study. Secondary endpoints included positive and negative syndrome scale (PANSS), clinical global impressions - improvement of illness scale (CGI-I), preference of medication (POM), subjective well-being under neuroleptics (SWN-K) and GEOPTE (Grupo Español para la Optimización del Tratamiento de la Esquizofrenia) scales. RESULTS: Rates of discontinuations due to AEs were similar between titrated-dose and fixed-dose strategies (3.5% vs. 5.0%; p=0.448). Improvements in mean PANSS total scores were similar between aripiprazole titrated-dose and fixed-dose strategies (-14.8 vs. -17.2; LOCF), as were mean CGI-I scores (2.9 vs. 2.8; p=0.425; LOCF) and SWN-K scores (+8.6 vs.+10.3; OC,+7.8 vs.+9.8; LOCF). CONCLUSION: Switching can be effectively and safely achieved through a titrated-dose or fixed-dose switching strategy for aripiprazole, with down-titration of risperidone.

Ryckmans V; Kahn JP; Modell S; Werner C; McQuade RD; Kerselaers W; Lissens J; Sanchez R

2009-05-01

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Effectiveness of long-acting injectable risperidone versus oral antipsychotics in the treatment of recent-onset schizophrenia: a case-control study.  

Science.gov (United States)

Long-acting injectable antipsychotics may offer a relevant improvement in treatment adherence in recent-onset psychosis, leading to a decreased rate of hospital readmission, a better rate of clinical remission and improved psychosocial adjustment. The aim of the study was to compare the clinical remission rates, number of hospital readmissions and personal and social functioning after 2 years between patients with recent-onset schizophrenia (<2 years) in treatment with risperidone long-acting injectable (RLAI) and patients with recent-onset schizophrenia receiving oral antipsychotics. This is a case-control study comparing patients with recent-onset schizophrenia who initiated RLAI treatment between 2004 and 2008 (n=26) with a control group matched for age and sex, diagnosed with recent-onset schizophrenia and treated with oral antipsychotics (n=26). Study assessments included sociodemographic variables, the Positive and Negative Syndrome Scale, the Personal and Social Functioning Scale, the number of hospital readmissions and the Andreasen remission criteria. To assess the effect of treatment on each dependent variable, separate generalized estimating equations models were constructed. After 2 years of treatment, and adjusting for educational level, the RLAI group showed a greater reduction in the Positive and Negative Syndrome Scale total scale [mean (SD)=47.7 (12.0) vs. 66.2 (18.5); mean difference =-17.56; 95% confidence interval (CI)=-27.11 to -8.00; P<0.001], as well as in the negative [mean (SD) 14.3 (6.1) vs. 19.4 (6.4); mean difference=-5.02; 95% CI=-8.28 to -1.77; P=0.002] and general psychopathology [mean (SD)=23.4 (6.3) vs. 32.7 (8.1); mean difference=-9.16; 95% CI=-13.3 to -5.03; P<0.001] subscales compared with the oral antipsychotic group. Personal and Social Functioning Scale scores were also higher in the RLAI group [mean (SD)=72.4 (14.8) vs. 59.7 (13.5); mean difference=13.41; 95% CI=5.65-21.18; P<0.001]. Although not statistically significant, there were fewer readmissions (adjusted odds ratio 0.28; 95% CI=0.06-1.35; P=0.114) and more illness remissions (adjusted odds ratio 3.24; 95% CI=0.20-11.93; P=0.077) in the RLAI group. Treatment with RLAI instead of oral antipsychotics in recent-onset schizophrenia might improve clinical symptoms and social functioning. The efficacy of RLAI treatment on remission and readmission rates should be researched further. PMID:23587986

Barrio, Pablo; Batalla, Albert; Castellví, Pere; Hidalgo, Diego; García, Marta; Ortiz, Ana; Grande, Iria; Pons, Alexandre; Parellada, Eduard

2013-07-01

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Signaling profile differences: paliperidone versus risperidone.  

UK PubMed Central (United Kingdom)

BACKGROUND AND PURPOSE: Paliperidone is an active metabolite of the second generation atypical antipsychotic, risperidone recently approved for the treatment of schizophrenia and schizoaffective disorder. Because paliperidone differs from risperidone by only a single hydroxyl group, questions have been raised as to whether there are significant differences in the effects elicited between these two drugs. EXPERIMENTAL APPROACH: We compared the relative efficacies of paliperidone versus risperidone to regulate several cellular signaling pathways coupled to four selected G-protein coupled receptor targets that are important for either therapeutic or adverse effects: human dopamine D2 , human 5-HT2A , human 5-HT2C , and human histamine H1 receptors. KEY RESULTS: Whereas the relative efficacies of paliperidone and risperidone were the same for some responses, significant differences were found for several receptor-signaling systems, with paliperidone having greater or less relative efficacy than risperidone depending upon the receptor-response pair. Interestingly, for 5-HT2A -mediated recruitment of ß-arrestin, 5-HT2A -mediated sensitization of ERK, and dopamine D2 -mediated sensitization of adenylyl cyclase signaling, both paliperidone and risperidone behaved as agonists. CONCLUSIONS AND IMPLICATIONS: These results suggest that the single hydroxyl group of paliperidone promotes receptor conformations that can differ from those of risperidone leading to differences in the spectrum of regulation of cellular signal transduction cascades. Such differences in signaling at the cellular level could lead to differences between paliperidone and risperidone in therapeutic efficacy or in the generation of adverse effects.

Clarke WP; Chavera TA; Silva M; Sullivan LC; Berg KA

2013-07-01

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Effectiveness of injectable risperidone long-acting therapy for schizophrenia: data from the US, Spain, Australia, and Belgium.  

UK PubMed Central (United Kingdom)

BACKGROUND: Because wide variations in mental health care utilization exist throughout the world, determining long-term effectiveness of psychotropic medications in a real-world setting would be beneficial to physicians and patients. The purpose of this analysis was to describe the effectiveness of injectable risperidone long-acting therapy (RLAT) for schizophrenia across countries. METHODS: This was a pragmatic analysis of data from two prospective observational studies conducted in the US (Schizophrenia Outcomes Utilization Relapse and Clinical Evaluation [SOURCE]; ClinicalTrials.gov registration number for the SOURCE study: NCT00246194) and Spain, Australia, and Belgium (electronic Schizophrenia Treatment Adherence Registry [eSTAR]). Two separate analyses were performed to assess clinical improvement during the study and estimate psychiatric hospitalization rates before and after RLAT initiation. Clinical improvement was evaluated using the Clinical Global Impressions-Severity (CGI-S) and Global Assessment of Functioning (GAF) scales, and change from baseline was evaluated using paired t tests. Psychiatric hospitalization rates were analyzed using incidence densities, and the bootstrap resampling method was used to examine differences between the pre-baseline and post-baseline periods. RESULTS: The initial sample comprised 3,069 patients (US, n = 532; Spain, n = 1,345; Australia, n = 784; and Belgium, n = 408). In all, 24 months of study participation, completed by 39.3% (n = 209), 62.7% (n = 843), 45.8% (n = 359), and 64.2% (n = 262) of patients from the US, Spain, Australia, and Belgium, respectively, were included in the clinical analysis. Improvements compared with baseline were observed on both clinical assessments across countries (P < 0.001 at all post-baseline visits). The mean improvement was approximately 1 point on the CGI-S and 15 points on the GAF. A total of 435 (81.8%), 1,339 (99.6%), 734 (93.6%), and 393 (96.3%) patients from the US, Spain, Australia, and Belgium, respectively, had ?1 post-baseline visit and were included in the analysis of psychiatric hospitalization rates. Hospitalization rates decreased significantly in all countries regardless of hospitalization status at RLAT initiation (P < 0.0001) and decreased significantly in the US and Spain (P < 0.0001) when the analysis was limited to outpatients only. CONCLUSIONS: RLAT in patients with schizophrenia was associated with improvements in clinical and functional outcomes and decreased hospitalization rates in the US, Spain, Australia, and Belgium, despite differences in health care delivery systems.

Lambert T; Olivares JM; Peuskens J; Desouza C; Kozma CM; Otten P; Crivera C; Jacobs A; Macfadden W; Mao L; Rodriguez SC; Dirani R; Akhras KS

2011-01-01

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Risperidone and Pregnancy  

Science.gov (United States)

... or visit us online at: www.OTISpregnancy.org . Risperidone and Pregnancy This sheet talks about the risks ... advice from your health care provider. What is risperidone? Risperidone is a medication used in the treatment ...

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Bone remodeling, bone mass and weight gain in patients with stabilized schizophrenia in real-life conditions treated with long-acting injectable risperidone.  

UK PubMed Central (United Kingdom)

BACKGROUND: Prolactin-raising antipsychotics, risperidone (antidopaminergic activity), may be associated with low bone mass. On the other hand, risperidone may cause an increase in body weight thought to be favorable for bone. OBJECTIVES: (1) To determine bone remodeling parameters and bone mass in patients with schizophrenia on long-term treatment with long-acting injectable risperidone (LAIR) in naturalistic settings, and (2) to evaluate the change in body weight, metabolic profile and neuroendocrine status in these patients. DESIGN: This was a prospective, cross-sectional study. PATIENTS: Patients included 26 outpatients with controlled schizophrenia in real-life conditions (age 31.3 ± 1.3 years, BMI 28.1 ± 1.0) on long-term maintenance therapy with LAIR for a mean of 18.0 ± 1.6 months (range 6-36) with a mean dose of 38 ± 2 mg. 35 subjects matched for sex, age, BMI and education served as healthy controls. METHODS: Serum osteocalcin, C-terminal telopeptide of type I collagen (CTx), vitamin D, leptin, prolactin, sex steroids, and parathyroid hormone were assessed. Indices of insulin sensitivity and resistance were determined following an oral glucose tolerance test (OGTT). Bone mineral density (BMD) was measured by dual X-ray absorptiometry at the lumbar spine (LS) and femoral neck (FN). RESULTS: Mild to moderate hyperprolactinemia (1,000-2,000 mU/l) was associated with asymptomatic hypogonadism. Prolactin values >2,000 mU/l occurred in a few female patients. Hypogonadism leads to a slight increase (upper limit of normal) in bone resorption marker (CTx) in patients with schizophrenia (p = 0.023). As for bone mass, although lower at the spine than in healthy subjects, it did not reach statistical significance (p = 0.094), while at the FN, BMD was not different from healthy subjects. Body weight increased on average 8.7 ± 1.6 kg in more than 50% of patients. Leptin levels adjusted for BMI in females were significantly higher in patients than in healthy female subjects (p = 0.018), while in males there was no difference between the groups (p = 0.833). A high prevalence of low vitamin D levels and more current smokers were found in patients with schizophrenia. As for the metabolic profile during treatment with risperidone, the low Matsuda index of insulin sensitivity (p = 0.039) confirmed insulin resistance in these patients. CONCLUSION: A potential long-term consequence of asymptomatic hypogonadism due to risperidone-induced hyperprolactinemia might cause a slight rise in bone resorption marker (CTx). On the other hand, by increasing body weight, risperidone could have a protective effect on the bone and thus no change in bone mass was recorded when compared with healthy controls.

Doknic M; Maric NP; Britvic D; Pekic S; Damjanovic A; Miljic D; Stojanovic M; Radojicic Z; Jasovic Gasic M; Popovic V

2011-01-01

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Cost analysis of risperidone long-acting injection in the treatment of schizophrenia and schizoaffective disorders in Hong Kong: An approach using generalised estimating equations.  

UK PubMed Central (United Kingdom)

Schizophrenia is one of the most expensive psychiatric illnesses. This study compared retrospectively health-care resources consumed 12 months before and 24 months after risperidone long-acting injection (RLAI) treatment in Hong Kong. A mirror-image analysis was conducted using data (N=191) from three public hospitals in Hong Kong from 2003 to 2007. The main outcome measure was hospitalisation cost. Other secondary outcomes such as hospitalisation episodes, outpatient visits and adverse events were also compared. A predictive model was established using linear regression based on generalised estimating equations. Analysis showed that RLAI was associated with a reduction in hospitalisation cost by HK$10,001,390 (24.7%) (HK$40,418,694 vs. HK$30,417,303; P-value <0.05). Days of hospitalisation were reduced by 1538 days (10.1%) (15,271 vs. 13,733; P-value <0.05). The predictive model estimated that the hospitalisation cost of patients using RLAI was only 11.1% (3.1-3.93%, 95% confidence interval (CI)) compared to those receiving conventional antipsychotics combined with oral risperidone. Cost of hospitalisation was significantly reduced after RLAI therapy. However, results should be considered as indicative or suggestive only, due to potential channelling bias where certain drug regimens are preferentially prescribed to patients with particular conditions. The findings from our study may be useful in health-care decision making considering treatment options for schizophrenia in resource-limited settings.

Wu DB; Lee EH; Chung WS; Chow DP; Lee VW; Wong MC; Lee KK

2013-09-01

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A model-based approach to characterize the population pharmacokinetics and the relationship between the pharmacokinetic and safety profiles of RBP-7000, a new, long-acting, sustained-released formulation of risperidone.  

UK PubMed Central (United Kingdom)

RBP-7000 is a sustained-release (once-monthly injection for subcutaneous administration) formulation of risperidone using the ATRIGEL® Delivery System, developed for treatment of schizophrenia to address compliance issues associated with oral administration. The objective of this analysis was to report the results of a population pharmacokinetic analysis and to describe the relationship between risperidone and 9-hydroxyrisperidone levels with dopamine (DA) D2-receptor occupancy, prolactin levels, and adverse events using data collected in 45 clinically stable schizophrenic patients receiving RBP-7000 in single ascending doses (risperidone) of 60, 90, and 120?mg. The population PK model accounted for an initial peak, a delayed and slow delivery, the disposition of risperidone, and the conversion of risperidone to 9-hydroxyrisperidone. BMI was a covariate affecting absorption of risperidone and ultimately formation of 9-hydroxyrisperidone. A logistic analysis indicated a correlation between the increase in Active Moiety (risperidone?+?9-OH-risperidone) exposure (Cmax ) and the probability of observing GI disorders. An Emax population PK/prolactin model best described the relationship between the circulating Active Moiety and the serum prolactin levels. Gender was a significant covariate associated with Emax . These data provided a comprehensive characterization of the relationship between circulating Active Moiety and the efficacy/safety profile of RBP-7000 in clinically stable schizophrenic patients.

Gomeni R; Heidbreder C; Fudala PJ; Nasser AF

2013-07-01

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Treatment of schizophrenia with depot preparations of fluphenazine, haloperidol, and risperidone among inpatients at state-operated psychiatric facilities.  

UK PubMed Central (United Kingdom)

BACKGROUND: This study aimed to characterize the inpatient utilization of depot antipsychotics. METHOD: The characteristics of adults with schizophrenia or schizoaffective disorder, hospitalized for at least 28 days, and who were prescribed depot antipsychotics were examined from 2004 to 2006 using a database from a large state-operated psychiatric hospital system. Demographic and clinical characteristics of patients receiving depot fluphenazine or haloperidol were compared to those prescribed depot risperidone. RESULTS: We identified 2210 unique patients who initiated treatment with a depot antipsychotic (after receiving oral antipsychotics). Of these, 1484 (67.1%) received depot fluphenazine or haloperidol, and 726 (32.9%) received risperidone as their initial depot antipsychotic. Patients who received depot risperidone did not differ from those receiving depot fluphenazine or haloperidol with regard to demographics, diagnosis of schizoaffective disorder, number of comorbid psychiatric or medical diagnoses, or diagnosis of substance abuse. Patients started on depot risperidone during the observation period had a longer length of stay prior to initiation of depot than those started on depot fluphenazine or haloperidol (583 days vs. 237 days, t=5.489, p<.001). Patients who started on depot risperidone were less likely to be discharged on that medication than were patients who started on depot fluphenazine or haloperidol (odds ratio from Cox regression model=0.846 [95% CI 0.745-0.960]). CONCLUSIONS: Patients initiated on depot risperidone had a longer length of stay prior to their first injection and were less likely to be discharged on that medication compared to patients initiated on depot fluphenazine or haloperidol, possibly indicating that patients initiating depot risperidone had a more severe or treatment-resistant course of illness and/or that there were reimbursement barriers for the outpatient utilization of depot risperidone, or that efficacy differences exist between the depot antipsychotics at the doses used in this population.

Citrome L; Jaffe A; Levine J

2010-06-01

55

Cost-effectiveness of long-acting injectable risperidone versus flupentixol decanoate in the treatment of schizophrenia: a Markov model parameterized using administrative data.  

UK PubMed Central (United Kingdom)

We use longitudinal patient-level data from a German sickness fund with 7.26 million insured in a Markov-simulation model to assess the cost-effectiveness of long-acting injectable risperidone (LAI-RIS) compared with long-acting injectable flupentixol (LAI-FLX) in the long-term management of schizophrenia. We simulate treatment costs from the payer's perspective, hospitalization, the probability to be prescribed co-medication, and treatment discontinuation over a 2-year time horizon. Model inputs were derived from 935 patients hospitalized with schizophrenia between 2005 and 2008 who received either LAI-RIS or LAI-FLX for at least 1 month. After 2 years, 89.4 % (95.8 %) of patients who were initiated on LAI-RIS (LAI-FLX) discontinued the initial regimen. The number of days spent in hospital per month and patient was slightly lower with LAI-RIS (1.08 vs. 1.28 days, p < 0.001). The proportion of patients receiving side-effect co-medication was lower with LAI-RIS (8.3 vs. 15.0 % per month, p < 0.001). Mean total costs of treatment per patient and month were 1,015 under LAI-RIS and 395 under LAI-FLX, resulting in an ICER of 3,088 (95 % CI [-913 ; 3,551 ]) for an avoided hospital day per patient and month in the base case scenario with a 15.1 % probability of LAI-FLX being the dominant treatment strategy. Cost differences were mainly attributable to the higher drug costs of LAI-RIS. The effectiveness of LAI-RIS in preventing hospital days appears to be similar to LAI-FLX, with a slight superiority in side-effect and switching rates. This comes at the cost of substantially higher treatment expenses. From a decision-maker's point of view, the use of health insurance data as a source of input for decision models appears to be a reasonable alternative to models driven by clinical data only.

Frey S; Linder R; Juckel G; Stargardt T

2013-02-01

56

Risperidone or Aripiprazole in Children and Adolescents with Autism and/or Intellectual Disability: A Bayesian Meta-Analysis of Efficacy and Secondary Effects  

Science.gov (United States)

Second-generation antipsychotics (SGAs) induce frequent adverse effects in children and adolescents with each compound appearing to have a specific adverse effect profile. Aripiprazole and risperidone are FDA-approved medications for behavioral disturbances associated with autism and/or intellectual disabilities (ID) in children and adolescents.…

Cohen, David; Raffin, Marie; Canitano, Roberto; Bodeau, Nicolas; Bonnot, Olivier; Perisse, Didier; Consoli, Angele; Laurent, Claudine

2013-01-01

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Effect of acute and chronic treatment with risperidone on the serotonin and dopamine receptors in the rat brain  

International Nuclear Information System (INIS)

The therapeutic efficacy of antipsychotic drugs is generally attributed to their ability to block dopamine D2 receptors. Classical D2 antagonists are not effective to treat negative symptoms and produce extrapyramidal side effects. On the other hand, atypical antipsychotic agents ameliorate negative symptoms without producing extrapyramidal side effects, and it is reported to be associated with blockade of serotonin 5-HT2 receptors. The purpose of this study was to evaluate the effect of risperidone on neuroreceptors in the rat brain by quantitative autoradiography method. In acute treatment group, risperidone was injected into peritoneal cavity of male Wistar rats with dose of 0, 0.1, 0.25, 0.5, 1.0 and 2.0mg/kg in each group (5/group), and they were decapitated after 2 hours. In chronic treatment group, risperidone was injected with dose of 0, 0.1, and 1m/kg (I.P.) for 21 ays and decapitated after 24 hours following last treatment. The effect of risperodone on the binding of [3H) spiperone to 5-HT2 and D2 receptors were analysed in 4 discrete regions of the striatum, nucleus accumbens, and frontal cortex by quantitative autoradiography. Acute treatment with risperidone reduced cortical 5-HT2 specific [3H]spiperone binding to 32% of vehicle-treated control. Subcortical 5-HR2 specific [3H]spiperone binding was not affected at all dose groups whereas a significant reduction (57%) in D2 specific [3H]spiperone binding was observed in risperidone treated group at doses of 1-2mg/kg. Chronic treatment with risperidone produced a decrease in the maximal number of cortical 5-HT2 receptors to 51% and 46% of control in 0.1mg/kg and 1mg/kg treated group respectively. In conclusion, risperidone is a cortical serotonin receptor antagonist with relatively weak antagonistic action on dopamine receptors. These effects on neuroreceptors may explain the therapeutic effect of risperidone as a atypical antipsychotic agents.

1997-01-01

58

Effect of acute and chronic treatment with risperidone on the serotonin and dopamine receptors in the rat brain  

Energy Technology Data Exchange (ETDEWEB)

The therapeutic efficacy of antipsychotic drugs is generally attributed to their ability to block dopamine D{sub 2} receptors. Classical D{sub 2} antagonists are not effective to treat negative symptoms and produce extrapyramidal side effects. On the other hand, atypical antipsychotic agents ameliorate negative symptoms without producing extrapyramidal side effects, and it is reported to be associated with blockade of serotonin 5-HT{sub 2} receptors. The purpose of this study was to evaluate the effect of risperidone on neuroreceptors in the rat brain by quantitative autoradiography method. In acute treatment group, risperidone was injected into peritoneal cavity of male Wistar rats with dose of 0, 0.1, 0.25, 0.5, 1.0 and 2.0mg/kg in each group (5/group), and they were decapitated after 2 hours. In chronic treatment group, risperidone was injected with dose of 0, 0.1, and 1m/kg (I.P.) for 21 ays and decapitated after 24 hours following last treatment. The effect of risperodone on the binding of [{sup 3}H) spiperone to 5-HT{sub 2} and D{sub 2} receptors were analysed in 4 discrete regions of the striatum, nucleus accumbens, and frontal cortex by quantitative autoradiography. Acute treatment with risperidone reduced cortical 5-HT{sub 2} specific [{sup 3}H]spiperone binding to 32% of vehicle-treated control. Subcortical 5-HR{sub 2} specific [{sup 3}H]spiperone binding was not affected at all dose groups whereas a significant reduction (57%) in D{sub 2} specific [{sup 3}H]spiperone binding was observed in risperidone treated group at doses of 1-2mg/kg. Chronic treatment with risperidone produced a decrease in the maximal number of cortical 5-HT{sub 2} receptors to 51% and 46% of control in 0.1mg/kg and 1mg/kg treated group respectively. In conclusion, risperidone is a cortical serotonin receptor antagonist with relatively weak antagonistic action on dopamine receptors. These effects on neuroreceptors may explain the therapeutic effect of risperidone as a atypical antipsychotic agents.

Choi, Yun Young; Moon, Dae Hyuk; Son, Hye Kyung; Kim, Chang Yoon; Lee, Chul; Lee, Hee Kyung [College of Medicine, Ulsan Univ., Seoul (Korea, Republic of)

1997-03-01

59

Risperidone induced stuttering.  

UK PubMed Central (United Kingdom)

Stuttering as a side effect of antipsychotics is rare. There are a few case reports of antipsychotic-induced stuttering, namely, chlorpromazine, levomepromazine, trifluoperazine, fluphenazine, olanzapine and clozapine. Risperidone is commonly used as an atypical antipsychotic. It is licensed for both acute and chronic psychosis and mania. There is only one documented case report mentioned on risperidone induced stuttering. One case report of risperidone-induced stuttering is now described. Stuttering is a rare side effect and requires a high index of suspicion for diagnosis. Further study and research to identify the neurophysiological and psychological processes behind adult onset stuttering and identification of the processes involved in risperidone induced stuttering would help our understanding further.

Yadav DS

2010-09-01

60

Adult rats treated with risperidone during development are hyperactive.  

UK PubMed Central (United Kingdom)

Risperidone is an antipsychotic drug approved for use in children, but little is known about the long-term effects of early-life risperidone treatment. In animals, prolonged risperidone administration during development increases forebrain dopamine receptor expression immediately upon the cessation of treatment. A series of experiments was performed to ascertain whether early-life risperidone administration altered locomotor activity, a behavior sensitive to dopamine receptor function, in adult rats. One additional behavior modulated by forebrain dopamine function, spatial reversal learning, was also measured during adulthood. In each study, Long-Evans rats received daily subcutaneous injections of vehicle or 1 of 2 doses of risperidone (1.0 and 3.0 mg/kg per day) from postnatal Days 14 to 42. Weight gain during development was slightly yet significantly reduced in risperidone-treated rats. In the first 2 experiments, early-life risperidone administration was associated with increased locomotor activity at 1 week postadministration through approximately 9 months of age, independent of changes in weight gain. In a separate experiment, it was found that the enhancing effect of early-life risperidone on locomotor activity occurred in males and female rats. A final experiment indicated that spatial reversal learning was unaffected in adult rats administered risperidone early in life. These results indicate that locomotor activity during adulthood is permanently modified by early-life risperidone treatment. The findings suggest that chronic antipsychotic drug use in pediatric populations (e.g., treatment for the symptoms of autism) could modify brain development and alter neural set points for specific behaviors during adulthood.

Bardgett ME; Franks-Henry JM; Colemire KR; Juneau KR; Stevens RM; Marczinski CA; Griffith MS

2013-06-01

 
 
 
 
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Switching patients from olanzapine or risperidone to a combination treatment using perphenazine plus buspirone: evaluation of antipsychotic efficacy and side-effects, including extrapyramidal effects and weight loss.  

UK PubMed Central (United Kingdom)

In this pilot study, we have investigated the effects of switching from olanzapine or risperidone treatment to low-dose perphenazine combined with buspirone in six schizophrenic patients who had experienced weight gain. We found no relapse as to psychotic symptoms measured by the CGI-S scale and no exacerbation of extrapyramidal side-effects as measured by the Simpson-Angus Scale. In addition, we observed a medium weight reduction of 10.5 kg (range 1-20 kg).

Andersen TH; Bech P; Larsen NE

2005-01-01

62

Long-acting risperidone and oral antipsychotics in unstable schizophrenia.  

UK PubMed Central (United Kingdom)

BACKGROUND: Long-acting injectable risperidone, a second-generation antipsychotic agent, may improve adherence to treatment and outcomes in schizophrenia, but it has not been tested in a long-term randomized trial involving patients with unstable disease. METHODS: We randomly assigned patients in the Veterans Affairs (VA) system who had schizophrenia or schizoaffective disorder and who had been hospitalized within the previous 2 years or were at imminent risk for hospitalization to 25 to 50 mg of long-acting injectable risperidone every two weeks or to a psychiatrist's choice of an oral antipsychotic. All patients were followed for up to 2 years. The primary end point was hospitalization in a VA or non-VA psychiatric hospital. Symptoms, quality of life, and functioning were assessed in blinded videoconference interviews. RESULTS: Of 369 participants, 40% were hospitalized at randomization, 55% were hospitalized within the previous 2 years, and 5% were at risk for hospitalization. The rate of hospitalization after randomization was not significantly lower among patients who received long-acting injectable risperidone than among those who received oral antipsychotics (39% after 10.8 months vs. 45% after 11.3 months; hazard ratio, 0.87; 95% confidence interval, 0.63 to 1.20). Psychiatric symptoms, quality of life, scores on the Personal and Social Performance scale of global functioning, and neurologic side effects were not significantly improved with long-acting injectable risperidone as compared with control treatments. Patients who received long-acting injectable risperidone reported more adverse events at the injection site and more extrapyramidal symptoms. CONCLUSIONS: Long-acting injectable risperidone was not superior to a psychiatrist's choice of oral treatment in patients with schizophrenia and schizoaffective disorder who were hospitalized or at high risk for hospitalization, and it was associated with more local injection-site and extrapyramidal adverse effects. (Supported by the VA Cooperative Studies Program and Ortho-McNeil Janssen Scientific Affairs; ClinicalTrials.gov number, NCT00132314.).

Rosenheck RA; Krystal JH; Lew R; Barnett PG; Fiore L; Valley D; Thwin SS; Vertrees JE; Liang MH

2011-03-01

63

Efficacy of Endoscopic Injection Sclerotherapy for Rectal Varices  

Directory of Open Access Journals (Sweden)

Full Text Available AIM: The study's aim was to evaluate the efficacy of endoscopicinjection sclerotherapy (EIS) in treating rectal varices.METHODS: Data from 32 consecutive patients who underwentEIS for rectal varices were analyzed the clinical outcomes, includingcomplications related to EIS. EIS was performed weekly using 5%ethanolamine oleate with iopamidol, which was injected to rectalvarices intermittently under fluoroscopy.RESULTS: In all 32 patients, EIS was performed weekly 2 to 5times (mean, 2.7), and the total amount of sclerosant ranged from3.2 to 12.0 mL (mean, 5.3 mL). After EIS, colonoscopy revealedshrinkage of the rectal varices in all 32 patients. There were noserious complications such as portal thrombosis and peritonitis.Colonoscopy revealed oozing bleeding from ulcers after EIS,however, no additional treatments were required. The recurrence ratefor rectal varices was 6 of 25 (24.0%) receiving EIS, over a 1-yearfollow-up period. The recurrence of bleeding was only one patient.CONCLUSION: EIS is useful and safety treatment for rectal variceswith regard to effectiveness and complications.

Takahiro Sato

2013-01-01

64

Formulation, in vitro and in vivo evaluation of transdermal patches containing risperidone.  

UK PubMed Central (United Kingdom)

The efficacy of oral risperidone treatment in prevention of schizophrenia is well known. However, oral side effects and patient compliance is always a problem for schizophrenics. In this study, risperidone was formulated into matrix transdermal patches to overcome these problems. The formulation factors for such patches, including eudragit RL 100 and eudragit RS 100 as matrix forming polymers, olive oil, groundnut oil and jojoba oil in different concentrations as enhancers and amount of drug loaded were investigated. The transdermal patches containing risperidone were prepared by solvent casting method and characterized for physicochemical and in vitro permeation studies through excised rat skin. Among the tested preparations, formulations with 20% risperidone, 3:2 ERL 100 and ERS 100 as polymers, mixture of olive oil and jojoba oil as enhancer, exhibited greatest cumulative amount of drug permeated (1.87 ± 0.09 mg/cm(2)) in 72 h, so batch ROJ was concluded as optimized formulation and assessed for pharmacokinetic, pharmacodynamic and skin irritation potential. The pharmacokinetic characteristics of the optimized risperidone patch were determined using rabbits, while orally administered risperidone in solution was used for comparison. The calculated relative bioavailability of risperidone transdermal patch was 115.20% with prolonged release of drug. Neuroleptic efficacy of transdermal formulation was assessed by rota-rod and grip test in comparison with control and marketed oral formulations with no skin irritation. This suggests the transdermal application of risperidone holds promise for improved bioavailability and better management of schizophrenia in long-term basis.

Aggarwal G; Dhawan S; Hari Kumar SL

2013-01-01

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Risperidone Improves Behavioral Symptoms in Children with Autism in a Randomized, Double-Blind, Placebo-Controlled Trial  

Science.gov (United States)

Subgroup analysis of children (5-12 years) with autism enrolled in an 8-week, double-blind, placebo-controlled trial of risperidone for pervasive developmental disorders. The primary efficacy measure was the Aberrant Behavior Checklist-Irritability (ABC-I) subscale. Data were available for 55 children given risperidone (n = 27) or placebo (n =…

Pandina, Gahan J.; Bossie, Cynthia A.; Youssef, Eriene; Zhu, Young; Dunbar, Fiona

2007-01-01

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Efficacy and safety of risperidone oral solution in agitation associated with dementia in the elderly/ Eficácia e segurança de risperidona solução oral na agitação associada a demência em idosos  

Scientific Electronic Library Online (English)

Full Text Available Abstract in portuguese FUNDAMENTOS: Sintomas psicológicos e do comportamento nas demências (BPSD) contribuem para a sobrecarga dos cuidadores e institucionalização dos idosos. Neurolépticos são prescritos para agitação. Efeitos colaterais dos típicos são prejudiciais, sendo os atípicos indicáveis. OBJETIVO: Avaliar eficácia e tolerabilidade da risperidona solução oral (RSO), dose única diária, em idosos demenciados ambulatoriais com BPSD (agitação). MÉTODO: Pacientes (n=26), (more) 76,35±8,63 anos, critérios do Manual Diagnóstico e Estatístico de Transtornos Mentais 4.ed. (DSM-IV) para demência. RSO administrada, com dose inicial de 0,25 mg e incrementos de 0,25 mg toda semana. Foram utilizados mini-mental (MEEM) para estado cognitivo, behavioral and emotional activities manifested in dementia (BEAM-D) e clinical and global impression (CGI) para BPSD, extrapyramidal symptom rating scale (ESRS) para sintomas extrapiramidais. Efeitos colaterais cardiovasculares foram avaliados clinicamente. RESULTADOS: Houve redução de 26% na agitação, sem efeitos colaterais cardiovasculares, numa faixa de 1,0 a 1,25 mg. Efeitos colaterais foram mais prevalentes acima de 2,5 mg. CONCLUSÃO: Risperidona melhorou agitação com boa tolerabilidade entre 0,5 e 1,25 mg. Dose única diária e aumentos de 0,25 mg podem ser mais aceitáveis para pacientes e cuidadores. Abstract in english BACKGROUND: Behavioral and psychological symptoms in dementia (BPSD) contribute to caregiver burden and institutionalization of elderly. Neuroleptics are prescribed to control agitation. Side effects of typical neuroleptics are harmful, making atypical neuroleptics an indication. OBJECTIVES: To evaluate efficacy and tolerability of risperidone oral solution (ROS) given once daily to demented elderly outpatients with BPSD (agitation). METHOD: Patients (n=26), 76.35±8.63 y (more) ears, Diagnostic and Statistical Manual of Mental Disorders 4th ed. (DSM-IV) criteria for dementia. RSO was given, starting dose of 0.25 mg and increments of 0.25 mg every week. Mini-Mental State Examination (MMSE) assessed cognitive status, Behavioral and Emotional Activities Manifested in Dementia (BEAM-D) and Clinical Global Impression (CGI) measured BPSD, Extrapiramidal Symptom Rating Scale (ESRS) evaluated extrapyramidal symptoms. Cardiovascular side effects were evaluated clinically. RESULTS: There was a 26% reduction in agitation and no cardiovascular side effects in the range from 1.0 to 1.25 mg. Side effects were more prevalent above 2.5 mg. CONCLUSION: Risperidone oral solution improved agitation with good tolerability from 0.5 to 1.25 mg. A single dose with increments of 0.25 mg may be more acceptable to patients and caregivers.

Laks, Jerson; Engelhardt, Eliasz; Marinho, Valeska; Rozenthal, Marcia; Souza, Fernando de Castro e; Bacaltchuk, Josué; Stoppe Jr., Alberto; Ferreira, R.C.R.; Bottino, Cassio; Scalco, Mônica

2001-12-01

67

Efficacy and safety of risperidone oral solution in agitation associated with dementia in the elderly Eficácia e segurança de risperidona solução oral na agitação associada a demência em idosos  

Directory of Open Access Journals (Sweden)

Full Text Available BACKGROUND: Behavioral and psychological symptoms in dementia (BPSD) contribute to caregiver burden and institutionalization of elderly. Neuroleptics are prescribed to control agitation. Side effects of typical neuroleptics are harmful, making atypical neuroleptics an indication. OBJECTIVES: To evaluate efficacy and tolerability of risperidone oral solution (ROS) given once daily to demented elderly outpatients with BPSD (agitation). METHOD: Patients (n=26), 76.35±8.63 years, Diagnostic and Statistical Manual of Mental Disorders 4th ed. (DSM-IV) criteria for dementia. RSO was given, starting dose of 0.25 mg and increments of 0.25 mg every week. Mini-Mental State Examination (MMSE) assessed cognitive status, Behavioral and Emotional Activities Manifested in Dementia (BEAM-D) and Clinical Global Impression (CGI) measured BPSD, Extrapiramidal Symptom Rating Scale (ESRS) evaluated extrapyramidal symptoms. Cardiovascular side effects were evaluated clinically. RESULTS: There was a 26% reduction in agitation and no cardiovascular side effects in the range from 1.0 to 1.25 mg. Side effects were more prevalent above 2.5 mg. CONCLUSION: Risperidone oral solution improved agitation with good tolerability from 0.5 to 1.25 mg. A single dose with increments of 0.25 mg may be more acceptable to patients and caregivers.FUNDAMENTOS: Sintomas psicológicos e do comportamento nas demências (BPSD) contribuem para a sobrecarga dos cuidadores e institucionalização dos idosos. Neurolépticos são prescritos para agitação. Efeitos colaterais dos típicos são prejudiciais, sendo os atípicos indicáveis. OBJETIVO: Avaliar eficácia e tolerabilidade da risperidona solução oral (RSO), dose única diária, em idosos demenciados ambulatoriais com BPSD (agitação). MÉTODO: Pacientes (n=26), 76,35±8,63 anos, critérios do Manual Diagnóstico e Estatístico de Transtornos Mentais 4.ed. (DSM-IV) para demência. RSO administrada, com dose inicial de 0,25 mg e incrementos de 0,25 mg toda semana. Foram utilizados mini-mental (MEEM) para estado cognitivo, behavioral and emotional activities manifested in dementia (BEAM-D) e clinical and global impression (CGI) para BPSD, extrapyramidal symptom rating scale (ESRS) para sintomas extrapiramidais. Efeitos colaterais cardiovasculares foram avaliados clinicamente. RESULTADOS: Houve redução de 26% na agitação, sem efeitos colaterais cardiovasculares, numa faixa de 1,0 a 1,25 mg. Efeitos colaterais foram mais prevalentes acima de 2,5 mg. CONCLUSÃO: Risperidona melhorou agitação com boa tolerabilidade entre 0,5 e 1,25 mg. Dose única diária e aumentos de 0,25 mg podem ser mais aceitáveis para pacientes e cuidadores.

Jerson Laks; Eliasz Engelhardt; Valeska Marinho; Marcia Rozenthal; Fernando de Castro e Souza; Josué Bacaltchuk; Alberto Stoppe Jr.; R.C.R. Ferreira; Cassio Bottino; Mônica Scalco

2001-01-01

68

Preparation of risperidone  

UK PubMed Central (United Kingdom)

The invention provides a simpler, more convenient and eco-friendly method for preparing risperidone. In the method, 6-fluorine-3-(4-piperydyl)-1,2-benzisoxazole hydrochloride reacts with 3-(2-chlorine-ethyl)-2-methyl-6,7,8,9-tetrahydrophthalic anhydride-4H- naphthyridine [1,2-a]pyrimidine-4-ketone in alkaline water solution in the alkaline water solution, the concentration of alkali carbonate ranges from 15 to 40 percent, and the reaction is completed within 10 minutes to 2 hours at the temperature ranging from 101 to 140 DEG C.

GUILING ZHANG; YIDONG ZHU; CHUANWEN FAN; MINGHUI ZHANG; JINGYI WANG

69

The accuracy and efficacy of palpation versus image-guided peripheral injections in sports medicine.  

UK PubMed Central (United Kingdom)

There is much debate in the sports medicine community regarding the need for image guidance during peripheral joint and soft tissue injections. With the increasing availability of office-based ultrasound, many injections that were performed previously with a palpation-guided technique are being performed now under direct sonographic guidance. However some question the need for such guidance, particularly given the increased cost. This manuscript will review the reported accuracy and efficacy for various injections commonly performed in a sports medicine practice.

Hall MM

2013-09-01

70

Paliperidone ER and oral risperidone in patients with schizophrenia: a comparative database analysis  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background To compare the efficacy and tolerability of paliperidone extended-release (ER) with risperidone immediate-release using propensity score methodology. Methods Six double-blind, randomized, placebo-controlled, short-term clinical trials for acute schizophrenia with availability of individual patient-level data were identified (3 per compound). Propensity score pairwise matching was used to balance observed covariates between the paliperidone ER and risperidone patient populations. Scores were generated using logistic regression models, with age, body mass index, race, sex, baseline Positive and Negative Syndrome Scale (PANSS) total score and baseline Clinical Global Impressions–Severity (CGI-S) score as factors. The dosage range of paliperidone ER (6-12 mg/day) was compared with 2 risperidone dosage ranges: 2-4 and 4-6 mg/day. The primary efficacy measure was change in PANSS total score at week 6 end point. Tolerability end points included adverse event (AE) reports and weight. AEs with rates ?5% and with a ?2% difference between paliperidone ER and risperidone were identified. Results Completion rates for placebo-treated subjects in paliperidone ER trials (n = 95) and risperidone trials (n = 122) groups were 36.8% and 51.6%, respectively; end point changes on PANSS total scores were similar (p = 0.768). Completion rates for subjects receiving paliperidone ER 6-12 mg/day (n = 179), risperidone 2-4 mg/day (n = 113) or risperidone 4-6 mg/day (n = 129) were 64.8%, 54.0% and 66.7%, respectively (placebo-adjusted rates: paliperidone ER vs risperidone 2-4 mg/day, p = 0.005; paliperidone ER vs risperidone 4-6 mg/day, p = 0.159). PANSS total score improvement with paliperidone ER was greater than with risperidone 2-4 mg/day (difference in mean change score, -6.7; p Conclusions This indirect database analysis suggested that paliperidone ER 6-12 mg/day may be more efficacious than risperidone 2-4 mg/day and as efficacious as risperidone 4-6 mg/day. The AE-adjusted incidence rates suggest differences between treatments that may be relevant for individual patients. Additional randomized, direct, head-to-head clinical trials are needed to confirm these findings.

Turkoz Ibrahim; Bossie Cynthia A; Lindenmayer Jean-Pierre; Schooler Nina; Canuso Carla M

2011-01-01

71

Risperidone in the treatment of behavioral disorders associated with autism in children and adolescents  

Directory of Open Access Journals (Sweden)

Full Text Available Roberto Canitano, Valeria ScandurraDivision of Child Neuropsychiatry, University Hospital of Siena, Siena, ItalyAbstract: This is a review of the clinical trials investigating the efficacy and safety of risperidone in the treatment of children with autistic spectrum disorders (ASD). The main clinical characteristics are impairment in social skills, communication difficulties, repetitive movements and behaviors, including stereotypies. Pharmacotherapy is mainly directed at the so-called target symptoms, ie, behavioral disorders and the various kinds of repetitions associated with ASD. According to the available data, risperidone seems to be moderately efficacious and safe for treating behavioral disorders. 4 double blind controlled trial. 3 reanalysis studies, and 12 open studies have documented the role of risperidone in children with ASD. Controlled studies have been thoroughly considered in this review.Keywords: autism, pervasive developmental disorders, risperidone

Roberto Canitano; Valeria Scandurra

2008-01-01

72

Efficacy and safety of prophylactic intracameral moxifloxacin injection in Japan.  

UK PubMed Central (United Kingdom)

PURPOSE: To report endophthalmitis rates after cataract surgery and the incidence of complications after intracameral moxifloxacin injection. SETTING: Nineteen clinics in Japanese institutions. DESIGN: Retrospective survey cohort study. METHODS: The number of surgeries and endophthalmitis cases in the past 4 years before and after the introduction of intracameral moxifloxacin was evaluated. The survey was performed by mail or interview in February 2013. RESULTS: All institutions used total-replacement administration rather than small-volume injection. At 3 institutions, 50 to 100 ?g/mL moxifloxacin; at 9 institutions, 100 to 300 ?g/mL moxifloxacin; and at 7 institutions, 500 ?g/mL moxifloxacin was administered. The highest concentration (500 ?g/mL) was administered in 14?124 cases. Endophthalmitis cases occurred 1 month or sooner postoperatively in 8 of 15?958 cases (ie, 1 in 1955) without intracameral moxifloxacin administration and in 3 of 18?794 cases (ie, 1 in 6265) with intracameral moxifloxacin administration. CONCLUSIONS: Intracameral moxifloxacin (50 to 500 ?g/mL) administration decreased the risk for endophthalmitis by 3-fold. In more than 18?000 cases, moxifloxacin administration of 500 ?g/mL or less did not result in severe complications, such as toxic anterior segment syndrome or corneal endothelial cell loss. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Matsuura K; Miyoshi T; Suto C; Akura J; Inoue Y

2013-09-01

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A randomized, double-blind comparison of risperidone versus low-dose risperidone plus low-dose haloperidol in treating schizophrenia.  

UK PubMed Central (United Kingdom)

Monotherapy is recommended for schizophrenia treatment, but the risk-benefit issue of antipsychotic drug combination (except for clozapine) remains unclear. Risperidone, an atypical antipsychotic drug, has a lower incidence of extrapyramidal syndrome but higher risks of prolactinemia and metabolic syndrome than haloperidol, a typical agent. This study compared efficacy and safety of risperidone monotherapy versus low-dose risperidone plus low-dose haloperidol in schizophrenia. In this 6-week, double-blind study, patients were randomized to the combination group (2-mg/d risperidone plus 2-mg/d haloperidol, n = 46) or the monotherapy group (4-mg/d risperidone, n = 42). Efficacy assessments included Clinical Global Impression-Severity, Positive and Negative Syndrome Scale and subscales, Calgary Depression Scale, Global Assessment of Functioning, and Medical Outcomes Study Short-Form 36. Safety was rigorously monitored. Response was defined as 30% reduction in the Positive and Negative Syndrome Scale total score. The 2 treatment groups were similar in (1) demographic and clinical characteristics at baseline, (2) response rate, and (3) improvement in various psychopathological measures and quality of life at end point. The monotherapy group had a higher increase in prolactin levels (P = 0.04) and Simpson-Angus Scale scores (P = 0.04) and a higher percentage of biperiden use (P = 0.045). There were no significant between-group difference in changes in weight, vital signs, corrected QT interval, liver/renal function, fasting glucose level, and lipid profiles. The findings suggest that risperidone monotherapy may yield higher prolactin levels than a combination of low-dose risperidone plus low-dose haloperidol. The 2 treatment groups are similar in efficacy, life quality, and other safety profiles. Future long-term studies are warranted.

Lin CH; Kuo CC; Chou LS; Chen YH; Chen CC; Huang KH; Lane HY

2010-10-01

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Extrapyramidal Side Effects of Risperidone in Iranian Schizophrenic Patients  

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Full Text Available Risperidone is one of a new generation of antipsychotic drugs with relatively fewer side effects and better efficacy. Our objects were study of relationship between the incidence of Iranian produced risperidone Extrapyramidal Side Effects (EPSE) and its relationship with age, sex, dosage and duration of treatment in patients with schizophrenia or schizoaffective disorders. One-hundred patients with schizophrenia or schizoaffective disorders admitted in Razi hospital of Tabriz, which underwent treatment with risperidone were selected by convenience method and the incidence of EPSE was evaluated for 6 weeks; the results were analyzed statistically. Seventy-two percent of patients showed no complications and 28% of them affected by EPSE. The incidence of complications was not related significantly with age and sex of patients but there was significant relationship between the duration of medication and dosage of drug (pv<0.05). The most EPSE were rigidity, tremor and bradykynesia, but there were not any acute dystonic reaction. Risperidone is one of the new generation antipsychotic drugs with lower side effects and its EPSE are dose-dependent. It is recommended that the treatment be initiated with minimum effective dose.

Mohammad-Ali Ghoreishizadeh; Faranak Deldoost

2008-01-01

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Registro Electrónico de Adherencia al Tratamiento de Esquizofrenia en Latinoamérica (e-STAR): Resultados clínicos del uso de risperidona inyectable de liberación prolongada a dos años de seguimiento/ Electronic Schizophrenia Treatment Adherence Registry in Latin America (e-STAR): Clinical outcomes of long-acting injectable risperidone in a 2-year follow up  

Scientific Electronic Library Online (English)

Full Text Available Abstract in spanish La esquizofrenia genera elevados costos al sistema de salud. La falta de adherencia al tratamiento es una de las principales causas de recaídas y hospitalizaciones en la esquizofrenia. Lo anterior conduce a un pobre pronóstico y deterioro funcional de los pacientes. La risperidona inyectable de liberación prolongada (RILP) ha demostrado su eficacia en el tratamiento de la esquizofrenia, ofreciendo la posibilidad de que los pacientes tengan una mayor adherencia terapéu (more) tica. Objetivo Determinar la eficacia y efecto sobre la funcionalidad y el uso de recursos hospitalarios de la RILP en una muestra de pacientes con esquizofrenia de América Latina a dos años de seguimiento. Método El Registro Electrónico de Adherencia al Tratamiento de Esquizofrenia en Latinoamérica (e-STAR) es un estudio observacional del uso de la RILP en la esquizofrenia. Se reclutaron pacientes de México, Colombia y Brasil. Se registró la información clínica del paciente un año previo al inicio del tratamiento con la RILP y de forma prospectiva cada tres meses hasta cumplir los 24 meses de seguimiento. Se registraron las hospitalizaciones y el esquema de tratamiento con la RILP. La escala de Impresión Clínica Global-Gravedad (CGI-S) se utilizó como indicador de eficacia mientras que la Escala Global de Funcionamiento (GAF) y la Escala de Desempeño Personal y Social (PSP) se utilizaron para evaluar el funcionamiento. Resultados Setenta y tres pacientes completaron los dos años de seguimiento. La proporción de pacientes hospitalizados disminuyó del 16.4 al 4.1% después de dos años de tratamiento con la RILP. El 2.7% descontinuó el tratamiento debido a falta de eficacia. Se observó una mejoría significativa en cuanto a la gravedad del padecimiento y el funcionamiento global. Discusión En la práctica clínica cotidiana, la RILP resulta ser un tratamiento a largo plazo efectivo para la esquizofrenia con el beneficio adicional de una menor utilización de recursos del sistema de salud. Abstract in english Schizophrenia is a chronic psychiatric disorder associated to high healthcare costs mainly driven by inpatient care. Lack of adherence to antipsychotic treatment is a common reason for relapse and rehospitalization leading to poor prognosis and global functional impairment of patients. Risperidone long-acting injection (RLAI) has demonstrated its efficacy in treating symptoms of schizophrenia and offers the potential to improve adherence to treatment. Objective To determi (more) ne clinical and functional efficacy of RLAI and use of health resources (eg., hospitalizations) in a 2-year follow up study among patients with schizophrenia from Latin America. Method The electronic Schizophrenia Treatment Adherence Registry (e-STAR) is an observational study of patients who start treatment with RLAI. Data from patients recruited in Mexico, Colombia and Brazil were collected retrospectively for one year prior to baseline, at baseline and every three months for 24 months. Hospitalization rates and treatment regime were registered. Efficacy was assessed using the Clinical Global Impression of Illness-Severity Scale (CGI-S), while the Global Assessment of Functioning (GAF) and the Personal and Social Performance (PSP) were used for the evaluation of functioning. Results Seventy-three patients completed the two-year follow-up. The proportion of patients hospitalized declined from 16.4% before treatment to 4.1% after 2 years of treatment with RLAI. Only 2.7% discontinued the treatment due to lack of efficacy. Significant improvements were reported in illness severity as well as in global functioning assessed by the CGI-S, GAF and PSP scales, respectively. Discussion Our results give further support of the efficacy of RLAI for the treatment of schizophrenia. Additional to symptom severity reduction and functional recovery, improved treatment adherence and reduced hospitalization rates were observed with the use of RLAI. In a real world clinical setting, RLAI offer an effective long-term treatment f

Apiquian, Rogelio; Córdoba, Rodrigo; Louzã, Mario; Fresán, Ana

2013-02-01

76

Ethanol injection of ornamental trees facilitates testing insecticide efficacy against ambrosia beetles (Coleoptera: Curculionidae: Scolytinae).  

UK PubMed Central (United Kingdom)

Exotic ambrosia beetles are damaging pests in ornamental tree nurseries in North America. The species Xylosandrus crassiusculus (Motshulsky) and Xylosandrus germanus (Blandford) are especially problematic. Management of these pests relies on preventive treatments of insecticides. However, field tests of recommended materials on nursery trees have been limited because of unreliable attacks by ambrosia beetles on experimental trees. Ethanol-injection of trees was used to induce colonization by ambrosia beetles to evaluate insecticides and botanical formulations for preventing attacks by ambrosia beetles. Experiments were conducted in Ohio, Tennessee, and Virginia. Experimental trees injected with ethanol had more attacks by ambrosia beetles than uninjected control trees in all but one experiment. Xylosandrus crassiusculus and X. germanus colonized trees injected with ethanol. In most experiments, attack rates declined 8 d after ethanol-injection. Ethanol-injection induced sufficient pressure from ambrosia beetles to evaluate the efficacy of insecticides for preventing attacks. Trunk sprays of permethrin suppressed cumulative total attacks by ambrosia beetles in most tests. Trunk sprays of the botanical formulations Armorex and Veggie Pharm suppressed cumulative total attacks in Ohio. Armorex, Armorex + Permethrin, and Veggie Pharm + Permethrin suppressed attacks in Tennessee. The bifenthrin product Onyx suppressed establishment of X. germanus in one Ohio experiment, and cumulative total ambrosia beetle attacks in Virginia. Substrate drenches and trunk sprays of neonicotinoids, or trunk sprays of anthranilic diamides or tolfenpyrad were not effective. Ethanol-injection is effective for inducing attacks and ensuring pressure by ambrosia beetles for testing insecticide efficacy on ornamental trees.

Reding ME; Oliver JB; Schultz PB; Ranger CM; Youssef NN

2013-02-01

77

Ethanol injection of ornamental trees facilitates testing insecticide efficacy against ambrosia beetles (Coleoptera: Curculionidae: Scolytinae).  

Science.gov (United States)

Exotic ambrosia beetles are damaging pests in ornamental tree nurseries in North America. The species Xylosandrus crassiusculus (Motshulsky) and Xylosandrus germanus (Blandford) are especially problematic. Management of these pests relies on preventive treatments of insecticides. However, field tests of recommended materials on nursery trees have been limited because of unreliable attacks by ambrosia beetles on experimental trees. Ethanol-injection of trees was used to induce colonization by ambrosia beetles to evaluate insecticides and botanical formulations for preventing attacks by ambrosia beetles. Experiments were conducted in Ohio, Tennessee, and Virginia. Experimental trees injected with ethanol had more attacks by ambrosia beetles than uninjected control trees in all but one experiment. Xylosandrus crassiusculus and X. germanus colonized trees injected with ethanol. In most experiments, attack rates declined 8 d after ethanol-injection. Ethanol-injection induced sufficient pressure from ambrosia beetles to evaluate the efficacy of insecticides for preventing attacks. Trunk sprays of permethrin suppressed cumulative total attacks by ambrosia beetles in most tests. Trunk sprays of the botanical formulations Armorex and Veggie Pharm suppressed cumulative total attacks in Ohio. Armorex, Armorex + Permethrin, and Veggie Pharm + Permethrin suppressed attacks in Tennessee. The bifenthrin product Onyx suppressed establishment of X. germanus in one Ohio experiment, and cumulative total ambrosia beetle attacks in Virginia. Substrate drenches and trunk sprays of neonicotinoids, or trunk sprays of anthranilic diamides or tolfenpyrad were not effective. Ethanol-injection is effective for inducing attacks and ensuring pressure by ambrosia beetles for testing insecticide efficacy on ornamental trees. PMID:23448043

Reding, Michael E; Oliver, Jason B; Schultz, Peter B; Ranger, Christopher M; Youssef, Nadeer N

2013-02-01

78

Sustained efficacy and safety of repeated incobotulinumtoxinA (Xeomin(®)) injections in blepharospasm.  

UK PubMed Central (United Kingdom)

IncobotulinumtoxinA (Xeomin(®), NT 201) is a purified botulinum toxin type A free from accessory (complexing) proteins. Previous studies evaluated single sets of incobotulinumtoxinA injections for the treatment of blepharospasm. Individualized injection intervals and other potential determinants of efficacy and safety need to be evaluated in a prospective, longitudinal study. Subjects with blepharospasm who completed a ?20 weeks double-blind, placebo-controlled main period entered a ?69 weeks open-label extension period (OLEX) and received ?5 additional incobotulinumtoxinA treatments at flexible doses (?50 U per eye) and flexible injection intervals (minimum of 6 weeks). Outcome measures included Jankovic Rating Scale (JRS) (sumscore, severity subscore and frequency subscore), Blepharospasm Disability Index, and adverse events. All 102 subjects who completed the main period entered the OLEX; 82 subjects completed the study, 56 received the maximum five injections. From each injection visit to a control visit 6 weeks later, investigator-rated JRS sumscores and subscores, and patient-rated Blepharospasm Disability Index were significantly improved (p ? 0.001 for all). All scores were still significantly improved at trial termination compared with the first injection visit (p < 0.05 for all). The most frequently reported adverse events were eyelid ptosis (31.4 %) and dry eye symptoms (17.6 %). The injection interval had no impact on the incidence of adverse events (post hoc analysis). No subject developed neutralizing antibodies during the study. Repeated incobotulinumtoxinA injections, administered at flexible doses and injection intervals from 6 to 20 weeks according to subjects' needs, provide sustained efficacy in the treatment of blepharospasm with no new or unexpected safety risks.

Truong DD; Gollomp SM; Jankovic J; Lewitt PA; Marx M; Hanschmann A; Fernandez HH

2013-09-01

79

Sustained efficacy and safety of repeated incobotulinumtoxinA (Xeomin(®)) injections in blepharospasm.  

Science.gov (United States)

IncobotulinumtoxinA (Xeomin(®), NT 201) is a purified botulinum toxin type A free from accessory (complexing) proteins. Previous studies evaluated single sets of incobotulinumtoxinA injections for the treatment of blepharospasm. Individualized injection intervals and other potential determinants of efficacy and safety need to be evaluated in a prospective, longitudinal study. Subjects with blepharospasm who completed a ?20 weeks double-blind, placebo-controlled main period entered a ?69 weeks open-label extension period (OLEX) and received ?5 additional incobotulinumtoxinA treatments at flexible doses (?50 U per eye) and flexible injection intervals (minimum of 6 weeks). Outcome measures included Jankovic Rating Scale (JRS) (sumscore, severity subscore and frequency subscore), Blepharospasm Disability Index, and adverse events. All 102 subjects who completed the main period entered the OLEX; 82 subjects completed the study, 56 received the maximum five injections. From each injection visit to a control visit 6 weeks later, investigator-rated JRS sumscores and subscores, and patient-rated Blepharospasm Disability Index were significantly improved (p ? 0.001 for all). All scores were still significantly improved at trial termination compared with the first injection visit (p ptosis (31.4 %) and dry eye symptoms (17.6 %). The injection interval had no impact on the incidence of adverse events (post hoc analysis). No subject developed neutralizing antibodies during the study. Repeated incobotulinumtoxinA injections, administered at flexible doses and injection intervals from 6 to 20 weeks according to subjects' needs, provide sustained efficacy in the treatment of blepharospasm with no new or unexpected safety risks. PMID:23435927

Truong, Daniel D; Gollomp, Stephen M; Jankovic, Joseph; Lewitt, Peter A; Marx, Michael; Hanschmann, Angelika; Fernandez, Hubert H

2013-02-23

80

Therapeutic Efficacy of Doramectin Injectable Against Gastrointestinal Nematodes in Donkeys (Equus asinus) in Khartoum, Sudan  

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Full Text Available A study was conducted to evaluate the therapeutic efficacy of doramectin administered intramuscularly and subcutaneously at a dose rate of 0.2 mg/kg to donkeys naturally infected with gastrointestinal nematodes in Khartoum State, Sudan. The study involved 34 donkeys, animals were randomly allocated to a non-medicated control group or doramectin treated groups (DT1 and DT2). On day 0, donkeys in DT1 received an intramuscular injection of doramectin (0.2 mg/kg), whereas those in group DT2 received a single subcutaneous injection of doramectin (0.2 mg/kg). Individual faecal egg counts were performed daily for the first week and then on days 14, 21, and 28. Between days 14 and 20, two animals from each group were slaughtered, and worm burdens were determined. Treatment efficacy was based on the mean faecal egg count reduction (FECR) 14 days post treatment. Faecal egg reduction of 100% was found after treatment with doramectin intramuscularly, but only 99.24% reduction was found after subcutaneous injection. At necropsy, only adult nematodes and mainly Strongylus vulgaris (L4) were recovered. Doramectin injected intramuscularly was highly efficacious against gastrointestinal nematodes of the donkey. Despite the fact that the drug has not being registered for use in donkeys, no abnormal clinical signs nor adverse reactions were observed in any of the donkeys treated with doramectin.

H. I .Seri; T. Hassan; M.M. Salih; A.D. Abakar; A. A. Ismail; T. A. Tigani

2004-01-01

 
 
 
 
81

Evaluation of anti-tumor efficacy of injectable Centchroman in mice bearing Ehrlich ascites carcinoma.  

UK PubMed Central (United Kingdom)

Anti-tumor efficacy of Centchroman formulated as niosomes and gel implant was evaluated in Swiss albino mice bearing Ehrlich ascites carcinoma at 10 mg/kg body weight dose given subcutaneously. Median day of death, percentage increase in host life span and changes in body weight were studied. Centchroman significantly (P < 0.05) increased the median day of death both in free and formulated systems. Also, injectable formulations exhibited a significant (P < 0.05) increase in host life span compared to free drug, hence, enhanced anti-tumor efficacy against Ehrlich ascites carcinoma.

Shenoy BD; Udupa N; Kamath R; Devi PU

1999-04-01

82

Risperidone versus zuclopenthixol in the treatment of schizophrenia with substance abuse comorbidity: a long-term randomized, controlled, crossover study  

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Full Text Available Background: Substance use disorders (SUDs) are present in more than 50% of subjects diagnosed with schizophrenia. However, there are no controlled studies assessing the efficacy of antipsychotic drugs in this subgroup of patients. The aim of the present work was to compare the efficacy of risperidone and zuclopenthixol in a sample of schizophrenic subjects with dual diagnosis. Method: Thirty-three male were selected for treatment with risperidone, while another 33 were treated with zuclopenthixol. Substances most commonly used were alcohol, cannabis (both 82%) and cocaine (32%). Patients were randomized and treated for the first six months with one antipsychotic and the second six months with the other antipsychotic. Psychopathological and clinical scales were used every two months. Participants received training on how to reduce their consumption of substances (Substance Abuse Management Module, SAMM). Results: During the first six months risperidone group patients presented fewer positive urine tests and showed better compliance with the SAMM programme. In the second period the patients treated with risperidone significantly improved their scores on the PANSS-negative subscale. Differences between the CGIs indicated that the subjects who moved from risperidone to zuclopenthixol worsened, while those who moved from zuclopenthixol to risperidone significantly improved. Conclusions: Risperidone was more effective than zuclopenthixol in improving the symptoms of schizophrenia and substance use.

Gabriel Rubio; Isabel Martínez; Ana Recio; Guillermo Ponce; Francisco López-Muñoz; Cecilio Alamo; Miguel Ángel Jiménez-Arriero; Tomás Palomo

2006-01-01

83

Safety and efficacy of an injectable extracellular matrix hydrogel for treating myocardial infarction.  

Science.gov (United States)

New therapies are needed to prevent heart failure after myocardial infarction (MI). As experimental treatment strategies for MI approach translation, safety and efficacy must be established in relevant animal models that mimic the clinical situation. We have developed an injectable hydrogel derived from porcine myocardial extracellular matrix as a scaffold for cardiac repair after MI. We establish the safety and efficacy of this injectable biomaterial in large- and small-animal studies that simulate the clinical setting. Infarcted pigs were treated with percutaneous transendocardial injections of the myocardial matrix hydrogel 2 weeks after MI and evaluated after 3 months. Echocardiography indicated improvement in cardiac function, ventricular volumes, and global wall motion scores. Furthermore, a significantly larger zone of cardiac muscle was found at the endocardium in matrix-injected pigs compared to controls. In rats, we establish the safety of this biomaterial and explore the host response via direct injection into the left ventricular lumen and in an inflammation study, both of which support the biocompatibility of this material. Hemocompatibility studies with human blood indicate that exposure to the material at relevant concentrations does not affect clotting times or platelet activation. This work therefore provides a strong platform to move forward in clinical studies with this cardiac-specific biomaterial that can be delivered by catheter. PMID:23427245

Seif-Naraghi, Sonya B; Singelyn, Jennifer M; Salvatore, Michael A; Osborn, Kent G; Wang, Jean J; Sampat, Unatti; Kwan, Oi Ling; Strachan, G Monet; Wong, Jonathan; Schup-Magoffin, Pamela J; Braden, Rebecca L; Bartels, Kendra; DeQuach, Jessica A; Preul, Mark; Kinsey, Adam M; DeMaria, Anthony N; Dib, Nabil; Christman, Karen L

2013-02-20

84

Safety and efficacy of an injectable extracellular matrix hydrogel for treating myocardial infarction.  

UK PubMed Central (United Kingdom)

New therapies are needed to prevent heart failure after myocardial infarction (MI). As experimental treatment strategies for MI approach translation, safety and efficacy must be established in relevant animal models that mimic the clinical situation. We have developed an injectable hydrogel derived from porcine myocardial extracellular matrix as a scaffold for cardiac repair after MI. We establish the safety and efficacy of this injectable biomaterial in large- and small-animal studies that simulate the clinical setting. Infarcted pigs were treated with percutaneous transendocardial injections of the myocardial matrix hydrogel 2 weeks after MI and evaluated after 3 months. Echocardiography indicated improvement in cardiac function, ventricular volumes, and global wall motion scores. Furthermore, a significantly larger zone of cardiac muscle was found at the endocardium in matrix-injected pigs compared to controls. In rats, we establish the safety of this biomaterial and explore the host response via direct injection into the left ventricular lumen and in an inflammation study, both of which support the biocompatibility of this material. Hemocompatibility studies with human blood indicate that exposure to the material at relevant concentrations does not affect clotting times or platelet activation. This work therefore provides a strong platform to move forward in clinical studies with this cardiac-specific biomaterial that can be delivered by catheter.

Seif-Naraghi SB; Singelyn JM; Salvatore MA; Osborn KG; Wang JJ; Sampat U; Kwan OL; Strachan GM; Wong J; Schup-Magoffin PJ; Braden RL; Bartels K; DeQuach JA; Preul M; Kinsey AM; DeMaria AN; Dib N; Christman KL

2013-02-01

85

Valproate-Risperidone versus Valproate-Lithium combination in acute mania  

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Full Text Available Background: We evaluated the efficacy of valproate plus risperidone versus valproate plus lithium combination in the treatment of acute mania. Methods: In 2-week, randomized, double-blind, parallel group study, 46 acute manic patients according to DSM-IV criteria were randomly assigned to receive combination of valproate 20 mg/ kg/day plus risperidone 2-4 mg/day (n=23) or lithium600-1200 mg/day (n=23). The assessment of efficacy measures were according to Young Mania Rating Scale (YMRS) and Clinical Global Impressions-Severity (CGI-S) and Improvement (CGI-I) scale. Other effectiveness measures included YMRS response (YMRS reduction >50 %) and YMRS remission (YMRS total scores <12). Results: In each group, 16 of 23 patients (70 %) completed the study. YMRS response, CGI-Improvement, and reduction in the total scores of YMRS and CGI-S observed in both groups, significantly greater for valproate-risperidone than valproate-lithium combination group (P=0.006, P=0.015, P=0.004, and P=0.007, respectively).YMRS remission were shown in both groups without statistical significance (P=0.073). The total scores of YMRS at 4th, 8th, and 14th days of trial were lower in valproate-risperidone than valproate-lithium combination group (P=0.017, P=0.005, and P=0.004, respectively). The rate of adverse events and mean weight gain in both groups were not statistically different. Conclusion: In acute manic patients, both combinations of valproate with lithium or with risperidone had efficacy in acutely manic patients, but valproate-risperidone combination was more effective. Both treatments were safe and well tolerated. Considering the small sample size and limited period of observation, further studies need to be conducted to find out the best combination in the treatment of acute mania. Key words: Acute mania, Valproate, Risperidone, Lithium, Combination Therapy

M Barekatain; A Fatemi; N Bashardoost; A Darougheh; M Salehi; GH Asadollahi

2005-01-01

86

Efficacy of preoperative injection versus intraoperative application of mitomycin in recurrent pterygium surgery.  

UK PubMed Central (United Kingdom)

PURPOSE: To determine the efficacy of preoperative subconjunctival injection of mitomycin C a day before surgery in the management of recurrent pterygium. MATERIALS AND METHODS: Randomized comparative case series. Fifty eyes with recurrent pterygium were randomly divided into two groups; the mitomycin injection group (25 eyes) and the mitomycin application group (25 eyes). The mitomycin injection group underwent preoperative subconjunctival injection of mitomycin C in low dose (0.1 ml of 0.15 mg/ml) a day before bare sclera pterygium excision surgery. The mitomycin application group underwent bare sclera pterygium excision with topical application of mitomycin C (same concentration). RESULTS: At one year of follow-up, 24 of 25 eyes (96%) in the mitomycin injection group and 23 of 25 (92%) eyes in the mitomycin application group were free of recurrence. The difference was statistically insignificant. As regards postoperative complications, delayed epithelization (more than two weeks) occurred in two eyes (8%) in the mitomycin injection group and in one eye (4%) in the mitomycin application group. Scleral thinning was reported in one eye (4%) in the mitomycin application group which resolved within three weeks after surgery, no other serious postoperative complications were reported. CONCLUSION: Preoperative subconjunctival injection of mitomycin C in low dose (0.1 ml of 0.15 mg/ml) a day before pterygium surgery is a simple and effective modality for management of recurrent pterygium. It has the advantage of low recurrence and complications' rate.

Zaky KS; Khalifa YM

2012-07-01

87

The efficacy of intradermal injection of botulinum toxin in patients with post-herpetic neuralgia.  

UK PubMed Central (United Kingdom)

BACKGROUND: Several treatments have been suggested in shingles viral infection caused by Varicella zoster virus that may lead to complications such as PHN (Post-herpetic neuralgia). Intradermal injection of botulinum toxin was shown with few side effects. This study evaluates the efficacy of intradermal injection of botulinum toxin in patients suffering from PHN. METHODS: Fifteen patients suffering from PHN for more than1 month were enrolled. Data collected were patients' age, sex, and lesion site, the dermatome involved and the duration and severity of pain by visual analog scale (VAS). Botulinum (15 units /every 10 cm(2) of body involved) was injected intradermally. The patients were followed 2, 14 and 30 days after injection. RESULTS: Of participants, 6 were males and 9 females. The mean age was 60 years and the mean duration of neuralgia was 6.5 months. The mean VAS on day 2 was 6.4, on day 14 was 7.2 and after 30 days was 7.6. The overall pain after injection decreased but was not significant. CONCLUSION: It seems that intradermal injection of botulinum toxin decreases pain in PHN patients and this decrease is less prominent by passing time.

Emad MR; Emad M; Taheri P

2011-05-01

88

Efficacy of intralesional triamcinolone injection in the treatment of mammillary fistula: a prospective study.  

UK PubMed Central (United Kingdom)

BACKGROUND: Recurring mammillary fistula (MF) is often difficult to manage. PURPOSE: To evaluate the efficacy of intralesional triamcinolone (ILT) injection versus irrigation with saline solution in the management of MF. MATERIAL AND METHODS: A prospective study was conducted including 10 patients with MF. The patients were distributed non-randomly into two groups: saline group (n = 5) and triamcinolone group (n = 5). Ultrasound guidance was used for ILT injection. The injection was repeated in the case of no response or recurrence. RESULTS: No statistically significant differences were observed between the saline and triamcinolone groups for clinical parameters and ultrasonographic characteristics of the MF and for the outcomes of the two methods of treatment. However, a statistically significant difference was observed between the two groups for recurrence of MF (P < 0.046). Success of the treatment with ILT injection was observed in 90% of the patients (9/10), and a failure in one case (10%) after three ILT injections, who was referred for surgery. CONCLUSION: ILT injection is an effective, simple, and safe treatment for the management of MF.

Berná-Serna JD; Berná-Mestre JD; Piñero A; Canteras M

2013-09-01

89

Risperidone-induced Acute Eosinophilic Pneumonia.  

UK PubMed Central (United Kingdom)

BACKGROUND: Acute eosinophilic pneumonia (AEP) is a severe syndrome which can be induced for many reasons, including drugs. AEP has rarely been associated with first-generation antipsychotics and never been reported after use of second-generation antipsychotics, such as risperidone. Case Report: We report a case of a 64-year-old man with a medical history of alchoholism and paranoid symptoms, treated with risperidone at low doses. Following risperidone medication, he presented with respiratory distress. Bronchoalveolar lavage (BAL) specimen was indicated of AEP. All evidence indicated risperidone as the most probable causal factor. The syndrome rapidly resolved after discontinuation of the drug. DISCUSSION: Pathophysiological mechanisms implicated in the development of AEP in our patient seem to be associated with eotaxin and serotonin eosinophilic-specific chemoattracting action, through the serotoninergic action of risperidone. CONCLUSION: To our knowledge, this is the first case report of a clinical adverse reaction of AEP from an atypical antipsychotic agent (risperidone).

Rizos E; Tsigkaropoulou E; Lambrou P; Kanakaki M; Chaniotou A; Alevyzakis E; Liappas I

2013-09-01

90

Systematic review on the efficacy and safety of injectable bulking agents for passive faecal incontinence.  

UK PubMed Central (United Kingdom)

OBJECTIVE: The aim of this study was to systematically review all published evidence to determine the efficacy and safety of injectable bulking agents for passive faecal incontinence (FI) in adults. METHOD: Electronic searches were performed for MEDLINE, EMBASE, ISI Web of Knowledge and other relevant databases. Hand searching of relevant conference proceedings was undertaken. Studies were considered if they met the predefined inclusion criteria of more than ten adult patients and receiving an injectable bulking agent for passive FI with a validated means of assessing preoperative and postoperative incontinence. RESULTS: Thirteen case series studies and one randomized placebo-controlled trial (RCT) were included with a total of 420 patients. Two completed RCTs with placebo control were identified but results were unobtainable. Coaptite, Contigen, Durasphere, EVOH and PTQ injections were assessed with 24, 73, 83, 21 and 208 patients respectively. Most studies reported a statistically significant improvement in incontinence scores and quality of life. No statistically significant difference was found between the treatment and placebo arms in the RCT. No serious adverse events were reported. CONCLUSIONS: Currently there is little evidence for the effectiveness of injectable bulking agents in managing passive FI. The inability to obtain results from two further RCTs concerned the reviewers and hindered their ability to make strong recommendations. The identified injectable bulking agents appear to be safe with only minor complications reported.

Luo C; Samaranayake CB; Plank LD; Bissett IP

2010-04-01

91

Long-Term Efficacy and Safety of Botulinum Toxin Injections in Dystonia  

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Full Text Available Local chemodenervation with botulinum toxin (BoNT) injections to relax abnormally contracting muscles has been shown to be an effective and well-tolerated treatment in a variety of movement disorders and other neurological and non-neurological disorders. Despite almost 30 years of therapeutic use, there are only few studies of patients treated with BoNT injections over long period of time. These published data clearly support the conclusion that BoNT not only provides safe and effective symptomatic relief of dystonia but also long-term benefit and possibly even favorably modifying the natural history of this disease. The adverse events associated with chronic, periodic exposure to BoNT injections are generally minor and self-limiting. With the chronic use of BoNT and an expanding list of therapeutic indications, there is a need to carefully examine the existing data on the long-term efficacy and safety of BoNT. In this review we will highlight some of the aspects of long-term effects of BoNT, including efficacy, safety, and immunogenicity.

Juan Ramirez-Castaneda; Joseph Jankovic

2013-01-01

92

Efficacy of musculoskeletal injections by primary care providers in the office: a retrospective cohort study  

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Full Text Available Anjali Bhagra,1 Husnain Syed,1 Darcy A Reed,1 Thomas H Poterucha,1 Stephen S Cha,2 Tammy J Baumgartner,1 Paul Y Takahashi1 1Department of Internal Medicine, 2Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA Background: Musculoskeletal joint pain of varied etiology can be diagnosed and treated with joint and soft-tissue corticosteroid injections. Purpose: The purpose of our study was to compare patients’ bodily pain and quality of life (QOL), in addition to the procedural benefit and patient satisfaction, before and after musculoskeletal injections in the office setting. Patients and methods: Patients were eligible for recruitment if they were over age 18 and had an injection for musculoskeletal pain from a primary care provider in an office procedural practice. Included in our analysis were knee joint/bursa, trochanteric bursa, and shoulder joint/bursa injection sites. The variables measured were pain, benefit from the injection, QOL physical and mental components, and patient satisfaction. This was a retrospective cohort study approved by the institutional review board. Results: Patients’ pain was assessed by the patients using a six-point Likert scale (none, very mild, mild, moderate, severe, and very severe). We noted that self-perception of pain decreased from 3.10 (± standard deviation at baseline 0.96) before to 2.36 (± standard deviation after the infection 1.21) (P = 0.0001) after the injection. In terms of the impact on QOL, our patients had a pre-injection physical score of 37.25 ± 8.39 and a mental score at 52.81 ± 8.98. After the injections, the physical score improved to 42.35 ± 9.07 (P = 0.0001) and the mental to 53.54 ± 8.20 (P = 0.0001) for the overall group. Ninety-six percent of the patients reported they were satisfied or extremely satisfied in the procedure clinic. Conclusion: In this study, we found significant pain relief and improved physical QOL in patients undergoing an injection in the knee joint/bursa, shoulder joint/bursa, or trochanteric bursa by primary care providers in the office setting. Keywords: injections, musculoskeletal, quality of life, joints, efficacy

Bhagra A; Syed H; Reed DA; Poterucha TH; Cha SS; Baumgartner TJ; Takahashi PY

2013-01-01

93

Long-term efficacy and safety of incobotulinumtoxinA injections in patients with cervical dystonia.  

UK PubMed Central (United Kingdom)

INTRODUCTION: Previously, controlled trials have demonstrated the efficacy and tolerability of fixed doses of incobotulinumtoxinA (Xeomin, NT 201, botulinum toxin type A free from complexing proteins) to treat cervical dystonia (CD). To explore the clinical relevance of these findings, this study evaluated long-term use of flexible dosing regimens of incobotulinumtoxinA in a setting close to real-life clinical practice. METHODS: Patients with CD received five injection sessions of incobotulinumtoxinA using flexible intervals (10-24 weeks) and dosing (?300 Units) based on patients' needs. Outcome measures included Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), the Dystonia Discomfort Scale (DDS), Investigator Global Assessment of Efficacy (IGAE) and Patient Evaluation of Global Response (PEGR). RESULTS: Of 76 patients enrolled (men: 34%; naïve to botulinum toxin: 25%), 64 completed the study, receiving treatment over a duration of 49.3-114.1 weeks (total maximum duration: 121 weeks). Mean TWSTRS-Total and DDS scores significantly improved from study baseline to 4 weeks after each injection session (ranges of improvement: TWSTRS-Total: -11.7 to -14.3; DDS: -20.2 to -23.0). Up to 81.6% of investigators rated the efficacy as 'good' or 'very good' (IGAE) and up to 78.9% of patients rated the treatment response as 'improved' (PEGR). The most common adverse events were dysphagia, nasopharyngitis and headache. CONCLUSIONS: In this long-term study, incobotulinumtoxinA was administered using more flexible dosing regimens than those permitted in previous controlled trials. Repeated injections of highly purified incobotulinumtoxinA are effective and well tolerated for the treatment of CD in a setting close to real-life clinical practice.

Dressler D; Paus S; Seitzinger A; Gebhardt B; Kupsch A

2013-09-01

94

Efficacy of Intra-articular Steroid Injection in Patients with Femoroacetabular Impingement.  

UK PubMed Central (United Kingdom)

Femoroacetabular Impingement (FAI) arises from morphological abnormalities between the proximal femur and acetabulum. Impingement caused by these morphologic abnormalities induces early degenerative changes in the hip joint. Furthermore, FAI patients complain of severe pain and limited range of motion in the hip, but a guideline for treatment of FAI has not yet been established. Medication, supportive physical treatment and surgical procedures have been used in the treatment of the FAI patients; however, the efficacies of these treatments have been limited. Here, we report the diagnosis and treatment for 3 cases of FAI patients. Intra-articular (IA) steroid injection of the hip joint was performed in all three patients. After IA injection, pain was reduced and function had improved for up to three months.

Park JS; Jang YE; Nahm FS; Lee PB; Choi EJ

2013-04-01

95

Efficacy of Intra-articular Steroid Injection in Patients with Femoroacetabular Impingement.  

Science.gov (United States)

Femoroacetabular Impingement (FAI) arises from morphological abnormalities between the proximal femur and acetabulum. Impingement caused by these morphologic abnormalities induces early degenerative changes in the hip joint. Furthermore, FAI patients complain of severe pain and limited range of motion in the hip, but a guideline for treatment of FAI has not yet been established. Medication, supportive physical treatment and surgical procedures have been used in the treatment of the FAI patients; however, the efficacies of these treatments have been limited. Here, we report the diagnosis and treatment for 3 cases of FAI patients. Intra-articular (IA) steroid injection of the hip joint was performed in all three patients. After IA injection, pain was reduced and function had improved for up to three months. PMID:23614077

Park, Jung Sun; Jang, Young Eun; Nahm, Francis Sahngun; Lee, Pyung Bok; Choi, Eun Joo

2013-04-03

96

Ultrasound-guided injections in rheumatology: actual knowledge on efficacy and procedures.  

UK PubMed Central (United Kingdom)

Ultrasound allows one to detect easily joint involvement. In addition to its primary use as a diagnostic tool, ultrasound is increasingly used by rheumatologists to guide musculoskeletal interventions. The correct position of the needle in the target area offers the chance to improve efficacy of the local procedure. Knowledge of anatomy and probe positioning as well as the ability to coordinate probe and needle are necessary when injecting patients with ultrasound guidance. Lack of training and of clear guidelines on their practice is demonstrated by recent surveys and by the high variability of the literature results evaluating practice and outcome of ultrasound-guided injections. This chapter deals with actual knowledge and practical suggestions for the indications and procedures of ultrasound guidance in rheumatology daily practice.

D'Agostino MA; Schmidt WA

2013-04-01

97

A Crossover Study of Risperidone in Children, Adolescents and Adults with Mental Retardation  

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Risperidone has shown safety and efficacy for aggressive and destructive behaviors in short-term studies. This longer-duration study includes a broad sample. Forty subjects, aged 8-56 years (mean=22), all with mental retardation and 36 with autism spectrum disorders participated in this 22-week crossover study, with 24 weeks of open maintenance…

Hellings, Jessica A.; Zarcone, Jennifer R.; Reese, R. Matthew; Valdovinos, Maria G.; Marquis, Janet G.; Fleming, Kandace K.; Schroeder, Stephen R.

2006-01-01

98

Long-Term Effects of Risperidone in Children with Autism Spectrum Disorders: A Placebo Discontinuation Study  

Science.gov (United States)

Objective: The short-term benefit of risperidone in ameliorating severe disruptive behavior in pediatric patients with autism spectrum disorders is well established; however, only one placebo-controlled, long-term study of efficacy is available. Method: Thirty-six children with an autism spectrum disorder (5-17 years old) accompanied by severe…

Troost, Pieter W.; Lahuis, Bertine E.; Steenhuis, Mark-Peter; Ketelaars, Cees E. J.; Buitelaar, Jan K.; van Engeland, Herman; Scahill, Lawrence; Minderaa, Ruud B.; Hoekstra, Pieter J.

2005-01-01

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Risperidone Versus Yokukansan in the Treatment of Severe Alzheimer’s Disease  

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PURPOSE: Patients with AD commonly exhibit behavioral and psychological symptoms of dementia (BPSD). This study is aimed to compare the efficacy of yokukansan (YKS) and risperidone (RIS) on BPSD in patients with severe Alzheimer’s disease (AD). METHODS: Thirty eight inpatients with AD were investiga...

Yuko Furuhashi; Kouichi Shin

100

Safety and efficacy of intradermal injection of botulinum toxin for the treatment of oily skin.  

UK PubMed Central (United Kingdom)

OBJECTIVE: To evaluate the safety and efficacy of intradermal injection of abobotulinumtoxinA for the treatment of oily skin. METHODS AND MATERIALS: Twenty-five patients with oily skin were treated in the forehead region with intradermal injections of botulinum toxin. Baseline and post-treatment sebum production was measured using a sebometer. Photographs were taken. Patients were also asked to rate their satisfaction with the treatment in terms of improvement in their oily skin. RESULTS: Treatment with botulinum toxin resulted in significantly lower sebum production at 1 week and 1, 2, and 3 months after injection (p < .001, t-test). Twenty-one patients (91%) reported that they were satisfied (50-75% improvement) with intradermal botulinum toxin as a treatment for oily skin. [Correction added after online publication 7-Jan-2013: the number of satisfied patients has been updated] CONCLUSION: Intradermal injection of botulinum toxin significantly reduced sebum production in the forehead region, with a high degree of patient satisfaction. Intradermal botulinum toxin may be an effective treatment to reduce sebum production in patients with oily skin. Larger, randomized, blinded, placebo-controlled studies are warranted.

Rose AE; Goldberg DJ

2013-03-01

 
 
 
 
101

Efficacy and tolerability of Day 2 manipulation and local anaesthesia after collagenase injection in patients with Dupuytren's contracture.  

UK PubMed Central (United Kingdom)

In clinical trials, treating Dupuytren's contracture with collagenase injection involves manipulation the day after injection, without local anaesthesia. We evaluated the efficacy and tolerability of manipulation 2 days after injection with local anaesthesia. Forty-five patients received 50 injections into cords contracting metacarpophalangeal and proximal interphalangeal joints; follow-up visits were at 3 and 14 weeks. For the metacarpophalangeal joints there were >90% reduction in contracture at both visits. The proximal interphalangeal joints that improved spontaneously after metacarpophalangeal injection or received direct injections showed 51-55% reduction in contracture. Changes in scores on the Patient Evaluation Measure suggest that patients perceived improvements in their hand function was good and they were satisfied with the procedure. Collagenase and local anaesthesia injections were well tolerated; adverse events were localized to the injection site and were mild and transient in nature. These findings provide another viable option for practising surgeons and may help with the logistics of patient care.

Manning CJ; Delaney R; Hayton MJ

2013-05-01

102

Treatment of Schizophrenia With Long-Acting Fluphenazine, Haloperidol, or Risperidone  

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Objective: This study compares 3 cohorts of patients with schizophrenia before, during, and after initiating treatment with fluphenazine decanoate (FD), haloperidol decanoate (HD), or long-acting injectable risperidone (LAR). Methods: Administrative data are analyzed from California Medicaid (Medi-C...

Olfson, Mark; Marcus, Steven C.; Ascher-Svanum, Haya

103

An Open-Label Study of Risperidone in the Improvement of Quality of Life and Treatment of Symptoms of Violent and Self-Injurious Behaviour in Adults with Intellectual Disability  

Science.gov (United States)

Background: We examined the benefits of risperidone, including quality of life (QoL), in the treatment of violent and self-injurious behaviour in adults with moderate, severe or profound intellectual disability. Methods: Twenty-four participants received open-label, oral, flexible-dose risperidone of 0.5-6 mg/day for 12 weeks. Efficacy was…

Read, Stephen G.; Rendall, Maureen

2007-01-01

104

Effects of risperidone on the acquisition and reinstatement of the conditioned place preference induced by MDMA.  

UK PubMed Central (United Kingdom)

Some users of 3,4-methylenedioxymethylamphetamine (MDMA or ecstasy) abuse this drug and/or become concerned about their use. These individuals would benefit greatly from the development of pharmacological strategies to reduce MDMA consumption. We have previously observed that antipsychotics block acquisition and expression of the conditioned place preference (CPP) induced by MDMA, though they do not modify priming-induced reinstatement of MDMA-induced CPP after extinction. In the present study we have evaluated the capacity of the mixed serotonin (5-HT2A)/dopamine (DA D2) antagonist risperidone to block acquisition and reinstatement of MDMA induced-CPP. Adolescent male mice conditioned with 10mg/kg of MDMA were treated with 0.1 or 0.3mg/kg of risperidone during acquisition of conditioning (experiment 1) or before the reinstatement test (experiment 2). Risperidone was devoid of motivational effects in the CPP paradigm, but the higher dose blocked acquisition of the MDMA-induced CPP. This behavioral effect was accompanied by an increase in the level of dopamine transporters in the striatum. However, risperidone had no effects on reinstatement of the CPP induced by a priming of MDMA. Our results suggest that risperidone induces the same effects as other antipsychotics, in which case its efficacy for treating MDMA abuse is limited.

Roger-Sánchez C; Rodríguez-Arias M; Miñarro J; Aguilar MA

2013-07-01

105

Review of risperidone for the treatment of pediatric and adolescent bipolar disorder and schizophrenia  

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Full Text Available Jeffrey R Bishop1,2, Mani N Pavuluri21Department of Pharmacy Practice, University of Illinois at Chicago College of Pharmacy, Chicago, IL, USA; 2Department of Psychiatry, Pediatric Mood Disorders Program and Center for Cognitive Medicine, University of Illinois at Chicago College of Medicine, Chicago, IL, USAAbstract: Risperidone is a commonly used medication for the treatment of bipolar disorder and schizophrenia in children and adolescents. It has been studied as a monotherapy treatment in early onset schizophrenia and as both monotherapy and combination therapy for pediatric bipolar disorder. Studies to date indicate that risperidone is an effective treatment for positive and negative symptoms of schizophrenia and mania symptoms of bipolar disorder. In young patient populations, side effects such as weight gain, extrapyramidal side effects, and prolactin elevation require consideration when evaluating the risk benefit ratio for individual patients. Here we review published studies of risperidone for the treatment of bipolar disorder and schizophrenia in children and adolescents to provide practitioners with an overview of published data on the efficacy and safety of risperidone in these patient populations.Keywords: risperidone, bipolar disorder, schizophrenia, children, adolescents

Jeffrey R Bishop; Mani N Pavuluri

2008-01-01

106

Effects of risperidone on the acquisition and reinstatement of the conditioned place preference induced by MDMA.  

Science.gov (United States)

Some users of 3,4-methylenedioxymethylamphetamine (MDMA or ecstasy) abuse this drug and/or become concerned about their use. These individuals would benefit greatly from the development of pharmacological strategies to reduce MDMA consumption. We have previously observed that antipsychotics block acquisition and expression of the conditioned place preference (CPP) induced by MDMA, though they do not modify priming-induced reinstatement of MDMA-induced CPP after extinction. In the present study we have evaluated the capacity of the mixed serotonin (5-HT2A)/dopamine (DA D2) antagonist risperidone to block acquisition and reinstatement of MDMA induced-CPP. Adolescent male mice conditioned with 10mg/kg of MDMA were treated with 0.1 or 0.3mg/kg of risperidone during acquisition of conditioning (experiment 1) or before the reinstatement test (experiment 2). Risperidone was devoid of motivational effects in the CPP paradigm, but the higher dose blocked acquisition of the MDMA-induced CPP. This behavioural effect was accompanied by an increase in the level of dopamine transporters in the striatum. However, risperidone had no effects on reinstatement of the CPP induced by a priming of MDMA. Our results suggest that risperidone induces the same effects as other antipsychotics, in which case its efficacy for treating MDMA abuse is limited. PMID:23892054

Roger-Sánchez, C; Rodríguez-Arias, M; Miñarro, J; Aguilar, M A

2013-07-24

107

POST MARKETING SURVEILLANCE STUDY ON RISPERIDONE IN PATIENTS SUFFERING FROM SCHIZOPHRENIA  

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Full Text Available Schizophrenia is one of the commonest psychiatric ailments. It has been estimated that approximately 1% of the population and 15% of the adults suffers from this disease. Risperidone, atypical antipsychotic, acts mainly by 5HT2 blockade action. Produce virtually no extra pyramidal side effects at low dose, has a broad efficacy. But extra pyramidal dysfunction can appear at higher doses. We conducted a post marketing surveillance study on risperidone in 40 patients suffering from schizophrenia at Psychiatric department of Civil Hospital, Ahmedabad. In this study we specially studied its efficacy and safety. The results of this study are consistent with phase III clinical studies on risperidone carried out in Indian patients except its effects on food intake. As far as the efficacy of risperidone in patient with schizophrenia is concerned, it provided good symptomatic relief In term of safety, 7 patients out of 40, experience adverse effects like decrease appetite, constipation, insomnia, EPS and NMS. Patient with NMS was admitted in hospital and was died later on. [National J of Med Res 2011; 1(2.000): 34-36

J R Zaveri; Vipul Chaudhari

2011-01-01

108

Sucrose acetate isobutyrate as an in situ forming system for sustained risperidone release.  

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The objective of this study was to develop sustained-release sucrose acetate isobutyrate (SAIB) in situ formulations of risperidone for parenteral delivery. The formulations contained SAIB, solvent (anhydrous ethanol, ethyl lactate, or N-methyl-2-pyrrolidone), and additives such as polylactic acid (PLA). In vitro release profiles of risperidone from the SAIB formulations, which followed the Higuchii square root law, were obtained. An increase in SAIB content from 75% to 85% resulted in a reduction in the initial burst and the rate of risperidone release. The initial drug release could be increased by reducing the pH of the release medium and the release rate could be increased by an increase in drug loading. The burst release fell significantly from 20.0% to 3.5% following the inclusion of 10% (w/w) PLA in the formulations. In the case of this high viscosity depot system containing SAIB, anhydrous ethanol, PLA, and 25 mg/g risperidone, the in vivo biocompatible test results obtained support the use of SAIB as an injectable risperidone sustained-release formulation. PMID:17721936

Lu, Yaxin; Yu, Yeling; Tang, Xing

2007-12-01

109

Injection  

International Nuclear Information System (INIS)

The author presents an introduction to beam injection. Especially considered are single-turn injection, multi-turn injection, H- charge-exchange injection, and injection from a cyclotron into a synchrotron. Finally some novel injection schemes are briefly mentioned. (HSI).

1994-01-26

110

A double-blind, placebo-controlled study of traditional Chinese medicine sarsasapogenin added to risperidone in patients with negative symptoms dominated schizophrenia.  

UK PubMed Central (United Kingdom)

OBJECTIVE To identify whether sarsasapogenin, a sapogenin from the Chinese medicinal herb Anemarrhena Asphodeloides Bunge, would augment the efficacy of risperidone and significantly improve cognitive functions in patients with negative symptoms dominated schizophrenia. METHODS The trial was a double-blind, placebo-controlled, parallel-group design. The eligible patients were randomized into 2 treatment groups: sarsasapogenin group (sarsasapogenin plus risperidone for 8 weeks, n = 41) and placebo group (risperidone only for 8 weeks, n = 39). At the baseline, as well as at weeks 2, 4 and 8 of treatment, the therapeutic response was measured by using scales including Positive and Negative Symptoms Scale (PANSS), Wechsler Memory Scale (WMS), modified Chinese Wechsler Adult Intelligence Scale (mWAIS), Clinical Global Impression (CGI) and Brief Psychiatry Rating Scale (BPRS). The study period for each subject was 8 weeks and duration of overall trial was 2 years. RESULTS Patients treated with sarsasapogenin plus risperidone demonstrated no statistically significant differences in changes in PANSS, WMS or mWAIS score at the end-point of the trial compared with patients treated with placebo plus risperidone. The incidence of treatment-emergent adverse events in patients treated with sarsasapogenin was not different from that observed in placebo group. CONCLUSION Sarsasapogenin did not augment the efficacy of risperidone in treating negative symptoms dominated schizophrenia. Sarsasapogenin at a dosage of 200 mg per day added to a flexible dosage of risperidone at 2-4 mg per day is safe and well tolerated by patients with negative symptoms dominated schizophrenia.

Xiao SF; Xue HB; Li X; Chen C; Li GJ; Yuan CM; Zhang MY

2011-08-01

111

Safety and efficacy of sling for persistent stress urinary incontinence after bulking injection.  

UK PubMed Central (United Kingdom)

OBJECTIVES: To evaluate the impact of injectable agents on subsequent incontinence surgery outcomes to assess safety and efficacy of this treatment combination. Periurethral bulking agents are a minimally invasive treatment option for stress urinary incontinence (SUI), but often lack durability necessitating further surgical intervention. METHODS: Retrospective review of 43 patients with SUI following bulking agent who underwent subsequent sling placement from November 2000 to September 2009 were evaluated for demographics, symptoms, urodynamics (UDS), bulking agent characteristics, concomitant procedures, pad requirements per day (PPD), subjective outcomes, and complications. RESULTS: Mean patient age was 67 years, with mean follow-up of 37.3 months. All demonstrated SUI, and mixed urinary incontinence (MUI) was noted in 81.4%. Almost half (48.8%) had undergone a prior antiincontinence procedure. Mean number of injections was 3. After a bulking injection, 25 autologous fascia pubovaginal slings, 13 midurethral slings, and 5 biological pubovaginal slings were placed. Concomitant pelvic surgery was performed in 37.2%. Postoperatively, mean PPD decreased from 5.3 to 0.65, with a 60.5% subjective cure rate (no pads or leakage under any circumstances). No association was seen between number or type of injection, or type of sling with regards to patient outcomes. Results were significantly related to concomitant surgery (P = .007). SUI recurred in 8 patients (18.6%), which was not statistically associated with other parameters. Complications included urinary retention (8 patients) de novo urgency (1 patient), UTI (4 patients), abdominal wound infection (3 patients), and cystotomy (1 patient). CONCLUSIONS: Prior treatment with bulking agents does not appear to negatively affect outcomes for future antiincontinence surgery in our patient population.

Koski ME; Enemchukwu EA; Padmanabhan P; Kaufman MR; Scarpero HM; Dmochowski RR

2011-05-01

112

The Efficacy of Intradiscal Steroid Injections in Degenerative Lumbar Disc Disease  

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Full Text Available Objective: We aimed to investigate the efficacy of intradiscal steroid injection in patients with chronic low back pain due to degenerative disc disease.Materials and Methods: A total of 18 patients (9 female, 9 male) with chronic low back pain of discogenic origin were enrolled in the study. The intervertebral disc level which met the diagnostic criteria for provocative discography was defined as discogenic pain level. After identification of positive disc level, 1 cc betamethasone was injected into the disc. The outcome measures (visual analog pain scale and Quebec Back Pain Disability Scale scores, finger-tip-to-floor distance and duration of sitting without pain) were assessed before the treatment and at second week and third month post injection. Results: The reduction in low back pain intensity between the baseline and second week, and between the baseline and third month was statistically significant (p=0.001 and p=0.002). Besides, statistically significant improvement was observed in Quebec Disability Scores between the baseline and second week, and between the baseline and third month (p=0.001 and p=0.002). The finger-tip-to-floor distance between the baseline and second week, and between the baseline and third month showed a statistically significant improvement (p=0.002 and p=0.02). The duration of sitting without pain between the baseline and second week, and between the baseline and third month showed a statistically significant increase (p=0.001 and p=0.009). Conclusion: As a result, we suggest that intradiscal steroid injection may be effective in short-term and mid-term for reducing the intensity of spinal pain and the proportion of disability due to chronic discogenic low back pain in patients who do not respond to conservative treatment. Turk J Phys Med Re­hab 2012;58:88-92.

Ferdi Yavuz; Mehmet Ali Ta?kaynatan; Koray Aydemir; Ahmet Özgül; Arif Kenan Tan

2012-01-01

113

Risperidone safety in pregnancy. A case report.  

Science.gov (United States)

The use of risperidone and other antipsychotic drugs during pregnancy is sometimes essential, although it is impossible to design clinical trials to demonstrate the safety of these kinds of drugs. The common method to communicate the absence of drug-related events is through case reports, even though they might be insufficient. This is a case report of a woman with a schizophreniform disorder who continued treatment with risperidone during all her pregnancy, and who gave birth to a healthy baby. The scientific evidence regarding risperidone safety during pregnancy is reviewed and the need to conduct followup studies evaluating the consequences of using antipsychotic drugs in pregnant women is stated. PMID:18985459

Rodríguez-Salgado, B

114

Anesthetic efficacy of a repeated intraosseous injection given 30 min following an inferior alveolar nerve block/intraosseous injection.  

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To determine whether a repeated intraosseous (IO) injection would increase or prolong pulpal anesthesia, we measured the degree of anesthesia obtained by a repeated IO injection given 30 min following a combination inferior alveolar nerve block/intraosseous injection (IAN/IO) in mandibular second pr...

Reitz, J.; Reader, A.; Nist, R.; Beck, M.; Meyers, W. J.

115

The efficacy of eprinomectin extended-release injection against Hypoderma spp. (Diptera: Oestridae) in cattle.  

UK PubMed Central (United Kingdom)

The efficacy of eprinomectin in an extended-release injection (ERI) formulation was determined in cattle harboring naturally acquired infestations of first- or second- and third-stage larvae of Hypoderma spp. in three studies conducted according to the same protocol in the USA (two studies) and Germany (one study). Thirty cattle sourced from herds with a history of Hypoderma infestation were included in each study. Cattle were formed into replicates of three animals each on the basis of pre-treatment anti-Hypoderma antibody titers. Within replicates each animal was randomly allocated to one of the following treatments: ERI vehicle (control) at 1 mL/50 kg bodyweight, administered once on Day 0; Eprinomectin 5% ERI at 1 mL/50 kg bodyweight (1.0 mg eprinomectin/kg), administered once on Day 0 (when larvae were expected to be first instars); or Eprinomectin 5% ERI at 1 mL/50 kg bodyweight (1.0 mg eprinomectin/kg), administered once when larvae were second or third instars (study dependent, Day 73, 119, or 140). Treatments were administered by subcutaneous injection in front of the shoulder. In all studies, emerging and/or expressed Hypoderma larvae were recovered, speciated, and counted and viability was determined. Eprinomectin LAI treatment was 100% (p<0.05) efficacious against first- and second- or third-stage larvae of Hypoderma bovis (two studies) and Hypoderma lineatum (one study). All animals accepted the treatment well. No adverse reaction to treatments was observed in any animal in any study.

Rehbein S; Holste JE; Smith LL; Lloyd JL

2013-03-01

116

A Head-to-Head Comparison of Aripiprazole and Risperidone for Safety and Treating Autistic Disorders, a Randomized Double Blind Clinical Trial.  

UK PubMed Central (United Kingdom)

Aripiprazole and risperidone are the only FDA approved medications for treating irritability in autistic disorder, however there are no head-to-head data comparing these agents. This is the first prospective randomized clinical trial comparing the safety and efficacy of these two medications in patients with autism spectrum disorders. Fifty nine children and adolescents with autism spectrum disorders were randomized to receive either aripiprazole or risperidone for 2 months. The primary outcome measure was change in Aberrant Behavior Checklist (ABC) scores. Adverse events were assessed. Aripiprazole as well as risperidone lowered ABC scores during 2 months. The rates of adverse effects were not significantly different between the two groups. The safety and efficacy of aripiprazole (mean dose 5.5 mg/day) and risperidone (mean dose 1.12 mg/day) were comparable. The choice between these two medications should be on the basis of clinical equipoise considering the patient's preference and clinical profile.

Ghanizadeh A; Sahraeizadeh A; Berk M

2013-06-01

117

Improved efficacy and reduced toxicity by ultrasound-guided intrahepatic injections of helper-dependent adenoviral vector in Gunn rats.  

UK PubMed Central (United Kingdom)

Crigler-Najjar syndrome type I is due to mutations of the uridine diphospho-glucuronosyl transferase 1A1 (UGT1A1) gene resulting in life-threatening increase of serum bilirubin. Life-long correction of hyperbilirubinemia was previously shown with intravenous injection of high doses of a helper-dependent adenoviral (HDAd) vector expressing UGT1A1 in the Gunn rat, the animal model of Crigler-Najjar syndrome. However, such high vector doses can activate an acute and potentially lethal inflammatory response with elevated serum interleukin-6 (IL-6). To overcome this obstacle, we investigated safety and efficacy of direct injections of low HDAd doses delivered directly into the liver parenchyma of Gunn rats. Direct hepatic injections performed by either laparotomy or by ultrasound-guided percutaneous injections were compared to the same doses given by intravenous injections. A greater reduction of hyperbilirubinemia and increased conjugated bilirubin in bile were achieved with 1x1011vp/kg by direct liver injections compared to intravenous injections. In sharp contrast to intravenous injections, direct hepatic injections did not raise serum IL-6 neither resulted in thrombocytopenia. In conclusion, ultrasound-guided percutaneous injection of HDAd vectors into liver parenchyma resulted in improved hepatocyte transduction and reduced toxicity compared to systemic injections and is clinically attractive for liver-directed gene therapy of Crigler-Najjar syndrome.

Pastore N; Nusco E; Piccolo P; Castaldo S; Vaníkova J; Vetrini F; Palmer D; Vitek L; Ng P; Brunetti-Pierri N

2013-08-01

118

Improved efficacy and reduced toxicity by ultrasound-guided intrahepatic injections of helper-dependent adenoviral vector in gunn rats.  

UK PubMed Central (United Kingdom)

Abstract Crigler-Najjar syndrome type I is caused by mutations of the uridine diphospho-glucuronosyl transferase 1A1 (UGT1A1) gene resulting in life-threatening increase of serum bilirubin. Life-long correction of hyperbilirubinemia was previously shown with intravenous injection of high doses of a helper-dependent adenoviral (HDAd) vector expressing UGT1A1 in the Gunn rat, the animal model of Crigler-Najjar syndrome. However, such high vector doses can activate an acute and potentially lethal inflammatory response with elevated serum interleukin-6 (IL-6). To overcome this obstacle, we investigated safety and efficacy of direct injections of low HDAd doses delivered directly into the liver parenchyma of Gunn rats. Direct hepatic injections performed by either laparotomy or ultrasound-guided percutaneous injections were compared with the same doses given by intravenous injections. A greater reduction of hyperbilirubinemia and increased conjugated bilirubin in bile were achieved with 1×10(11) vp/kg by direct liver injections compared with intravenous injections. In sharp contrast to intravenous injections, direct hepatic injections neither raised serum IL-6 nor resulted in thrombocytopenia. In conclusion, ultrasound-guided percutaneous injection of HDAd vectors into liver parenchyma resulted in improved hepatocyte transduction and reduced toxicity compared with systemic injections and is clinically attractive for liver-directed gene therapy of Crigler-Najjar syndrome.

Pastore N; Nusco E; Piccolo P; Castaldo S; Vaníkova J; Vetrini F; Palmer DJ; Vitek L; Ng P; Brunetti-Pierri N

2013-10-01

119

Efficacy of spirulina as an antioxidant adjuvant to corticosteroid injection in management of oral submucous fibrosis.  

UK PubMed Central (United Kingdom)

Background and Objectives: Oral submucous fibrosis (OSF) is a chronic condition of the oral cavity which results in permanent disability. A number of studies have proven that the management of premalignant diseases should include antioxidants. Therefore, a study was carried out to evaluate the efficacy of spirulina as an antioxidant adjuvant to corticosteroid injections in the management of 40 oral submucous fibrosis subjects of south Karnataka and north Kerala. Materials and Methods: An intervention study was conducted on 40 oral submucous fibrosis cases, 40 patients were divided into two groups, group A (spirulina group) and group B (placebo group). Group A received spirulina 500 mg twice daily and biweekly intralesional steroid injection of Betamethasone 4 mg/ml for 3 months and group B was given placebo capsules twice daily and biweekly intralesional steroid injection of Betamethasone 4 mg/ml for 3 months. The results were analyzed with the paired " t" test and the unpaired " t" test. Results: Clinical improvements in mouth opening was significant in the posttreatment period in both Spirulina and placebo groups. Both the groups showed statistically significant reduction in burning sensation. However, when both groups were compared, mouth opening and burning sensation was found to be statistically very highly significant in favor of the spirulina group. Conclusion: Spirulina can bring about clinical improvements in OSF patients. The observed effects suggest that spirulina can be used as an adjuvant therapy in the initial management of OSF patients. However, studies involving larger samples and longer period of treatment follow up are suggested in the future.

Shetty P; Shenai P; Chatra L; Rao PK

2013-05-01

120

Efficacy of spirulina as an antioxidant adjuvant to corticosteroid injection in management of oral submucous fibrosis.  

Science.gov (United States)

Background and Objectives: Oral submucous fibrosis (OSF) is a chronic condition of the oral cavity which results in permanent disability. A number of studies have proven that the management of premalignant diseases should include antioxidants. Therefore, a study was carried out to evaluate the efficacy of spirulina as an antioxidant adjuvant to corticosteroid injections in the management of 40 oral submucous fibrosis subjects of south Karnataka and north Kerala. Materials and Methods: An intervention study was conducted on 40 oral submucous fibrosis cases, 40 patients were divided into two groups, group A (spirulina group) and group B (placebo group). Group A received spirulina 500 mg twice daily and biweekly intralesional steroid injection of Betamethasone 4 mg/ml for 3 months and group B was given placebo capsules twice daily and biweekly intralesional steroid injection of Betamethasone 4 mg/ml for 3 months. The results were analyzed with the paired " t" test and the unpaired " t" test. Results: Clinical improvements in mouth opening was significant in the posttreatment period in both Spirulina and placebo groups. Both the groups showed statistically significant reduction in burning sensation. However, when both groups were compared, mouth opening and burning sensation was found to be statistically very highly significant in favor of the spirulina group. Conclusion: Spirulina can bring about clinical improvements in OSF patients. The observed effects suggest that spirulina can be used as an adjuvant therapy in the initial management of OSF patients. However, studies involving larger samples and longer period of treatment follow up are suggested in the future. PMID:24025883

Shetty, Prathima; Shenai, Prashanth; Chatra, Laxmikanth; Rao, Prasanna Kumar

 
 
 
 
121

Therapeutic effects of cerebrolysin added to risperidone in patients with schizophrenia dominated by negative symptoms.  

UK PubMed Central (United Kingdom)

OBJECTIVE: Cerebrolysin is a nootropic drug with unique neurotrophic activities directly affecting cerebral neurons. This study evaluated the efficacy and safety of cerebrolysin added to risperidone in patients with schizophrenia dominated by negative symptoms. METHODS: The trial was a double-blind, placebo-controlled, parallel-group design. A total of 109 patients who met the DSM-IV diagnostic criteria for schizophrenia were randomly assigned to cerebrolysin (cerebrolysin plus risperidone, n=55) or placebo (risperidone only, n=54) groups. Intravenous infusions of 30 ml cerebrolysin or placebo were given once daily from Monday to Friday for 4 weeks. Efficacy was assessed with measurements including the Positive and Negative Symptoms Scale (PANSS), Wechsler Memory Scale (WMS), modified Chinese Wechsler Adult Intelligence Scale (mWAIS). and Clinical Global Impression (CGI). RESULTS: Patients in both groups demonstrated improvements in psychiatric symptoms and cognitive and memory performance as assessed by PANSS, mWAIS, and WMS over the trial. There was no difference in rates of change in the PANSS total score or negative score between the two treatment groups. Patients treated with cerebrolysin showed significantly greater improvements in cognitive and memory function from week 2. No severe treatment adverse events were observed in either group. The frequency of adverse events was comparable between the two groups at the end of the treatment. CONCLUSION: Cerebrolysin added to risperidone did not augment the efficacy of risperidone in treating the psychotic symptoms of schizophrenia patients over an 8-week trial. Cerebrolysin at 30 ml per day as an adjunctive treatment was safe and may improve cognitive and memory functions of patients with schizophrenia dominated by negative symptoms.

Xiao S; Xue H; Li G; Yuan C; Li X; Chen C; Wu HZ; Mitchell P; Zhang M

2012-02-01

122

Efficacy of oral, injectable and pour-on formulations of moxidectin against gastrointestinal nematodes in cattle in New Zealand.  

Science.gov (United States)

The efficacy of moxidectin administered by different routes, against naturally acquired infections of gastrointestinal nematode parasites of cattle, was compared using faecal egg count reduction tests on 14 commercial farms throughout New Zealand. On each farm, groups of 15 calves were sampled for faecal nematode egg count and then treated with ivermectin administered orally, or with moxidectin administered either by the oral, subcutaneous injection or topical (pour-on) route. Samples were again collected 14 days after treatment and efficacy was calculated as the percentage reduction in-group mean egg count between the pre- and post-treatment samples. In addition, efficacy was calculated for individual animals, in order to compare the variability of the different treatments. On four farms untreated control groups were run and five animals from each of the control and all of the moxidectin-treated groups were bled over time to estimate plasma-moxidectin concentrations. Averaged across all tests, the reduction in faecal egg count was significantly greater after treatment with moxidectin oral (91.1%) than following treatment with moxidectin injection (55.5%) or with moxidectin pour-on (51.3%). Low efficacies were invariably against Cooperia oncophora. The oral treatments were significantly less variable in efficacy than the injection and pour-on treatments. Moxidectin concentrations in plasma were highest following subcutaneous injection and lowest following pour-on administration. Plasma levels following oral administration were intermediate, being significantly lower than post-injection and significantly higher than post-pour-on. There was no evidence of transfer of moxidectin to untreated animals through licking. Based on these results, along with those of other studies, it is proposed that oral administration of macrocyclic lactone anthelmintics results in higher concentrations of active reaching the target worms in the gastrointestinal tract than following either administration by injection or by pour-on. PMID:23063773

Leathwick, D M; Miller, C M

2012-09-24

123

Efficacy of oral, injectable and pour-on formulations of moxidectin against gastrointestinal nematodes in cattle in New Zealand.  

UK PubMed Central (United Kingdom)

The efficacy of moxidectin administered by different routes, against naturally acquired infections of gastrointestinal nematode parasites of cattle, was compared using faecal egg count reduction tests on 14 commercial farms throughout New Zealand. On each farm, groups of 15 calves were sampled for faecal nematode egg count and then treated with ivermectin administered orally, or with moxidectin administered either by the oral, subcutaneous injection or topical (pour-on) route. Samples were again collected 14 days after treatment and efficacy was calculated as the percentage reduction in-group mean egg count between the pre- and post-treatment samples. In addition, efficacy was calculated for individual animals, in order to compare the variability of the different treatments. On four farms untreated control groups were run and five animals from each of the control and all of the moxidectin-treated groups were bled over time to estimate plasma-moxidectin concentrations. Averaged across all tests, the reduction in faecal egg count was significantly greater after treatment with moxidectin oral (91.1%) than following treatment with moxidectin injection (55.5%) or with moxidectin pour-on (51.3%). Low efficacies were invariably against Cooperia oncophora. The oral treatments were significantly less variable in efficacy than the injection and pour-on treatments. Moxidectin concentrations in plasma were highest following subcutaneous injection and lowest following pour-on administration. Plasma levels following oral administration were intermediate, being significantly lower than post-injection and significantly higher than post-pour-on. There was no evidence of transfer of moxidectin to untreated animals through licking. Based on these results, along with those of other studies, it is proposed that oral administration of macrocyclic lactone anthelmintics results in higher concentrations of active reaching the target worms in the gastrointestinal tract than following either administration by injection or by pour-on.

Leathwick DM; Miller CM

2013-01-01

124

Efficacy of moxidectin 6-month injectable and milbemycin oxime/lufenuron tablets against naturally acquired trichuris vulpis infections in dogs.  

UK PubMed Central (United Kingdom)

Efficacy of moxidectin injection (ProHeart 6 Sustained Release Injectable for Dogs, Fort Dodge Animal Health) against naturally acquired infections of Trichuris vulpis was compared with that of milbemycin oxime/lufenuron tablets (Sentinel Flavor Tabs, Novartis Animal Health). Eighteen dogs infected with T. vulpis were ranked by egg counts and randomly allocated to treatment with moxidectin (170 micro g/kg), milbemycin (500 micro g/kg)/lufenuron (10 mg/kg), or to an untreated control group (six dogs per treatment). Dogs were euthanized for worm counting 7 days after treatment. Efficacy of milbemycin/lufenuron against T. vulpis was 99.6 %, compared with 67.5 % for moxidectin. The commercial formulation of milbemycin oxime/lufenuron provided excellent control of whipworm infection, whereas moxidectin demonstrated variable efficacy against this parasite.

Bowman DD; Legg W; Stansfield DG

2002-01-01

125

Efficacy of moxidectin 6-month injectable and milbemycin oxime/lufenuron tablets against naturally acquired trichuris vulpis infections in dogs.  

Science.gov (United States)

Efficacy of moxidectin injection (ProHeart 6 Sustained Release Injectable for Dogs, Fort Dodge Animal Health) against naturally acquired infections of Trichuris vulpis was compared with that of milbemycin oxime/lufenuron tablets (Sentinel Flavor Tabs, Novartis Animal Health). Eighteen dogs infected with T. vulpis were ranked by egg counts and randomly allocated to treatment with moxidectin (170 micro g/kg), milbemycin (500 micro g/kg)/lufenuron (10 mg/kg), or to an untreated control group (six dogs per treatment). Dogs were euthanized for worm counting 7 days after treatment. Efficacy of milbemycin/lufenuron against T. vulpis was 99.6 %, compared with 67.5 % for moxidectin. The commercial formulation of milbemycin oxime/lufenuron provided excellent control of whipworm infection, whereas moxidectin demonstrated variable efficacy against this parasite. PMID:12447836

Bowman, Dwight D; Legg, Walter; Stansfield, David G

2002-01-01

126

Efficacy of injections of phosphatidylcholine into fat deposits-a non-surgical alternative to liposuction in body-contouring  

Directory of Open Access Journals (Sweden)

Full Text Available Injecting phosphatidylcholine has been used in South America as a non-surgical treatment in body contouring. The objective of this study was to demonstrate the efficacy of injecting phosphatidylcholine in the reduction of localised fat deposits. 86 patients were included in the study. Patients received 1-3 treatments in localised fat deposits in various areas of the body using phosphatidylcholine. After treatment with phosphatidylcholine (250 mg / 5 ml), fat deposits show an average circumferential reduction per application of 2.70 cm. No patient showed irregularities, dimples or any serious side effect after treatment. Results remained stable during the time of follow up. All patients showed remarkable reductions of the fat deposits treated with phosphatidylcholine. Using the correct technique, injecting phosphatidylcholine may be a safe and efficacious alternative to liposuction in patients objecting to surgery.

Karl-G Heinrich

2005-01-01

127

The relationship between prepulse inhibition and general psychopathology in patients with schizophrenia treated with long-acting risperidone.  

UK PubMed Central (United Kingdom)

Patients with schizophrenia exhibit impairments in prepulse inhibition (PPI) of the startle response. Available data suggest that atypical antipsychotics may be more effective than typical antipsychotics in improving PPI deficits in schizophrenia. However, previous studies have used between-subjects rather than longitudinal within-subjects designs to demonstrate superiority of particular atypical antipsychotics over typical antipsychotics in improving PPI in patients with schizophrenia. This longitudinal within-subjects test-retest study was designed to evaluate changes in PPI and clinical symptoms in patients with schizophrenia after switching from the conventional antipsychotic zuclopenthixol to long-acting injectable risperidone. PPI was measured in 45 chronic male patients with schizophrenia treated with zuclophentixol depot (session T1), and 12 weeks after switching to long-acting injectable risperidone (session T2). Thirty-six healthy control subjects were also evaluated. Patients with schizophrenia showed a significant improvement in PPI after changing to long-acting risperidone. Improvement of PPI deficits between T1 and T2 assessments correlated significantly with improvements in PANSS general psychopathology subscale scores. Our findings indicate that long-acting risperidone improves PPI deficits in subjects with chronic schizophrenia. These results also suggest that the PPI-restoring effect of risperidone may be related to improvement in symptoms other than positive and negative symptoms.

Martinez-Gras I; Rubio G; del Manzano BA; Rodriguez-Jimenez R; Garcia-Sanchez F; Bagney A; Leza JC; Borrell J

2009-12-01

128

Efficacy and safety of penile girth enhancement by autologous fat injection for patients with thin penises.  

UK PubMed Central (United Kingdom)

BACKGROUND: This study aimed to investigate the efficacy and safety of autologous fat injection (AFI) for penile girth enhancement (PGE) in patients with thin penises. METHODS: This study investigated 52 patients with a small penile circumference who underwent AFI for PGE and were followed up for more than 6 months. The patients whose proximal one third (G1) and distal one third of their penis (G2) had a mean thickness of 7.4 cm or less were selected as subjects. After fat suction using a liposuction device, fat was evenly injected into the superficial, middle, and deep layers of the Colles' fascia. Patient age and operative time were analyzed. The G1, G2, flaccid (L1), stretched length (L2), and five-item version of the International Index of Erectile Function-5 (IIEF-5) before and 6 months after the surgery were compared. Postoperative complications were surveyed. RESULTS: The patient mean age was 42.15 years (range, 22-56) years, and the operative time was 44.44 min (range, 37-49 min). The injected fat volume was 38.54 ml (range, 25-49 ml). Preoperatively, G1 was 7.01±0.39 cm, and G2 was 7.06±0.37 cm. Postoperatively, G1 was 9.29±0.82 cm (P<0.001), and G2 was 9.34±0.86 (P<0.001) cm 6 months after the surgery. The difference between L1 and L2 before and after the surgery was not significant. The IIEF-5 was 19.10±3.22 before the surgery and 19.90±3.05 after the surgery (P=0.001). The only complication was nodular fat observed in one case (1.92%). CONCLUSION: The use of AFI for PGE in men with thin penises was effective and safe without major complications. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors at www.springer.com/00266.

Kang DH; Chung JH; Kim YJ; Lee HN; Cho SH; Chang TH; Lee SW

2012-08-01

129

Efficacy of perioperative parecoxib injection on postoperative pain relief after laparoscopic cholecystectomy: A prospective, randomized study  

Directory of Open Access Journals (Sweden)

Full Text Available AIM: To determine the efficacy of perioperative parecoxib injection on postoperative pain relief after laparoscopic cholecystectomy.METHODS: A prospective, double-blind, randomized, placebo-controlled study was conducted on 70 patients who underwent elective laparoscopic cholecystectomy under general anesthesia at Siriraj Hospital, Bangkok, from January 2006 to December 2007. Patients were randomized to receive either 20 mg parecoxib infusion 30 min before induction of anesthesia and at 12 h after the first dose (treatment group), or normal saline infusion, in the same schedule, as a placebo (control group). The degree of the postoperative pain was assessed every 3 h in the first 24 h after surgery, and then every 12 h the following day, using a visual analog scale. The consumption of analgesics was also recorded.RESULTS: There were 40 patients in the treatment group, and 30 patients in the control group. The pain scores at each time point, and analgesic consumption did not differ between the two groups. However, there were fewer patients in the treatment group than placebo group who required opioid infusion within the first 24 h (60% vs 37%, P = 0.053).CONCLUSION: Perioperative administration of parecoxib provided no significant effect on postoperative pain relief after laparoscopic cholecystectomy. However, preoperative infusion 20 mg parecoxib could significantly reduce the postoperative opioid consumption.

Thawatchai Akaraviputh, Charay Leelouhapong, Varut Lohsiriwat, Somkiat Aroonpruksakul

2009-01-01

130

Double-blind comparison of ziprasidone and risperidone in the treatment of Chinese patients with acute exacerbation of schizophrenia  

Directory of Open Access Journals (Sweden)

Full Text Available Hongyan Zhang1, Huafang Li2, Liang Shu1, Niufan Gu2, Gang Wang3, Yongzhen Weng3, Shiping Xie4, Xinbao Zhang4, Ting Li5, Cui Ma5, Wei Yu6, Bruce Parsons7, Manjula Schou81Institute of Mental Health, Peking University, Beijing, China; 2Shanghai Mental Health Center, Shanghai, China; 3Capital Medical University, Beijing An Ding Hospital, Beijing, China; 4Nanjing Brain Hospital, Nanjing, China; 5Guangzhou Brain Hospital, Guangzhou, China; 6Pfizer China, Beijing, China; 7Pfizer Inc, New York, NY, USA; 8Pfizer Australia, Sydney, AustraliaBackground: The aim of the study was to evaluate the efficacy and safety of ziprasidone versus risperidone in Chinese subjects with acute exacerbation of schizophrenia.Methods: In patients meeting the Chinese Classification of Mental Disorders criteria for schizophrenia and with a Positive and Negative Syndrome Scale (PANSS) total score ?60 were randomly assigned to six weeks of double-blind treatment with ziprasidone 40–80 mg twice daily or risperidone 1–3 mg bid, flexibly dosed. Noninferiority was demonstrated if the upper limit of the two-sided 95% confidence interval (CI) for the difference in PANSS total score improvement from baseline in the evaluable population was smaller than the prespecified noninferiority margin of 10 units.Results: The intent-to-treat population comprised 118 ziprasidone-treated and 121 risperidone-treated subjects. Improvement (reduction) from baseline to week 6 in PANSS total score was (-35.6 [95% CI: -38.6, -32.6]) for ziprasidone and (-37.1 [95% CI: -39.9, -34.4]) for risperidone. Noninferiority was demonstrated in the evaluable population with a difference score of 1.5 [95% CI: -2.5, 5.5]. Mean prolactin levels decreased at week 6 compared with baseline for ziprasidone (-3.5 ng/mL), but significantly increased for risperidone (61.1 ng/mL; P < 0.001). More risperidone-treated subjects (14.9%) than ziprasidone-treated subjects (4.2%) reported weight gain ?7%. Akathisia and somnolence in the ziprasidone group and akathisia and insomnia in the risperidone group were the most common side effects. Treatment-related/treatment-emergent adverse events were reported by 79.7% and 71.1% of ziprasidone-treated and risperidone-treated subjects, respectively.Conclusion: In Chinese subjects, ziprasidone was as effective as risperidone, with less weight gain and less prolactin elevation.Keywords: ziprasidone, risperidone, schizophrenia

Hongyan Zhang; Huafang Li; Liang Shu; et al

2011-01-01

131

Comparison of Risperidone and Methylphenidate for Reducing ADHD Symptoms in Children and Adolescents with Moderate Mental Retardation.  

Science.gov (United States)

Objective: To evaluate the short-term efficacy and tolerability of risperidone and methylphenidate for reducing symptoms related to attention-deficit/hyperactivity disorder (ADHD) in children and adolescents with moderate mental retardation. Method: In a 4-week, single-blind, parallel-group trial, 45 subjects with moderate mental retardation and…

Filho, Alceu Gomes Correia; Bodanese, Rafael; Silva, Tatiana Laufer; Alvares, Julia Paglioza; Aman, Michael; Rohde, Luis Augusto

2005-01-01

132

Assessment And Comparing The Efficacy Of Propofol Pretreatment With Dexamethasone In Prevalence And Severity Of Its Pain On Injection.  

Directory of Open Access Journals (Sweden)

Full Text Available Background: One of the disturbing complications of propofol is pain on venous injection. Some investigators had reported that corticosteroids effectively induce and prolong the duration of local anesthetics. The aim of this study was to assess and comparing the efficacy of propofol pretreatment with dexamethasone in prevalence and severity of its pain on injection. Materials and Methods: In a randomized, double-blinded, placebo-controlled prospective study, 90ASA I and II, 20 to 60 years-old patients scheduled for elective surgery under general anesthesia were enrolled. In all patients, one of the veins of both hands was catheterized with a 20 G catheter. Then randomly, and simultaneously 2 ml dexamethasone (8 mg) was injected to one of them and 2 ml of normal saline was injected to other. After 30 seconds, 2 ml propofol (20 mg) was injected to both hands, at the same time in 30 seconds. Pain intensity was measured using VAS system. Results: The age mean was 32.87±5.61. Twenty nine patients were male (32.2%). The mean of pain during propofol injection was significantly lower in dexamethasone group than normal saline group (1.61 vs.4.21 respectively, p 0.05). Conclusion: Intravenous administration of 8 mg dexamethasone before propofol IV injection significantly decreases the pain on injection of propofol.

Shoeibi G; Khajavi Khan J; Movafegh A

2005-01-01

133

Treatment of paradoxical insomnia with atypical antipsychotic drugs. A comparison of olanzapine and risperidone.  

UK PubMed Central (United Kingdom)

OBJECTIVE: To compare the efficacy of 2 atypical anti-psychotic drugs, olanzapine and risperidone, in the treatment of paradoxical insomnia. METHODS: In this cross-sectional study over a 2-year period (September 2008 to September 2010), 29 patients with paradoxical insomnia, diagnosed in Kermanshah, Iran by both psychiatric interview and actigraphy, were randomly assigned to 2 groups. For 8 weeks, the first group (n=14) was treated with 10 mg olanzapine daily, and the second group (n=15) was treated with 4 mg risperidone daily. All participants completed the Pittsburgh Sleep Quality Inventory (PSQI) at baseline and at the end of the study. RESULTS: As expected, a baseline actigraphy analysis showed that total sleep time was not significantly different between the 2 treatment groups (p<0.3). In both groups, sleep quality was improved (p<0.001) with treatment. When comparing the 2 treatments directions, a significant difference emerged (9.21+/-2.35, 6.07+/-4.46) among the 2 treatment groups based on data from the PSQI. Patients who were treated with olanzapine showed greater improvement than patients who were treated by risperidone (p<0.04). CONCLUSION: Atypical anti-psychotic drugs such as olanzapine and risperidone may be beneficial options for treatment of paradoxical insomnia. Larger clinical trials with longer periods of follow-up are needed for further investigation.

Khazaie H; Rezaie L; Darvishi F; Najafi F; Avis K

2013-01-01

134

[Increased risk of stroke during the use of olanzapine or risperidone in patients with dementia  

UK PubMed Central (United Kingdom)

Post-hoc analysis by the pharmaceutical company Eli Lilly of 5 randomised clinical trials concerning the efficacy ofolanzapine in patients with dementia, has shown that patients taking olanzapine have a risk of experiencing a cerebrovascular accident which is 3 times higher than patients taking placebo. This increased risk has also been found in patients with dementia who take risperidone. Details concerning this relationship cannot be obtained from the sparse information supplied by the producers of risperidone and olanzapine. The pathophysiological mechanisms by which atypical antipsychotics may lead to cerebrovascular accidents are not well understood. Atypical antipsychotics are often prescribed for conditions in which evidence of the efficacy of this group of medications is lacking. This association between antipsychotics and cerebrovascular accidents emphasises the need for a stricter and evidence-based prescription policy for antipsychotics. In cases of adverse drug reaction, more openness on the part of pharmaceutical companies is desirable.

van Marum RJ; Jansen PA

2005-01-01

135

Evaluation of the efficacy of intravitreal injection of triamcinolone acetonide in patients with pseudophakic cystoid macular edema  

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Full Text Available Aim: To evaluate the efficacy of 4mg/0.1ml intravitreal injection of triamcinolone acetonide (IVTA) in patients with pseudophakic cystoid macular edema.Materials and Methods: Thirteen eyes of 13 patients with pseudophakic cystoid macular edema (mean age: 66.5±8.4 years) were included in the study. Before and after 4mg/0.1ml IVTA injections, visual acuity, fundus fluorescein angiography (FFA) findings, intraocular pressures (IOP) and complications were recorded in all patients.Results: It was observed that visual acuity increases with improvement in FFA findings in all patients. The difference in IOP values before and after IVTA injection was statistically significant (P21mmHg was observed in 3 eyes that required antiglaucomatous medication to control IOP.Conclusion: IVTA injection is an effective and safe treatment option in patients with pseudophakic cystoid macular edema to increase the visual acuity and resolution of macular edema.

Abdullah Özk?r??; Kuddusi Erk?l?ç; Özgür ?lhan; Esra Ayhan Tuzcu

2007-01-01

136

The effect of location of the ureteric orifice on the efficacy of endoscopic injection to correct vesico-ureteric reflux.  

UK PubMed Central (United Kingdom)

OBJECTIVE: To review our 11-year experience and identify the mechanisms responsible for the failure of endoscopic injection for vesico-ureteric reflux (VUR) with three different injectable agents, based on the location of the ureteric orifice on endoscopy. PATIENTS AND METHODS: We retrospectively reviewed the charts and endoscopic video-photographs of 46 patients (26 girls, 20 boys, median age 6 years, range 2-16) with VUR treated once or twice by subureteric injection with PTFE, or polydimethylsiloxane or dextranomer/hyaluronic acid copolymer, from 1992 to 2003. Five patients were lost to follow-up and six ectopic and/or duplicated ureters were excluded from the analysis; in all, 52 ureters were analysed. According to the international classification, the VUR was grades I to V in four (8%), 12 (23%), 16 (31%), 13 (25%) and seven (13%) ureters, respectively. RESULTS: After 3 months, voiding cysto-urethrography showed that VUR continued in six of 19, seven of 12 and eight of 21 ureters (38%), respectively, after subureteric PTFE, polydimethylsiloxane and dextranomer/hyaluronic acid copolymer injection; after the second injection, reflux continued in two of six, four of seven and three of eight ureters, respectively. Mound displacement and/or volume loss was the most common failure with all three bulking agents after both the first (62%) and second injections (44%) (P < 0.05). The first injection failed in 32% (11 of 35) normally located ureters and 10 of 17 lateral ureters (P < 0.05). The second injection failed in 11% (four of 35) normal and five of 17 lateral ureters (P < 0.05). CONCLUSIONS: A lateral ureteric orifice may decrease the efficacy of endoscopic injection, as the likelihood of a faulty injection is greater. However, a more careful second injection decreases the failure rate, particularly in those with low- to medium-grade refluxing ureters.

Yucel S; Ucar M; Guntekin E; Kukul E; Melikoglu M; Baykara M

2005-06-01

137

A 12-week intramuscular toxicity study of risperidone-loaded microspheres in Beagle dogs.  

UK PubMed Central (United Kingdom)

Long-acting formulations of antipsychotics are important treatment options to increase the compliance of schizophrenic patients. Risperidone, a 5-HT2 and dopaminergic D2 receptor antagonist, was developed as long-acting sustained-release microspheres with poly(lactide-co-glycolide) (PLGA) as a drug carrier for the treatment of schizophrenia. In the present study, the main objective is to determine the nonclinical safety profile of risperidone-loaded microspheres (RM) in Beagle dogs after intramuscular administration for 3 months, once in 2 weeks, followed by 8-week recovery phase. No animal death was found and no special toxicological findings were observed. The findings, such as hypoactivity, ptosis, increased heart rate, and elevated serum and pituitary prolactin levels, were observed and related to the pharmacological effects of risperidone. The changes in the reproductive system (uterus, ovary, vagina, cervix, and mammary gland) were considered secondary to the prolactin elevation, and the congestion of spleen was related to risperidone. The foreign body granulomas at injection sites might be caused by PLGA. At the end of recovery phase, the above changes mostly recovered to normal, and on administering 3 mg/kg dose level once in 2 weeks on Beagle dogs showed no observed adverse effect. Taken together, RM had exhibited the acceptable safety.

Tian J; Wang W; Ye L; Cen X; Guan X; Zhang J; Yu P; Du G; Liu W; Li Y

2013-08-01

138

Risperidone Associated Paralytic Ileus in Schizophrenia  

Science.gov (United States)

A 32-year-old man, diagnosed with catatonic schizophrenia, was treated with risperidone and lorazepam in the general hospital psychiatry setup. He developed signs of intestinal obstruction, which was diagnosed as paralytic ileus and was treated conservatively along with stopping the offending drug. Risperidone is said to be devoid of anticholinergic side effects, but prevalence of these varies from 7% to 13% in patients receiving treatment for schizophrenia. Constipation has been reported but fatal adverse effect like paralytic ileus with risperidone is rarely reported. Timely diagnosis can save the need for surgical interventions and fatal complications. This predisposition in schizophrenia could be due to neurodevelopmentally shared abnormality of brain and gut nervous system.

Ramamourthy, Parthasarathy; Kumaran, Arunkumar; Kattimani, Shivanand

2013-01-01

139

Risperidone associated paralytic ileus in schizophrenia.  

UK PubMed Central (United Kingdom)

A 32-year-old man, diagnosed with catatonic schizophrenia, was treated with risperidone and lorazepam in the general hospital psychiatry setup. He developed signs of intestinal obstruction, which was diagnosed as paralytic ileus and was treated conservatively along with stopping the offending drug. Risperidone is said to be devoid of anticholinergic side effects, but prevalence of these varies from 7% to 13% in patients receiving treatment for schizophrenia. Constipation has been reported but fatal adverse effect like paralytic ileus with risperidone is rarely reported. Timely diagnosis can save the need for surgical interventions and fatal complications. This predisposition in schizophrenia could be due to neurodevelopmentally shared abnormality of brain and gut nervous system.

Ramamourthy P; Kumaran A; Kattimani S

2013-01-01

140

Efficacy of moxidectin 6-month injectable and milbemycin oxime/lufenuron tablets against naturally acquired toxocara canis infections in dogs.  

UK PubMed Central (United Kingdom)

The efficacy of moxidectin injection (ProHeart 6 Sustained Release Injectable for Dogs, Fort Dodge Animal Health) against naturally acquired infections of Toxocara canis was compared with that of milbemycin oxime/lufenuron tablets (Sentinel Flavor Tabs, Novartis Animal Health). Eighteen dogs with naturally acquired infections of T. canis were ranked by egg counts and randomly assigned to treatment with moxidectin (170 micro g/kg), milbemycin (500 micro g/kg)/lufenuron (10 mg/kg), or to an untreated control group (six dogs per treatment). Dogs were euthanized 7 days after treatment for recovery, identification, and enumeration of parasites by species. There was no apparent efficacy for moxidectin against T. canis. Conversely, milbemycin oxime/lufenuron was 91.5 % effective against naturally occurring infections of this canine parasite.

Bowman DD; Legg W; Stansfield DG

2002-01-01

 
 
 
 
141

Efficacy of moxidectin 6-month injectable and milbemycin oxime/lufenuron tablets against naturally acquired toxocara canis infections in dogs.  

Science.gov (United States)

The efficacy of moxidectin injection (ProHeart 6 Sustained Release Injectable for Dogs, Fort Dodge Animal Health) against naturally acquired infections of Toxocara canis was compared with that of milbemycin oxime/lufenuron tablets (Sentinel Flavor Tabs, Novartis Animal Health). Eighteen dogs with naturally acquired infections of T. canis were ranked by egg counts and randomly assigned to treatment with moxidectin (170 micro g/kg), milbemycin (500 micro g/kg)/lufenuron (10 mg/kg), or to an untreated control group (six dogs per treatment). Dogs were euthanized 7 days after treatment for recovery, identification, and enumeration of parasites by species. There was no apparent efficacy for moxidectin against T. canis. Conversely, milbemycin oxime/lufenuron was 91.5 % effective against naturally occurring infections of this canine parasite. PMID:12447835

Bowman, Dwight D; Legg, Walter; Stansfield, David G

2002-01-01

142

Risperidone in the treatment of conduct disorder in preschool children without intellectual disability  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background The DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, 4th edition Textrevision) highlights the especially poor outcomes of early-onset conduct disorder (CD). The strong link between the patient's age at treatment and its efficacy points the importance of early intervention. Risperidone is one of the most commonly studied medications used to treat CD in children and adolescents. The aim of this study is to obtain preliminary data about the efficacy and tolerability of risperidone treatment in otherwise typically developing preschool children with conduct disorder and severe behavioral problems. Method We recruited 12 otherwise normally developing preschoolers (ten boys and two girls) with CD for this study. We could not follow up with 4 children at control visits properly; thus, 8 children (six girls, two boys; mean age: 42.4 months) completed the study. We treated the patients with risperidone in an open-label fashion for 8 weeks, starting with a daily dosage of 0.125 mg/day or 0.25 mg/day depending on the patient's weight (20 kg children: 0.25 mg/day). Dosage titration and increments were performed at 2-week interval clinical assessments. The Turgay DSM-IV Based Disruptive Behavior Disorders Child and Adolescent Rating & Screening Scale (T-DSM-IV-S) as well as the Clinical Global Impression Scale (CGI) assessed treatment efficacy; the Extrapyramidal Symptom Rating Scale (ESRS) and laboratory evaluations assessed treatment safety. Results The mean daily dosage of risperidone at the end of 8 weeks was 0.78 mg/day (SD: 0.39) with a maximum dosage of 1.50 mg/day. Based on the CGI global improvement item, we classified all patients as "responders" (very much or much improved). Risperidone was associated with a 78% reduction in the CGI Severity score. We also detected significant improvements on all of the subscales of the T-DSM-IV-S. Tolerability was good, and serious adverse effects were not observed. We detected statistically significant prolactin level increments (p Conclusion The results of this study suggest that risperidone may be an effective and well-tolerated atypical antipsychotic for the treatment of CD in otherwise normally developing preschool children. The findings of the study should be interpreted as preliminary data considering its small sample size and open-label methodology.

Ercan Eyup S; Basay Burge; Basay Omer; Durak Sibel; Ozbaran Burcu

2011-01-01

143

Effect of aripiprazole on cognitive function and hyperprolactinemia in patients with schizophrenia treated with risperidone.  

UK PubMed Central (United Kingdom)

OBJECTIVE: This study aimed to assess the efficacy of aripiprazole for the management of cognitive impairments and hyperprolactinemia in patients with schizophrenia on a stable dose of risperidone. METHODS: Thirty-five subjects stabilized on risperidone (3-6 mg/day) for a minimum of 3 months were enrolled in a double-blind, placebo-controlled phase for 12 weeks and an open-label phase for another 12 weeks. Subjects were randomly assigned to receive 10 mg/day aripiprazole (n=17) or placebo (n=18). Over the following 12 weeks, the the aripiprazole group received a flexible dose of aripiprazole while tapering risperidone. At baseline, week 12, and week 24, subjects were evaluated using the Positive and Negative Syndrome Scale (PANSS), Extrapyramidal Syndrome Rating Scale (ESRS), and standardized neuropsychological assessments. Serum prolactin levels were checked at baseline, week 1, week 2, and week 24. RESULTS: The mean change in total PANSS and cognitive function test scores between baseline and endpoint were similar in the aripiprazole and placebo groups. Scores on the ESRS and negative subscale of PANSS differed significantly between groups in both phases of the study (p<0.05), indicating a positive effect of aripiprazole. Compared with placebo, aripiprazole significantly reduced mean baseline serum prolactin levels within 1 week (p=0.015). CONCLUSION: Adjunctive treatment with and switching to aripiprazole were not associated with improved cognitive function in patients with schizophrenia receiving risperidone; however, aripiprazole treatment decreased negative symptoms and risperidone-induced motor side effects and lowered serum prolactin levels.

Lee BJ; Lee SJ; Kim MK; Lee JG; Park SW; Kim GM; Kim YH

2013-08-01

144

Pharmacokinetic and efficacy study of cisplatin and paclitaxel formulated in a new injectable poly(sebacic-co-ricinoleic acid) polymer.  

Science.gov (United States)

Injectable biodegradable polymer poly(sebacic-co-ricinoleic acid), P(SA-RA) is currently under development for intratumoral (IT) delivery of drugs for treating solid tumors. This study presents formulation development, pharmacokinetic and efficacy studies of two anticancer drugs (cisplatin and paclitaxel) formulated with P(SA-RA) polymer. In pharmacokinetic study, systemic exposure and pharmacokinetic parameters of cisplatin/paclitaxel following single intravenous (IV) or subcutaneous (SC) doses of cisplatin/paclitaxel was compared with intramuscular (IM) or SC doses of cisplatin/paclitaxel formulated with P(SA-RA) polymer in male CD rat. Simultaneously, the tumor reduction effect and toxicity for these formulations were evaluated in human FaDu head and neck tumor xenograft subcutaneous nude mouse model. Pharmacokinetic data reflect the lower maximal concentrations and sustained release of polymer-cisplatin/paclitaxel formulations compared to standard cisplatin/paclitaxel administration. Regarding efficacy study, a single IT or near the tumor injection (NT) of polymer-paclitaxel or polymer-cisplatin formulation significantly reduced the tumor size, compared to the standard paclitaxel or cisplatin treatments. No death or toxicity and no effect on body weight as well as macroscopic and/or microscopic changes in or near the injected area were observed, proving biocompatibility and acceptability of polymer-formulations. In conclusion, the developed formulation demonstrated controlled release and significant efficacy in delivering these agents and exhibit potential for further clinical development. PMID:22732267

Levy-Nissenbaum, Etgar; Khan, Wahid; Pawar, Rajendra P; Tabakman, Rinat; Naftali, Esmira; Winkler, Ilan; Kaufman, Olga; Klapper, Leah; Domb, Abraham J

2012-06-23

145

Pharmacokinetic and efficacy study of cisplatin and paclitaxel formulated in a new injectable poly(sebacic-co-ricinoleic acid) polymer.  

UK PubMed Central (United Kingdom)

Injectable biodegradable polymer poly(sebacic-co-ricinoleic acid), P(SA-RA) is currently under development for intratumoral (IT) delivery of drugs for treating solid tumors. This study presents formulation development, pharmacokinetic and efficacy studies of two anticancer drugs (cisplatin and paclitaxel) formulated with P(SA-RA) polymer. In pharmacokinetic study, systemic exposure and pharmacokinetic parameters of cisplatin/paclitaxel following single intravenous (IV) or subcutaneous (SC) doses of cisplatin/paclitaxel was compared with intramuscular (IM) or SC doses of cisplatin/paclitaxel formulated with P(SA-RA) polymer in male CD rat. Simultaneously, the tumor reduction effect and toxicity for these formulations were evaluated in human FaDu head and neck tumor xenograft subcutaneous nude mouse model. Pharmacokinetic data reflect the lower maximal concentrations and sustained release of polymer-cisplatin/paclitaxel formulations compared to standard cisplatin/paclitaxel administration. Regarding efficacy study, a single IT or near the tumor injection (NT) of polymer-paclitaxel or polymer-cisplatin formulation significantly reduced the tumor size, compared to the standard paclitaxel or cisplatin treatments. No death or toxicity and no effect on body weight as well as macroscopic and/or microscopic changes in or near the injected area were observed, proving biocompatibility and acceptability of polymer-formulations. In conclusion, the developed formulation demonstrated controlled release and significant efficacy in delivering these agents and exhibit potential for further clinical development.

Levy-Nissenbaum E; Khan W; Pawar RP; Tabakman R; Naftali E; Winkler I; Kaufman O; Klapper L; Domb AJ

2012-09-01

146

In vivo efficacy of paclitaxel-loaded injectable in situ-forming gel against subcutaneous tumor growth.  

UK PubMed Central (United Kingdom)

Injectable in situ-forming gels have received considerable attention as localized drug delivery systems. Here, we examined a poly(ethylene glycol)-b-polycaprolactone (MPEG-PCL) diblock copolymer gel as an injectable drug depot for paclitaxel (Ptx). The copolymer solution remained liquid at room temperature and rapidly gelled in vivo at body temperature. In vitro experiments showed that Ptx was released from MPEG-PCL copolymer gels over the course of more than 14 days. Experiments employing intratumoral injection of saline (control), gel-only, Taxol, or Ptx-loaded gel into mice bearing B16F10 tumor xenografts showed that Ptx-loaded gel inhibited the growth of B16F10 tumors more effectively than did saline or gel alone. Further, intratumoral injection of Ptx-loaded gel was more efficacious in inhibiting the growth of B16F10 tumor over 10 days than was injection of Taxol. A histological analysis demonstrated an increase in necrotic tissue in tumors treated with Ptx-loaded gel. In conclusion, our data show that intratumoral injection of Ptx-loaded MPEG-PCL diblock copolymer yielded an in situ-forming gel that exhibited controlled Ptx release profile, and that was effective in treating localized solid tumors.

Lee JY; Kim KS; Kang YM; Kim ES; Hwang SJ; Lee HB; Min BH; Kim JH; Kim MS

2010-06-01

147

Choline acetyltransferase expression in rat prefrontal cortex and hippocampus after acute and chronic exposure to amisulpride, haloperidol, and risperidone.  

Science.gov (United States)

Recently, there has been an increasing concern that atypical antipsychotics as well as typical ones may cause detrimental effects on cognitive function. Supporting evidence comes from many preclinical studies demonstrating that long-term administration of haloperidol, risperidone, and ziprasidone reduced choline acetyltransferase (ChAT) expression in rat hippocampus (HIP). However, to the best of our knowledge, no studies have examined the effects of amisulpride on ChAT expression in rats. Therefore, the aim of this study was to investigate the effects of acute and chronic administration of amisulpride, haloperidol, and risperidone on ChAT expression in the rat prefrontal cortex (PFC) and HIP. Animals received daily intraperitoneal (i.p.) injections of amisulpride (5 or 100mg/kg), haloperidol (1 or 2mg/kg), risperidone (1 or 2mg/kg) or vehicle for 7 or 45 days. One day after the last injection, rats were sacrificed. ChAT immunoreactivity was assessed with immunofluorescence staining. Target areas of brain were PFC and HIP (CA1, CA3 and DG). The short-term administration of haloperidol and risperidone produced significant decrease of ChAT immunoreactivity in the PFC and HIP compared to vehicle whereas amisulpride had no effects on ChAT immunoreactivity in the PFC and HIP. In long-term study, haloperidol and risperidone decreased ChAT-positive cells and/or fiber pixel density in the PFC and HIP whereas amisulpride decreased ChAT-positive cells in the PFC and had no effects on fiber pixel density of ChAT in the HIP. The results suggest that both short-term and long-term administration of haloperidol and risperidone, and long-term administration of amisulpride may produce detrimental effects on cognitive function by reducing ChAT expression in the PFC and/or HIP. PMID:22999925

Huang, Guang-Biao; Zhao, Tong; Li, Chun-Rong; Sui, Zhi-Yan; Kang, Nam-In; Han, Eui-Hyeog; Chung, Young-Chul

2012-09-19

148

Choline acetyltransferase expression in rat prefrontal cortex and hippocampus after acute and chronic exposure to amisulpride, haloperidol, and risperidone.  

UK PubMed Central (United Kingdom)

Recently, there has been an increasing concern that atypical antipsychotics as well as typical ones may cause detrimental effects on cognitive function. Supporting evidence comes from many preclinical studies demonstrating that long-term administration of haloperidol, risperidone, and ziprasidone reduced choline acetyltransferase (ChAT) expression in rat hippocampus (HIP). However, to the best of our knowledge, no studies have examined the effects of amisulpride on ChAT expression in rats. Therefore, the aim of this study was to investigate the effects of acute and chronic administration of amisulpride, haloperidol, and risperidone on ChAT expression in the rat prefrontal cortex (PFC) and HIP. Animals received daily intraperitoneal (i.p.) injections of amisulpride (5 or 100mg/kg), haloperidol (1 or 2mg/kg), risperidone (1 or 2mg/kg) or vehicle for 7 or 45 days. One day after the last injection, rats were sacrificed. ChAT immunoreactivity was assessed with immunofluorescence staining. Target areas of brain were PFC and HIP (CA1, CA3 and DG). The short-term administration of haloperidol and risperidone produced significant decrease of ChAT immunoreactivity in the PFC and HIP compared to vehicle whereas amisulpride had no effects on ChAT immunoreactivity in the PFC and HIP. In long-term study, haloperidol and risperidone decreased ChAT-positive cells and/or fiber pixel density in the PFC and HIP whereas amisulpride decreased ChAT-positive cells in the PFC and had no effects on fiber pixel density of ChAT in the HIP. The results suggest that both short-term and long-term administration of haloperidol and risperidone, and long-term administration of amisulpride may produce detrimental effects on cognitive function by reducing ChAT expression in the PFC and/or HIP.

Huang GB; Zhao T; Li CR; Sui ZY; Kang NI; Han EH; Chung YC

2012-10-01

149

Evaluation of the long-term efficacy of CT-guided epidural steroid injection for the treatment of sciatica  

International Nuclear Information System (INIS)

Objective: To evaluate the long-term efficacy of CT-guided epidural steroid injection for the treatment of sciatica. Methods: CT-guided epidural steroid injection was performed in 180 patients with sciatica from May 1998 to March 2004, and all patients had failure to previous conservative treatment. Visual analogue scale was used to evaluate the pain of the patient before and after the treatment. Results: Follow-up was taken for 112 cases during 1-6 years after the treatment, 89 patients (79.5%) had successful long-term outcome and 80 patients (71.4%) were satisfied. Conclusions: CT-guided epidural steroid injection can reduce low back pain and radical pain. It should be preferentially considered as the first choice when conservative treatments are failed. (authors)

2005-01-01

150

Experimental study on effects of Shengmai Injection: enhancing 5-FU anti-tumor efficacy and reducing its toxicity  

Directory of Open Access Journals (Sweden)

Full Text Available Objevtive: To observe the effects of Shengmai Injection on enhancing efficacy and reducing toxicity of 5-fluorouracil (5-FU). Methods: Fifty hepatoma 22 bearing mice were randomly divided into five groups: control group, 5-Fu group, Shengmai Injection (low, medium and high dose) combined with 5-FU groups. There were 10 mice in each group. Mice in the five groups were injected introperitoneally the same amount of normal saline, 5-FU (20 mg·kg?1·d?1) and Shengmai Injection (3.5 ml·kg?1·d?1, 7 ml·kg?1·d?1 and 14 ml·kg?1·d?1) combined with 5-FU respectively, once a day for 14 days. After that, all mice were killed and the tumor inhibiting rates, index of immunological function, liver and kidney function and the blood cells in the peripheral blood were observed. Results: The tumor inhibiting rates were higher in each Shengmai Injection combined with 5-FU group than that in the 5-FU group (P?0.05). The levels of CD3, CD4, CD4/CD8, IgG, IgM in 5-FU group were lower (P?0.05), while those in the three Shengmai Injection combined with 5-FU groups were higher than those in the control group (P?0.05). The level of serum alanine aminotransferase (ALT) was higher and the WBC and PLT counts in the peripheral blood were lower in 5-FU group than those in the control group (P?0.05). But the levels of serum ALT in the three Shengmai Injection combined with 5-FU groups were consistent with that in the control group and the amounts of WBC decreased slightly. Conclusion: Shengmai Injection can enhance the anti-tumor effect of 5-FU. It can also improve the immunological function and reduce the adverse reactions of chemotherapy.

CHEN Zhen

2005-01-01

151

Escitalopram versus risperidone for the treatment of behavioral and psychotic symptoms associated with Alzheimer's disease: a randomized double-blind pilot study.  

UK PubMed Central (United Kingdom)

ABSTRACTBackground: Antipsychotics are frequently used to treat psychosis, aggression and agitation in patients with Alzheimer's disease (AD), but safety warnings abound. Escitalopram was investigated since citalopram has demonstrated some effectiveness in AD. We compared escitalopram and risperidone for psychotic symptoms and agitation associated with AD.Methods: Inpatients with AD, who had been hospitalized because of behavioral symptoms, were recruited to a six-week randomized, double-blind, controlled trial. Participants (n = 40) were randomized to once daily risperidone 1 mg or escitalopram 10 mg.Results: The NPI total score improved in both groups. Onset was earlier in the risperidone-treated group, but improvement did not significantly differ between groups by study end. Completion rates differed for escitalopram (75%) and risperidone (55%), mainly due to adverse events. There were no adverse events in the escitalopram group, while in the risperidone group two patients suffered severe extrapyramidal symptoms and four patients suffered acute physical illness necessitating transfer to general hospital.Conclusion: Escitalopram and risperidone did not differ in efficacy in reducing psychotic symptoms and agitation in patients with AD. Completion rates were higher for escitalopram-treated patients. Replication in larger trials with ambulatory patients is needed.

Barak Y; Plopski I; Tadger S; Paleacu D

2011-11-01

152

Comparison of topiramate and risperidone for the treatment of behavioral disturbances of patients with Alzheimer disease: a double-blind, randomized clinical trial.  

UK PubMed Central (United Kingdom)

INTRODUCTION: Behavioral disturbances are determining factors in handling patients with Alzheimer dementia. The current pharmacotherapy for behavioral symptoms associated with dementia is not satisfactory. Our goal was to compare a new anticonvulsant, topiramate, with a usually used medication, risperidone, for controlling behavioral disturbances of patients with Alzheimer dementia. METHOD: Elderly patients with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of Alzheimer disease and significant behavioral disturbances were randomized to receive, for a period of 8 weeks, a flexible dose of either topiramate (25-50 mg/d) or risperidone (0.5-2 mg/d). Outcome measures were the Cohen-Mansfield Agitation Inventory, Neuropsychiatry Inventory parts 1 and 2, and the Clinical Global Impression. RESULT: Forty-eight patients were randomized to treatment with either topiramate or risperidone, and 41 patients (21 of 25 in topiramate group and 20 of 23 in risperidone group) completed the trial. Both groups showed significant improvement in all outcome measures without important difference (Neuropsychiatry Inventory total score P < 0.531, Z = 0.62; Cohen-Mansfield Agitation Inventory P < 0.927, Z = 0.09; Clinical Global Impression, P < 0.654, Z = 0.48). There were no significant changes in the cognitive status of patients (assessed by Mini-Mental Status Examination) taking topiramate or risperidone during the trial. CONCLUSION: Treatment with a low dose of topiramate (25-50 mg/d) demonstrated a comparable efficacy with risperidone in controlling behavioral disturbances of patients with Alzheimer dementia.

Mowla A; Pani A

2010-02-01

153

Results of the Tokyo Trial of Prevention of Post-ERCP Pancreatitis with Risperidone-2: a multicenter, randomized, placebo-controlled, double-blind clinical trial.  

UK PubMed Central (United Kingdom)

BACKGROUND: Our previous study suggested that a combination of ulinastatin and risperidone reduced post-ERCP pancreatitis (PEP) compared with ulinastatin alone. OBJECTIVE: The aim of this study was to evaluate the efficacy of risperidone alone for prevention of PEP. DESIGN: A multicenter, randomized, placebo-controlled, double-blind clinical trial. SETTING: Two academic hospitals and 5 referral hospitals in Tokyo and Saitama, Japan. PATIENTS: Patients undergoing therapeutic or interventional-diagnostic ERCP. INTERVENTION: The patients were randomized to receive 2 mg of oral risperidone or oral placebo at 0.5 to 2 hours before ERCP. MAIN OUTCOME MEASUREMENTS: The primary endpoint was the incidence of PEP. Secondary endpoints were the incidence of hyperenzymemia and enzyme levels (amylase, pancreatic amylase, lipase). Risk factors for PEP were evaluated. RESULTS: We initially enrolled 500 patients in the study (250 in the risperidone group and 250 in the placebo group), but 17 (11 in the risperidone and 6 in the placebo group) were excluded after randomization. PEP developed in 24 patients (10.0%) in the risperidone group and 21 patients (8.6%) in the placebo group (P = .587). Serum amylase levels at 3 hours after ERCP were lower in the risperidone group (P = .007 in a single test of hypothesis, significance removed by Bonferroni correction for multiple testing). In multivariate analysis, a small papilla of Vater, total procedure time ?40 minutes, and stenosis of the intrahepatic duct were significantly associated with PEP. LIMITATIONS: Multiplicity of study centers and a relatively wide time range of drug administration time. CONCLUSION: Risperidone did not show a benefit in prevention of PEP in this trial. (Clinical trial registration number: NCT000004592).

Uchino R; Isayama H; Tsujino T; Sasahira N; Ito Y; Matsubara S; Takahara N; Arizumi T; Toda N; Mohri D; Togawa O; Yagioka H; Yanagihara Y; Nakajima K; Akiyama D; Hamada T; Miyabayashi K; Mizuno S; Kawakubo K; Kogure H; Sasaki T; Yamamoto N; Nakai Y; Hirano K; Tada M; Koike K

2013-07-01

154

De Quervain’s disease: efficacy of intra-sheath triamcinolone injection  

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The methods and clinical outcomes of intra-sheath triamcinolone injection in the treatment of de Quervain’s disease are described. We used 38 hands of 36 patients. A mixture of 1 ml of triamcinolone and 1 ml of 1% lidocaine hydrochloride was injected, with an interval of 2 weeks. The fluid was injec...

Sawaizumi, Takuya; Nanno, Mitsuhiko; Ito, Hiromoto

155

Efficacy and Safety of 10,600-nm Carbon Dioxide Fractional Laser on Facial Skin with Previous Volume Injections  

Science.gov (United States)

Background: Fractionated carbon dioxide (CO2) lasers are a new treatment modality for skin resurfacing. The cosmetic rejuvenation market abounds with various injectable devices (poly-L-lactic acid, polymethyl-methacrylate, collagens, hyaluronic acids, silicone). The objective of this study is to examine the efficacy and safety of 10,600-nm CO2 fractional laser on facial skin with previous volume injections. Materials and Methods: This is a retrospective study including 14 patients treated with fractional CO2 laser and who have had previous facial volume restoration. The indication for the laser therapy, the age of the patients, previous facial volume restoration, and side effects were all recorded from their medical files. Objective assessments were made through clinical physician global assessment records and improvement scores records. Patients’ satisfaction rates were also recorded. Results: Review of medical records of the 14 patients show that five patients had polylactic acid injection prior to the laser session. Eight patients had hyaluronic acid injection prior to the laser session. Two patients had fat injection, two had silicone injection and one patient had facial thread lift. Side effects included pain during the laser treatment, post-treatment scaling, post-treatment erythema, hyperpigmentation which spontaneously resolved within a month. Concerning the previous facial volume restoration, no granulomatous reactions were noted, no facial shape deformation and no asymmetry were encountered whatever the facial volume product was. Conclusion: CO2 fractional laser treatments do not seem to affect facial skin which had previous facial volume restoration with polylactic acid for more than 6 years, hyaluronic acid for more than 0.5 year, silicone for more than 6 years, or fat for more than 1.4 year. Prospective larger studies focusing on many other variables (skin phototype, injected device type) are required to achieve better conclusions.

Helou, Josiane; Maatouk, Ismael; Moutran, Roy; Obeid, Grace; Stephan, Farid

2013-01-01

156

[Treatment of behavioral disorders by risperidone in children with autism].  

UK PubMed Central (United Kingdom)

OBJECTIVE: To study the effect of risperidone treatment on behavioral disorders in children with autism. METHODS: Forty children with behavioral disorders (aged from 5 to 12 years) were treated with risperidone for 8 weeks. The behavioral symptoms were evaluated by the Clinical Global Impression (CGI) and the Autism Treatment Evaluation Checklist (ATEC) before and after the treatment. The adverse events related to risperidone treatment were observed. RESULTS: The score of severity of illness and the ATEC total scores were significantly reduced 8 weeks after risperidone treatment. Besides the social intercourse ability, great improvements have been shown on the verbal communication, apperception and behavioural symptoms by the ATEC. No severe adverse events related to risperidone treatment were observed. CONCLUSIONS: Risperidone can significantly improve the behavioral disorders in children with autism and is well-tolerated.

Wei BY; Huang F; Qin XT; Liang QQ

2011-03-01

157

Divalproex ER combined with olanzapine or risperidone for treatment of acute exacerbations of schizophrenia.  

Science.gov (United States)

The objective of this study was to evaluate the efficacy and safety of divalproex sodium extended release (divalproex ER) vs placebo in combination with olanzapine or risperidone for the treatment of acute exacerbations of schizophrenia. In this 12-week, randomized, double-blind, parallel-group, multi-center trial, a total of 402 patients were randomized and treated; 103 received olanzapine/placebo, 99 received olanzapine/divalproex ER, 101 received risperidone/placebo, and 99 received risperidone/divalproex ER. Divalproex ER was initiated on day 1 at 20 mg/kg per day q AM and was titrated to clinical effect on days 3, 7, and 10, not to exceed a maximum dosage of 35 mg/kg per day. Olanzapine and risperidone were initiated at 5 and 2 mg/day q PM, respectively, increased to 10 and 4 mg/day on day 3, and increased to fixed target doses of 15 and 6 mg/day on day 6. No significant treatment difference was demonstrated between the combination therapy and antipsychotic monotherapy groups on the primary efficacy variable of the mean change from baseline to day 14 last observation carried forward on the Positive and Negative Syndrome Scale (PANSS) total score, although antipsychotic monotherapy did demonstrate superiority to combination therapy on the PANSS Negative subscale at several time points. Combination therapy also failed to show an advantage over antipsychotic monotherapy at day 84 on the PANSS total score. Most adverse events observed in the study were mild to moderate in severity, and the overall number of adverse events did not differ significantly between the combination therapy groups and their corresponding antipsychotic monotherapy group. PMID:19052541

Casey, Daniel E; Daniel, David G; Tamminga, Carol; Kane, John M; Tran-Johnson, Tram; Wozniak, Patricia; Abi-Saab, Walid; Baker, Jeff; Redden, Laura; Greco, Nicholas; Saltarelli, Mario

2008-12-03

158

Postoperative analgesia for arthroscopic shoulder surgery: a prospective randomized controlled study of intraarticular, subacromial injection, interscalenic brachial plexus block and intraarticular plus subacromial injection efficacy.  

UK PubMed Central (United Kingdom)

BACKGROUND AND OBJECTIVES: The aim of the present study was to compare the new combination of intraarticular + subacromial injection, with intraarticular, subacromial injection and interscalenic brachial plexus block as postoperative analgesia in shoulder arthroscopy. METHODS: One hundred and twenty patients scheduled for shoulder arthroscopy were enrolled and randomly assigned to one of five groups: intraarticular, subacromial, interscalenic brachial plexus block (IBPB), intraarticular + subacromial (intraarticular + subacromial) injection or a control group. All patients received standardized general anaesthesia and all the injections were given with the same dose and volume of local anaesthetic. The number of boluses (fentanyl 1 microg kg(-1) delivered by a patient-controlled analgesia pump applied at the end of the surgery and the visual analogue pain score (VAPS) at 0, 2, 4, 6, 12, 18 and 24 h after the intervention were recorded. A patient satisfaction score was also assessed at 24 h. RESULTS: Mean bolus consumption, compared with control group, was significantly less in all groups (P < 0.01). Intraarticular + subacromial group utilized fewer boluses compared with subacromial group and significantly lower boluses than intraarticular group (P < 0.01), but IBPB group utilized significantly fewer boluses than intraarticular + subacromial group. Patients in IBPB, intraarticular + subacromial and subacromial groups showed VAPSs that were significantly better than that of the control group at all time points (P < 0.01). The VAPS in intraarticular + subacromial group was statistically comparable with those in IBPB and subacromial groups at each time interval. IBPB and intraarticular + subacromial groups showed comparable patient satisfaction scores. CONCLUSION: These results confirm the analgesic efficacy of IBPB for shoulder surgery. Nonetheless, the combination of intraarticular and subacromial infiltration, studied for the first time, appears to be a clinically valid alternative with no clinical meaningful adverse effects.

Fontana C; Di Donato A; Di Giacomo G; Costantini A; De Vita A; Lancia F; Caricati A

2009-08-01

159

The long-term efficacy of corticosteroid injection into the acromioclavicular joint using a dynamic fluoroscopic method  

Directory of Open Access Journals (Sweden)

Full Text Available Purpose: Accuracy and efficacy of an intra-articular infiltration of corticosteroid and local anesthetic in the symptomatic acromioclavicular joint were studied in 44 patients. Methods: Accuracy of the infiltration was studied using a blind technique with a dynamic fluoroscopic control. Results: Accuracy of the blind infiltration technique was only 50% and the dynamic fluoroscopic technique remains our preferred technique in the clinical setting. On average patients reported a 65% decrease in the intensity of the pain following the injection. At an average follow-up of forty-two months, 59% had undergone surgery, 14% of patients reported more than three months of symptoms relief. Conclusions: Despite the poor long-term results of injecting the acromioclavicular joint, it remains a valuable technique. It has a low cost, minor risks of complications and has high diagnostic value. All but one patients reporting short-term pain relief. Level of Evidence: Level III, case control study.

Bain G; Van Riet R; Gooi C; Ashwood N

2007-01-01

160

Efficacy of multimodal perioperative analgesia protocol with periarticular medication injection in total knee arthroplasty: a randomized, double-blinded study.  

UK PubMed Central (United Kingdom)

Pain control is necessary for successful rehabilitation and outcome after total knee arthroplasty. Our goal was to compare the clinical efficacy of periarticular injections consisting of a long-acting local anesthetic (ropivacaine) and epinephrine with and without combinations of an ?2-adrenergic agonist (clonidine) and/or a nonsteroidal anti-inflammatory agent (ketorolac). In a double-blinded controlled study, we randomized 160 patients undergoing total knee arthroplasty to receive 1 of 4 intraoperative periarticular injections: Group A, ropivacaine, epinephrine, ketorolac, and clonidine; Group B, ropivacaine, epinephrine, and ketorolac; Group C, ropivacaine, epinephrine, and clonidine; Group D (control), ropivacaine and epinephrine. Compared with Group D, Group A and B patients had significantly lower postoperative visual analog pain scores and nurse pain assessment and Group C patients had a significantly greater reduction in physical therapist pain assessment. We found no differences in other parameters analyzed.

Kelley TC; Adams MJ; Mulliken BD; Dalury DF

2013-09-01

 
 
 
 
161

Efficacy of multimodal perioperative analgesia protocol with periarticular medication injection in total knee arthroplasty: a randomized, double-blinded study.  

Science.gov (United States)

Pain control is necessary for successful rehabilitation and outcome after total knee arthroplasty. Our goal was to compare the clinical efficacy of periarticular injections consisting of a long-acting local anesthetic (ropivacaine) and epinephrine with and without combinations of an ?2-adrenergic agonist (clonidine) and/or a nonsteroidal anti-inflammatory agent (ketorolac). In a double-blinded controlled study, we randomized 160 patients undergoing total knee arthroplasty to receive 1 of 4 intraoperative periarticular injections: Group A, ropivacaine, epinephrine, ketorolac, and clonidine; Group B, ropivacaine, epinephrine, and ketorolac; Group C, ropivacaine, epinephrine, and clonidine; Group D (control), ropivacaine and epinephrine. Compared with Group D, Group A and B patients had significantly lower postoperative visual analog pain scores and nurse pain assessment and Group C patients had a significantly greater reduction in physical therapist pain assessment. We found no differences in other parameters analyzed. PMID:23608085

Kelley, Todd C; Adams, Mary Jo; Mulliken, Brian D; Dalury, David F

2013-04-20

162

Pu and Am decorporation in beagles: effects of magnitude of initial Ca-DTPA injection upon chelation efficacy  

International Nuclear Information System (INIS)

[en] To investigate the effects of magnitude of initial DTPA injection upon chelation efficacy, five young adult beagles were each given an intravenous injection of 237+239Pu(IV) citrate + 241Am(III) citrate, followed by a single intravenous injection of Ca-DTPA 0.5 hr later. Amounts of this chelating agent administered were 3, 10, 30, 100, and 300 ?mole Ca-DTPA/kg body mass. Animals were sacrificed 7 days later. Total-body retention of both plutonium and americium was influenced strongly by the amount of DTPA administered, although the removal of Pu by DTPA was less pronounced than that of Am; and in the range of 30 ?mole/kg, an increase of DTPA administration by a factor of 2 resulted in only a 25% decrease in residual body content. Plutonium retention at 7 days was reduced from about 77% in the dog given 3 ?mole/kg to 14% in the animal injected with 300 ?mole/kg. Corresponding values for americium were 40 and 9%. Also, liver content of both Pu and Am was reduced significantly by larger amounts of administered DTPA, decreasing from 18 to 2% for Pu with increasing levels of DTPA, and from 21 to 1% for Am. If there is a level of Ca-DTPA administration at 30 min after injection in a beagle at which no additional chelation of Pu or Am is produced with increasing dosage, it is greater than 300 ?mole/kg. In a 70-kg human, this would be equivalent to the injection of 10 g Ca-DTPA

1979-01-01

163

Intraoperative mydriasis by intracameral injection of mydriatic eye drops: in vivo efficacy and in vitro safety studies.  

UK PubMed Central (United Kingdom)

BACKGROUND: This study investigated the efficacy and safety of intracameral injection of commercially available eye drops containing 0.5% tropicamide and 0.5% phenylephrine hydrochloride (Mydrin-P, Santen Pharmaceutical, Osaka, Japan). DESIGN: In vitro experiment and prospective clinical study at a private hospital. PARTICIPANTS AND SAMPLES: Mydrin-P was applied to confluent cultured human corneal endothelial cells, and the cellular morphology was examined. Clinical study subjects were 65 eyes of 65 patients that underwent phaco-emulsification and aspiration with intraocular lens implantation and received intracameral injection of Mydrin-P for poor mydriasis after preoperative topical instillation of mydriatics (intraocular mydriasis group; with five subgroups based on cause: diabetes, pseudo-exfoliation, post-surgery, uveitis, unknown). Controls, comprising 39 eyes of 39 patients, were not injected with Mydrin-P. METHODS: The ratio of pupillary diameter to corneal diameter was determined before and after injection of Mydrin-P. Corneal endothelial density was measured preoperatively and 3 months and 1 year postoperatively. MAIN OUTCOME MEASURES: Pupillary diameter and corneal endothelial density. RESULTS: Human corneal endothelial cell morphology was unaltered after Mydrin-P injection. The mean ratio of the pupillary diameter to corneal diameter increased in the intraocular mydriasis group (before: 54.2 ± 4.8%, after: 58.4 ± 6.6%; P < 0.001) and in the diabetes and unknown subgroups. The corneal endothelial cell density reduction rate 3 months and 1 year after surgery was not significantly different between the intraocular mydriasis group and controls. CONCLUSION: Intracameral injection of Mydrin-P appears to be effective and safe for dilating the pupil in cases with poor mydriasis after preoperative instillation of mydriatics.

Mori Y; Miyai T; Kagaya F; Nagai N; Osakabe Y; Miyata K; Amano S

2011-07-01

164

Olanzapine vs. risperidone in patients with first-episode schizophrenia and a lifetime history of cannabis use disorders: 16-week clinical and substance use outcomes.  

UK PubMed Central (United Kingdom)

The purpose of this study is to compare the efficacy of olanzapine and risperidone for the acute treatment of first-episode schizophrenia patients with cannabis use disorders. This secondary analysis of a previously published study included 49 first-episode patients with a diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder and a co-occurring lifetime diagnosis of cannabis use disorders randomly assigned to treatment with either olanzapine (n=28) or risperidone (n=21) for 16weeks. The olanzapine group did not differ significantly from the risperidone group for initial response rates of positive symptoms, and rates of cannabis use or alcohol use during the study. Positive symptoms and the Scale for Assessment of Negative Symptoms (SANS) global asociality-anhedonia scores improved over time but did not differ between study medications. In both groups, cannabis use during the study was higher in patients who used cannabis within three months of the admission. Thus, our results suggest that olanzapine and risperidone had a similar initial efficacy on psychotic symptoms and substance use in first-episode patients with co-occurring cannabis use disorders. If clinicians are choosing between olanzapine versus risperidone treatment for this population, their decision should be based upon factors other than symptom response and short-term substance misuse.

Sevy S; Robinson DG; Sunday S; Napolitano B; Miller R; McCormack J; Kane J

2011-08-01

165

Olanzapine vs. risperidone in patients with first-episode schizophrenia and a lifetime history of cannabis use disorders: 16-week clinical and substance use outcomes.  

Science.gov (United States)

The purpose of this study is to compare the efficacy of olanzapine and risperidone for the acute treatment of first-episode schizophrenia patients with cannabis use disorders. This secondary analysis of a previously published study included 49 first-episode patients with a diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder and a co-occurring lifetime diagnosis of cannabis use disorders randomly assigned to treatment with either olanzapine (n=28) or risperidone (n=21) for 16weeks. The olanzapine group did not differ significantly from the risperidone group for initial response rates of positive symptoms, and rates of cannabis use or alcohol use during the study. Positive symptoms and the Scale for Assessment of Negative Symptoms (SANS) global asociality-anhedonia scores improved over time but did not differ between study medications. In both groups, cannabis use during the study was higher in patients who used cannabis within three months of the admission. Thus, our results suggest that olanzapine and risperidone had a similar initial efficacy on psychotic symptoms and substance use in first-episode patients with co-occurring cannabis use disorders. If clinicians are choosing between olanzapine versus risperidone treatment for this population, their decision should be based upon factors other than symptom response and short-term substance misuse. PMID:21636134

Sevy, Serge; Robinson, Delbert G; Sunday, Suzanne; Napolitano, Barbara; Miller, Rachel; McCormack, Joanne; Kane, John

2011-06-01

166

Efficacy and safety of atypical antipsychotic drugs (quetiapine, risperidone, aripiprazole and paliperidone) compared with placebo or typical antipsychotic drugs for treating refractory schizophrenia: overview of systematic reviews/ Eficácia e segurança dos antipsicóticos atípicos (quetiapina, risperidona, aripiprazol, paliperidona) em comparação com um placebo ou medicamentos antipsicóticos típicos no tratamento da esquizofrenia refratária: overview de revisão sistemática  

Scientific Electronic Library Online (English)

Full Text Available Abstract in portuguese CONTEXTO E OBJETIVO: De acordo com alguns estudos de coorte, a prevalência da esquizofrenia refratária (ER) está entre 20-40%. Nosso objetivo foi avaliar a efetividade e segurança de aripiprazol, paliperidona, quetiapina e risperidona no tratamento da esquizofrenia refratária. MÉTODOS: Avaliação crítica das revisões Cochrane publicadas na Biblioteca Cochrane e complementação com referências de ensaios clínicos randomizados (ECRs) mais atualizados sobre ER. A (more) s seguintes bases de dados foram pesquisadas: Medline (Medical Literature Analysis and Retrieval System Online) (1966-2009), Ensaios Controlados da Colaboração Cochrane (2009, edição 2), Embase (Excerpta Database) (1980-2009), Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) (1982-2009). Não houve restrição a idiomas. Ensaios clínicos randomizados, revisões sistemáticas e metanálises que avaliaram antipsicóticos atípicos no tratamento da esquizofrenia refratária foram incluídos. RESULTADOS: Sete revisões sistemáticas Cochrane e 10 ECRs complementares foram incluídos nessa revisão. No geral os dados demonstram pequenas diferenças entre os antipsicóticos atípicos avaliados e os típicos na melhora dos sintomas da doença, apesar da melhor adesão ao tratamento com os atípicos. A risperidona foi avaliada especificamente em pacientes com esquizofrenia refratária em uma das revisões sistemáticas incluídas, a qual demonstrou desfechos favoráveis, porém não definitivos quando comparada a drogas também com eficácia comprovada como amisulprida, clozapina e olanzapina. CONCLUSÕES: Os dados reforçam a dificuldade de tratar esses pacientes, com elevadas taxas de desistência do tratamento e padrões de melhora modestos nas avaliações de eficácia. Os antipsicóticos atípicos têm vantagens sobre os típicos principalmente pelo melhor perfil de segurança, o que leva a melhor adesão ao tratamento. A associação de antipsicóticos também pode ser uma opção em alguns pacientes refratários ao tratamento. Abstract in english CONTEXT AND OBJECTIVE: According to some cohort studies, the prevalence of refractory schizophrenia (RS) is 20-40%. Our aim was to evaluate the effectiveness and safety of aripiprazole, paliperidone, quetiapine and risperidone for treating RS. METHODS: This was a critical appraisal of Cochrane reviews published in the Cochrane Library, supplemented with reference to more recent randomized controlled trials (RCTs) on RS. The following databases were searched: Medical Liter (more) ature Analysis and Retrieval System Online (Medline) (1966-2009), Controlled Trials of the Cochrane Collaboration (2009, Issue 2), Embase (Excerpta Medica) (1980-2009), Literatura Latino-Americana e do Caribe em Ciências da Saúde (Lilacs) (1982-2009). There was no language restriction. Randomized controlled trials, systematic reviews and meta-analyses evaluating atypical antipsychotics for treating RS were included. RESULTS: Seven Cochrane systematic reviews and 10 additional RCTs were included in this review. The data generally showed minor differences between the atypical antipsychotics evaluated and typical antipsychotics, regarding improvement in disease symptoms, despite better adherence to treatment with atypical antipsychotics. Risperidone was specifically evaluated in patients with RS in one of the systematic reviews included, with favorable outcomes, but without definitive superiority compared with other drugs of proven efficacy, like amisulpride, clozapine and olanzapine. CONCLUSIONS: The findings underscore the difficulty in treating these patients, with high dropout rates and treatment patterns of modest improvement in assessments of effectiveness. Atypical antipsychotics have advantages over typical antipsychotics mainly through their better safety profile, which leads to better adherence to treatment. A combination of antipsychotics may also be an option for some refractory patients.

Melnik, Tamara; Soares, Bernardo Garcia; Puga, Maria Eduarda dos Santos; Atallah, Álvaro Nagib

2010-05-01

167

Cognitive-Behavioral Therapy vs Risperidone for Augmenting Serotonin Reuptake Inhibitors in Obsessive-Compulsive Disorder: A Randomized Clinical Trial.  

UK PubMed Central (United Kingdom)

IMPORTANCE Obsessive-compulsive disorder (OCD) is one of the world's most disabling illnesses according to the World Health Organization. Serotonin reuptake inhibitors (SRIs) are the only medications approved by the Food and Drug Administration to treat OCD, but few patients achieve minimal symptoms from an SRI alone. In such cases, practice guidelines recommend adding antipsychotics or cognitive-behavioral therapy consisting of exposure and ritual prevention (EX/RP). OBJECTIVE To compare the effects of these 2 SRI augmentation strategies vs pill placebo for the first time, to our knowledge, in adults with OCD. DESIGN, SETTING, AND PARTICIPANTS A randomized clinical trial (conducted January 2007-August 2012) at 2 academic outpatient research clinics that specialize in OCD and anxiety disorders. Patients (aged 18-70 years) were eligible if they had OCD of at least moderate severity despite a therapeutic SRI dose for at least 12 weeks prior to entry. Of 163 who were eligible, 100 were randomized (risperidone, n?=?40; EX/RP, n?=?40; and placebo, n?=?20), and 86 completed the trial. INTERVENTIONS While continuing their SRI at the same dose, patients were randomized to the addition of 8 weeks of risperidone (up to 4 mg/d), EX/RP (17 sessions delivered twice weekly), or pill placebo. Independent assessments were conducted every 4 weeks. MAIN OUTCOME AND MEASURE The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) to measure OCD severity. RESULTS Patients randomized to EX/RP had significantly greater reduction in week 8 Y-BOCS scores based on mixed-effects models (vs risperidone: mean [SE], -9.72 [1.38]; P?risperidone did not significantly differ from those receiving placebo (mean [SE], -0.38 [1.72]; P?=?.83). More patients receiving EX/RP responded (Y-BOCS score decrease ?25%: 80% for EX/RP, 23% for risperidone, and 15% for placebo; P?risperidone, and 5% for placebo; P?=?.001). Adding EX/RP was also superior to risperidone and placebo in improving insight, functioning, and quality of life. CONCLUSIONS AND RELEVANCE Adding EX/RP to SRIs was superior to both risperidone and pill placebo. Patients with OCD receiving SRIs who continue to have clinically significant symptoms should be offered EX/RP before antipsychotics given its superior efficacy and less negative adverse effect profile. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00389493.

Simpson HB; Foa EB; Liebowitz MR; Huppert JD; Cahill S; Maher MJ; McLean CP; Bender J Jr; Marcus SM; Williams MT; Weaver J; Vermes D; Van Meter PE; Rodriguez CI; Powers M; Pinto A; Imms P; Hahn CG; Campeas R

2013-09-01

168

Efficacy of Intra-Articular Injection of Celecoxib in a Rabbit Model of Osteoarthritis  

Directory of Open Access Journals (Sweden)

Full Text Available Introduction: Osteoarthritis is the most common form of arthritis. It is a slowly progressive joint disease typically seen in middle-age to elderly people. Intra-articular injection of hyaluronic acid is a well-documented treatment for knee osteoarthritis. Celebrex® (celecoxib) is a novel nonsteroidal anti-inflammatory drug, which could help to reduce inflammation and to reduce pain. The aim of this study was to evaluate the effects of intra-articular injection of celecoxib in a rabbit osteoarthritis model. Methods: Thirty New Zealand white rabbits underwent unilateral knee joint surgery using the Hulth technique. Six weeks post-surgery, the animals were randomly divided into three groups, and each group was respectively given weekly intra-articular injections with Celebrex®, hyaluronic acid and saline. On the sixth week, the results were assessed in rabbit models by gross observation, histological evaluation, and expression of IL-1?, TNF-?, MMP-3. Results: In the group given Celebrex® and hyaluronic acid, the pathological changes in the rabbit articular cartilage improved significantly, much more than in the saline group. The statistically significant suppression of IL-1?, TNF-?, MMP-3 was shown in the Celebrex group. No significant differences were detected between two treatment groups. Conclusions: Intra-articular injection of celecoxib is beneficial for knee osteoarthritis. It might repair and protect early osteoarthritis cartilage by delaying cartilage degeneration and impairing the function of inflammatory mediators, therefore, intra-articular injection of celecoxib can be used as an alternative to the current treatment of osteoarthritis.

Dinghua Jiang; Jun Zou; Lixin Huang; Qin Shi; Xuesong Zhu; Genlin Wang; Huilin Yang

2010-01-01

169

Intra-articular steroid injection for temporomandibular joint arthritis in juvenile idiopathic arthritis: A systematic review on efficacy and safety.  

UK PubMed Central (United Kingdom)

OBJECTIVE: To determine the current level of evidence for the use of intra-articular corticosteroid injections (IACI) against temporomandibular joint (TMJ) arthritis in patients with juvenile idiopathic arthritis (JIA) with a particular focus on clinical and radiological improvements and safety profile. METHODS: A comprehensive electronic search strategy was performed in all major medical databases in February 2012. Studies were selected independently by two reviewers in accordance with a pre-specified protocol and a risk of bias assessment for all included studies. RESULTS: Ninety-four unique citations were identified of which seven remained after the inclusion criteria were applied and all of these were assessed to have a high risk of bias. The current limited level of evidence suggests potential beneficial properties of IACI in patients with TMJ arthritis-related symptoms and/or MRI-verified signs of TMJ inflammation. Currently, no scientific evidence substantiates the effect of IACI in terms of (I) improving maximal mouth opening capacity significantly, (II) reducing radiological disease progression, (III) normalising/improving mandibular growth, and (IV) increasing efficacy upon repeated injections. CONCLUSION: The current level of evidence allows only very limited conclusions on the effect of IACI therapy in patients with TMJ arthritis. Knowledge on the long-term impact of IACI on mandibular growth is not available. Future studies designed in accordance with evidence-based standards are needed to allow a more general conclusion on efficacy and safety of this treatment modality in patients with TMJ arthritis.

Stoustrup P; Kristensen KD; Verna C; Küseler A; Pedersen TK; Herlin T

2013-08-01

170

[Efficacy of combination of ondansetron injection and tablet in CAF-induced emesis in breast cancer patients].  

UK PubMed Central (United Kingdom)

Efficacy of combination of ondansetron injection and tablet on CAF (cyclophosphamide, adriamycin, 5-fluorouracil) induced emesis were investigated in 10 breast cancer patients (33 courses). Complete suppression rate of nausea or vomiting were approximately 75%, approximately 90% respectively for every treatment day. According to judgement criteria, antiemetic rate of approximately 100% was achieved during the study period. As to food intake of each treatment day, in approximately 70% of treatment courses was assessed as '(patient was) able to eat most of the meal'. Trend in emetic episodes and food intake in each patient receiving several courses of CAF therapy were evaluated. As a result, those patients experiencing nausea or vomiting or had effect on their food intake, were found to be in the similar condition in the following course (s) of CAF. No adverse drug reaction nor clinical laboratory test abnormalities due to ondansetron was observed. In this investigation, combination of ondansetron injection and tablet was shown to sufficiently suppress CAF-induced nausea and vomiting, and their efficacy was confirmed. Still, the study suggested that number of emetic episodes or degree of anorexia differs according to each individual. Therefore we regard additional administration of ondansetron or concomitant use of steroids should be considered when necessary.

Shinohara H; Yonekawa H; Machimura T; Furukawa T; Nishihori H; Kurihara N; Urakami H; Nemoto Y

1998-02-01

171

Intra-articular steroid injection for temporomandibular joint arthritis in juvenile idiopathic arthritis : A systematic review on efficacy and safety  

DEFF Research Database (Denmark)

OBJECTIVE: To determine the current level of evidence for the use of intra-articular corticosteroid injections (IACI) against temporomandibular joint (TMJ) arthritis in patients with juvenile idiopathic arthritis (JIA) with a particular focus on clinical and radiological improvements and safety profile. METHODS: A comprehensive electronic search strategy was performed in all major medical databases in February 2012. Studies were selected independently by two reviewers in accordance with a pre-specified protocol and a risk of bias assessment for all included studies. RESULTS: Ninety-four unique citations were identified of which seven remained after the inclusion criteria were applied and all of these were assessed to have a high risk of bias. The current limited level of evidence suggests potential beneficial properties of IACI in patients with TMJ arthritis-related symptoms and/or MRI-verified signs of TMJ inflammation. Currently, no scientific evidence substantiates the effect of IACI in terms of (I) improving maximal mouth opening capacity significantly, (II) reducing radiological disease progression, (III) normalising/improving mandibular growth, and (IV) increasing efficacy upon repeated injections. CONCLUSION: The current level of evidence allows only very limited conclusions on the effect of IACI therapy in patients with TMJ arthritis. Knowledge on the long-term impact of IACI on mandibular growth is not available. Future studies designed in accordance with evidence-based standards are needed to allow a more general conclusion on efficacy and safety of this treatment modality in patients with TMJ arthritis.

Stoustrup, Peter; Kristensen, Kasper D

2013-01-01

172

Efficacy of Botulinum Toxin A injection in treatment of Congenital Esotropia  

Directory of Open Access Journals (Sweden)

Full Text Available Backgroud and Objective: Congenital esotropia is one of most common ocular disorder in children with genetic origin. Amblyopia, decreased streopsis and cosmetic problems are its complication that affect person's fate in terms of career psychological issues. The aim of this study was to determine the effect of botulinum toxin A (Dysport) injection in subconjunctival space near medial rectus insertion of both eyes for treatment of congenital esotropia.Subjects and Methods: Thirty babies (aged 6-54 months) with congenital esotropia who were otherwise systemically and neurologically normal were enrolled in this study. Ten units of toxin (Dysport) were injected (under sedation) into the subconjunctival space near medial rectus insertion of both eyes. The angle of deviation was measured six times: after 3 days, 1 week, 1, 3, 6 and 12 months after injection.Results: Twelve months after injection ,angle of deviation decreased from 52 ± 17 PD to 27.8 ± 21.29 PD in 86.3% of patients . Success of treatment achieved in 23.3% of patients ( P=0.008) .In seventeen cases (56.6%) with angle of deviation? 45 PD (before injection) improvement was better (p=0.030), 41.1% of this group after 1 month , 70% after 3 months , 76% after 6 months, and 41.1% after 12 months follow up achieved orthophoria.Conclusion: Botulinum toxin A injection into subconjunctival space near medial rectus insertion is a safe method that is not only effective transiently for eye alignment but also can reduce total deviation. Long term improvement seems to be achievable in cases with small angle deviation (equal or less than of 45 PD). Sci Med J 2011; 10(2):179-186

Ghaderpanah M; Azarish A

2011-01-01

173

[Three cases of cancer-related pain for which oxycodone injection was efficacious].  

UK PubMed Central (United Kingdom)

The intravenous or subcutaneous route is a useful option for administering opioids when cancer patients with moderate to severe pain are unable to take oral medication. An injectable form of oxycodone is now available, and three patients with cancer-related pain were treated successfully with continuous intravenous or subcutaneous oxycodone. The first case showed transient switching from oral oxycodone to the parenteral form during the active treatment phase, resulting in satisfactory pain management. The second case suggested that oxycodone may have a more favorable analgesic profile in severe neuropathic cancer pain compared with fentanyl. Finally, the third case demonstrated that oxycodone injection is relatively safe for renal-impaired patients.

Shinozaki K; Nitta T; Yamauchi M; Doi M

2013-01-01

174

Relative effectiveness of adjunctive risperidone on manic and depressive symptoms in mixed mania.  

UK PubMed Central (United Kingdom)

Mixed states are common and severe manifestations of bipolar disorder, with limited data on the differential efficacy of treatments on depressive and manic symptoms. This study assessed the effectiveness of open-label adjunctive risperidone in achieving sustained effectiveness in patients with mixed mania, with a specific focus on the differential benefits on manic and depressive symptomatology. Forty patients with bipolar disorder I, currently in a mixed manic episode, were treated with adjunctive risperidone. Behavioral measures at baseline and weeks 1, 2, 4, 8, 12, 16, and 20 were assessed using the following scales: the Young Mania Rating Scale, the Montgomery Asberg Depression Rating Scale (MADRS), and the Global Assessment Scale. The primary outcome measure was the proportion of patients who attained a sustained response on either depressive or manic symptomatology, defined as at least 50% reduction from the baseline on the Montgomery Asberg Depression Rating Scale or the Young Mania Rating Scale, maintained over at least 8 weeks without subsequent relapse during the 20-week trial. A significantly higher proportion of patients achieved a sustained response for mania than depression, 16/40 versus 6/40, respectively (McNemar's ?² 8.33, P=0.004). Higher elevated mood at baseline and lower apparent sadness (P<0.016) each predicted a sustained response for mania (P<0.0001). Mixed manic patients who were treated with risperidone adjunctive to mood stabilizer/s for 20 weeks were significantly more likely to achieve a sustained response for manic than for depressive symptomatology.

Singh V; Bowden CL; Mintz J

2013-03-01

175

Risperidone in the treatment of psychoses in the elderly: a case report series.  

UK PubMed Central (United Kingdom)

Risperidone is one of the newer atypical antipsychotic agents, which combines potent serotonin and dopamine receptor antagonism. It shows efficacy against the positive and negative symptoms of schizophrenic psychoses and other psychotic conditions, and has a low propensity to cause extrapyramidal side effects. The aim of these case reports in elderly patients is to provide the benefit of personal experience with risperidone to the body of published literature and to demonstrate the types of patients that may benefit from treatment. These cases were compiled retrospectively from data collected on referral and during routine hospital appointments. This series covers four main areas of concern when treating the elderly: low-maintenance dosing minimising the likelihood of adverse events; successful treatment of patients previously uncontrolled and experiencing side effects with other antipsychotics; the possibility of intermittent rather than continuous treatment; and the benefits to patients, carers and the health services. At low doses, risperidone is an effective and well-tolerated treatment for psychoses in elderly patients that improves the quality of life for both patients and their caregivers.

Bullock R; Libretto S

2002-04-01

176

Risperidone in the treatment of psychoses in the elderly: a case report series.  

Science.gov (United States)

Risperidone is one of the newer atypical antipsychotic agents, which combines potent serotonin and dopamine receptor antagonism. It shows efficacy against the positive and negative symptoms of schizophrenic psychoses and other psychotic conditions, and has a low propensity to cause extrapyramidal side effects. The aim of these case reports in elderly patients is to provide the benefit of personal experience with risperidone to the body of published literature and to demonstrate the types of patients that may benefit from treatment. These cases were compiled retrospectively from data collected on referral and during routine hospital appointments. This series covers four main areas of concern when treating the elderly: low-maintenance dosing minimising the likelihood of adverse events; successful treatment of patients previously uncontrolled and experiencing side effects with other antipsychotics; the possibility of intermittent rather than continuous treatment; and the benefits to patients, carers and the health services. At low doses, risperidone is an effective and well-tolerated treatment for psychoses in elderly patients that improves the quality of life for both patients and their caregivers. PMID:11973118

Bullock, R; Libretto, S

2002-04-01

177

Comparative evaluation of efficacy and safety of etodolac and diclofenac sodium injection in patients with postoperative orthopedic pain.  

UK PubMed Central (United Kingdom)

OBJECTIVE: The objective of this study was to compare the analgesic efficacy of etodolac injection and diclofenac injection in patients with postoperative orthopedic pain. METHODS: This was multicentric, randomized, assessor-blind and parallel-group study. A group of 158 patients with moderate to severe pain following orthopedic surgery were randomly assigned to receive either etodolac 400 mg twice a day (n?=?78) or diclofenac 75 mg thrice a day (n?=?80). MAIN OUTCOME MEASURES: The primary efficacy outcome measures were pain intensity difference, sum of pain intensity differences and pain relief whereas secondary efficacy variables included maximum fall in pain intensity, number of doses of study medication consumed, number of patients who required rescue medication and overall response to therapy. RESULTS: Mean pain intensity differences assessed on 10 cm VAS were significantly better for etodolac arm compared to diclofenac arm at 4, 8, 20 and 24 hours (p?injection was significantly more effective than diclofenac injection (p?

Pareek A; Chandurkar N; Gupta A; Desai Y; Kumar S H; Swamy A; Sirsikar A

2011-11-01

178

Haloperidol and risperidone in the treatment of delirium and its subtypes  

Directory of Open Access Journals (Sweden)

Full Text Available Background and Objectives: To compare the safety and efficacy of haloperidol and risperidone in the treatment of delirium and its subtypes Methods: We collected sociodemographic data and medical variables in addition to systematically rating all patients with delirium with the Memorial Delirium Assessment Scale (MDAS), Karnofsky Performance Status Scale (KPS) and abbreviated Udvalg for Kliniske Undersogelser (UKU) at baseline (T1), 2-3 days (T2) and 4-7 days (T3) and created an IRB-approved delirium database. For this secondary analysis we extracted all data containing haloperidol (HAL) and risperidone (RIS). Results: We were able to retrieve 32 patients treated with haloperidol (HAL) and risperidone (RIS) each. Both samples did not significantly differ in respect to age, cancer diagnoses or etiologies. The MDAS scores at baseline were higher in HAL treated subjects (20.2) compared to RIS treated subjects (17.7). The treatment results between HAL and RIS were not significantly different: Over the course of treatment MDAS scores improved from 20.2 to 8.3 (HAL) and 17.7 to 7.5 in (RIS), delirium resolution rates were 68.8% (HAL) and 84.4% (RIS). In hypoactive delirium the MDAS scores improved from 18.5 to 9.3 (HAL) and from 15.3 to 6.6 (RIS), delirium resolution rates were 64.3% (HAL) and 91.3% (RIS). In hyperactive delirium the MDAS scores improved from 22.5 to 6.6 (HAL) and 20.1 to 8.4 (RIS), delirium resolution rates were 72.2% (HAL) and 75% (RIS). There were no significant differences in KPS scores at all observation times. Treatment with HAL caused more EPS. Conclusions: Both haloperidol and risperidone may be equally effective in the treatment of delirium and its subtypes. Treatment with haloperidol resulted in more side effects.

Soenke Boettger; William Breitbart; Steven Passik

2011-01-01

179

Haloperidol and risperidone in the treatment of delirium and its subtypes  

Scientific Electronic Library Online (English)

Full Text Available Abstract in english Background and Objectives: To compare the safety and efficacy of haloperidol and risperidone in the treatment of delirium and its subtypes Methods: We collected sociodemographic data and medical variables in addition to systematically rating all patients with delirium with the Memorial Delirium Assessment Scale (MDAS), Karnofsky Performance Status Scale (KPS) and abbreviated Udvalg for Kliniske Undersogelser (UKU) at baseline (T1), 2-3 days (T2) and 4-7 days (T3) and crea (more) ted an IRB-approved delirium database. For this secondary analysis we extracted all data containing haloperidol (HAL) and risperidone (RIS). Results: We were able to retrieve 32 patients treated with haloperidol (HAL) and risperidone (RIS) each. Both samples did not significantly differ in respect to age, cancer diagnoses or etiologies. The MDAS scores at baseline were higher in HAL treated subjects (20.2) compared to RIS treated subjects (17.7). The treatment results between HAL and RIS were not significantly different: Over the course of treatment MDAS scores improved from 20.2 to 8.3 (HAL) and 17.7 to 7.5 in (RIS), delirium resolution rates were 68.8% (HAL) and 84.4% (RIS). In hypoactive delirium the MDAS scores improved from 18.5 to 9.3 (HAL) and from 15.3 to 6.6 (RIS), delirium resolution rates were 64.3% (HAL) and 91.3% (RIS). In hyperactive delirium the MDAS scores improved from 22.5 to 6.6 (HAL) and 20.1 to 8.4 (RIS), delirium resolution rates were 72.2% (HAL) and 75% (RIS). There were no significant differences in KPS scores at all observation times. Treatment with HAL caused more EPS. Conclusions: Both haloperidol and risperidone may be equally effective in the treatment of delirium and its subtypes. Treatment with haloperidol resulted in more side effects.

Boettger, Soenke; Breitbart, William; Passik, Steven

2011-06-01

180

Fasting insulin serum levels and psychopathology profiles in male schizophrenic inpatients treated with olanzapine or risperidone.  

UK PubMed Central (United Kingdom)

OBJECTIVE: Recent studies have suggested that higher insulin levels are associated with better psychopathology profiles in cross-sectional samples of patients with schizophrenia. This study examines whether drug-induced fasting insulin changes between third and eight week of treatment are related to clinical improvement in non-diabetic patients receiving the atypical neuroleptics: risperidone or olanzapine. METHODS: non-diabetic men with a diagnosis of schizophrenia according to the DSM-IV diagnostic classification were recruited from psychiatric inpatient units. Following a drug-free period, neuroleptic treatment was initiated (risperidone n=36, olanzapine n=35) and doses were adjusted to achieve maximal clinical efficacy. All patients were hospitalized throughout the study. Initial and final evaluations of serum insulin levels and psychopathology (assessed with the Positive and Negative Syndrome Scale, PANSS), were carried out at weeks 3 and 8 after the onset of treatment, respectively. RESULTS: There were no differences between and within the risperidone and olanzapine groups in changes of serum insulin level between the third and eighth week of treatment. In the olanzapine group, Pearson correlation analysis revealed a significant negative correlation between changes in fasting serum insulin levels and the PANSS-Total, Positive and General Psychopathology subscale scores. Only improvement in the PANSS-Negative Symptom subscale score was not correlated with insulin level change between the third and eighth week of treatment. In the risperidone group, correlations between PANSS subscales scores and the corresponding serum insulin levels change were positive, albeit statistically non-significant. In both groups the improvement in PANSS-Total scores was not correlated with changes in BMI. CONCLUSION: Olanzapine-related changes in endogenous fasting insulin levels were correlated with clinical improvement in acutely ill non-diabetic schizophrenic patients. Because the interesting linkage between insulin and positive and negative symptoms could be an epiphenomenon, randomized studies are needed to further explore the role of insulin in therapeutic responses in patients with schizophrenia.

Konarzewska B; Waszkiewicz N; Gali?ska B; Szulc A

2013-01-01

 
 
 
 
181

Chronic administration of risperidone in a rat model of schizophrenia: a behavioural, morphological and molecular study.  

UK PubMed Central (United Kingdom)

In the present work we analyzed the effect of the chronic administration of risperidone (2mg/kg over 65 days) on behavioural, morphological and molecular aspects in an experimental model of schizophrenia obtained by bilateral injection of ibotenic acid into the ventral hippocampus of new-born rats. Our results show that during their adult lives the animals with hippocampal lesions exhibit different alterations, mainly at behavioural level and in the gene expression of dopamine D(2) and 5-HT(2A) receptors. However, at morphological level the study performed on the prefrontal cortex did not reveal any alterations in either the thickness or the number of cells immunoreactive for c-Fos, GFAP, CBP or PV. Overall, risperidone administration elicited a trend towards the recovery of the values previously altered by the hippocampal lesion, approaching the values seen in the animals without lesions. It may be concluded that the administration of risperidone in the schizophrenia model employed helps to improve the altered functions, with no significant negative effects.

Castellano O; Arji M; Sancho C; Carro J; Riolobos AS; Molina V; Gómez-Nieto R; de Anchieta de Castro E Horta J Jr; Herrero-Turrión MJ; López DE

2013-04-01

182

A Double-Blind, Placebo-Controlled Study of Risperidone for the Treatment of Adolescents and Young Adults with Anorexia Nervosa: A Pilot Study  

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Objective: The purpose of this double-blind, placebo-controlled exploratory pilot study was to evaluate the safety and efficacy of risperidone for the treatment of anorexia nervosa. Method: Forty female subjects 12 to 21 years of age (mean, 16 years) with primary anorexia nervosa in an eating disorders program were randomized to receive…

Hagman, Jennifer; Gralla, Jane; Sigel, Eric; Ellert, Swan; Dodge, Mindy; Gardner, Rick; O'Lonergan, Teri; Frank, Guido; Wamboldt, Marianne Z.

2011-01-01

183

A double-blind randomised comparison of risperidone and haloperidol in the treatment of behavioural and psychological symptoms in Chinese dementia patients  

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Background: Behavioural and psychological (BPSD) are common during the course of dementia and present severe problems to patients and their caregivers. Objectives: To assess the therapeutic efficacy and safety of haloperidol and risperidone in treating BPSD in Chinese dementia patients. Methods: A 1...

Chan, WC; Lam, LCW; Choy, CNP; Leung, VPY; Li, SW; Chiu, HFK

184

In vitro-in vivo correlations of scalable PLGA-risperidone implants for the treatment of schizophrenia.  

UK PubMed Central (United Kingdom)

PURPOSE: Nonadherence to antipsychotic medications is a major obstacle preventing optimal outcomes for patients with schizophrenia. Extended release systems exist in the form of depot injections, but these formulations exhibit several disadvantages. To address these concerns, we previously demonstrated proof of concept for an antipsychotic implant containing risperidone and the biodegradable polymer poly(lactic-co-glycolic) acid (PLGA). METHODS: We build upon recently published data by utilizing a scalable single-screw extrusion system for the production of PLGA-risperidone implants. Implants were composed of 40% risperidone and 60% PLGA, with varying ratios of lactide to glycolide (50:50, 65:35, 75:25 or 85:15). Risperidone release was assessed in vitro and in vivo in rats, and Level A, B and C correlations (IVIVCs) attempted for all. Bioavailability was verified with locomotor testing RESULTS: Level B analysis yielded the greatest correlation between in vitro and in vivo data (R (2) = 0.9425), while Level C yielded the lowest (R (2) = 0.8336). Although, based on qualitative results, a Level A correlation was not achieved, it did produce an R (2) of 0.9261. Locomotor testing demonstrated that peak serum concentrations coincide with significant reductions in activity. CONCLUSION: Data demonstrate the applicability of our modeling system and advance long-term, implantable antipsychotics toward clinical application.

Amann LC; Gandal MJ; Lin R; Liang Y; Siegel SJ

2010-08-01

185

Efficacy evaluation of Shengmai Injection in treating coronary heart disease based on random walk model  

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Full Text Available Objective: To evaluate the clinical effects of Shengmai Injection in treating coronary heart disease (CHD) based on correct syndrome differentiation and incorrect syndrome differentiation.Methods: The patients' information was collected by a system of individual diagnosis and treatment of CHD. The score of main symptoms was calculated and recorded during the treatment. Patients were divided into two groups (incorrect syndrome and correct syndrome groups) on the basis of syndrome differentiation treatment or not. The clinical therapeutic effects of the two treatments were evaluated based on statistic theory combined with random walk method.Results: There were 273 patients in the correct syndrome group and 4 patients died (case-fatality rate was 1.47%). There were 297 patients in the incorrect syndrome group and 7 patients died (case-fatality rate was 2.36%). In the correct syndrome group, random fluctuation peak of comprehensive evaluation index, walk steps, positive growth rate of walk, ratio, random fluctuation power-law, increase rate and record times of comprehensive evaluation index were 1 472, 13 617, 0.108 1, 9.25, 0.674 2, 0.470 6 and 3 128 respectively, while in the incorrect syndrome group, 1 030, 14 588, 0.070 6, 14.16, 0.660 6, 0.312 8 and 3 293 respectively. The random fluctuation power-law in both groups exceeded 0.5.Conclusion: There is a long-range correlation between the comprehensive evaluation index and therapeutic method as the CHD patients were treated with Shengmai Injection. The clinical therapeutic effects of Shengmai Injection under correct syndrome differentiation are better than the effects of Shengmai Injection under incorrect syndrome differentiation.

Zhu-ye GAO; Hao XU

2008-01-01

186

Factors associated with uptake, adherence, and efficacy of hepatitis C treatment in people who inject drugs: a literature review  

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Full Text Available Viktor Mrav?ík,1,2 Lisa Strada,3 Josef Štolfa,4,5 Vladimir Bencko,6 Teodora Groshkova,7 Jens Reimer,3 Bernd Schulte3 1National Monitoring Centre for Drugs and Drug Addiction, 2Department of Addictology, First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic; 3Centre for Interdisciplinary Addiction Research, University of Hamburg, Hamburg, Germany; 4Department of General Practice, Institute for Postgraduate Medical Education in Prague, 5Department of General Practice, Second Faculty of Medicine, 6Institute of Hygiene and Epidemiology, First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic; 7European Monitoring Centre for Drugs and Drug Addiction, Lisbon, Portugal Introduction and methods: Hepatitis C virus (HCV) infections are highly prevalent amongst people who inject drugs (PWID). Despite well documented evidence of its effectiveness, suggested cost-effectiveness, and potential to reduce HCV prevalence rates, the uptake of antiviral HCV treatment by PWID is low. This nonsystematic literature review describes factors associated with the uptake, adherence, and efficacy of HCV treatment among PWID and discusses strategies to increase their uptake of treatment. Results: Low HCV treatment uptake among PWID is associated with a number of patient-related and provider-related barriers. Beliefs and fears about low efficacy and adverse effects on the patient’s part are common. A substantial number of factors are associated with the chaotic lifestyle and altered social functioning of PWID, which are often associated with decompensation or relapsing into drug addiction. This may lead to perceived low adherence with treatment and low efficacy on the provider’s part too, where lack of support, inadequate management of addiction, and other drug-related problems and poor treatment of side effects have been described. Practical issues such as the accessibility of treatment and finances also play a role. Strategies to improve the HCV treatment rate among PWID involve pretreatment management and assessment, a multidisciplinary approach, management of side effects, and enhanced education and counseling. Conclusion: Specific factors are associated with poorer treatment outcomes in PWID on the side of both the patient and the treatment system. However, given that PWID can achieve treatment adherence and sustained virologic response rates comparable with those in nondrug users, drug use per se should not be considered a criterion for exclusion from treatment. Further development of measures leading to higher uptake of treatment and adherence in PWID and appropriate adaptation of HCV treatment guidelines represent important tools in this regard. Keywords: hepatitis C virus, people who inject drugs, treatment uptake, adherence, efficacy

Mrav?ík V; Strada L; Štolfa J; Bencko V; Groshkova T; Reimer J; Schulte B

2013-01-01

187

Efficacy and safety of 121 injections of the greater occipital nerve in episodic and chronic cluster headache.  

UK PubMed Central (United Kingdom)

INTRODUCTION: Infiltration of the greater occipital nerve (GON) with local anaesthetics and corticosteroids is a treatment option for cluster headache. METHODS: We retrospectively analysed the efficacy and safety of 121 GON injections in 60 patients with episodic or chronic cluster headache over a period of 4 years. RESULTS: Almost 80% of the infiltrations were at least partially effective (reduction of attack frequency, duration or severity) and 45% resulted in a complete response (no further attacks). The effect was maintained for 3.5 weeks on average in chronic cluster headache. In episodic cluster headache, the effect lasted for most of the bout. In 18 infiltrations, transient side effects were reported, such as local pain, steroid effects (facial oedema, sleeping disorders, acne), bradycardia or syncope. CONCLUSION: Our data show that GON infiltration is a valuable and safe option in the clinical setting to treat patients suffering from cluster headache, especially for the episodic form of the disorder.

Gantenbein AR; Lutz NJ; Riederer F; Sándor PS

2012-06-01

188

[The efficacy of treatment of oral and maxillofacial venous malformations by pingyangmycin injection with different concentrations].  

UK PubMed Central (United Kingdom)

PURPOSE: To evaluate the clinical effect of using different concentrations of pingyangmycin to treat venous malformations in oral and maxillofacial region. METHODS: One hundred and ninety-four patients with venous malformations in oral and maxillofacial region were included and treated by pingyangmycin injection with different concentrations. For superficial cutaneous venous malformations, the concentration of pingyangmycin was 8mg/mL while 8mg/5mL for venous malformations limited to oral mucosa or submucosa. RESULTS: The efficient of cutaneous venous malformations was 94.9%,while 100% for oral mucosal and submucosa. CONCLUSIONS: Using different concentrations of pingyangmycin for venous malformations in different sites can get good results and reduce unnecessary complications.

Liu ZY; Xue L; Yuan WL; Wei JJ; Lei BC; Wang XK

2013-04-01

189

Efficacy of an injection of dinoprost tromethamine when given subcutaneously on luteal regression in lactating Holstein cows.  

UK PubMed Central (United Kingdom)

The objectives of these studies were to evaluate the efficacy of a PGF(2alpha) (PGF) analog given through different routes on causing luteal regression in lactating dairy cows. In Experiment 1, lactating Holstein cows (n=118) at random stages of lactation were blocked by parity and days in milk (DIM) and, within each block, randomly assigned to receive PGF as an intra-muscular (IM) injection in the semimembranous/semitendinous muscle (CON), subcutaneous (SC) injection in the cervical area (SCN), or SC injection in the ischio-rectal fossa (IRF). Blood was sampled at 0, 12, 24, 36, and 48 h after treatment for assessment of progesterone concentration. In Experiment 2, a total of 379 lactating Holstein cows, 46+/-7 DIM, were blocked by DIM and, within each block, randomly assigned to receive treatment similar to CON or IRF groups from Experiment 1. Blood was sampled 0 and 48 h after treatment for assessment of progesterone concentration. Cows were classified as experiencing luteal regression when progesterone concentration was <1.0 ng/mL or <40% of initial concentration (0 h=100%). In Experiment 1, there was no effect of route of PGF treatment on decline in progesterone concentration and on the proportion of cows experiencing luteal regression by 12, 24, 36, and 48 h after treatment. Similarly, in Experiment 2, route of treatment did not affect either the decline in progesterone concentration or the proportion of cows that had luteal regression by 48 h after treatment. Treatment of lactating dairy cows with 25mg of PGF given SC in the ischio-rectal fossa did not affect either the decline in progesterone concentration or the proportion of cows that experienced luteal regression by 12, 24, 36, and 48 h after PGF treatment.

Chebel RC; Santos JE; Rutigliano HM; Cerri RL

2007-02-01

190

Efficacy of an injection of dinoprost tromethamine when given subcutaneously on luteal regression in lactating Holstein cows.  

Science.gov (United States)

The objectives of these studies were to evaluate the efficacy of a PGF(2alpha) (PGF) analog given through different routes on causing luteal regression in lactating dairy cows. In Experiment 1, lactating Holstein cows (n=118) at random stages of lactation were blocked by parity and days in milk (DIM) and, within each block, randomly assigned to receive PGF as an intra-muscular (IM) injection in the semimembranous/semitendinous muscle (CON), subcutaneous (SC) injection in the cervical area (SCN), or SC injection in the ischio-rectal fossa (IRF). Blood was sampled at 0, 12, 24, 36, and 48 h after treatment for assessment of progesterone concentration. In Experiment 2, a total of 379 lactating Holstein cows, 46+/-7 DIM, were blocked by DIM and, within each block, randomly assigned to receive treatment similar to CON or IRF groups from Experiment 1. Blood was sampled 0 and 48 h after treatment for assessment of progesterone concentration. Cows were classified as experiencing luteal regression when progesterone concentration was <1.0 ng/mL or <40% of initial concentration (0 h=100%). In Experiment 1, there was no effect of route of PGF treatment on decline in progesterone concentration and on the proportion of cows experiencing luteal regression by 12, 24, 36, and 48 h after treatment. Similarly, in Experiment 2, route of treatment did not affect either the decline in progesterone concentration or the proportion of cows that had luteal regression by 48 h after treatment. Treatment of lactating dairy cows with 25mg of PGF given SC in the ischio-rectal fossa did not affect either the decline in progesterone concentration or the proportion of cows that experienced luteal regression by 12, 24, 36, and 48 h after PGF treatment. PMID:17126390

Chebel, Ricardo C; Santos, José E P; Rutigliano, Heloísa M; Cerri, Ronaldo L A

2006-11-28

191

A comparison of the oral application and injection routes using the Onderstepoort Biological Products Fowl Typhoid vaccine, its safety, efficacy and duration of protection in commercial laying hens  

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This study was undertaken to establish whether the Onderstepoort Biological Products Fowl Typhoid (OBPft) vaccine registered as an injectable vaccine was effective and safe when administered orally to commercial layers. Its efficacy and duration of protection were compared with application by intram...

Purchase, Cromwell; Picard, J.A.; McDonald, R.; Bisschop, S.P.R.

192

Randomized trial of clozapine vs. risperidone in treatment-naïve first-episode schizophrenia: Results after one year.  

Science.gov (United States)

In first-episode patients with psychosis, clozapine may be potentially valuable as an initial treatment seeking to limit early on clinical and cognitive deterioration. Nevertheless, until recently its restricted use has limited the study of this possibility. Our research group is developing a non-commercial, multicentric and open label study on the differential efficacy between clozapine and risperidone in first-episode schizophrenia. In this paper, we present the results related to clinical variables after a one-year follow-up. So far, we have recruited 30 patients diagnosed with schizophrenia or schizophreniform disorder with illness duration of less than two years. The patients had not received any previous treatment and they were randomized to treatment with clozapine or risperidone. Our results indicate that on average, patients on clozapine adhered to their original treatment for a longer time period than patients on risperidone. By last observation carried forward (LOCF) analysis, patients on clozapine and risperidone displayed similar clinical improvements, although marginally greater improvements in positive and total symptoms scores were found in the clozapine group. At the 12-month point we observed a marginal improvement in negative symptom scores in patients on clozapine. Subjective secondary effects, as measured with the Udvalg for KliniskeUndersøgelser (UKU) scale, correlated negatively with negative symptoms at follow-up. Our data, although preliminary, suggest that clozapine may have a slightly superior efficacy in the initial year of treatment of first-episode treatment-naïve patients with schizophrenia, and this can be explained for the most part by greater adherence to this treatment. PMID:23870807

Sanz-Fuentenebro, Javier; Taboada, Diana; Palomo, Tomás; Aragües, María; Ovejero, Santiago; Del Alamo, Cristina; Molina, Vicente

2013-07-18

193

Randomized trial of clozapine vs. risperidone in treatment-naive first-episode schizophrenia: Results after one year.  

UK PubMed Central (United Kingdom)

In first-episode patients with psychosis, clozapine may be potentially valuable as an initial treatment seeking to limit early on clinical and cognitive deterioration. Nevertheless, until recently its restricted use has limited the study of this possibility. Our research group is developing a non-commercial, multicentric and open label study on the differential efficacy between clozapine and risperidone in first-episode schizophrenia. In this paper, we present the results related to clinical variables after a one-year follow-up. So far, we have recruited 30 patients diagnosed with schizophrenia or schizophreniform disorder with illness duration of less than two years. The patients had not received any previous treatment and they were randomized to treatment with clozapine or risperidone. Our results indicate that on average, patients on clozapine adhered to their original treatment for a longer time period than patients on risperidone. By last observation carried forward (LOCF) analysis, patients on clozapine and risperidone displayed similar clinical improvements, although marginally greater improvements in positive and total symptoms scores were found in the clozapine group. At the 12-month point we observed a marginal improvement in negative symptom scores in patients on clozapine. Subjective secondary effects, as measured with the Udvalg for KliniskeUndersøgelser (UKU) scale, correlated negatively with negative symptoms at follow-up. Our data, although preliminary, suggest that clozapine may have a slightly superior efficacy in the initial year of treatment of first-episode treatment-naïve patients with schizophrenia, and this can be explained for the most part by greater adherence to this treatment.

Sanz-Fuentenebro J; Taboada D; Palomo T; Aragües M; Ovejero S; Del Alamo C; Molina V

2013-09-01

194

A comparison of low-dose risperidone to paroxetine in the treatment of panic attacks: a randomized, single-blind study  

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Full Text Available Abstract Background Because a large proportion of patients with panic attacks receiving approved pharmacotherapy do not respond or respond poorly to medication, it is important to identify additional therapeutic strategies for the management of panic symptoms. This article describes a randomized, rater-blind study comparing low-dose risperidone to standard-of-care paroxetine for the treatment of panic attacks. Methods Fifty six subjects with a history of panic attacks were randomized to receive either risperidone or paroxetine. The subjects were then followed for eight weeks. Outcome measures included the Panic Disorder Severity Scale (PDSS), the Hamilton Anxiety Scale (Ham-A), the Hamilton Depression Rating Scale (Ham-D), the Sheehan Panic Anxiety Scale-Patient (SPAS-P), and the Clinical Global Impression scale (CGI). Results All subjects demonstrated a reduction in both the frequency and severity of panic attacks regardless of treatment received. Statistically significant improvements in rating scale scores for both groups were identified for the PDSS, the Ham-A, the Ham-D, and the CGI. There was no difference between treatment groups in the improvement in scores on the measures PDSS, Ham-A, Ham-D, and CGI. Post hoc tests suggest that subjects receiving risperidone may have a quicker clinical response than subjects receiving paroxetine. Conclusion We can identify no difference in the efficacy of paroxetine and low-dose risperidone in the treatment of panic attacks. Low-dose risperidone appears to be tolerated equally well as paroxetine. Low-dose risperidone may be an effective treatment for anxiety disorders in which panic attacks are a significant component. Trial Registration ClinicalTrials.gov Identifier: NCT100457106

Prosser James M; Yard Samantha; Steele Annie; Cohen Lisa J; Galynker Igor I

2009-01-01

195

Investigator global evaluations of efficacy of injectable poly-L-lactic acid versus human collagen in the correction of nasolabial fold wrinkles.  

UK PubMed Central (United Kingdom)

BACKGROUND: Injectable poly-L-lactic acid (PLLA) is indicated in the United States for use in immune-competent patients for correction of shallow-to-deep nasolabial fold contour deficiencies and other facial wrinkles in which a deep dermal grid pattern injection technique is appropriate. It is also indicated for restoration and/or correction of signs of lipoatrophy in patients with human immunodeficiency virus. OBJECTIVE: The authors examine the efficacy of injectable PLLA for correction of nasolabial fold wrinkles, based on Investigator Global Evaluations (IGE). METHODS: A randomized, multicenter, subject-blinded, parallel-group study compared injectable PLLA versus human collagen for correction of nasolabial fold wrinkles for 13 months after up to four treatments (intent-to-treat population, 233). Injectable PLLA-treated subjects were followed up for an additional 12 months (total, 25 months) after the final treatment session. Efficacy was also assessed through secondary IGE for improvement, which is the subject of this report. RESULTS: IGE reports of improvement were significantly greater in subjects who received injectable PLLA versus those who received human collagen (p < .001). Overall improvement with injectable PLLA was 100% three weeks after the final treatment, remaining above 85% through month 25. Overall IGE of improvement with human collagen declined from 94.0% at week three to 6.0% at month 13. Both treatment groups had similar safety profiles. CONCLUSIONS: IGE of improvement were significantly greater with injectable PLLA treatment than with human collagen treatment at all time points following the last treatment. Injectable PLLA treatment continued to show a beneficial effect for up to 25 months.

Brandt FS; Cazzaniga A; Baumann L; Fagien S; Glazer S; Kenkel JM; Lowe NJ; Monheit GD; Narins RS; Rendon MI; Rohrich RJ; Werschler WP

2011-07-01

196

The safety and efficacy of an injectable bone substitute in dental sockets demonstrated in a human clinical trial.  

UK PubMed Central (United Kingdom)

This study is the first report of a clinical evaluation of an injectable bone substitute (IBS). This IBS was prepared by suspending biphasic calcium phosphate (BCP) particles with diameters ranging between 80 and 200 microm in a water-soluble cellulose polymer carrier phase. It was used for filling bone defects after tooth extractions in 11 patients. The first objective of the study was to investigate the safety of the filler material. The second objective was to investigate the efficacy of the material for filling human tooth sockets and preventing alveolar bone loss. Radiographic density measurements of the surgical sites gradually increased to those of the surrounding host bone. Three years after surgery, small biopsies of the implanted areas were harvested and analyzed by using micro-computed tomography, non-decalcified histology and histomorphometry. The BCP granules appeared in direct contact with mineralized bone tissue, thereby supporting bone growth. A gradual substitution of the filler by bone tissue was observed thus preserving the height of the alveolar bone crest.

Weiss P; Layrolle P; Clergeau LP; Enckel B; Pilet P; Amouriq Y; Daculsi G; Giumelli B

2007-08-01

197

Efficacy of homemade hemostatics of injected gelatin matrix for immediately treating blunt hepatic trauma in canine model without additional pressure.  

UK PubMed Central (United Kingdom)

OBJECTIVE: To explore the efficacy of homemade hemostatics of injected gelatin matrix (HIGM) for immediately treating blunt hepatic trauma in canine model without additional pressure. METHODS: A total of 27 commercial hybrid dogs underwent celiotomy to establish hepatic trauma model after general anesthesia. The dogs were prospectively randomized into 3 groups: the treatment group (n=9, with the direct application of homemade hemostat), the positive control group (n=9, with thrombin solution), and the negative control group (n=9, with 0.9% normal saline). Time to hemostasis and intra-abdominal blood loss were recorded, and heart rate (HR), mean arterial pressure (MAP), and hematological parameters were compared among these three groups. Gross examinations were performed 30 minutes after surgery. RESULTS: Significantly shorter time to hemostasis [(1.20±0.33) min] and less blood loss [(47.22±8.61) ml] were observed in the treatment group than in control groups (P 0.05). No cases of bleeding occurred in any animals in the treatment group, and no signs of infection and adhesion formation were evident due to exposure to HIGM. Two cases in the positive control group (22.22%) were found to have rebleeding. All animals in the negative control group experienced visible bleeding. CONCLUSION: HIGM is effective for controlling bleeding after hepatic trauma without the additional compression, and therefore may be valuable in field surgery.

Xie X; Tian JK; Yu TF; Lv FQ; Wu R; Luo YK; Tang J

2012-08-01

198

Development of an injectable formulation of albendazole and in vivo evaluation of its efficacy against Echinococcus multilocularis metacestode.  

UK PubMed Central (United Kingdom)

The loading of poly (D, L-lactide) nanoparticles with ABZ has led us to evaluate the potential of this new colloidal drug delivery system against E. multilocularis, using a murine model of hepatic alveolar echinococcosis. ABZ-loaded nanoparticles had a monodisperse size distribution between 100 and 150 nm. The efficiency of drug loading to nanoparticles was over 97%. In vitro, at an ABZ concentration of 1.0 microgram ml-1, the formulation had no toxicity for peritoneal macrophages harvested from uninfected mice. In vivo, the ABZ-loaded nanoparticles exhibited no signs of toxicity at any of the doses tested. Intravenous injections of 6 mg kg-1 of bound ABZ to infected mice had an equivalent antiparasitic effect on the metacestode growth to that of a treatment with 1500 mg kg-1 of orally administered free ABZ. The parasite hepatic superficial size as well as the peritoneal metastatic burden was significantly reduced by these 2 courses of treatment, as compared to those of untreated mice. Our results should encourage further study in order to explain the absence of dose-dependent efficacy of ABZ-loaded nanoparticles demonstrated in the present study.

Rodrigues JM Jr; Bories C; Emery I; Fessi H; Devissaguet JP; Liance M

1995-12-01

199

Development of an injectable formulation of albendazole and in vivo evaluation of its efficacy against Echinococcus multilocularis metacestode.  

Science.gov (United States)

The loading of poly (D, L-lactide) nanoparticles with ABZ has led us to evaluate the potential of this new colloidal drug delivery system against E. multilocularis, using a murine model of hepatic alveolar echinococcosis. ABZ-loaded nanoparticles had a monodisperse size distribution between 100 and 150 nm. The efficiency of drug loading to nanoparticles was over 97%. In vitro, at an ABZ concentration of 1.0 microgram ml-1, the formulation had no toxicity for peritoneal macrophages harvested from uninfected mice. In vivo, the ABZ-loaded nanoparticles exhibited no signs of toxicity at any of the doses tested. Intravenous injections of 6 mg kg-1 of bound ABZ to infected mice had an equivalent antiparasitic effect on the metacestode growth to that of a treatment with 1500 mg kg-1 of orally administered free ABZ. The parasite hepatic superficial size as well as the peritoneal metastatic burden was significantly reduced by these 2 courses of treatment, as compared to those of untreated mice. Our results should encourage further study in order to explain the absence of dose-dependent efficacy of ABZ-loaded nanoparticles demonstrated in the present study. PMID:8719955

Rodrigues, J M; Bories, C; Emery, I; Fessi, H; Devissaguet, J P; Liance, M

1995-12-01

200

The efficacy of guanxinning injection in treating angina pectoris: systematic review and meta-analysis of randomized controlled trials.  

UK PubMed Central (United Kingdom)

Objective. The randomized controlled trials (RCTs) on Guanxinning injection (GXN) in treating angina pectoris were published only in Chinese and have not been systematically reviewed. This study aims to provide a PRISMA-compliant and internationally accessible systematic review to evaluate the efficacy of GXN in treating angina pectoris. Methods. The RCTs were included according to prespecified eligibility criteria. Meta-analysis was performed to evaluate the symptomatic (SYMPTOMS) and electrocardiographic (ECG) improvements after treatment. Odds ratios (ORs) were used to measure effect sizes. Subgroup analysis, sensitivity analysis, and metaregression were conducted to evaluate the robustness of the results. Results. Sixty-five RCTs published between 2002 and 2012 with 6064 participants were included. Overall ORs comparing GXN with other drugs were 3.32 (95% CI: [2.72, 4.04]) in SYMPTOMS and 2.59 (95% CI: [2.14, 3.15]) in ECG. Subgroup analysis, sensitivity analysis, and metaregression found no statistically significant dependence of overall ORs upon specific study characteristics. Conclusion. This meta-analysis of eligible RCTs provides evidence that GXN is effective in treating angina pectoris. This evidence warrants further RCTs of higher quality, longer follow-up periods, larger sample sizes, and multicentres/multicountries for more extensive subgroup, sensitivity, and metaregression analyses.

Jia Y; Leung SW; Lee MY; Cui G; Huang X; Pan F

2013-01-01

 
 
 
 
201

One-Shot Percutaneous Ethanol Injection of Liver Tumors Under General Anesthesia: Preliminary Data on Efficacy and Complications  

International Nuclear Information System (INIS)

Purpose: To verify the efficacy of ultrasound (US)-guided injection of large amounts of ethanol into large or multiple liver lesions, in a single session under general anesthesia (one-shot PEI) for percutaneous ablation of hepatic tumors. Methods: Twenty-nine patients (27 with 51 hepatocellular carcinoma (HCC) nodules on cirrhosis, diameter range 1.0-9.0 cm; two patients with a single metastasis from the gastroenteric tract, 5.0 and 9.0 cm, respectively, in diameter) were treated with one-shot PEI. Results: The total volume of alcohol delivered per patient ranged from 16 to 210 ml. Mean ethanol volume in all patients was 49 ml. Dynamic computed tomography (CT) examination showed complete necrosis in 41 of 50 lesions. Two patients died of hypovolemic shock due to massive upper gastrointestinal bleeding, 3 and 7 days, respectively, after the interventional procedure. All the remaining patients are alive (follow-up 5-14 months) except one who died of liver failure 5 months after. New HCC nodules occurred in six patients within 6 months and one intralesional relapse was recorded. Conclusion: In this preliminary experience, one-shot PEI is as effective in inducing liver tumor necrosis as traditional PEI; its advantages are shorter treatment time and the capability of treating larger and multiple liver lesions.

1996-01-01

202

Risperidone-induced acromegaly: a case report.  

Science.gov (United States)

Today, considering their adverse side effects, the first-generation antipsychotics have been replaced by the new-generation antipsychotics (also known as second-generation antipsychotic agents). The superiority of new-generation antipsychotics compared with first-generation antipsychotic agents in terms of side effects, especially movement disorders, are acknowledged by clinicians. But in recent years during the use of second-generation antipsychotic agents, endocrine side effects have been noteworthy. In our study with a diagnosis of paranoid schizophrenia treated with risperidone for 14 years and operated with the diagnosis of pituitary macroadenoma, a 32-year-old female patient is presented in the light of the literature examining the framework of the history of disease. PMID:23983960

Koroglu, Ay?e; Hocaoglu, Cicek

2012-04-01

203

Risperidone-induced acromegaly: a case report.  

UK PubMed Central (United Kingdom)

Today, considering their adverse side effects, the first-generation antipsychotics have been replaced by the new-generation antipsychotics (also known as second-generation antipsychotic agents). The superiority of new-generation antipsychotics compared with first-generation antipsychotic agents in terms of side effects, especially movement disorders, are acknowledged by clinicians. But in recent years during the use of second-generation antipsychotic agents, endocrine side effects have been noteworthy. In our study with a diagnosis of paranoid schizophrenia treated with risperidone for 14 years and operated with the diagnosis of pituitary macroadenoma, a 32-year-old female patient is presented in the light of the literature examining the framework of the history of disease.

Koroglu A; Hocaoglu C

2012-04-01

204

Anti-depressive effectiveness of olanzapine, quetiapine, risperidone and ziprasidone: a pragmatic, randomized trial  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background Efficacy studies indicate anti-depressive effects of at least some second generation antipsychotics (SGAs). The Bergen Psychosis Project (BPP) is a 24-month, pragmatic, industry-independent, randomized, head-to-head comparison of olanzapine, quetiapine, risperidone and ziprasidone in patients acutely admitted with psychosis. The aim of the study is to investigate whether differential anti-depressive effectiveness exists among SGAs in a clinically relevant sample of patients acutely admitted with psychosis. Methods Adult patients acutely admitted to an emergency ward for psychosis were randomized to olanzapine, quetiapine, risperidone or ziprasidone and followed for up to 2 years. Participants were assessed repeatedly using the Positive and Negative Syndrome Scale - Depression factor (PANSS-D) and the Calgary Depression Scale for Schizophrenia (CDSS). Results A total of 226 patients were included. A significant time-effect showing a steady decline in depressive symptoms in all medication groups was demonstrated. There were no substantial differences among the SGAs in reducing the PANSS-D score or the CDSS sum score. Separate analyses of groups with CDSS sum scores > 6 or ?6, respectively, reflecting degree of depressive morbidity, revealed essentially identical results to the primary analyses. There was a high correlation between the PANSS-D and the CDSS sum score (r = 0.77; p Conclusions There was no substantial difference in anti-depressive effectiveness among olanzapine, quetiapine, risperidone or ziprasidone in this clinically relevant sample of patients acutely admitted to hospital for symptoms of psychosis. Based on our findings we can make no recommendations concerning choice of any particular SGA for targeting symptoms of depression in a patient acutely admitted with psychosis. Trial Registration ClinicalTrials.gov ID; URL: http://www.clinicaltrials.gov/: NCT00932529

Kjelby Eirik; Jørgensen Hugo A; Kroken Rune A; Løberg Else-Marie; Johnsen Erik

2011-01-01

205

Oral versus Long-Acting Injectable Antipsychotics in the Treatment of Schizophrenia and Special Populations at Risk for Treatment Nonadherence: A Systematic Review.  

UK PubMed Central (United Kingdom)

Long-acting injectable antipsychotics (LAIs) should offer better efficacy and tolerability, compared to oral antipsychotics due to improved adherence and more stable pharmacokinetics. However, data on LAIs has been mixed, with some studies finding that they are more effective and tolerable than oral antipsychotics, and others finding the contrary. One possibility for the disparate results may be that some studies administered different antipsychotics in the oral and injectable form. The present systematic review examined the efficacy and tolerability of LAIs versus their oral equivalents in randomized and naturalistic studies. In addition, it examined the impact of LAIs on special populations such as patients with first-episode psychosis, substance use disorders, and a history of violence or on involuntary outpatient commitment. Randomized studies suggest that not all LAIs are the same; for example, long-acting risperidone may be associated with equal or less side effects than oral risperidone, whereas fluphenazine decanoate and enanthate may be associated with equal or more side effects than oral fluphenazine. They also suggest that LAIs reduce risk of relapse versus oral antipsychotics in schizophrenia outpatients when combined with quality psychosocial interventions. For their part, naturalistic studies point to a larger magnitude of benefit for LAIs, relative to their oral equivalents particularly among first-episode patients.

Zhornitsky S; Stip E

2012-01-01

206

Long-term effectiveness of flexibly dosed Paliperidone Extended-Release: Comparison among patients with schizophrenia switching from risperidone and other antipsychotic agents.  

UK PubMed Central (United Kingdom)

Abstract Objective: The current study compared the long-term effectiveness, safety, and tolerability of paliperidone extended-release (ER) among patients with schizophrenia who had switched from risperidone (risperidone group) or other antipsychotic medications (non-risperidone group) due to lack of efficacy, intolerability, or non-adherence. Research design and methods: This open-label, prospective, multicenter, 48-week study utilized the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression-Severity scale (CGI-S), the Personal and Social Performance scale (PSP), and the Subjective Well-being under Neuroleptics scale (SWN) to assess patients with schizophrenia. Additionally, extrapyramidal symptoms (EPS) and subjective side effects were evaluated with validated scales. Clinical trial registration: a clinicaltrials.gov identifier: NCT00864045 Results: The completion rate for this study was 51.6% (95/184), and 169 patients finished with ?1 post-baseline assessment (81 patients in the risperidone group, 88 in the non-risperidone group). The mean (SD) PANSS total score decreased significantly from 78.3 [18.8] to 65.5 [19.7] in the risperidone group and from 79.1 [19.8] to 65.4 [20.8] in the other group (all p?risperidone group. Conclusions: Switching from previously unsuccessful antipsychotic treatments to paliperidone ER can be a useful option to achieve long-term improvement in symptoms and functioning for patients with schizophrenia. The clinical effectiveness appeared to be similar in patients who previously received risperidone and those treated with other antipsychotic medications. The open-label design and lack of a placebo group were limitations.

Kim EY; Chang SM; Shim JC; Joo EJ; Kim JJ; Kim YS; Ahn YM

2013-06-01

207

Long-term effectiveness of flexibly dosed paliperidone extended-release: comparison among patients with schizophrenia switching from risperidone and other antipsychotic agents.  

Science.gov (United States)

Abstract Objective: The current study compared the long-term effectiveness, safety, and tolerability of paliperidone extended-release (ER) among patients with schizophrenia who had switched from risperidone (risperidone group) or other antipsychotic medications (non-risperidone group) due to lack of efficacy, intolerability, or non-adherence. Research design and methods: This open-label, prospective, multicenter, 48 week study utilized the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression-Severity scale (CGI-S), the Personal and Social Performance scale (PSP), and the Subjective Well-being under Neuroleptics scale (SWN) to assess patients with schizophrenia. Additionally, extrapyramidal symptoms (EPS) and subjective side effects were evaluated with validated scales. Clinical trial registration: Clinicaltrials.gov identifier: NCT00864045. Results: The completion rate for this study was 51.6% (95/184), and 169 patients finished with ?1 post-baseline assessment (81 patients in the risperidone group, 88 in the non-risperidone group). The mean (SD) PANSS total score decreased significantly from 78.3 (18.8) to 65.5 (19.7) in the risperidone group and from 79.1 (19.8) to 65.4 (20.8) in the other group (all p?risperidone group. Conclusions: Switching from previously unsuccessful antipsychotic treatments to paliperidone ER can be a useful option to achieve long-term improvement in symptoms and functioning for patients with schizophrenia. The clinical effectiveness appeared to be similar in patients who previously received risperidone and those treated with other antipsychotic medications. The open-label design and lack of a placebo group were limitations. PMID:23777311

Kim, Eun Young; Chang, Sung Man; Shim, Joo Cheol; Joo, Eun Jeong; Kim, Jae Jin; Kim, Yong Sik; Ahn, Yong Min

2013-07-16

208

Comparative efficacy of two microdoses of a potentized homeopathic drug, arsenicum album, to ameliorate toxicity induced by repeated sublethal injections of arsenic trioxide in mice.  

UK PubMed Central (United Kingdom)

OBJECTIVES: To evaluate the efficacy of 2 potentized homeopathic remedies of Arsenicum Album (Ars Alb)--6C and 30C--in combating chronic arsenic toxicity induced by repeated sublethal injections in mice (Mus musculus). METHODS: Mice were randomized and divided into sets: (1) normal (control 1); (2) normal + succussed alcohol (control 2); (3) As(2)O(3) (0.016%) injected at 1 ml/100 g body weight every 7 days (treated); (4) As(2)O(3) injected + succussed alcohol (positive control); (5) As(2)O(3) injected + Ars Alb 6C (drug-fed); (6) As(2)O(3) injected + Ars Alb 30C (drug-fed). Cytogenetical endpoints like chromosome aberrations, micronuclei, mitotic index, sperm head abnormality and biochemical protocols like acid and alkaline phosphatases, aspartate and alanine aminotransferases, reduced glutathione, lipid peroxidation, catalase and succinate dehydrogenase were studied at 30, 60, 90 and 120 days. RESULTS: Compared to controls, chromosome aberrations, micronuclei, sperm head abnormality frequencies and activities of acid and alkaline phosphatases, aspartate and alanine aminotransferases and lipid peroxidation were reduced in both drug-fed series, while mitotic index and activities of glutathione, catalase and succinate dehydrogenase were increased. Ars Alb 30C showed marginally better efficacy than Ars Alb 6C. CONCLUSION: Both remedies indicated potentials of use against arsenic intoxication.

Banerjee P; Bhattacharyya SS; Pathak S; Naoual B; Belon P; Khuda-Bukhsh AR

2008-01-01

209

Effects of Risperidone on Cognitive-Motor Performance and Motor Movements in Chronically Medicated Children  

Science.gov (United States)

This study was designed to explore the placebo-controlled effects of risperidone on cognitive-motor processes, dyskinetic movements, and behavior in children receiving maintenance risperidone therapy. Sixteen children aged 4-14 years with disruptive behavior were randomly assigned to drug order in a crossover study of risperidone and placebo for 2…

Aman, Michael G.; Hollway, Jill A.; Leone, Sarah; Masty, Jessica; Lindsay, Ronald; Nash, Patricia; Arnold, L. Eugene

2009-01-01

210

Prospective microperimetry and OCT evaluation of efficacy of repeated intravitreal bevacizumab injections for persistent clinically significant diabetic macular edema.  

UK PubMed Central (United Kingdom)

To prospectively investigate morphologic and functional changes after intravitreal bevacizumab for persistent diffuse and clinically significant diabetic macular edema. In total, 26 eyes in 26 patients were treated with three intravitreal injections of bevacizumab (Avastin™) given at 4-week intervals. Study parameters included: visual acuity (VA), perceived visual improvement, central macular thickness as measured by Spectralis OCT, macular sensitivity and fixation pattern as measured by MP-1 microperimetry, and the incidence of ocular and systemic side-effects. At the time of follow-up, 76.9 % of eyes showed a significant improvement in VA (p = 0.012), 38.4 % showed a one-line improvement on the ETDRS chart compared with VA at day 0, 30.7 % showed a two-line improvement, and 7.6 % showed at least a three-line improvement. The mean central macular thickness was 447 microns at day 0 and 311.1 microns at follow-up (p = 0.003). The mean baseline macular sensitivity, by MP-1 microperimetry, was 8.29 dB; at follow -up, macular sensitivity had improved to 14.26 dB (p = 0.025). These results support further controlled trials on the efficacy of intravitreal bevacizumab in treating diabetic macular edema. Microperimetry and OCT are important tools in managing diabetic patients, providing a detailed study of the macular region, particularly when it is necessary to monitor the morphological and functional outcome after various interventions. A good correlation between retinal sensitivity and perceived visual performance was found.

Malagola R; Spinucci G; Cofone C; Pattavina L

2013-06-01

211

Long-acting injectable antipsychotics: focus on olanzapine pamoate  

Directory of Open Access Journals (Sweden)

Full Text Available JP LindenmayerDepartment of Psychiatry, New York University School of Medicine, New York NY, USAAbstract: Medication non-adherence in patients with schizophrenia continues to be a significant problem and threatens successful treatment outcomes. Medication non-adherence is often associated with negative consequences, including symptom exacerbation, more frequent emergency room visits, re-hospitalizations and relapse. Long-acting injectable (LAI) forms of antipsychotics allow for rapid identification of non-adherence, obviate the need for the patient to take the medication on a daily basis and increase adherence to some significant degree. Eli Lilly has developed a long-acting depot formulation of olanzapine, olanzapine pamoate, which has recently been approved by the FDA for the US market, and which will be reviewed here. Olanzapine LAI appears to be an effective antipsychotic at dosages of 210 mg every 2 weeks, 300 mg every 2 weeks and 405 mg every 4 weeks in patients with acute schizophrenia, and at 150 mg every 2 weeks, 300 mg every 2 weeks and at 405 mg every 4 weeks for the maintenance treatment of stable patients. Oral supplementation appears not to be needed, particularly not at the onset of treatment with the LAI as is necessary with risperidone LAI. Its efficacy is in general comparable to the efficacy seen with oral olanzapine at a corresponding dose. The side effect profile is also comparable to the side effects observed with oral olanzapine, including lower rates of extrapyramidal symptoms, prolactin elevation and cardiovascular side effects, but significant metabolic effects. The latter include significant weight gain, lipid abnormalities and glucose dysregulation. While the injection site adverse events are overall mild, the most significant serious adverse event is the post-injection delirium sedation syndrome (PDSS). While rare, this syndrome results from inadvertent intravascular injection of olanzapine LAI and can cause a range of olanzapine overdose-type of symptoms. Olanzapine LAI needs therefore to be administered by trained personnel in settings where a post-injection observation period for at least 3 hours by medical personnel is available. The overall use of olanzapine LAI will probably be limited by the possibility of a PDSS event. Patients who have a history of good response to oral olanzapine and are in need of assured medication administration may present a good indication for its use, provided that the appropriate mental health delivery setting is available.Keywords: olanzapine, risperidone, schizophrenia

JP Lindenmayer

2010-01-01

212

Neurocognitive effectiveness of quetiapine, olanzapine, risperidone, and ziprasidone: a pragmatic, randomized trial.  

UK PubMed Central (United Kingdom)

PURPOSE: Cognitive effects of second generation antipsychotics (SGAs) are indicated in efficacy studies but the generalizability of the results may be limited by rigid designs and selected samples. The aim of this naturalistic, industry-independent study is to investigate whether differential neurocognitive effectiveness can be found among olanzapine, quetiapine, risperidone, and ziprasidone in a clinically relevant sample with psychosis. SUBJECTS AND METHODS: Adult patients acutely admitted to an emergency ward for psychosis were randomized to risperidone, olanzapine, quetiapine or ziprasidone and followed for up to 2 years. Participants were assessed repeatedly using the Positive and Negative Syndrome Scale and a repeatable neurocognitive test battery. RESULTS: A total of 226 patients were included and 171 patients underwent neurocognitive assessments. The sample had a global cognitive performance score at baseline about one standard deviation below that of the general population. The ziprasidone group had the fastest increase in global functioning which was significantly superior to that of the olanzapine group for the entire follow-up period. Before 90 days, the quetiapine group had the fastest increase which was statistically superior to the olanzapine group. DISCUSSION: Ziprasidone and quetiapine demonstrated superiority to olanzapine in increasing global neurocognitive performance in this naturalistic sample.

Johnsen E; Jørgensen HA; Kroken RA; Løberg EM

2013-03-01

213

A Case of Diabetic Ketoacidosis Associated with Risperidone Treatment  

Directory of Open Access Journals (Sweden)

Full Text Available The association between schizophrenia and diabetes has been previously documented. Case reports have also demonstrated that initiation of atypical antipsychotic agents may induce or exacerbate diabetes mellitus. A 26-year-old man without a family history of diabetes mellitus presented with deep coma after 5 months of treatment with risperidone. He was diagnosed with diabetic ketoacidosis, was given insulin and saline infusion, and his antipsychotic agent was changed from risperidone to ziprasidone.Insulin therapy and oral agent was discontinued within two months of follow-up. The rapid onset of diabetes, and the disappearance of hyperglycemia after discontinuation of the drug suggested that risperidone had been a factor in his diabetic ketoacidosis. During three years of subsequent follow-up, testing revealed no evidence of elevated serum glucose levels or impaired glucose tolerance. In our opinion psychiatrists should routinely ask patients treated with antipsychotic agents such as risperidone for diabetic symptoms, weight loss, lethargy, polydipsia and/or polyuria, and monitor serum glucose levels. Although there is no consensus on the best way to switch from one antipsychotic drug to another, for those patients who develop diabetes during therapy with risperidone a change to ziprasidone treatment may maintain normal glucose levels.

Abdullah Ta?l?p?nar; Mahmut Yaz?c?; Levent Kebapç?lar; Deniz Engin Gök; Mustafa ?ahin; Sinan Yetkin; Erol Bolu; Zeynel Beyhan; Mustafa Kutlu

2008-01-01

214

RP-HPLC estimation of risperidone in tablet dosage forms  

Directory of Open Access Journals (Sweden)

Full Text Available A simple, specific, accurate, and precise reverse phase liquid chromatographic method was developed and validated for the estimation of risperidone in tablet dosage forms. A Phenomenex Gemini C-18, 5 µm column having 250x4.6 mm i.d. in isocratic mode, with mobile phase containing methanol: acetonitrile: 50 mM potassium dihydrogen orthophosphate (80:10:10 v/v) was used. The flow rate was 1.3 ml/min and effluents were monitored at 234 nm. Clozapine was used as an internal standard. The retention time of risperidone and clozapine were 2.5 min and 3.3 min, respectively. The method was validated for linearity, accuracy, precision, specificity, limit of quantification, limit of detection, robustness and stability. The limit of detection and limit of quantification for estimation of risperidone was found to be 500 ng/ml and 990 ng/ml, respectively. Recovery of risperidone was found to be in the range of 99.02-101.68%. Proposed method was successfully applied for the quantitative determination of risperidone in tablet formulations.

Bladania S; Bhatt K; Mehta R; Shah D

2008-01-01

215

Comparison of the efficacy of weekly vs. twice a week intralesional injections of meglumine antimoniate in the treatment of anthroponotic cutaneous leishmaniasis: a randomized clinical trial  

Directory of Open Access Journals (Sweden)

Full Text Available "nBackground and Aim: Treatment of cutaneous leishmaniasis, especially when caused by L. tropica, is challenging. Meglumine antimoniate (Glucantime®) is used as the standard treatment, but multiple injectiond are necessary. The objective of this study was to compare the efficacy of weekly intralesional injections with twice weekly injections of Glucantime for the treatment of anthroponotic cutaneous leishmaniasis (ACL)."n"nMethods: This randomized open clinical trial was conducted, in Bam, Kerman province, Iran. 96 eligible patients according to inclusion and exclusion criteria who were willing to participate were included. The included patients were randomly assigned into two groups, one group treated with weekly intralesional injections of Glucantime® and the other group treated with intralesional Glucantime® twice a week. Type and size of each lesion (induration, ulcer and scar) were recorded weekly. Complete healing was defined as complete re-epithelialization and absence of induration in all lesions and was considered as the primary outcome measure."n"nResults: A total of 48 patients completed the study; complete cure was seen in 24 of 27 (89%) patients who received weekly intralesional MA with a mean duration of healing equals to 70±10 days. Complete cure was seen in 24 of 31 (77%) patients who received intralesional MA twice a week, the mean duration of healing in the latter group was 58±5 days. There was no significant difference between the two groups (P=0.23)."n"nConclusion: It seems that the efficacy of intralesional injections of Glucantime® once a week is similar to efficacy of twice a week Glucantime® injections.

Ali Khamesipour; Alireza Khatami; Iraj Sharifi; Mahdie Bahrami; Amir Javadi; Seyed Ebrahim Eskandari; Alireza Firooz; Alireza Fekri; Mohammadr Reza Aflatoonian

2010-01-01

216

[Efficacy and safety of a single intra-articular injection of 2% hyaluronic acid plus mannitol in knee osteoarthritis over a 6-month period].  

UK PubMed Central (United Kingdom)

OBJECTIVE: To evaluate the safety and efficacy of a single intra-articular injection of 2% hyaluronic acid (HA)+mannitol in symptomatic knee osteoarthritis (KOA). MATERIAL AND METHODS: Pilot, multicentre, open, non-comparative study performed in eighty patients with painful KOA, of whom 79 completed the study. They received one injection of 2ml of 2% HA+0.5% mannitol (Day 0) and were followed-up for 6 months. On Days 0, 15, 30, 60, 90, 120, 150 and 180, pain and joint function were assessed using a visual analogue scale (VAS) and WOMAC index. Efficacy and safety by investigator and patient, and rescue medication, as an indirect measure of pain, were also recorded. RESULTS: A significant reduction in joint pain, stiffness and functional disability compared with baseline was observed at every follow-up visit (P<.001). Joint function improved by 38.7% on Day 30, reaching 47.5% on Day 180. Rescue medication use decreased from 58.2% at baseline to 2.5% on Day 90, increasing in the last visits. Efficacy and safety were positively evaluated by investigators and patients. No serious adverse events were observed. Mild side effects were reported in 4 patients (local pain and swelling in the infiltration area). DISCUSSION: There is evidence that repeated intra-articular injections of HA improve symptoms in KOA. However, studies with a single injection of HA have shown mixed results. This study demonstrates that one single intra-articular injection of non-cross-linked HA reduces joint pain and increases function in patients with KOA over a period of at least 6 months.

Borrás-Verdera A; Calcedo-Bernal V; Ojeda-Levenfeld J; Clavel-Sainz C

2012-07-01

217

[The review of acute risperidone poisoning].  

UK PubMed Central (United Kingdom)

Risperidone (RIS) is a benzisoxazole derivative, an atypical neuroleptic used in the treatment of schizophrenia and other psychoses. The therapeutic action of RIS depends not only on the parent compound but also its major active metabolite, 9-hydroxyrisperidone (9-OH-RIS), and the pharmacokinetics is modified by the genetic polymorphism of CYP2D6, the main site o RIS metabolism. Diverse symptoms of an acute RIS poisoning result from its interaction with multiple receptors, i.e. serotoninergic 5-HT2A and 5-HT7, dopaminergic D2, adrenergic alpha1 and alpha2, as well as histamine H1. The clinical picture of acute RIS poisoning consists predominantly of central nervous system and cardiovascular effects and the most severe symptoms are: hypotension, dysrrhythmias, consciousness disturbances, seizures and respiratory failure. No specific antidote for RIS poisoning is known and the treatment is only symptomatic and supportive. Quantitative determination of RIS blood concentration seems to be helpful in confirmation and monitoring of acute poisoning, nevertheless further investigations are needed to evaluate the relation between drug concentration and clinical symptoms.

Ciszowski K; Szpak D; Wilimowska J

2010-01-01

218

Bacterial degradation of risperidone and paliperidone in decomposing blood.  

UK PubMed Central (United Kingdom)

The stability of two benzisoxazole antipsychotics was determined in vitro in decomposing porcine blood inoculated with bacteria, utilizing a high-performance liquid chromatography with ultraviolet and fluorescence detection method for drug quantitation. Stability experiments for risperidone and paliperidone were conducted at 7, 20 and 37°C for 4 days using sterile and bacterially inoculated porcine blood. The drugs were stable in sterile blood at each temperature and in inoculated blood at 7°C, but degraded significantly in inoculated blood at 20 and 37°C. Complete loss occurred within 2 days when incubated at 37°C. The benzisoxazole-cleaved degradation products for both drugs were identified as 2-hydroxybenzoyl-risperidone and 2-hydroxybenzoyl-paliperidone utilizing liquid chromatography quadrupole-time-of-flight mass spectrometry and accurate mass measurements. The degradation products have been found in postmortem case studies, including one case where risperidone and paliperidone were not detected, indicating complete conversion can occur in situ.

Butzbach DM; Stockham PC; Kobus HJ; Sims DN; Byard RW; Lokan RJ; Walker GS

2013-01-01

219

Risperidone, a risk factor for valproate-induced encephalopathy?  

Science.gov (United States)

Valproate-induced encephalopathy (ViE) has been increasingly reported and several risk factors have been proposed. We report a case whereby a patient became encephalopathic while treated with valproate and upon initiation of risperidone. The underlying mechanism could be risperidone's interference with valproate's binding to albumin, raising free valproate levels, which would impair the urea cycle and reduce ammonia conversion, leading to a hyperammonemic encephalopathy. The present case suggests a causal link, although further studies will be necessary to establish this. Nevertheless, clinicians should be aware of this possible interaction and consider carefully before concomitant administration of valproate and risperidone, mainly in patients with other risk factors for ViE, so this complication can be avoid or promptly diagnosed and treated. PMID:23317937

Rodrigues-Silva, Nuno; Venâncio, Ângela; Bouça, Jorge

2013-01-12

220

Risperidone, a risk factor for valproate-induced encephalopathy?  

UK PubMed Central (United Kingdom)

Valproate-induced encephalopathy (ViE) has been increasingly reported and several risk factors have been proposed. We report a case whereby a patient became encephalopathic while treated with valproate and upon initiation of risperidone. The underlying mechanism could be risperidone's interference with valproate's binding to albumin, raising free valproate levels, which would impair the urea cycle and reduce ammonia conversion, leading to a hyperammonemic encephalopathy. The present case suggests a causal link, although further studies will be necessary to establish this. Nevertheless, clinicians should be aware of this possible interaction and consider carefully before concomitant administration of valproate and risperidone, mainly in patients with other risk factors for ViE, so this complication can be avoid or promptly diagnosed and treated.

Rodrigues-Silva N; Venâncio Â; Bouça J

2013-07-01

 
 
 
 
221

Comparison of mental health resources used by patients with bipolar disorder treated with risperidone, olanzapine, or quetiapine.  

UK PubMed Central (United Kingdom)

OBJECTIVE: The atypical antipsychotics, risperidone, olanzapine, and quetiapine, have been approved by the U.S. Food and Drug Administration for treatment of mania associated with bipolar disorder. Information on the relative mental health resource use of these therapies is helpful to pharmacy managers since differences in efficacy and safety may translate into differences in mental health care utilization. We compared charges for other mental health services associated with risperidone, olanzapine, and quetiapine treatment of patients with bipolar disorder to assess whether there were significant differences between these therapies. A secondary analysis involved dose-equivalent adjustment of the average allowed charge of the 3 atypical antipsychotics. METHODS: This was a retrospective study based on administrative data for 46 U.S. commercial health plans represented in a commercial database covering the period January 1998 through April 2002. The 6,625 patients included in the study had at least 2 contiguous pharmacy claims for a study antipsychotic, had received no other antipsychotics concurrently, and had not switched from an alternative antipsychotic in the preceding 90 days. Provider-submitted (billed) charges were selected in preference to paid amounts as being more accurate indicators of relative differences in the use of mental health resources. Mental health care charges were measured per patient per month (PPPM) and included charges for the study antipsychotics and charges for the other mental health care services (inpatient, physician and other ambulatory, and other psychotropic medications). Differences in other mental health care charges PPPM among the 3 therapies were assessed with multivariate regression, adjusting for differing patient characteristics. Differences in antipsychotic drug charges PPPM were assessed after adjustment to reflect an equivalent average daily dose. RESULTS: Regression estimates adjusted for patient differences did not show statistically significant differences in other mental health care charges PPPM among the 3 antipsychotic drug therapies. Other mental health charges associated with quetiapine were estimated to be 14 US dollars, or 3% lower than those associated with risperidone, but this difference was not statistically significant (P = 0.069). The PPPM charges for quetiapine versus olanzapine and olanzapine versus risperidone were also not different (P = 0.231 and P = 0.39, respectively). After adjusting for differences in average daily dose, risperidone and quetiapine had antipsychotic drug charges that were 84 US dollars and 76 US dollars PPPM lower than those of olanzapine (P < 0.01); the difference between the adjusted drug charges PPPM for risperidone and quetiapine was not significant. CONCLUSION: Total charges for mental health services other than the study drug were not different for risperidone, olanzapine, and quetiapine in patients treated for bipolar disorder. However, based on prescription charges, olanzapine appears to be considerably more costly at an equivalent daily dose than either risperidone or quetiapine.

Gianfrancesco F; Pesa J; Wang RH

2005-04-01

222

Risperidone and Corrected QT-interval Prolongation in Surface Electrocardiogram  

Directory of Open Access Journals (Sweden)

Full Text Available Risperidone is an antipsychotic medication suspected of causing QT prolongation and several cases are reported in this regard. However, available information with respect to its effect on QT interval is limited especially from different settings. The aim of this study was to assess the effect of risperidone in lengthening QT interval among psychotic patients referred to a psychiatric ward in North West of Iran. A controlled cohort study was conducted on psychotic patients referred to Razi Hospital from April 2010-2011. The treatment cohort groups were 120 patients receiving risperidone for the first time during their treatment. The comparison cohort included 60 control patients who were not receiving risperidone. An electrocardiogram was obtained from all the study participants at admission time, one week afterwards and at discharge. Corrected QT interval (QTc) was determined using Bazett’s formula. QTc dispersion was calculated as MaxQTc-MinQTc. Data were analyzed using SPSS statistical software package. The mean change in QTc measures over time was not statistically significant in control group. However, QTc increment was statistically significant over time in V1 and V3 leads in risperidone group. Multivariate longitudinal data analysis, using between-effects model, to manage multiple measurements over time found the overall QTc trend to be different between the groups (p<0.01). Risperidone may have significant effects on QT interval and QT dispersion. Physicians and psychiatrists should be aware that prolonged QTc interval is a potential indicator of cardiovascular risk and should be cautious in prescribing potentially QT-prolonging medications, at least to certain patients.

F. Ranjbar; F. Akbarzadeh; N.M. Ahmadi; M. Abbasnejhad

2012-01-01

223

Persistent efficacy and production benefits following use of extended-release injectable eprinomectin in grazing beef cattle under field conditions.  

UK PubMed Central (United Kingdom)

Seven studies were conducted in commercial grazing operations to confirm anthelmintic efficacy, assess acceptability, and measure the productivity response of cattle to treatment with eprinomectin in an extended-release injectable formulation (ERI) when exposed to nematode infected pastures for 120 days. The studies were conducted under one protocol in the USA in seven locations (Arkansas, Idaho, Louisiana, Minnesota, Missouri, Oregon, and Wisconsin). Each study had 67-68 naturally infected animals for a total of 475 (226 female, 249 male castrate) Angus or beef-cross cattle. The animals weighed 133-335 kg prior to treatment and were approximately 3-12 months of age. The studies were conducted under a randomized block design based on pre-treatment body weights to sequentially form 17 replicates of four animals each within sex in each study. Animals within a replicate were randomly assigned to treatments, one to Eprinomectin ERI vehicle (control) and three to Eprinomectin ERI (5%, w/v eprinomectin). Treatments were administered at 1 mL/50 kg body weight once subcutaneously anterior to the shoulder. All animals in each study grazed one pasture throughout the observation period of 120 days. Cattle were weighed and fecal samples collected pre-treatment and on 28, 56, 84, and 120 days after treatment for fecal egg and lungworm larval counts. Positive fecal samples generally were cultured en masse to determine the nematode genera attributable to the gastrointestinal helminth infection. Bunostomum, Cooperia, Haemonchus, Nematodirus, Oesophagostomum, Ostertagia, and Trichostrongylus, when present, were referred to as strongylids. At all post-treatment sampling intervals, Eprinomectin ERI-treated cattle had significantly (P<0.05) lower strongylid egg counts than vehicle-treated controls, with ?95% reduction after 120 days of grazing. Over this same period, Eprinomectin ERI-treated cattle gained more weight (43.9 lb/head) than vehicle-treated controls in all studies. This weight gain advantage was significant (P<0.05) in six of the studies with the Eprinomectin ERI-treated cattle gaining an average of 42.8% and the control cattle gaining 33.1% of their initial weight. No adverse reactions were observed in the treated animals.

Kunkle BN; Williams JC; Johnson EG; Stromberg BE; Yazwinski TA; Smith LL; Yoon S; Cramer LG

2013-03-01

224

Efficacy of the computed tomographic scanning (CT) with contrast media injection from foot vein for abdominal mass of the child  

International Nuclear Information System (INIS)

CT with contrast media injection from forearm vein revealed poor information about the inferior vena cava (IVC), in two cases of neuroblastoma from the right adrenal gland. While, CT with contrast media injection from foot vein well demonstrated the tumor extension around the IVC in one case of neuroblastoma, and the tumor, thrombus in the IVC in two cases of Wilms' tumor. Bolus injection from foot vein is helpful to evaluate the extension of malignant tumor around the IVC. (author).

1988-01-01

225

Efficacy, adherence and tolerability of once daily tenofovir DF-containing antiretroviral therapy in former injecting drug users with HIV-1 receiving opiate treatment: results of a 48-week open-label study  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Abstract Objective To assess efficacy, adherence and tolerability of once daily antiretroviral therapy containing tenofovir disoproxil fumarate (DF) 300 mg in HIV-1-infected former injecting drug users receiving opiate treatment (IVDU). Methods European, 48-week, open-...

Esser S; Haberl A; Mulcahy F; Gölz J; Lazzarin A; Teofilo E; Vera J; Körber A; Staszewski S

226

Safety and efficacy of a bolus injection of landiolol hydrochloride as a premedication for multidetector-row computed tomography coronary angiography.  

UK PubMed Central (United Kingdom)

BACKGROUND: We evaluated the safety and efficacy of a bolus injection of landiolol hydrochloride, an ultrashort-acting ?1-selective antagonist, as an additional treatment after premedication with an oral ?-blocker to reduce heart rate prior to multidetector-row computed tomography (MDCT) coronary angiography (CAG). METHODS AND RESULTS: A total of 458 patients who underwent MDCT CAG were retrospectively enrolled. Image quality and hemodynamic parameters were compared in patients before and after approval of landiolol hydrochloride. If heart rate reduction was insufficient after premedication with an oral ?-blocker, a bolus injection of landiolol hydrochloride (n=66) or other drugs (n=30) was used. The percentage of evaluable images per segment in patients after approval of landiolol (99.3%) was greater than that in patients before approval of landiolol (97.4%, P<0.01). Heart rates before scanning in patients receiving landiolol hydrochloride were similar to those receiving other drugs. Heart rate was significantly reduced approximately 5 min after injection of landiolol hydrochloride and increased shortly. No decrease in systolic blood pressure or other adverse effects was observed. CONCLUSIONS: Bolus injection of landiolol hydrochloride sufficiently reduced heart rate without significantly reducing systolic blood pressure and produced a high percentage of evaluable images, suggesting that bolus injection of landiolol hydrochloride as an additional pretreatment is feasible in MDCT CAG.

Osawa K; Miyoshi T; Sato S; Akagi N; Morimitsu Y; Nakamura K; Kohno K; Kusano K; Kanazawa S; Ito H

2013-01-01

227

Comparison of haemostatic efficacy for endoscopic injection therapy of epinephrine and combination therapy of epinephrine and hemoclips for bleeding peptic ulcers  

Directory of Open Access Journals (Sweden)

Full Text Available Introduction. Endoscopic injection therapy of epinephrine is safe and effective in the treatment of bleeding peptic ulcer, but with high risk of rebleeding. The combination therapy of epinephrine and hemoclips could lead to a reduction of rebleeding and a potential reduction in mortality. Objective. To investigate the efficacy and safety of epinephrine injection therapy and combination therapy with epinephrine and hemoclips in treating bleeding peptic ulcers. Methods. A prospective randomized study included 58 patients with bleeding gastric or duodenal ulcer. In 30 patients endoscopic injection therapy with diluted epinephrine was applied (group I), while in 28 patients combination therapy of epinephrine and hemoclips was applied (group II). Results. Initial haemostasis was achieved in most patients treated with epinephrine injection therapy (93.3%) and patients treated with combination therapy of epinephrine and hemoclips (96.4%). After initial haemostasis was achieved rebleeding was significantly more frequent in the patients treated with epinephrine (28.5%) than in the patients treated with combination therapy (3.7%, p<0.05). Two patients treated with epinephrine injection therapy were subjected to surgical intervention, whereas no patient treated with combination therapy needed surgery. Lethal ending occurred in one patient treated with epinephrine and in one patient treated with combination therapy. The difference between the two groups of patients in need for surgical intervention and mortality was not statistically significant. Conclusion. Combination therapy with epinephrine and hemoclips is more efficient than epinephrine alone in the treatment of bleeding peptic ulcers.

Grgov Saša; Stamenkovi? Perica; Janji? Dejan

2012-01-01

228

Articaine (4%) with epinephrine (1:100,000 or 1:200,000) in intraosseous injections in symptomatic irreversible pulpitis of mandibular molars: anesthetic efficacy and cardiovascular effects.  

UK PubMed Central (United Kingdom)

OBJECTIVE: The aim of this study was to compare the cardiovascular effects and the anesthetic efficacy of intraosseous injections of 4% articaine with 1:100,000 epinephrine (EPI100) or 4% articaine with 1:200,000 epinephrine (EPI200). STUDY DESIGN: In this prospective, randomized, double-blind study, 0.9 mL EPI100 and EPI200 solutions were administered for endodontic treatment of mandibular molars with symptomatic irreversible pulpitis in 60 patients. The anesthetic success and pain during anesthesia were evaluated by visual analog scale. The cardiovascular parameters evaluated were heart rate, diastolic/systolic blood pressure, pulse oximetry, and electrocardiogram changes. RESULTS: Both solutions provided high anesthetic efficacy (96.8% and 93.1% for EPI100 and EPI200, respectively; P > .05), and the cardiovascular parameters showed minimal incidences of significant differences throughout the clinical procedure. CONCLUSIONS: The epinephrine concentration did not affect the efficacy of 4% articaine, and both solutions produced a high success level of pulpal anesthesia. Intraosseous delivery by slow speed of injection did not induce significant clinical changes in cardiovascular parameters.

Pereira LA; Groppo FC; Bergamaschi Cde C; Meechan JG; Ramacciato JC; Motta RH; Ranali J

2013-08-01

229

Celecoxib as adjunctive treatment to risperidone in children with autistic disorder: a randomized, double-blind, placebo-controlled trial.  

UK PubMed Central (United Kingdom)

RATIONAL: Autism is associated with activation of the inflammatory response system. OBJECTIVE: This study aims to assess the efficacy of a cyclooxygenase-2 inhibitor, celecoxib, as adjunctive therapy in the treatment of autism METHODS: In a 10-week randomized double-blind placebo-controlled study, 40 outpatient children with a Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision clinical diagnosis of autism were randomly allocated to celecoxib plus risperidone or placebo plus risperidone. The dose of risperidone and celecoxib were titrated up to 3 and 300 mg/day, respectively. Patients were assessed at baseline and after 2, 4, 6, and 10 weeks of starting medication using the Aberrant Behavior Checklist-Community (ABC-C) Rating Scale. Primary outcome measure was the change in irritability subscale of ABC-C. RESULTS: Significant time?×?treatment interaction was observed for Irritability (F (1.658, 63.021)?=?13.580, P?risperidone and celecoxib was superior to risperidone alone in treating irritability, social withdrawal, and stereotypy of children with autism. (Registration, www.irct.ir ; IRCT138711091556N2).

Asadabadi M; Mohammadi MR; Ghanizadeh A; Modabbernia A; Ashrafi M; Hassanzadeh E; Forghani S; Akhondzadeh S

2013-01-01

230

Risperidone and Adaptive Behavior in Children with Autism  

Science.gov (United States)

Objective: To evaluate the impact of risperidone on adaptive behavior in children with autistic disorder who have serious behavior problems and to examine different methods of scoring the Vineland Adaptive Behavior Scales to measure change. Method: Forty-eight children (5 years to 16 years, 5 months) who showed behavioral improvement during acute…

Williams, Susan K.; Scahill, Lawrence; Vitiello, Benedetto; Aman, Michael G.; Arnold, L. Eugene; McDougle, Christopher J.; McCracken, James T.; Tierney, Elaine; Ritz, Louise; Posey, David J.; Swiezy, Naomi B.; Hollway, Jill; Cronin, Pegeen; Ghuman, Jaswinder; Wheeler, Courtney; Cicchetti, Domenic; Sparrow, Sara

2006-01-01

231

RP-HPLC Estimation of Risperidone in Tablet Dosage Forms  

Digital Repository Infrastructure Vision for European Research (DRIVER)

A simple, specific, accurate, and precise reverse phase liquid chromatographic method was developed and validated for the estimation of risperidone in tablet dosage forms. A Phenomenex Gemini C-18, 5 ?m column having 250×4.6 mm i.d. in isocratic mode, with mobile phase containing methanol: acetonitr...

Baldania, S. L.; Bhatt, K. K.; Mehta, R. S.; Shah, D. A.

232

Influence of risperidone on balance control in young healthy individuals.  

UK PubMed Central (United Kingdom)

RATIONALE: It has previously been shown that impairment of postural stability is a side effect of typical antipsychotic drugs, which are largely administered to control psychosis and behavioral symptoms in elderly patients. Surprisingly, no study has yet addressed this problem with second-generation antipsychotics. OBJECTIVE: The objective of this study was to determine the extent to which risperidone at low doses altered balance control in healthy participants. METHODS: Twelve healthy young adults received, following a randomized double-blind crossover design, a single oral dose of placebo, 1 and 3 mg of risperidone on separate days at least 14 days apart. Evaluation of extrapyramidal symptoms using the Extrapyramidal Symptom Rating Scale-abbreviated scoring form (ESRS-A) and measures of postural sway using a force platform were assessed over 9 h following drug ingestion. RESULTS: There is a significant increase in the postural stability item of the ESRS-A parkinsonism subscale at 3 and 6 h following 3 mg of risperidone only when compared to placebo. With regard to balance control, body sway measures were increased at 1 mg of risperidone but more pronounced at 3 mg. The peak effects were observed at 3 h after administration of the drug and had not completely returned to baseline after 9 h. CONCLUSIONS: Risperidone administered at low doses did not elicit clinically detectable EPS but had significant effects on balance control. A dose-response effect on impairment of balance was observed that followed the expected time course of the drug pharmacokinetics. These results are likely to apply to older or demented individuals who have pre-existing balance control deficit.

Corbeil P; Rodrigue J; Simoneau M; Cohen H; Pourcher E

2012-07-01

233

Long-term efficacy and safety of polyacrylamide hydrogel injection in the treatment of human immunodeficiency virus-related facial lipoatrophy: a 5-year follow-up.  

UK PubMed Central (United Kingdom)

BACKGROUND: Facial lipoatrophy, a human immunodeficiency virus-related wasting of the facial soft tissues, can compromise patients' quality of life. Injection of different materials in the cheeks can improve this condition. Concern regarding potential long-term complications of nonbiodegradable fillers remains. The authors investigated the long-term efficacy and safety of polyacrylamide gel injections. METHODS: Human immunodeficiency virus-infected patients treated with polyacrylamide gel for moderate to severe facial lipoatrophy with a minimum of 5 years' follow-up were included. Aquamid (1 ml) was injected monthly into each cheek until adequate correction was obtained. Outcome measures were ultrasound measurement of cheek soft-tissues thickness, evaluation of aesthetic improvement, and self-evaluation of satisfaction and psychological consequences of treatment (visual analogue scale for the face, Assessment of Body Change and Distress questionnaire, and Beck Depression Inventory score). Adverse events were classified as acute (<1 week), early (1 week to 1 month), midterm (1 month to 1 year), or late (>1 year). RESULTS: One hundred forty-one patients completed the treatment as of June of 2005; 38 (32 men; mean age, 42 years) were available for follow-up of more than 5 years (mean, 62 months). The mean number of treatment sessions was seven over a mean period of 8 months. Significant improvement of cheek thickness and aesthetic result and highly significant satisfaction and psychological improvement were obtained. No serious adverse events occurred during the follow-up period. CONCLUSION: The long-term efficacy and safety of polyacrylamide gel injection for the treatment of human immunodeficiency virus-related facial lipoatrophy were shown over a period of 5 years. CLINICAL QUESTION/LEVEL OF EVIDENCE: : Therapeutic, IV.

De Santis G; Pignatti M; Baccarani A; Pedone A; Spaggiari A; Orlando G; Guaraldi G

2012-01-01

234

A prospective, randomized, double-blind study to compare the efficacy of lidocaine + metoclopramide and lidocaine + ketamine combinations in preventing pain on propofol injection.  

UK PubMed Central (United Kingdom)

PURPOSE: Propofol injection is known to cause distressing pain, and various methods have been used to decrease this pain. We investigated the efficacy of the lidocaine + metoclopramide and lidocaine + ketamine combinations on modulating propofol injection pain. METHODS: Ninety ASA I/II patients aged 20-60 years were randomly assigned to three groups to receive lidocaine 20 mg (group L), lidocaine 20 mg + metoclopramide 10 mg (group LM), or lidocaine 20 mg + ketamine 5 mg (group LK), respectively, with venous occlusion for 1 min using a forearm tourniquet. Propofol 0.5 mg/kg was subsequently administered into a dorsal hand vein, and pain was assessed during its injection using a verbal rating score. The results were analyzed statistically with analysis of variance, the chi-square test, and the Wilcoxon rank sum test, where appropriate. The significance level was set at p < 0.05. RESULTS: The incidence of pain was rated to be significantly less in patients in groups LM (40 %) and LK (6.7 %) than in those in group L (83.3 %) (p = 0.001 and p < 0.001, respectively). The pain score [median (range)] was also significantly less in patients in groups LM [0 (0-3)] and LK [0 (0-2)] than in those in group L [2 (0-3)] (p = 0.001 for both groups). CONCLUSION: The lidocaine-ketamine combination is most effective for decreasing the pain on propofol injection.

Chaudhary K; Gupta P; Gogia AR

2013-06-01

235

Efficacy, safety, and patient satisfaction of a monophasic cohesive polydensified matrix versus a biphasic nonanimal stabilized hyaluronic acid filler after single injection in nasolabial folds.  

UK PubMed Central (United Kingdom)

BACKGROUND: Intradermal injection of hyaluronic acid (HA) is currently the criterion standard to reduce the appearance of nasolabial folds (NLF). OBJECTIVE: Effects of a monophasic HA filler using cohesive polydensified matrix (CPM) technology were compared with those of nonanimal stabilized HA (NASHA). MATERIALS AND METHODS: In a double-blind, half-side comparison, 20 subjects (ages 35-65, mean 52 ± 5.6) with symmetric NLF grade 3 to 4 were randomized to contralateral treatment with a monophasic polydensified filler (CPM) and a biphasic HA filler (NASHA). Efficacy was assessed at baseline and after 2, 24, and 48 weeks using a wrinkle severity rating scale (WSRS) for NLF, subject questionnaire, and biophysical in vivo methods. RESULTS: All subjects showed significant improvements with both fillers up to day 365. Subject questionnaires confirmed significantly less injection pain for the CPMHA, significantly greater patient satisfaction after 2 weeks with both fillers, and after 24 and 48 weeks significantly greater improvement with the CPMHA compared to baseline. WSRS and skin surface topography parameters improved significantly up to 48 weeks with both fillers. CONCLUSION: A single intradermal injection of a monophasic CPMHA and a biphasic NASHA filler showed significant improvements in WSRS and measured wrinkle depth up to 48 weeks for both fillers and significant differences in injection comfort and patient satisfaction in favor of CPMHA.

Buntrock H; Reuther T; Prager W; Kerscher M

2013-07-01

236

Efficacy and safety of collagenase clostridium histolyticum injection for Dupuytren contracture: short-term results from 2 open-label studies.  

UK PubMed Central (United Kingdom)

PURPOSE: The JOINT I (United States) and JOINT II (Australia and Europe) studies evaluated the efficacy and safety of collagenase clostridium histolyticum (CCH) injection for the treatment of Dupuytren contracture. METHODS: Both studies used identical open-label protocols. Patients with fixed-flexion contractures of metacarpophalangeal (MCP) (20° to 100°) or proximal interphalangeal (PIP) joints (20° to 80°) could receive up to three 0.58-mg CCH injections per cord (up to 5 total injections per patient). We performed standardized finger extension procedures to disrupt injected cords the next day, with follow-up 1, 2, 6, and 9 months thereafter. The primary end point (clinical success) was reduction in contracture to within 0° to 5° of full extension 30 days after the last injection. Clinical improvement was defined as 50% or more reduction from baseline contracture. RESULTS: Dupuytren cords affecting 879 joints (531 MCP and 348 PIP) in 587 patients were administered CCH injections at 14 U.S. and 20 Australian/European sites, with similar outcomes in both studies. Clinical success was achieved in 497 (57%) of treated joints using 1.2 ± 0.5 (mean ± SD) CCH injections per cord. More MCP than PIP joints achieved clinical success (70% and 37%, respectively) or clinical improvement (89% and 58%, respectively). Less severely contracted joints responded better than those more severely contracted. Mean change in contracture was 55° for MCP joints and 25° for PIP joints. With average contracture reductions of 73% and improvements in range of motion by 30°, most patients (92%) were "very satisfied" (71%) or "quite satisfied" (21%) with treatment. Physicians rated change from baseline as "very much improved" (47%) or "much improved" (35%). The CCH injections were well tolerated, causing no tendon ruptures or systemic reactions. CONCLUSIONS: Collagenase clostridium histolyticum was an effective, minimally invasive option for the treatment of Dupuytren contracture of a broad range of severities. Most treated joints (625 of 879) required a single injection. Treatment earlier in the course of disease provided improved outcomes. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.

Witthaut J; Jones G; Skrepnik N; Kushner H; Houston A; Lindau TR

2013-01-01

237

Safety and efficacy of a continuous-flow, injection-assisted device in delivery of dermal fillers.  

UK PubMed Central (United Kingdom)

BACKGROUND: A device to assist in the delivery of dermal filler may achieve reductions in patient discomfort and adverse events, as well physician fatigue. It may also increase the accuracy of material placement. OBJECTIVES: The authors assess the safety and performance of the Artiste Assisted Injection System (Nordson Micromedics, St Paul, Minnesota) in normal therapeutic use compared with the standard manual administration of dermal fillers. METHODS: At 3 study sites, a total of 52 patients (48 women and 4 men) received bilateral full-correction injections of dermal fillers into randomized nasolabial folds (NLF). Injection into 1 NLF was made via Artiste, and injection into the other NLF was made via manual delivery. Immediately posttreatment and through 29 days, physician investigators, patients, and blinded evaluators recorded treatment durations and volumes, evaluated designated posttreatment characteristics using questionnaires, and documented adverse events (AE) and differences in cosmetic effects. RESULTS: Mean filler volume was 1.25 mL for the Artiste-treated NLF and 1.29 mL for manually treated NLF. One investigator used significantly less volume with Artiste than with manual injection (0.95 mL vs 1.12 mL; P = .001). Blinded evaluators rated Wrinkle Severity Rating Scale (WSRS) results as "identical" in 81% of patients. Investigator questionnaires showed a clear and statistically significant preference for Artiste over manual injection in all parameters (P < .001). CONCLUSIONS: The Artiste device is a viable option for physicians seeking a continuous-flow, injection-assisted device for ease of treatment, better accuracy, and improved results.

Lorenc ZP; Bruce S; Werschler WP

2013-07-01

238

Treatment outcome in patients with chronic schizophrenia during long-term administration with risperidone.  

Science.gov (United States)

Treatment outcome was evaluated in outpatients with chronic schizophrenia during long-term administration of risperidone in a study reflecting clinical practice. This UK multicenter, noncomparative, open trial was conducted in 79 patients. Risperidone treatment for 52 weeks commenced at 2 mg/d, with the option to titrate to 6 mg/d. The primary efficacy variable was study failure (study discontinuation for relapse, adverse events, insufficient response, withdrawn consent, lost to follow-up, or noncompliance). The most common dosage was 6 mg/d. Of the 79 patients in the intent-to-treat analysis, 38 completed the study (sustained treatment success), 29 were classified as treatment failure, and 12 were "not evaluable." When the intent-to-treat population was reclassified into study success or study failure, there were 40 study successes (38 treatment successes and 2 ineligible to continue) and 39 study failures (29 treatment failures, 3 lost to follow-up, and 7 noncompliant). Among patients considered to be treatment failures, only 10 had relapse and 10 had adverse events, 2 had insufficient response, and 7 withdrew consent. Raw mean time to treatment failure was 101.7 +/- 90.9 days, and median time was 77 days (range 7 to 284). From Kaplan-Meier curves, mean time to treatment failure was 213.3 +/- 12.2 days; the median was longer than the study period. There was significant improvement (reduction in severity of symptoms) for the intent-to-treat population in total and all Positive and Negative Syndrome Scale subscale scores (P < or =0.0119), Clinical Global Impression Severity (P = 0.0003), cognitive function "letter fluency totals" (P = 0.0044), Abnormal Involuntary Movement Scale (P < 0.0001), and Targeting Abnormal Kinetic Effects scale (measures abnormal kinetic effects; P < 0.0001) at study end point. Most patients considered the treatment at least "acceptable" during the study, and mean change at study end corresponded to between "acceptable" and "quite acceptable." After 1 year of risperidone treatment in a naturalistic setting reflecting usual UK clinical practice, patients with chronic schizophrenia showed improvement in symptoms and reduction in disease severity, and only 10 of 79 had relapse; 48.1% of patients were considered to be sustained treatment successes, 36.7% as treatment failures, and 15.2% as not "evaluable." Fifty-one percent of patients were considered to be study successes and 49% as study failures. PMID:15118479

Reveley, Michael A; Libretto, Susan E

2004-06-01

239

Treatment outcome in patients with chronic schizophrenia during long-term administration with risperidone.  

UK PubMed Central (United Kingdom)

Treatment outcome was evaluated in outpatients with chronic schizophrenia during long-term administration of risperidone in a study reflecting clinical practice. This UK multicenter, noncomparative, open trial was conducted in 79 patients. Risperidone treatment for 52 weeks commenced at 2 mg/d, with the option to titrate to 6 mg/d. The primary efficacy variable was study failure (study discontinuation for relapse, adverse events, insufficient response, withdrawn consent, lost to follow-up, or noncompliance). The most common dosage was 6 mg/d. Of the 79 patients in the intent-to-treat analysis, 38 completed the study (sustained treatment success), 29 were classified as treatment failure, and 12 were "not evaluable." When the intent-to-treat population was reclassified into study success or study failure, there were 40 study successes (38 treatment successes and 2 ineligible to continue) and 39 study failures (29 treatment failures, 3 lost to follow-up, and 7 noncompliant). Among patients considered to be treatment failures, only 10 had relapse and 10 had adverse events, 2 had insufficient response, and 7 withdrew consent. Raw mean time to treatment failure was 101.7 +/- 90.9 days, and median time was 77 days (range 7 to 284). From Kaplan-Meier curves, mean time to treatment failure was 213.3 +/- 12.2 days; the median was longer than the study period. There was significant improvement (reduction in severity of symptoms) for the intent-to-treat population in total and all Positive and Negative Syndrome Scale subscale scores (P < or =0.0119), Clinical Global Impression Severity (P = 0.0003), cognitive function "letter fluency totals" (P = 0.0044), Abnormal Involuntary Movement Scale (P < 0.0001), and Targeting Abnormal Kinetic Effects scale (measures abnormal kinetic effects; P < 0.0001) at study end point. Most patients considered the treatment at least "acceptable" during the study, and mean change at study end corresponded to between "acceptable" and "quite acceptable." After 1 year of risperidone treatment in a naturalistic setting reflecting usual UK clinical practice, patients with chronic schizophrenia showed improvement in symptoms and reduction in disease severity, and only 10 of 79 had relapse; 48.1% of patients were considered to be sustained treatment successes, 36.7% as treatment failures, and 15.2% as not "evaluable." Fifty-one percent of patients were considered to be study successes and 49% as study failures.

Reveley MA; Libretto SE

2004-06-01

240

Different MK-801 administration schedules induce mild to severe learning impairments in an operant conditioning task: Role of buspirone and risperidone in ameliorating these cognitive deficits.  

UK PubMed Central (United Kingdom)

Blockade of N-methyl-d-aspartate receptor (NMDA) by the noncompetitive NMDA receptor (NMDAR) antagonist MK-801 produces behavioral abnormalities and alterations in prefrontal cortex (PFC) functioning. Due to the critical role of the PFC in operant conditioning task learning, we evaluated the effects of acute, repeated postnatal injections of MK-801 (0.1mg/kg) on learning performance. We injected Long-Evans rats i.p. with MK-801 (0.1mg/kg) using three different administration schedules: injection 40min before beginning the task (during) (n=12); injection twice daily for six consecutive days prior to beginning the experimental procedures (prior) (n=12); or twice daily subcutaneous injections from postnatal day 7 to 11 (postnatal) (n=12). Next, we orally administered risperidone (serotonin receptor 2A and dopamine receptor 2 antagonist, 1mg/kg) or buspirone (serotonin receptor 1A partial agonist, 10mg/kg) to animals treated with the MK-801 schedule described above. The postnatal and prior administration schedules produced severe learning deficits, whereas injection of MK-801 just before training sessions had only mild effects on acquisition of an operant conditioning. Risperidone was able to reverse the detrimental effect of MK-801 in the animals that were treated with MK-801 during and prior training sessions. In contrast, buspirone was only effective at mitigating the cognitive deficits induced by MK-801 when administered during the training procedures. The data demonstrates that NMDA antagonism disrupts basic mechanisms of learning in a simple PFC-mediated operant conditioning task, and that buspirone and risperidone failed to attenuate the learning deficits when NMDA neurotransmission was blocked in the early stages of the postnatal period.

Rapanelli M; Frick LR; Bernardez-Vidal M; Zanutto BS

2013-10-01

 
 
 
 
241

Tolerability and efficacy of newly developed penile injection of cross-linked dextran and polymethylmethacrylate mixture on penile enhancement: 6 months follow-up.  

UK PubMed Central (United Kingdom)

Cross-linked dextran and polymethylmethacrylate mixture (Lipen-10) is newly developed tissue filler. The purpose of this study was to evaluate tolerability and efficacy of Lipen-10 on penile enhancement. Twenty adult males were included in this study. Lipen-10 was injected into the subcutaneous tissue of the penile shaft. The penile girth and length were measured in the flaccid state, before and 1, 3 and 6 months after the injection. The circumference increased by 3.7±1.2?cm (50.8%, P<0.0001) at penile base, 4.2±0.9?cm (59.0%, P<0.001) at mid-shaft, and 3.8±1.0?cm (53.2%, P<0.0001) at distal shaft and the length increased by 2.3±1.4?cm (63.2%, P<0.001). There was, however, no significant difference between 3 and 6 months post-treatment in girth and length (P-values: 0.796, 0.498, 0.600 and 0.084 for penile base, mid- and distal-shaft and length, respectively). The complications were only one mild asymmetry of penile shape and one 5-mm-sized nodule in the injected site. There were no clinically significant adverse events in all subjects. Penile injection of Lipen-10 led to a significant increase in penile size, showed a good durability and was well-tolerated, without serious adverse events. These results suggest that penile injection of Lipen-10 may be a new effective method for penile enhancement.

Yang DY; Lee WK; Kim SC

2013-05-01

242

Ablation of lumbar sympathetic ganglia by absolute ethanol injection and paravertebral catheter placement under CT guidance: evaluation of the efficacy  

International Nuclear Information System (INIS)

Objective: To evaluate the ablation of lumbar sympathetic ganglia by using single injection of absolute ethanol and retaining a paravertebral catheter under CT guidance for the treatment of lower extremity ischemia. Methods: Single absolute ethanol injection of L2 sympathetic ganglia was done in 25 cases (group B), single absolute ethanol injection of L2 sympathetic ganglia together with placement of a paravertebral catheter at L3 was carried out in 23 cases (group BT). All the procedures were performed under CT guidance. Three days after the procedure, the pain severity of the lower limbs was evaluated based on VAS method. If the patient in group BT still had a VAS score ?4 on the third day, 3 ml of 1% lidocaine was infected via the retained catheter in the prone position. If VAS score became ?3 at 5 min after the injection, additional 5 ml of ethanol was given through the catheter. The pain severity was evaluated again one week later. VAS score, analgesic dose and temperature of lower limbs were recorded. Results: One week after the procedure the excellent rate and effective rate for group B were 32% and 80% respectively, while for group BT were 60.9% and 95.7% respectively, with a significant difference between two groups (P

2009-01-01

243

N20-272S046 Risperidone Clinical Statistical BPCA/FDASIA  

Science.gov (United States)

Text Version... 444 SE 021 Risperidone (Risperdal®) Treatment of schizophrenia and bipolar disorder in adolescents Johnson & Johnson ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

244

Risperidone, quetiapine, and olanzapine adjunctive treatments in major depression with psychotic features: a comparative study  

Directory of Open Access Journals (Sweden)

Full Text Available A Gabriel Departments of Psychiatry and Community Health Sciences, University of Calgary, Calgary, AB, Canada Objectives: The purpose of this study was to compare the effectiveness of novel antipsychotics in the treatment of psychotic depression. Method: Consecutive patients who were admitted (n = 51) with a confirmed diagnosis of major depression with psychotic features (delusions or hallucinations or both) participated in this open-label, naturalistic study. All patients were treated with selective serotonin reuptake inhibitors (SSRIs) and serotonin–norepinephrine reuptake inhibitors (SNRIs) (citalopram or venlafaxine extended release [XR]), and atypical antipsychotic agents were added, as tolerated, during the first week of initiating the citalopram or venlafaxine. There were patients (n = 16) who received risperidone, who received quetiapine (n = 20), and who received olanzapine (n = 15), as an adjunctive treatment to either citalopram or venlafaxine for at least 8 weeks. Outcome measures included the Clinical Global Impression-Severity subscale (CGI-S), as the primary outcome measure, as well as the Hamilton Rating Scale for Depression-21 item (HAM-D21) and the Brief Psychiatric Rating Scale (BPRS). Tolerance to treatments and weight changes were monitored over the period of the trial. Results: All patients completed the trial with no drop outs. At 8 weeks, there was a statistically significant (P 0.01) in the olanzapine group. Conclusion: Quetiapine, risperidone, and olanzapine, given as adjunctive treatment with SSRIS or SNRIs can significantly and equally improve depressive and psychotic symptoms, in the short-term treatment of major depression with psychotic features. The author recommends that large controlled trials be conducted to examine the differences in long-term efficacy and tolerance between the atypical antipsychotic agents, in the treatment of major depression with or without psychotic features. Keywords: depression, novels, antipsychotics, treatment, augmentation

Gabriel A

2013-01-01

245

Short- and long-term efficacy of intra-articular injections with betamethasone as part of a treat-to-target strategy in early rheumatoid arthritis : impact of joint area, repeated injections, MRI findings, anti-CCP, IgM-RF and CRP  

DEFF Research Database (Denmark)

To investigate the short-term and long-term efficacy of intra-articular betamethasone injections, and the impact of joint area, repeated injections, MRI pathology, anticyclic citrullinated peptide (CCP) and immunoglobulin M rheumatoid factor (IgM-RF) status in patients with early rheumatoid arthritis (RA).

Hetland, Merete Lund; Østergaard, Mikkel

2012-01-01

246

Double jeopardy--drug and sex risks among Russian women who inject drugs: initial feasibility and efficacy results of a small randomized controlled trial  

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Full Text Available Abstract Background With HIV prevalence estimated at 20% among female injecting drug users (IDUs) in St. Petersburg, Russia, there is a critical need to address the HIV risks of this at-risk population. This study characterized HIV risks associated with injecting drug use and sex behaviors and assessed the initial feasibility and efficacy of an adapted Woman-Focused intervention, the Women's CoOp, relative to a Nutrition control to reduce HIV risk behaviors among female IDUs in an inpatient detoxification drug treatment setting. Method Women (N = 100) were randomized into one of two one-hour long intervention conditions--the Woman-Focused intervention (n = 51) or a time and attention-matched Nutrition control condition (n = 49). Results The results showed that 57% of the participants had been told that they were HIV-positive. At 3-month follow-up, both groups showed reduced levels of injecting frequency. However, participants in the Woman-Focused intervention reported, on average, a lower frequency of partner impairment at last sex act and a lower average number of unprotected vaginal sex acts with their main sex partner than the Nutrition condition. Conclusion The findings suggest that improvements in sexual risk reduction are possible for these at-risk women and that more comprehensive treatment is needed to address HIV and drug risks in this vulnerable population.

Wechsberg Wendee M; Krupitsky Evgeny; Romanova Tatiana; Zvartau Edwin; Kline Tracy L; Browne Felicia A; Ellerson Rachel; Bobashev Georgiy; Zule William A; Jones Hendrée E

2012-01-01

247

Double jeopardy--drug and sex risks among Russian women who inject drugs: initial feasibility and efficacy results of a small randomized controlled trial.  

UK PubMed Central (United Kingdom)

BACKGROUND: With HIV prevalence estimated at 20% among female injecting drug users (IDUs) in St. Petersburg, Russia, there is a critical need to address the HIV risks of this at-risk population. This study characterized HIV risks associated with injecting drug use and sex behaviors and assessed the initial feasibility and efficacy of an adapted Woman-Focused intervention, the Women's CoOp, relative to a Nutrition control to reduce HIV risk behaviors among female IDUs in an inpatient detoxification drug treatment setting. METHOD: Women (N = 100) were randomized into one of two one-hour long intervention conditions--the Woman-Focused intervention (n = 51) or a time and attention-matched Nutrition control condition (n = 49). RESULTS: The results showed that 57% of the participants had been told that they were HIV-positive. At 3-month follow-up, both groups showed reduced levels of injecting frequency. However, participants in the Woman-Focused intervention reported, on average, a lower frequency of partner impairment at last sex act and a lower average number of unprotected vaginal sex acts with their main sex partner than the Nutrition condition. CONCLUSION: The findings suggest that improvements in sexual risk reduction are possible for these at-risk women and that more comprehensive treatment is needed to address HIV and drug risks in this vulnerable population.

Wechsberg WM; Krupitsky E; Romanova T; Zvartau E; Kline TL; Browne FA; Ellerson RM; Bobashev G; Zule WA; Jones HE

2012-01-01

248

Multi-drug overdose risperidone, ziprasidone, valproate, trihexyphenidyl, and clonazepam  

DEFF Research Database (Denmark)

Risperidone and ziprasidone are commonly used as first line drugs for the treatment of psychotic disorders and overdose with these agents is increasingly being reported. Relatively few of these reports have involved co-ingestion of multiple psychotropic agents. We report a case of overdose with risperidone, ziprasidone, valproate, trihexyphenidyl and clonazepam in a 25 years female, who recovered uneventfully with supportive management. Notwithstanding the benign outcome in this instance, age, co-ingested drugs, active metabolites and medical co-morbidity are critical issues in overdose with atypical antipsychotics. As prescription of these drugs continues to increase in developing countries, systematic studies evaluating their clinical toxicity and management are necessary. The issues associated with overdose of multiple psychotropic agents and appropriate management policies are highlighted.

Rajamani, Anto Praveen Rajkumar; Jebaraj, P

2007-01-01

249

Neuroleptic malignant syndrome due to risperidone misdiagnosed as status epilepticus  

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Full Text Available Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disease characterized by fever, muscle rigidity, delirium and autonomic instability. Here we report a child, with NMS due to the risperidone misdiagnosed as status epilepticus. Nine year old boy, who had been under high dose risperidone treatment for 8 weeks, admitted to the emergency room because of the contractions (evaluated as status epilepticus) persisting for 7 hours. Since there was neuroleptic treatment in the past medical history and, unconsciousness, muscular rigidity, diaphoresis, hypertermi and, hypotension in physical examination, leucocytosis and elevated creatininphosphokinase levels in laboratory tests, the patient was evaluated as NMS and discharged without any complications. We reported this case to point out that; NMS may be misdiagnosed as status epilepticus in children when EEG monitoring is unavailable. When a child admitted to the emergency room because of suspicious convulsion neuroleptic drug use must surely be asked.

Ali Ertug Arslankoylu; Meryem Ozlem Kutuk; Cetin Okuyaz; Fevziye Toros

2011-01-01

250

Idiopathic granulomatous mastitis associated with risperidone-induced hyperprolactinemia  

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Full Text Available Abstract Idiopathic granulomatous mastitis (IGM) is a rare inflammatory breast disease. The etiology and treatment options of IGM remain controversial. Previous case reports have suggested that hyperprolactinemia may be associated with IGM. In the present report, we describe the first case of IGM associated with risperidone-induced hyperprolactinemia. Virtual slides The virtual slide(s) for this article can be found here: http://www.diagnosticpathology.diagnomx.eu/vs/8120093785928228

Lin Chih-Hsun; Hsu Chih-Wei; Tsao Tang-Yi; Chou Jason

2012-01-01

251

[Priapism associated with risperidone use: Report of one case].  

Science.gov (United States)

The use of drugs with ?-adrenergic antagonistic effect is one of the most prominent etiologies of priapism. We report a 32-year-old schizophrenic male in treatment with risperidone who consulted in the emergency room for a painful priapism. A low flow priapism was diagnosed. Medical treatment was unsuccessful and the patient was subjected to a proximal corporo-spongiosal shunt (Quackels technique), with good results. The patient was discharged in good conditions. PMID:23677191

Cruzado, Lizardo; Vallejos, César E

2012-11-01

252

[Priapism associated with risperidone use: Report of one case].  

UK PubMed Central (United Kingdom)

The use of drugs with ?-adrenergic antagonistic effect is one of the most prominent etiologies of priapism. We report a 32-year-old schizophrenic male in treatment with risperidone who consulted in the emergency room for a painful priapism. A low flow priapism was diagnosed. Medical treatment was unsuccessful and the patient was subjected to a proximal corporo-spongiosal shunt (Quackels technique), with good results. The patient was discharged in good conditions.

Cruzado L; Vallejos CE

2012-11-01

253

Ocular tolerability and efficacy of intravitreal and subconjunctival injections of sirolimus in patients with non-infectious uveitis: primary 6-month results of the SAVE Study.  

UK PubMed Central (United Kingdom)

BACKGROUND: The purpose of this study is to evaluate the ocular tolerability and efficacy of sirolimus administered as subconjunctival or intravitreal injections in patients with non-infectious uveitis. Sirolimus as a Therapeutic Approach for Uveitis (SAVE) is a prospective, randomized, open-label, interventional study. Thirty patients were enrolled and randomized in 1:1 ratio to receive either intravitreal injections of 352 ?g sirolimus or subconjunctival injections of 1,320 ?g at days 0, 60, and 120, with primary endpoint at month 6. RESULTS: At month 6, all subjects with active uveitis at baseline showed reduction in vitreous haze of one or more steps. Forty percent of subjects showed reduction of two steps or more of vitreous haze (four in each group), and 60% showed a reduction of one-step vitreous haze (seven in group 1 and five in group 2). Changes in the inflammatory indices were statistically significant (p < 0.05) in both study groups. Thirty percent of patients gained one or more lines of visual acuity, 20% lost one or more lines, and 50% maintained the same visual acuity. There were no statistically significant differences between the two study groups at month 6. No serious adverse events were found to be related to the study drug. CONCLUSION: Local administration of sirolimus, either intravitreally or subconjunctivally, appears to be safe and tolerable. No drug-related systemic adverse events or serious adverse events were noted. Sirolimus delivered as either an intravitreal or subconjunctival injection has demonstrated bioactivity as an immunomodulatory and corticosteroid-sparing agent in reducing vitreous haze and cells, improving visual acuity, and in decreasing the need for systemic corticosteroids.

Nguyen QD; Ibrahim MA; Watters A; Bittencourt M; Yohannan J; Sepah YJ; Dunn JP; Naor J; Shams N; Shaikh O; Leder HA; Do DV

2013-01-01

254

Effect of cytochrome P450 3A4 inhibitor ketoconazole on risperidone pharmacokinetics in healthy volunteers.  

UK PubMed Central (United Kingdom)

WHAT IS KNOWN AND OBJECTIVE: Risperidone is an atypical antipsychotic agent used for the treatment of schizophrenia. It is mainly metabolized by human cytochrome P450 CYP2D6 and partly by CYP3A4 to 9-hydroxyrisperidone. Ketoconazole is used as a CYP3A4 inhibitor probe for studying drug-drug interactions. We aim to investigate the effect of ketoconazole on the pharmacokinetics of risperidone in healthy male volunteers. METHODS: An open-label, randomized, two-phase crossover design with a 2-week washout period was performed in 10 healthy male volunteers. The volunteers received a single oral dose of 2mg of risperidone alone or in combination with 200mg of ketoconazole, once daily for 3days. Serial blood samples were collected at specific periods after ingestion of risperidone for a period of 96h. Plasma concentrations of risperidone and 9-hydroxyrisperidone were determined using a validated HPLC-tandem mass spectrometry method. RESULTS AND DISCUSSION: After pretreatment with ketoconazole, the clearance of risperidone decreased significantly by 34·81±5·10% and the T(1/2) of risperidone increased significantly by 28·03±40·60%. The AUC(0-96) and AUC(0-?) of risperidone increased significantly by 66·61± 43·03% and 66·54±39·76%, respectively. The Vd/f of risperidone increased significantly by 39·79±53·59%. However, the C(max) and T(max) of risperidone were not significantly changed, indicating that ketoconazole had minimal effect on the absorption of risperidone. The C(max) , T(max) and T(1/2) of 9-hydroxyrisperidone did not decrease significantly. However, the Cl/f of 9-hydroxyrisperidone increased significantly by 135·07± 124·68%, and the Vd/f of 9-hydroxyrisperidone decreased significantly by 29·47±54·64%. These changes led to a corresponding significant decrease in the AUC(0-96) and AUC(0-?) of 9-hydroxyrisperidone by 47·76±22·39% and 48·49± 20·03%, respectively. Ketoconazole significantly inhibited the metabolism of risperidone through the inhibition of hepatic CYP3A4. our results suggest that besides CYP2D6, CYP3A4 contributes significantly to the metabolism of risperidone. WHAT IS NEW AND CONCLUSION: The pharmacokinetics of risperidone was affected by the concomitant administration of ketoconazole. If a CYP3A4 inhibitor is used concomitantly with risperidone, it is necessary for the clinicians to monitor their patients for signs of adverse drug reactions.

Mahatthanatrakul W; Sriwiriyajan S; Ridtitid W; Boonleang J; Wongnawa M; Rujimamahasan N; Pipatrattanaseree W

2012-04-01

255

Risperidone compared with olanzapine in a naturalistic clinical study: a cost analysis.  

UK PubMed Central (United Kingdom)

BACKGROUND: Risperidone and olanzapine are thought to have broadly similar clinical effects. This study was designed as a cost analysis study comparing costs and basic clinical outcomes of treatment with risperidone or olanzapine in a naturalistic setting. METHOD: The U.K. Risperidone Olanzapine Drug Outcomes Studies in Schizophrenia (RODOS-UK) program consisted of a retrospective review of medical notes and prescription charts for 501 patients with schizophrenia or schizoaffective disorder who had been admitted to the hospital for the treatment of psychosis. The main outcome measure was cost of inpatient drug treatment. Clinical outcomes (clinician-assessed and -documented effectiveness, time to discharge) were also evaluated. Data were collected and verified between June and September 2000. RESULTS: Clinical outcomes were similar for risperidone and olanzapine. Clinician-assessed effectiveness was similar for both treatments (78% risperidone, 74% olanzapine; p =.39), but mean time to documented onset of effectiveness was significantly shorter for those treated with risperidone versus olanzapine (17.6 vs. 22.4 days; p =.01). Risperidone-treated patients stayed a mean of 9 fewer days in the hospital compared with olanzapine-treated patients (49 vs. 58 days; p =.007). The possibility that these observed differences were a result of different baseline characteristics could not be entirely discounted. Mean +/- SD doses of risperidone and olanzapine were 5.5 +/- 2.4 mg/day and 14.1 +/- 4.7 mg/day, respectively. The mean daily cost of all inpatient drugs was significantly higher for olanzapine than for risperidone (pound 5.63 vs. pound 3.92; p <.0001). Mean total costs of all inpatient drugs were significantly higher for olanzapine than for risperidone (pound 164 vs. pound 96; p <.0001), which partly reflected the longer mean treatment duration for olanzapine compared with risperidone (44 vs. 37 days). Concomitant antipsychotic use was similar for both groups (66% risperidone, 67% olanzapine). The number of patients documented as experiencing adverse events was not different between groups (22% risperidone, 19% olanzapine; p =.32). CONCLUSION: Risperidone and olanzapine produced broadly comparable clinical outcome in this cohort of hospitalized patients, but the use of risperidone was associated with significantly lower drug treatment costs.

Taylor DM; Wright T; Libretto SE

2003-05-01

256

Intranasal nanoemulsion based brain targeting drug delivery system of risperidone.  

Science.gov (United States)

The objective of investigation was to prepare nanoemulsion containing risperidone (RSP) to accomplish the delivery of drug to the brain via nose. Risperidone nanoemulsion (RNE) and mucoadhesive nanoemulsion (RMNE) were characterized for drug content, pH, percentage transmittance, globule size and zeta potential. Biodistribution of RNE, RMNE, and risperidone solution (RS) in the brain and blood of Swiss albino rats following intranasal (i.n.) and intravenous (i.v.) administration was examined using optimized technetium labeled ((99m)Tc-labeled) RSP formulations. Gamma scintigraphy imaging of rat brain following i.v. and i.n. administrations were performed to ascertain the localization of drug in brain. The brain/blood uptake ratio of 0.617, 0.754, 0.948, and 0.054 for RS (i.n.), RNE (i.n.), RMNE (i.n.), and RNE (i.v.), respectively, at 0.5h are indicative of direct nose to brain transport bypassing the blood-brain barrier. Higher drug transport efficiency (DTE%) and direct nose to brain drug transport (direct transport percentage, DTP%) for mucoadhesive nanoemulsions indicated more effective and best brain targeting of RSP amongst the prepared nanoemulsions. Studies conclusively demonstrated rapid and larger extent of transport of RSP by RMNE (i.n.) when compared to RS (i.n.), RNE (i.n.) and RNE (i.v.) into the rat brain. PMID:18455333

Kumar, Mukesh; Misra, Ambikanandan; Babbar, A K; Mishra, A K; Mishra, Puspa; Pathak, Kamla

2008-03-27

257

Intranasal nanoemulsion based brain targeting drug delivery system of risperidone.  

UK PubMed Central (United Kingdom)

The objective of investigation was to prepare nanoemulsion containing risperidone (RSP) to accomplish the delivery of drug to the brain via nose. Risperidone nanoemulsion (RNE) and mucoadhesive nanoemulsion (RMNE) were characterized for drug content, pH, percentage transmittance, globule size and zeta potential. Biodistribution of RNE, RMNE, and risperidone solution (RS) in the brain and blood of Swiss albino rats following intranasal (i.n.) and intravenous (i.v.) administration was examined using optimized technetium labeled ((99m)Tc-labeled) RSP formulations. Gamma scintigraphy imaging of rat brain following i.v. and i.n. administrations were performed to ascertain the localization of drug in brain. The brain/blood uptake ratio of 0.617, 0.754, 0.948, and 0.054 for RS (i.n.), RNE (i.n.), RMNE (i.n.), and RNE (i.v.), respectively, at 0.5h are indicative of direct nose to brain transport bypassing the blood-brain barrier. Higher drug transport efficiency (DTE%) and direct nose to brain drug transport (direct transport percentage, DTP%) for mucoadhesive nanoemulsions indicated more effective and best brain targeting of RSP amongst the prepared nanoemulsions. Studies conclusively demonstrated rapid and larger extent of transport of RSP by RMNE (i.n.) when compared to RS (i.n.), RNE (i.n.) and RNE (i.v.) into the rat brain.

Kumar M; Misra A; Babbar AK; Mishra AK; Mishra P; Pathak K

2008-06-01

258

Persistent efficacy of a long acting injectable formulation of moxidectin against natural infestations of the sheep nasal bot (Oestrus ovis) in Spain.  

Science.gov (United States)

Cydectin(®) 2% LA Solution for Injection for Sheep (Pfizer Animal Health) is a long-acting (LA) formulation of moxidectin for the treatment and prevention of mixed infections of gastro-intestinal nematodes, respiratory nematodes and certain arthropod parasites in sheep. To evaluate the duration of persistent efficacy against nasal bots (Oestrus ovis), a natural exposure study was conducted in Spain during the summer of 2011. One hundred and twenty nasal bot-free, Rasa Aragonesa sheep were randomly allocated to eight groups of 15 animals each. On Day 0, four groups were treated at the recommended dose rate of 1 mg moxidectin/kg bodyweight. Four groups remained untreated as negative controls. All animals were held in nasal bot-proof housing except for exposure to natural challenge when one group of treated sheep and one of group of control animals were transferred to a local pasture at either 0-20, 20-40, 40-60, or 60-80 days after treatment. Following challenge, sheep were scored for clinical signs of bot infestation, necropsied and the heads sectioned for larval recovery. Nasal bot larvae were retrieved from 7 to 11 control sheep following each exposure period indicating that adult bots were active throughout the study. In the first challenge up to 20 days after treatment, when sheep were slaughtered immediately after exposure, the majority of larvae were first instar (L1) and only 3 of the 15 control sheep were infested with second instars (L2). There was 100% efficacy against L2 and 38.1% reduction in the number of live L1 in the treated sheep but mean counts were not significantly different between treatment and control groups (P ? 0.05). For the subsequent exposure periods 20-80 days after treatment (necropsies 7-9 days after challenge), 6-10 sheep were infested with L1 and 9-11 control sheep were infested with L2 and third instars (L3). There was negligible efficacy against L1, but treatment with moxidectin resulted in 100% control of L2 and L3. These results are consistent with the biology of nasal bots and control with a systemic agent, as the slower growing L1 have limited feeding and are therefore less susceptible to systemic parasiticides. The study demonstrated that the persistent efficacy of this long-acting injectable formulation of moxidectin protects against the development of active O. ovis infestations for at least 80 days after treatment. PMID:22541795

Rugg, Douglas; Ferrer, Luis Miguel; Sarasola, Patxi; Figueras, Luis; Lacasta, Delia; Liu, Bo; Bartram, David

2012-04-04

259

Persistent efficacy of a long acting injectable formulation of moxidectin against natural infestations of the sheep nasal bot (Oestrus ovis) in Spain.  

UK PubMed Central (United Kingdom)

Cydectin(®) 2% LA Solution for Injection for Sheep (Pfizer Animal Health) is a long-acting (LA) formulation of moxidectin for the treatment and prevention of mixed infections of gastro-intestinal nematodes, respiratory nematodes and certain arthropod parasites in sheep. To evaluate the duration of persistent efficacy against nasal bots (Oestrus ovis), a natural exposure study was conducted in Spain during the summer of 2011. One hundred and twenty nasal bot-free, Rasa Aragonesa sheep were randomly allocated to eight groups of 15 animals each. On Day 0, four groups were treated at the recommended dose rate of 1 mg moxidectin/kg bodyweight. Four groups remained untreated as negative controls. All animals were held in nasal bot-proof housing except for exposure to natural challenge when one group of treated sheep and one of group of control animals were transferred to a local pasture at either 0-20, 20-40, 40-60, or 60-80 days after treatment. Following challenge, sheep were scored for clinical signs of bot infestation, necropsied and the heads sectioned for larval recovery. Nasal bot larvae were retrieved from 7 to 11 control sheep following each exposure period indicating that adult bots were active throughout the study. In the first challenge up to 20 days after treatment, when sheep were slaughtered immediately after exposure, the majority of larvae were first instar (L1) and only 3 of the 15 control sheep were infested with second instars (L2). There was 100% efficacy against L2 and 38.1% reduction in the number of live L1 in the treated sheep but mean counts were not significantly different between treatment and control groups (P ? 0.05). For the subsequent exposure periods 20-80 days after treatment (necropsies 7-9 days after challenge), 6-10 sheep were infested with L1 and 9-11 control sheep were infested with L2 and third instars (L3). There was negligible efficacy against L1, but treatment with moxidectin resulted in 100% control of L2 and L3. These results are consistent with the biology of nasal bots and control with a systemic agent, as the slower growing L1 have limited feeding and are therefore less susceptible to systemic parasiticides. The study demonstrated that the persistent efficacy of this long-acting injectable formulation of moxidectin protects against the development of active O. ovis infestations for at least 80 days after treatment.

Rugg D; Ferrer LM; Sarasola P; Figueras L; Lacasta D; Liu B; Bartram D

2012-09-01

260

Efficacy of olanzapine long-acting injection in patients with acutely exacerbated schizophrenia: an insight from effect size comparison with historical oral data  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background To treat acute schizophrenia, a long-acting injectable antipsychotic needs a rapid onset of action and therapeutic profile similar to that of oral agents. The present post-hoc analyses compared results from a randomized, double-blind, placebo-controlled trial of olanzapine long-acting injection (LAI) for acute schizophrenia with those observed in similarly designed trials of oral olanzapine. Methods Six-week results from the olanzapine LAI study (N?=?404) were compared with those of 3 oral studies (study 1: olanzapine vs. haloperidol vs. placebo [N?=?335]; study 2: olanzapine vs. haloperidol vs. low-dose olanzapine [N?=?431]; study 3: olanzapine vs. placebo vs. low-dose olanzapine [N?=?152]). All patients had baseline Brief Psychiatric Rating Scale (BPRS) scores ?24 (0–6 scale). Six-week effect sizes were calculated. Efficacy onset, pharmacokinetics, discontinuations, weight gain, and extrapyramidal symptoms were also assessed. Results At 6?weeks, mean BPRS scores decreased by 14 to 15 points for olanzapine LAI (405?mg/4?weeks, 210 or 300?mg/2?weeks), by 8 to 16 for oral olanzapine (10?±?2.5 or 15?±?2.5?mg/day), and by 12 to 13 for haloperidol (15?±?5?mg/day). For those same dose groups, effect sizes vs. placebo for the BPRS were 0.7 to 0.8 for olanzapine LAI, 0.5 to 0.7 for oral olanzapine, and 0.6 for haloperidol. The first statistically significant separation from placebo on the BPRS occurred at 3?days for the olanzapine LAI groups and at 1?week for oral olanzapine and haloperidol (15?±?5?mg/day) in oral study 1 although as late as week 6 for the 10-mg/day olanzapine dose in oral study 3. Olanzapine concentrations were similar across studies. Weight gain ?7% of baseline occurred in up to 35% of olanzapine LAI and oral patients versus up to 12% of haloperidol and placebo patients. Extrapyramidal symptoms were lowest in the olanzapine LAI groups and significantly greater in the haloperidol groups. No post-injection delirium/sedation syndrome events occurred in the olanzapine LAI study. Conclusions Patients treated acutely with olanzapine LAI showed a similar pattern of improvement to that seen historically with oral olanzapine. With the exception of injection-related adverse events, the efficacy and tolerability profile of olanzapine LAI is similar to oral olanzapine. Trial registration ClinicalTrials.gov ID; URL: http://http//www.clinicaltrials.gov/: NCT00088478; ClinicalStudyResults.org ID; URL: http://www.clinicalstudyresults.org/: 917, 978, 982, and 5984.

Detke Holland C; Zhao Fangyi; Witte Michael M

2012-01-01

 
 
 
 
261

Long-Term Safety and Adverse Events of Risperidone in Children, Adolescents, and Adults with Pervasive Developmental Disorders  

Science.gov (United States)

The objective of this study was to examine long-term adverse events of risperidone in 19 children, adolescents, and adults with Pervasive Developmental Disorders and intellectual disability, continuing risperidone for a mean of 186.5 weeks, following a 46-week risperidone study. Nineteen individuals continued long-term follow-up after our…

Hellings, Jessica A.; Cardona, Alicia M.; Schroeder, Stephen R.

2010-01-01

262

Efficacy of moxidectin long-acting injectable formulation (1 mg/kg bodyweight) against first instar larvae of Oestrus ovis in naturally infected sheep.  

Science.gov (United States)

The objective of the current study was to evaluate the efficacy of a single treatment with a long-acting injectable formulation of moxidectin (MOX) at 1.0 mg/kg bodyweight (b.w.) against natural infection by nasal bots (Oestrus ovis) in sheep with special attention to first instar larvae (L1). Firstly, a local farm with clinical history of oestrosis was chosen to conduct the assay. A total of 49 sheep were pre-selected at the end of the summer according to the presence of evident clinical signs of infection and confirmed later by means of an indirect ELISA against excretory-secretory products from L1 to detect IgG antibodies. After that, 24 sheep were chosen to carry out the study on the basis of positive serology and age since the oldest ones were selected. The day 0 of the assay, the treatment group was administered with the MOX formulation by subcutaneous injection at the base of the left ear and the control group was administered with a saline solution in the same way. All sheep were slaughtered on day 28 post-treatment (pt). At the necropsy, the head of all sheep were cut off and split into two sagital sections and all larvae from nasal passages, septum, middle meatus, conchae and sinuses were recovered. After the necropsy, a significant number of L1 was only found in the control group and therefore the efficacy of the MOX formulation was only calculated against this stage. As a result, the formulation was 90.2% effective against L1 for sheep slaughtered at day 28 pt. PMID:23333136

Martínez-Valladares, M; Valcárcel, F; Álvarez-Sánchez, M A; Cordero-Pérez, C; Fernández-Pato, N; Frontera, E; Meana, A; Rojo-Vázquez, F A

2012-10-17

263

Efficacy of moxidectin long-acting injectable formulation (1 mg/kg bodyweight) against first instar larvae of Oestrus ovis in naturally infected sheep.  

UK PubMed Central (United Kingdom)

The objective of the current study was to evaluate the efficacy of a single treatment with a long-acting injectable formulation of moxidectin (MOX) at 1.0 mg/kg bodyweight (b.w.) against natural infection by nasal bots (Oestrus ovis) in sheep with special attention to first instar larvae (L1). Firstly, a local farm with clinical history of oestrosis was chosen to conduct the assay. A total of 49 sheep were pre-selected at the end of the summer according to the presence of evident clinical signs of infection and confirmed later by means of an indirect ELISA against excretory-secretory products from L1 to detect IgG antibodies. After that, 24 sheep were chosen to carry out the study on the basis of positive serology and age since the oldest ones were selected. The day 0 of the assay, the treatment group was administered with the MOX formulation by subcutaneous injection at the base of the left ear and the control group was administered with a saline solution in the same way. All sheep were slaughtered on day 28 post-treatment (pt). At the necropsy, the head of all sheep were cut off and split into two sagital sections and all larvae from nasal passages, septum, middle meatus, conchae and sinuses were recovered. After the necropsy, a significant number of L1 was only found in the control group and therefore the efficacy of the MOX formulation was only calculated against this stage. As a result, the formulation was 90.2% effective against L1 for sheep slaughtered at day 28 pt.

Martínez-Valladares M; Valcárcel F; Álvarez-Sánchez MA; Cordero-Pérez C; Fernández-Pato N; Frontera E; Meana A; Rojo-Vázquez FA

2013-03-01

264

Therapeutic efficacy of eprinomectin extended-release injection against induced infections of developing (fourth-stage larvae) and adult nematode parasites of cattle.  

Science.gov (United States)

The therapeutic efficacy of eprinomectin in an extended-release injection (ERI) formulation was evaluated against induced infections of developing fourth-stage larval or adult gastrointestinal and pulmonary nematodes of cattle in a series of six studies under two identical protocols (three each for developing fourth-stage larvae or adults) conducted in the USA, Germany or the UK (two studies at each location, one per stage). Each study initially included 16 nematode-free cattle. The cattle were of various breeds or crosses, weighed 109-186.5 kg prior to treatment, and were approximately 4-7 months old. The animals were blocked based on pre-treatment bodyweight and then randomly allocated to treatment: eprinomectin ERI vehicle (control) at 1 mL/50 kg body weight or eprinomectin 5% ERI at 1 mL/50 kg bodyweight (1.0 mg eprinomectin/kg) for a total of eight and eight animals in each group. Treatments were administered once on Day 0 by subcutaneous injection in front of the shoulder. In each study, cattle were infected with a combination of infective third-stage larvae or eggs of gastrointestinal and pulmonary nematodes. Inoculation was scheduled so that the nematodes were expected to be fourth-stage larvae or adults at the time of treatment. For parasite recovery, all study animals were humanely euthanized and necropsied 14-15 (adult infections) or 21-22 days after treatment (developing fourth-stage larval infections). When compared with the vehicle-treated control counts, efficacy of eprinomectin ERI against developing fourth-stage larvae and adults was ?98% (pHaemonchus contortus, H. placei, Nematodirus helvetianus, Oesophagostomum radiatum, Oes. venulosum, Ostertagia leptospicularis, O. ostertagi, O. circumcincta, O. pinnata, O. trifurcata (developing fourth-stage larval infections only), Strongyloides papillosus, Trichostrongylus axei, T. colubriformis, and Trichuris ovis (adult infections only). All animals accepted the treatment well. No adverse reaction to treatments was observed in any animal in any study. PMID:23273929

Rehbein, S; Baggott, D G; Royer, G C; Yoon, S; Cramer, L G; Soll, M D

2012-12-07

265

Risperidone dosing in children and adolescents with autistic disorder: a double-blind, placebo-controlled study.  

UK PubMed Central (United Kingdom)

Efficacy and safety of 2 risperidone doses were evaluated in children and adolescents with autism. Patients (N = 96; 5-17 years), received risperidone (low-dose: 0.125 mg/day [20 to <45 kg], 0.175 mg/day [>45 kg] or high-dose: 1.25 mg/day [20 to <45 kg], 1.75 mg/day [>45 kg]) or placebo. Mean baseline (range 27-29) to endpoint change in Aberrant Behavior Checklist-Irritability (primary endpoint) was significantly greater in the high-dose-(-12.4 [6.5]; p < 0.001), but not low-dose (-7.4 [8.1]; p = 0.164) group, versus placebo (-3.5 [10.7]). Clinical Global Impressions-Severity and Children's Yale-Brown Obsessive Compulsive Scale scores improved significantly only in the high-dose group, consistent with ABC-I results. Somnolence, sedation and increased appetite occurred more frequently in high-versus low-dose groups. Overall, increased appetite occurred most frequently.

Kent JM; Kushner S; Ning X; Karcher K; Ness S; Aman M; Singh J; Hough D

2013-08-01

266

Risperidone dosing in children and adolescents with autistic disorder: a double-blind, placebo-controlled study.  

Science.gov (United States)

Efficacy and safety of 2 risperidone doses were evaluated in children and adolescents with autism. Patients (N = 96; 5-17 years), received risperidone (low-dose: 0.125 mg/day [20 to 45 kg] or high-dose: 1.25 mg/day [20 to 45 kg]) or placebo. Mean baseline (range 27-29) to endpoint change in Aberrant Behavior Checklist-Irritability (primary endpoint) was significantly greater in the high-dose-(-12.4 [6.5]; p < 0.001), but not low-dose (-7.4 [8.1]; p = 0.164) group, versus placebo (-3.5 [10.7]). Clinical Global Impressions-Severity and Children's Yale-Brown Obsessive Compulsive Scale scores improved significantly only in the high-dose group, consistent with ABC-I results. Somnolence, sedation and increased appetite occurred more frequently in high-versus low-dose groups. Overall, increased appetite occurred most frequently. PMID:23212807

Kent, Justine M; Kushner, Stuart; Ning, Xiaoping; Karcher, Keith; Ness, Seth; Aman, Michael; Singh, Jaskaran; Hough, David

2013-08-01

267

Case Report: Valproic Acid and Risperidone Treatment Leading to Development of Hyperammonemia and Mania  

Science.gov (United States)

This case report describes two children who developed hyperammonemia together with frank manic behavior during treatment with a combination of valproic acid and risperidone. One child had been maintained on valproic acid for years and risperidone was added. In the second case, valproic acid was introduced to a child who had been treated with…

Carlson, Teri; Reynolds, Charles A.; Caplan, Rochelle

2007-01-01

268

Effects of Risperidone on Destructive Behavior of Persons with Developmental Disabilities: III. Functional Analysis  

Science.gov (United States)

Functional analyses were conducted during a double-blind, placebo-controlled study of the atypical antipsychotic medication risperidone with 13 individuals. Risperidone was effective in reducing destructive behavior (compared to placebo) for 10 participants. For 7 of these responders, an undifferentiated pattern of responding occurred across their…

Zarcone, Jennifer R.; Lindauer, Steven E.; Morse, Paige S.; Crosland, Kimberly A.; Valdovinos, Maria G.; McKerchar, Todd L.; Reese, R. Matthew; Hellings, Jessica A.; Schroeder, Stephen R.

2004-01-01

269

Successful risperidone rechallenge after blepharospasm in a patient with schizophrenia: 24-month follow-up.  

Science.gov (United States)

We report the case of a 44-year-old female patient with paranoid schizophrenia, who developed blepharospasm on risperidone treatment, but who was successfully rechallenged by risperidone without recurrence of blepharospasm. Possible mechanisms of action and implications for clinical care are discussed. PMID:14870960

Gulati, Sanjiv; Singh, Ashok N; Libretto, Sue E

2003-12-01

270

Successful risperidone rechallenge after blepharospasm in a patient with schizophrenia: 24-month follow-up.  

UK PubMed Central (United Kingdom)

We report the case of a 44-year-old female patient with paranoid schizophrenia, who developed blepharospasm on risperidone treatment, but who was successfully rechallenged by risperidone without recurrence of blepharospasm. Possible mechanisms of action and implications for clinical care are discussed.

Gulati S; Singh AN; Libretto SE

2003-12-01

271

[Efficacy and adverse reactions of antipsychotics for neuropsychiatric symptoms in dementia: a systematic review  

UK PubMed Central (United Kingdom)

OBJECTIVE: To assess the efficacy and adverse reactions of typical and atypical antipsychotics in the treatment of neuropsychiatric symptoms in dementia, and to examine the evidence for the cerebrovascular events warning for atypical antipsychotics. DESIGN: Systematic review. METHOD: Using Medline, Cinahl, PsyclNFO, Embase and the Cochrane central register of controlled trials (1980-2005), double-blind randomized controlled trials with intention-to-treat analysis were selected, which evaluated efficacy and adverse reactions of antipsychotics in the treatment of neuropsychiatric symptoms in dementia. The studies underwent a standardised validity assessment. RESULTS: After screening 950 studies, 14 studies on the effect of haloperidol, risperidone, olanzapine, quetiapine, tiapride, loxapine and perphenazine were selected. In 7 out of 10 studies, haloperidol, risperidone and olanzapine appeared to be more effective than placebo in the treatment of aggression and psychosis. Direct comparison between typical and atypical antipsychotics revealed no statistically significant difference. The most common adverse reactions were extrapyramidal symptoms and somnolence. These adverse reactions were less frequent with low-dose risperidone than with haloperidol or olanzapine, but risperidone and olanzapine were found to be associated with a higher risk of cerebrovascular events in two studies. CONCLUSION: The efficacy of typical and atypical antipsychotics is comparable, but only low-dose risperidone seems to be associated with fewer (extrapyramidal) side effects. The adverse reactions are inadequately described in the published data and consequently the warning of an increased risk of mortality could not be confirmed.

Zuidema SU; van Iersel MB; Koopmans RT; Verhey FR; Olde Rikkert MG

2006-07-01

272

Transtympanic injections of N-acetylcysteine for the prevention of cisplatin-induced ototoxicity: a feasible method with promising efficacy.  

UK PubMed Central (United Kingdom)

OBJECTIVES: Ototoxicity is a common and irreversible adverse effect of cisplatin treatment with great impact on the patients' quality of life. N-acetylcysteine is a low-molecular-weight agent which has shown substantial otoprotective activity. The role of transtympanic infusions of N-acetylcysteine was examined in a cohort of patients treated with cisplatin-based regimens. PATIENTS AND METHODS: Twenty cisplatin-treated patients were subjected, under local anesthesia, to transtympanic N-acetylcysteine (10%) infusions in 1 ear, during the hydration procedure preceding intravenous effusion of cisplatin. The contralateral ear was used as control. The number of transtympanic infusions was respective to the number of administered cycles. Hearing acuity was evaluated before each cycle with pure tone audiometry by an audiologist blinded to the treated ear. RESULTS: A total of 84 transtympanic infusions were performed. In treated ears, no significant changes in auditory thresholds were recorded. In the control ears cisplatin induced a significant decrease of auditory thresholds at the 8000 Hz frequency band (P=0.008). At the same frequency (8000 Hz), the changes in auditory thresholds were significantly larger for the control ears than the treated ones (P=0.005). An acute pain starting shortly after the injection and lasting for a few minutes seemed to be the only significant adverse effect. CONCLUSIONS: Transtympanic injections of N-acetylcysteine seem to be a feasible and effective otoprotective strategy for the prevention of cisplatin-induced ototoxicity. Additional studies are required to further clarify the efficiency of this treatment and determine the optimal dosage and protocol.

Riga MG; Chelis L; Kakolyris S; Papadopoulos S; Stathakidou S; Chamalidou E; Xenidis N; Amarantidis K; Dimopoulos P; Danielides V

2013-02-01

273

Efficacy, safety and outcomes of 'inject and cut' endoscopic mucosal resection for large sessile and flat colorectal polyps.  

UK PubMed Central (United Kingdom)

BACKGROUND AND STUDY AIMS: The study examines the outcomes of the 'inject and cut' endoscopic mucosal resection (EMR), for large sessile and flat colorectal polyps. PATIENTS AND METHODS: Between January 2006 and December 2008 all patients referred to our institution for EMR of large polyps were prospectively evaluated. The accuracy of lifting sign and the rate of en bloc and piecemeal resection, complications and recurrence were analyzed. RESULTS: A total of 157 patients with 182 lesions (median size 24.7 +/- 10.2 mm) were included in the study. The most frequent location was the sigmoid colon in 30.2%. Because of non-lifting sign, 5/182 lesions were referred to surgical resection and 177 (43 flat and 134 sessile) were resected, 79 (44.6%) en bloc and 98 (55.4%) piecemeal. There were 20 procedural (11.3%) and 2 late (1.1%) bleeding, 4 post-polypectomy syndrome (2.2%) and 2 perforations (1.1%). Bleeding was related to malignancy (p = 0.01). Intramucosal cancer was observed in 5 cases (2.8%) while invasive cancer was seen in 8 (4.5%). Malignancy was related to polyp size >or=30 mm (p = 0.002). Follow-up colonoscopy was performed in 147 patients with 172 EMR for a mean of 19.8 months. Recurrence was observed in 12/172 (6.9%) polyps. CONCLUSION: Inject and cut EMR is practical and effective with a low risk of complication and local recurrence.

Ferrara F; Luigiano C; Ghersi S; Fabbri C; Bassi M; Landi P; Polifemo AM; Billi P; Cennamo V; Consolo P; Alibrandi A; D'Imperio N

2010-01-01

274

Diabetes mellitus does not affect the efficacy and safety of intravesical onabotulinumtoxinA injection in patients with refractory detrusor overactivity.  

UK PubMed Central (United Kingdom)

AIMS: To investigate the efficacy and safety of intravesical onabotulinumtoxinA injection in patients with diabetes mellitus (DM) and refractory detrusor overactivity (DO). METHODS: Forty-eight type 2 DM patients with refractory DO received intravesical 100?U onabotulinumtoxinA injection. Another 48 age-matched patients were randomly selected from a non-diabetic group as controls. Video-urodynamic studies were performed at baseline and were repeated 3 months after treatment. The treatment outcomes were graded on the basis of changes in the Patient's Perception of Bladder Condition (PPBC) and a PPBC decrease of 2 or more points was considered successful. Treatment-related adverse events including acute urinary retention, large post-voiding residual (PVR) volumes, straining to void, urinary tract infection, hematuria, and general weakness were recorded. RESULTS: The mean ages of the diabetic and non-diabetic patients were 73.1?±?8.8 and 72.0?±?9.3 (P?=?0.552), respectively. The changes of urodynamic parameters were comparable between the two groups. Similar successful results were noted at the 6-month follow-up (DM, 56% vs. non-DM, 61%, P?=?0.128). Diabetic patients had a significantly greater incidence of large PVR volumes (DM, 60.4% vs. non-DM, 33.3%; P?=?0.007) and general weakness (DM, 10.4% vs. non-DM, 0%; P?=?0.03) after treatment. Baseline urodynamic parameters in diabetic patients did not predict the occurrence of adverse events. No major complication was noted in either group. CONCLUSIONS: Intravesical onabotulinumtoxinA injection is a safe and effective treatment for DM patients with refractory DO. Patients with DM should be informed of the increased risk of large PVR before initiation of treatment. Neurourol. Urodynam. 9999:XX-XX, 2013. © 2013 Wiley Periodicals, Inc.

Wang CC; Liao CH; Kuo HC

2013-09-01

275

EFFICACY AND SAFETY OF TWO OR MORE DEXAMETHASONE INTRAVITREAL IMPLANT INJECTIONS FOR TREATMENT OF MACULAR EDEMA RELATED TO RETINAL VEIN OCCLUSION (SHASTA STUDY).  

UK PubMed Central (United Kingdom)

PURPOSE:: To evaluate the efficacy, safety, and reinjection interval of dexamethasone intravitreal implant (DEX implant) in branch retinal vein occlusion and central retinal vein occlusion patients receiving ?2 DEX implant treatments. METHODS:: Multicenter (26-site), retrospective chart review study. Data were collected from baseline (at first DEX implant) through 3 months to 6 months after last DEX implant. RESULTS:: Patients (n = 289) received 2 to 9 (mean, 3.2) DEX implants as monotherapy (29.1% of patients) or with adjunctive treatments/procedures. Mean duration of macular edema before first DEX implant was 18.4 months. Mean reinjection interval was 5.6 months. Mean peak change in best-corrected visual acuity from baseline through 4 weeks to 20 weeks after final DEX implant was +1.0 line (P < 0.001). Best-corrected visual acuity and central retinal thickness improved significantly from baseline after each of the first 6 DEX implant injections (P ? 0.037); 59.7% of branch retinal vein occlusion and 66.7% of central retinal vein occlusion patients achieved ?2-line best-corrected visual acuity improvement. Intraocular pressure increase (?10 mmHg) occurred in 32.6% of patients; 29.1% used intraocular pressure-lowering medication to treat increases associated with DEX implant. Only 1.7% of patients required incisional glaucoma surgery. CONCLUSION:: Retinal vein occlusion patients treated with multiple DEX implant injections, either alone or combined with other therapies, had improved central retinal thickness and visual acuity with each subsequent injection. No new safety concerns developed with multiple implants.

Capone A Jr; Singer MA; Dodwell DG; Dreyer RF; Oh KT; Roth DB; Walt JG; Scott LC; Hollander DA

2013-07-01

276

An unusual case of risperidone instability in a fatality presenting an analytical and interpretative challenge.  

UK PubMed Central (United Kingdom)

This paper describes the detection and characterization of unusual metabolite/breakdown products of the anti-psychotic drug risperidone in post-mortem blood and urine as part of a toxicological investigation into an unexpected death of a male suffering from paranoid schizophrenia prescribed risperidone and previously paroxetine. Compounds detected in the post-mortem blood and urine specimens were shown to be benzisoxazole ring scission products of risperidone and a hydroxy metabolite. These compounds are never routinely detected in blood and urine but can be present in mammalian faeces indicating that gut bacteria could be responsible for their formation. In this case, evidence for this process was demonstrated by the controlled in vitro stability study of risperidone spiked into the case blood and urine leading to the hypothesis that the post-mortem blood and urine samples analyzed could have contained bacteria with the ability to breakdown risperidone and its metabolite in this way. This finding is very unusual and has not been encountered before in any previous risperidone cases investigated by the authors, or widely reported in the post-mortem toxicological literature. However, a recently published paper has supported these findings in blood. As a result of this work, it was shown that the deceased had taken risperidone prior to death, even in the absence of any risperidone or its hydroxy metabolite(s) in the blood and urine. Given that risperidone has been reported to interact with paroxetine, the ingestion of risperidone could have been a factor that contributed to the death. Copyright © 2013 John Wiley & Sons, Ltd.

Taylor K; Elliott S

2013-07-01

277

A novel technique for increasing charge injection capacity of neural electrodes for efficacious and safe neural stimulation.  

UK PubMed Central (United Kingdom)

Neural prostheses require chronically implanted small area penetrating electrode arrays that can stimulate and record neural activity. The fundamental requirement of neural electrodes is to have low interface impedance and large charge injection capacity (CIC). To achieve this fundamental requirement, we developed a novel technique to modify the surface of the Utah Electrode Array (UEA) to increase the real surface area without changing the geometrical surface area. Pt was coated on modified and unmodified (control) UEAs and electrochemical characterization such as impedance and CIC was measured and compared. The surface modified electrode impedance and CIC was ?188 Ohm and ?24 mC/cm(2) respectively. Increasing the real surface area of electrodes decreases the impedance by 1000 times and increases the CIC by 80 times compared to the control samples. The CIC of modified UEA was significantly higher than of any material reported in the literature, higher than sputtered iridium oxide (4 mC/cm(2)) or PEDOT (15 mC/cm(2)).

Negi S; Bhandari R; Solzbacher F

2012-01-01

278

Efficacy and Safety of Lixisenatide Once-Daily Morning or Evening Injections in Type 2 Diabetes Inadequately Controlled on Metformin (GetGoal-M).  

UK PubMed Central (United Kingdom)

OBJECTIVE To examine the efficacy and safety of lixisenatide (20 ?g once daily, administered before the morning or evening meal) as add-on therapy in patients with type 2 diabetes insufficiently controlled with metformin alone. RESEARCH DESIGN AND METHODS This was a 24-week, randomized, double-blind, placebo-controlled study in 680 patients with inadequately controlled type 2 diabetes (HbA1c 7-10% [53-86 mmol/mol]). Patients were randomized to lixisenatide morning (n = 255), lixisenatide evening (n = 255), placebo morning (n = 85), or placebo evening (n = 85) injections. RESULTS Lixisenatide morning injection significantly reduced mean HbA1c versus combined placebo (mean change -0.9% [9.8 mmol/mol] vs. -0.4% [4.4 mmol/mol]; least squares [LS] mean difference vs. placebo -0.5% [5.5 mmol/mol], P < 0.0001). HbA1c was significantly reduced by lixisenatide evening injection (mean change -0.8% [8.7 mmol/mol] vs. -0.4% [4.4 mmol/mol]; LS mean difference -0.4% [4.4 mmol/mol], P < 0.0001). Lixisenatide morning injection significantly reduced 2-h postprandial glucose versus morning placebo (mean change -5.9 vs. -1.4 mmol/L; LS mean difference -4.5 mmol/L, P < 0.0001). LS mean difference in fasting plasma glucose was significant in both morning (-0.9 mmol/L, P < 0.0001) and evening (-0.6 mmol/L, P = 0.0046) groups versus placebo. Mean body weight decreased to a similar extent in all groups. Rates of adverse events were 69.4% in both lixisenatide groups and 60.0% in the placebo group. Rates for nausea and vomiting were 22.7 and 9.4% for lixisenatide morning and 21.2 and 13.3% for lixisenatide evening versus 7.6 and 2.9% for placebo, respectively. Symptomatic hypoglycemia occurred in 6, 13, and 1 patient for lixisenatide morning, evening, and placebo, respectively, with no severe episodes. CONCLUSIONS In patients with type 2 diabetes inadequately controlled on metformin, lixisenatide 20 ?g once daily administered in the morning or evening significantly improved glycemic control, with a pronounced postprandial effect, and was well tolerated.

Ahrén B; Leguizamo Dimas A; Miossec P; Saubadu S; Aronson R

2013-09-01

279

A comparison of the oral application and injection routes using the Onderstepoort Biological Products Fowl Typhoid vaccine, its safety, efficacy and duration of protection in commercial laying hens : article  

Digital Repository Infrastructure Vision for European Research (DRIVER)

This study was undertaken to establish whether the Onderstepoort Biological Products Fowl Typhoid (OBPft) vaccine registered as an injectable vaccine was effective and safe when administered orally to commercial layers. Its efficacy and duration of protection were compared with application by intram...

C. Purchase; J. Picard; R. McDonald; S.P.R. Bisschop

280

Critical appraisal of the efficacy, safety, and patient acceptability of hydroxyprogesterone caproate injection to reduce the risk of preterm birth.  

Science.gov (United States)

Prevention of preterm delivery is a major desiderate in contemporary obstetrics and a societal necessity. The means to achieve this goal remain elusive. Progesterone has been used in an attempt to prevent preterm delivery since the 1970s, but the evidence initially accumulated was fraught by mixed results and was based on mostly underpowered studies with variable eligibility criteria, including history of spontaneous abortion as an indication for treatment. More recent randomized controlled clinical trials restimulated the interest in progesterone supplementation, suggesting that progesterone may favorably influence the rate of preterm delivery. Preterm delivery is a complex disorder and consequently it is unlikely that one generalized prevention strategy will be effective in all patients. Further, an additional impediment in accepting progesterone as the "magic bullet" in the prevention of preterm delivery is that its mechanism of action is not fully understood and the optimal formulations, route of administration, and dose have yet to be established. We have concerned ourselves in this review with the most recent status of 17 alpha-hydroxyprogesterone caproate (17OH-PC) supplementation for prevention of preterm delivery. Our intention is to emphasize the efficacy, safety, and patient acceptability of this intervention, based on a comprehensive and unbiased review of the available literature. Currently there are insufficient data to suggest that 17OH-PC is superior or inferior to natural progesterone. Based on available evidence, we suggest a differential approach giving preferential consideration to either 17OH-PC or other progestins based on obstetric history and cervical surveillance. Progestin therapy for risk factors other than a history of preterm birth and/or a short cervix in the current pregnancy is not currently supported by the published evidence. The experience to date with 17OH-PC indicates that there are population subgroups that may be harmed by administration of 17OH-PC. Therefore, extending the use of 17OH-PC to unstudied populations or for indications that are not evidence-based is inadvisable outside of a research protocol. PMID:23874089

Vidaeff, Alex C; Belfort, Michael A

2013-07-11

 
 
 
 
281

Critical appraisal of the efficacy, safety, and patient acceptability of hydroxyprogesterone caproate injection to reduce the risk of preterm birth.  

UK PubMed Central (United Kingdom)

Prevention of preterm delivery is a major desiderate in contemporary obstetrics and a societal necessity. The means to achieve this goal remain elusive. Progesterone has been used in an attempt to prevent preterm delivery since the 1970s, but the evidence initially accumulated was fraught by mixed results and was based on mostly underpowered studies with variable eligibility criteria, including history of spontaneous abortion as an indication for treatment. More recent randomized controlled clinical trials restimulated the interest in progesterone supplementation, suggesting that progesterone may favorably influence the rate of preterm delivery. Preterm delivery is a complex disorder and consequently it is unlikely that one generalized prevention strategy will be effective in all patients. Further, an additional impediment in accepting progesterone as the "magic bullet" in the prevention of preterm delivery is that its mechanism of action is not fully understood and the optimal formulations, route of administration, and dose have yet to be established. We have concerned ourselves in this review with the most recent status of 17 alpha-hydroxyprogesterone caproate (17OH-PC) supplementation for prevention of preterm delivery. Our intention is to emphasize the efficacy, safety, and patient acceptability of this intervention, based on a comprehensive and unbiased review of the available literature. Currently there are insufficient data to suggest that 17OH-PC is superior or inferior to natural progesterone. Based on available evidence, we suggest a differential approach giving preferential consideration to either 17OH-PC or other progestins based on obstetric history and cervical surveillance. Progestin therapy for risk factors other than a history of preterm birth and/or a short cervix in the current pregnancy is not currently supported by the published evidence. The experience to date with 17OH-PC indicates that there are population subgroups that may be harmed by administration of 17OH-PC. Therefore, extending the use of 17OH-PC to unstudied populations or for indications that are not evidence-based is inadvisable outside of a research protocol.

Vidaeff AC; Belfort MA

2013-01-01

282

Steroid-induced psychosis in a child: treatment with risperidone.  

UK PubMed Central (United Kingdom)

Steroid-induced psychosis is one of the most serious adverse effects of steroid therapy but is a little-known complication in children. There is no clear mechanism model for steroid-induced behavioral disturbance, but it may be related with dose or level of free fraction of steroids. Our case is a 12-year-old boy diagnosed with steroid-induced psychosis and treated with risperidone, an atypical antipsychotic, due to distinct psychotic symptoms. Pediatricians should be aware of this rare complication when administering corticosteroids for various medical illnesses.

Bag O; Erdo?an I; Onder ZS; Altinoz S; Ozturk A

2012-01-01

283

Therapeutic efficacy of eprinomectin extended-release injection against induced infections of developing (fourth-stage larvae) and adult nematode parasites of cattle.  

UK PubMed Central (United Kingdom)

The therapeutic efficacy of eprinomectin in an extended-release injection (ERI) formulation was evaluated against induced infections of developing fourth-stage larval or adult gastrointestinal and pulmonary nematodes of cattle in a series of six studies under two identical protocols (three each for developing fourth-stage larvae or adults) conducted in the USA, Germany or the UK (two studies at each location, one per stage). Each study initially included 16 nematode-free cattle. The cattle were of various breeds or crosses, weighed 109-186.5 kg prior to treatment, and were approximately 4-7 months old. The animals were blocked based on pre-treatment bodyweight and then randomly allocated to treatment: eprinomectin ERI vehicle (control) at 1 mL/50 kg body weight or eprinomectin 5% ERI at 1 mL/50 kg bodyweight (1.0 mg eprinomectin/kg) for a total of eight and eight animals in each group. Treatments were administered once on Day 0 by subcutaneous injection in front of the shoulder. In each study, cattle were infected with a combination of infective third-stage larvae or eggs of gastrointestinal and pulmonary nematodes. Inoculation was scheduled so that the nematodes were expected to be fourth-stage larvae or adults at the time of treatment. For parasite recovery, all study animals were humanely euthanized and necropsied 14-15 (adult infections) or 21-22 days after treatment (developing fourth-stage larval infections). When compared with the vehicle-treated control counts, efficacy of eprinomectin ERI against developing fourth-stage larvae and adults was ?98% (p<0.05) for the following nematodes: Dictyocaulus viviparus, Bunostomum phlebotomum, Cooperia curticei, C. oncophora, C. surnabada, C. punctata, Haemonchus contortus, H. placei, Nematodirus helvetianus, Oesophagostomum radiatum, Oes. venulosum, Ostertagia leptospicularis, O. ostertagi, O. circumcincta, O. pinnata, O. trifurcata (developing fourth-stage larval infections only), Strongyloides papillosus, Trichostrongylus axei, T. colubriformis, and Trichuris ovis (adult infections only). All animals accepted the treatment well. No adverse reaction to treatments was observed in any animal in any study.

Rehbein S; Baggott DG; Royer GC; Yoon S; Cramer LG; Soll MD

2013-03-01

284

The efficacy of eprinomectin extended-release injection against naturally acquired nematode parasites of cattle, with special regard to inhibited fourth-stage Ostertagia larvae.  

UK PubMed Central (United Kingdom)

The efficacy of eprinomectin in an extended-release injection (ERI) formulation in the treatment of cattle harboring naturally acquired nematode populations (including inhibited nematodes) was evaluated. Five studies were conducted under a similar protocol in the USA, the UK, and in Germany. All study animals were infected by grazing naturally contaminated pastures. The adequacy of pasture infectivity was confirmed by examining tracer calves prior to allocation and treatment of the study animals. The cattle were of various breeds or crosses, weighing 79-491 kg, and aged approximately 6-15 months. In each study, 20 animals were infected by grazing, and then removed from pasture and housed in a manner to preclude further nematode infections for 8-16 days until treatment. Animals were blocked based on descending pre-treatment body weight and randomly allocated to one of two treatments: ERI vehicle (control) at 1 mL/50 kg body weight or eprinomectin 5% (w/v) ERI at 1 mL/50 kg body weight (1.0 mg eprinomectin/kg). Treatments were administered once on Day 0 by subcutaneous injection in front of the shoulder. For parasite recovery and count, all study animals were humanely euthanized 14/15 days after treatment. Cattle treated with eprinomectin ERI had significantly (p<0.05) fewer of the following nematodes than the controls with overall reduction of parasite counts of ?94%: adult Dictyocaulus viviparus, Capillaria spp., Cooperia oncophora, Cooperia pectinata, Cooperia punctata, Cooperia surnabada, Haemonchus placei, Nematodirus helvetianus, Oesophagostomum radiatum, Ostertagia lyrata, Ostertagia ostertagi, Trichostrongylus axei, Trichostrongylus colubriformis, Trichuris discolor, Trichuris skrjabini, and Trichuris spp.; developing fourth-stage larvae of Ostertagia spp. and Trichostrongylus spp.; and inhibited fourth-stage larvae of Cooperia spp., Haemonchus spp., Nematodirus spp., Oesophagostomum spp., Ostertagia spp., and Trichostrongylus spp. Animal treatments were well accepted, with no adverse reactions to treatment observed in any study animals. The results of this series of controlled studies demonstrated high therapeutic efficacy and acceptability of eprinomectin ERI against pulmonary nematodes and a wide range of gastrointestinal parasitic infections, including inhibited gastrointestinal nematodes, in cattle.

Hunter JS 3rd; Yoon S; Yazwinski TA; Williams JC; Rehbein S

2013-03-01

285

A Comparison of the Efficacy of Intra-Articular Injection of Morphine with Marcaine in Patients to Relief the Pain Associated with  

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Full Text Available . *AbstractBackground and purpose: Knee arthroscopy is an approved technique for the diagnosis and treatment of intra-articular lesions. Moderate to severe pain is experienced after surgery; thus, relieving pain post arthroscopy, will help patients in performing their daily activities as soon as possible. Many studies have been performed for reducing pain after arthroscopy. The aim of this study is to compare the efficacy of intra-articular injection of morphine with marcaine in patients for pain relief after arthroscopy.Materials and Methods: 30 patients were considered for arthroscopic surgery, due to the tearing of the menisci. In this simple non-probability trial, patients were divided in two groups. The first group received 7cc intra-articular marcaine at 0.5% and the second group received 10mg of intra-articular morphine after the arthroscopy. The response was measured by VAS in hours 6, 12, 18, 24 postoperatively and by flexion, extension and walking.Results: The results showed that there was no significant statistical difference between the two groups, except in hour 6 after surgery, indicating marcaine is more effective than morphine. There were no side effects experienced within the two groups. Age, gender, height and weight also had no effect in reducing the pain in patients.Conclusion: Intra-articular Injection of marcaine is more effective than morphine six hours after surgery; however, there are no differences between them after that time frame. More research is needed in order to reduce pain after arthroscopy. Key words:

S.E. Shafiei,; M.H. Karimi nasab, M.D; M. Shayesteh azar, M.D; M. Shayesteh azar, M.D; M. Sajjadi, M.D

2007-01-01

286

Risperidone compared with olanzapine in a naturalistic clinical study in Ireland: a cost analysis.  

UK PubMed Central (United Kingdom)

BACKGROUND: Risperidone and olanzapine are thought to have similar clinical effects. This study was designed to compare costs of treatment. AIM: To compare costs of treatment with risperidone or olanzapine in a naturalistic setting. METHOD: The Irish Risperidone Olanzapine Drug Outcomes studies in Schizophrenia (RODOS) programme was a retrospective review of medical notes and prescription charts in 396 inpatients with schizophrenia or schizoaffective disorder. The main outcome measure was cost of inpatient drug treatment. RESULTS: There was no statistical difference in length of hospital stay between risperidone-treated and olanzapine-treated patients (mean duration of stay 37.8 and 40.5 days, p=0.90). Mean+/-SD doses of risperidone and olanzapine were 4.2+/-2.1 mg/day and 12.9+/-5.0 mg/day, respectively. Average daily cost of all inpatient drugs was significantly higher for olanzapine than for risperidone (i.e. IEP5.61 [7.12] vs IEP3.38 [4.29]; p<0.0001), as was mean total costs of all inpatient drugs (i.e. IEP114.8 [145.8] vs IEP62.0 [78.7]; p<0.0001). This partly reflected the mean, non-significant, longer treatment duration for olanzapine compared with risperidone (mean 30.0 vs 26.4 days; p=0.27). Concomitant neuroleptic use was similar for both groups (71% risperidone, 73% olanzapine; p=0.54). CONCLUSION: Risperidone was associated with significantly lower drug treatment costs.

Lucey JV; Libretto SE

2003-10-01

287

Short- and long-term efficacy of intra-articular injections with betamethasone as part of a treat-to-target strategy in early rheumatoid arthritis: impact of joint area, repeated injections, MRI findings, anti-CCP, IgM-RF and CRP.  

UK PubMed Central (United Kingdom)

OBJECTIVE: To investigate the short-term and long-term efficacy of intra-articular betamethasone injections, and the impact of joint area, repeated injections, MRI pathology, anticyclic citrullinated peptide (CCP) and immunoglobulin M rheumatoid factor (IgM-RF) status in patients with early rheumatoid arthritis (RA). METHODS: During 2 years of follow-up in the CIMESTRA trial, 160 patients received intra-articular betamethasone in up to four swollen joints/visit in combination with disease-modifying antirheumatic drugs. Short-term efficacy was assessed by EULAR good response. Long-term efficacy by Kaplan-Meier plots of the joint injection survival (ie, the time between injection and renewed flare). Potential predictors of joint injection survival were tested. RESULTS: 1373 Unique joints (ankles, elbows, knees, metacarpophalangeal (MCP), metatarsophalangeal, proximal interphalangeal (PIP), shoulders, wrists) were injected during 2 years. 531 Joints received a second injection, and 262 a third. At baseline, the median numbers of injections (dose of betamethasone) was 4 (28 mg), declining to 0 (0 mg) at subsequent visits. At weeks 2, 4 and 6, 50.0%, 58.1% and 61.7% had achieved a EULAR good response. After 1 and 2 years, respectively, 62.3% (95% CI 58.1% to 66.9%) and 55.5% (51.1% to 60.3%) of the joints injected at baseline had not relapsed. All joint areas had good 2-year joint injection survival, longest for the PIP joints: 73.7% (79.4% to 95.3%). 2-Year joint injection survival was higher for first injections: 56.6% (53.7% to 59.8%) than for the second: 43.4% (38.4% to 49.0%) and the third: 31.3% (25.0% to 39.3%). Adverse events were mild and transient. A high MRI synovitis score of MCP joints and anti-CCP-negativity were associated with poorer joint injection survival, whereas IgM-RF and C-reactive protein were not. CONCLUSION: In early RA, intra-articular injections of betamethasone in small and large peripheral joints resulted in rapid, effective and longlasting inflammatory control. The cumulative dose of betamethasone was low, and the injections were well tolerated.

Hetland ML; Østergaard M; Ejbjerg B; Jacobsen S; Stengaard-Pedersen K; Junker P; Lottenburger T; Hansen I; Andersen LS; Tarp U; Svendsen A; Pedersen JK; Skjødt H; Ellingsen T; Lindegaard H; Pødenphant J; Hørslev-Petersen K

2012-06-01

288

Risperidone-induced leukopenia: a case report and brief review of literature.  

UK PubMed Central (United Kingdom)

A Caucasian, male, young adult with recurrent agitated depression and suicidal ideation received lithium and oral olanzapine. His white blood cell count was normal at that time. Due to unsatisfactory response, he received 4 mg/day risperidone. While symptoms improved, leukopenia emerged, specifically directed towards neutrophils. Upon risperidone discontinuation, white blood cell count returned to reference values within 1 week. As symptom control was satisfactory, we attempted no risperidone rechallenge. Accurate blood testing must accompany atypical antipsychotic drug administration since blood dyscrasias are always possible with these drugs.

Manfredi G; Solfanelli A; Dimitri G; Cuomo I; Sani G; Kotzalidis GD; Girardi P

2013-01-01

289

Risperidone Versus Yokukansan in the Treatment of Severe Alzheimer’s Disease  

Directory of Open Access Journals (Sweden)

Full Text Available PURPOSE: Patients with AD commonly exhibit behavioral and psychological symptoms of dementia (BPSD). This study is aimed to compare the efficacy of yokukansan (YKS) and risperidone (RIS) on BPSD in patients with severe Alzheimer’s disease (AD). METHODS: Thirty eight inpatients with AD were investigated. Patients were randomly as-signed to the YKS group (N = 18) or the RIS group (N = 20) and treated for 4 weeks. The primary outcomes were changes in the scores on the Neuropsychiatric Inventory (NPI), the Mini-Mental State Examination (MMSE), the Bar-thel Index, and the Cohen-Mansfield Agitation Inventory (CMAI). The frequency of extrapyramidal symptoms (EPS) and other adverse events were recorded at every visit. RESULTS: All participants in both groups completed the trial. The Barthel Index did not significantly change either in the RIS group or the YKS group. The MMSE scores did not change either in the RIS group or the YKS group. Significant improvements in mean total NPI and CMAI scores showed in both groups. Between the YKS and the RIS groups, there were no significant differences in the NPI or the CMAI scores. EPS and other serious adverse effects were not observed in either group. CONCLUSIONS: In this 4-week trial, YKS treatment significantly improved BPSD in the patients with severe AD. The present study suggests that YKS is as effective as RIS on BPSD with severe AD.

Yuko Furuhashi; Kouichi Shin

2011-01-01

290

Development of Analytical Method for Risperidone by UV Spectrophotometry  

Directory of Open Access Journals (Sweden)

Full Text Available A simple, sensitive, specific, spectrophotometric method developed for the detection of Risperidone in bulk drug and Pharmaceutical formulation. The optimum conditions for the analysis of the drug wereestablished. The ? max of the Risperidone was found to be 280 nm. The method shows high sensitivity with linearity 2 to 6? g/ml. The lower limit of detection and the limit of quantification was found to be 1.012 and 3.036 respectively. All the calibration curves shows a linear relationship between the absorbance and concentration and coefficient correlation was higher than 0.99. The regression of the curve was Y = 0.039x - 0.002. Precision of the method was found to be 2.0325 ± 0.044 against the label claim of 2mg. The percentage recovery was found to be 102 ? 0.188. The sample solution was stable up to 2 hours. The proposed method will be suitable for the analysis of RIS in bulk and pharmaceutical formulation.

M.Sravan Kumar,; A.Anton Smith; G.Alagumani Vasagam,; A.Kottai Muthu; R.Manavalan

2010-01-01

291

Microsphere delivery of Risperidone as an alternative to combination therapy.  

UK PubMed Central (United Kingdom)

The purpose of this study was to develop a parenteral delivery system of Risperidone that would provide initial and extended drug release and thereby avoid the need for co-administration of oral tablets. Key formulation parameters utilized to achieve desired therapeutic levels in vivo were particle size and drug loading. Three poly (d,l-lactide-co-glycolide) (PLGA) microsphere formulations (Formulations A, B, and C) that encapsulated Risperidone were prepared by varying particle size (19-49?m) and drug loading parameters (31-37%) but with a uniform bulk density (0.66-0.69) and internal porosity utilizing the solvent extraction/evaporation method. The microspheres were characterized for drug content by HPLC, particle size by laser diffractometry, surface morphology by scanning electron microscopy (SEM), and in vivo drug release. In vivo studies were performed in male Sprague-Dawley rats, and levels of the active moiety (Risperidone and its metabolite, 9-hydroxyrisperidone) were assessed. In vivo release profiles from the three microsphere formulations were dependent on particle size and drug loading. The smaller sized microspheres (Formulation A) exhibited a large initial burst and a shorter duration of action, while the larger particles exhibited a smaller initial burst (Formulations B and C) but released drug for a much longer period in vivo. Extended duration of drug release was ascribed to higher drug content in the microspheres. A biweekly simulation of multiple dosing revealed that Formulation C, the selected formulation, with a high load and large particle size would provide adequate initial and maintenance levels of the active moiety (Risperidone and its metabolite, 9-hydroxyrisperidone). A comparison of biweekly dosing in vivo of Formulation C with the marketed product showed that at steady state, though average concentrations for both preparations were similar, the time taken to achieve steady state was much faster for Formulation C. The delay in attaining steady state with Risperdal Consta® was attributed to the 3week latency in drug release from the microspheres was in accordance with previous studies indicating a good corroboration with clinical findings. Calculated cumulative AUC (area under the curve) levels for Formulation C were similar to the Risperdal Consta®, though there were marked differences in AUC levels at the early time points. Comparison of Risperidal Consta® and Formulation C by multiple dosing in vivo experiments revealed that the marketed preparation demonstrated a substantial delay in providing an initial loading dose, continuous circulating levels, and attainment of steady state; all of which were observed rapidly with Formulation C. Findings from the current study strongly suggest that a microsphere dosage form of Risperidone can be formulated with an optimum particle size and drug loading to provide an initial bolus followed by maintenance levels, thereby eliminating combination therapy and improving patient compliance.

D'Souza S; Faraj J; Deluca P

2013-07-01

292

A randomized controlled trial of risperidone, lithium, or divalproex sodium for initial treatment of bipolar I disorder, manic or mixed phase, in children and adolescents.  

UK PubMed Central (United Kingdom)

CONTEXT: There was a paucity of comparative pharmacological research for initial treatment of bipolar I disorder, manic or mixed phase, in children and adolescents. OBJECTIVE: To investigate which medication to administer first to antimanic medication-naive subjects. DESIGN, SETTING, AND PARTICIPANTS: The Treatment of Early Age Mania (TEAM) study recruited 6- to 15-year-old children and adolescents with DSM-IV bipolar I disorder (manic or mixed phase) at 5 US sites from 2003 to 2008 into a controlled, randomized, no-patient-choice, 8-week protocol. Blinded, independent evaluators conducted all baseline and end-point assessments. INTERVENTIONS: Subjects received a titrated schedule of lithium, divalproex sodium, or risperidone. Medications were increased weekly only if there was inadequate response, and no dose-limiting adverse effects, to maximum doses of lithium carbonate (1.1-1.3 mEq/L), divalproex sodium (111-125 ?g/mL), and risperidone (4-6 mg). MAIN OUTCOME MEASURES: Primary outcome measures were the Clinical Global Impressions for Bipolar Illness Improvement-Mania and the Modified Side Effects Form for Children and Adolescents. RESULTS: There were 279 antimanic medication-naive subjects (mean [SD] age, 10.1 [2.8] years; 50.2% female) who had the following characteristics: 100% elated mood and/or grandiosity, 77.1% psychosis, 97.5% mixed mania, 99.3% daily rapid cycling, and mean (SD) mania duration of 4.9 (2.5) years. The mean (SD) titrated lithium level was 1.09 (0.34) mEq/L, and the mean (SD) divalproex sodium level was 113.6 (23.0) ?g/mL. The mean (SD) titrated risperidone dose was 2.57 (1.21) mg. Higher response rates occurred with risperidone vs lithium (68.5% vs 35.6%; ?(2)(1) = 16.9, P < .001) and vs divalproex sodium (68.5% vs 24.0%; ?(2)(1) = 28.3, P < .001). Response to lithium vs divalproex sodium did not differ. The discontinuation rate was higher for lithium than for risperidone (?(2)(1) = 6.4, P = .011). Increased weight gain, body mass index, and prolactin level occurred with risperidone vs lithium (F(1,212) = 45.5, P < .001; F(1,212) = 39.1, P < .001; and F(1,213) = 191.4, P < .001, respectively) and vs divalproex sodium (F(1,212) = 34.7, P < .001; F(1,212) = 45.3, P < .001; and F(1,213) = 209.4, P < .001, respectively). The thyrotropin level increased in subjects taking lithium (t(62) = 11.3, P < .001). CONCLUSIONS: Risperidone was more efficacious than lithium or divalproex sodium for the initial treatment of childhood mania but had potentially serious metabolic effects. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00057681

Geller B; Luby JL; Joshi P; Wagner KD; Emslie G; Walkup JT; Axelson DA; Bolhofner K; Robb A; Wolf DV; Riddle MA; Birmaher B; Nusrat N; Ryan ND; Vitiello B; Tillman R; Lavori P

2012-05-01

293

Induction of Drug Transporters Alters Disposition of Risperidone - A Study in Mice  

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Full Text Available Pharmacokinetic interactions, e.g. modulation of drug transporters like P-glycoprotein at the blood-brain barrier, can be a reason for treatment non-response. This study focuses on the influence of induction of drug transporters on the disposition of the antipsychotic drugs risperidone and 9-hydroxyrisperidone. Brain and serum concentrations of risperidone and its active metabolite 9-hydroxyrisperidone, which are known P-glycoprotein substrates, were measured after drug transporter induction with rifampicin, dexamethasone or 5-pregnene-3beta-ol-20-on-16alpha-carbonitrile using high performance liquid chromatography. Disposition of risperidone and 9-hydroxyrisperidone was dramatically decreased in mouse brain and serum after drug transporter induction. The metabolism of risperidone was also affected.

David Holthoewer; Christoph Hiemke; Ulrich Schmitt

2010-01-01

294

Memantine add-on to risperidone for treatment of negative symptoms in patients with stable schizophrenia: randomized, double-blind, placebo-controlled study.  

UK PubMed Central (United Kingdom)

We aimed to evaluate the efficacy of memantine add-on in the treatment of primary negative symptoms of patients with stable schizophrenia. In a double-blind placebo-controlled clinical trial, 40 patients with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) who were stabilized on risperidone for a minimum of 8 weeks were randomized to either memantine (20 mg) or placebo in addition to risperidone, 6 mg/d, for eight weeks. Assessment was done using the Positive and Negative Syndrome Scale at baseline, week 4, and week 8. The Hamilton Depression Rating Scale and the Extrapyramidal Symptom Rating Scale at baseline and week 8 were used to assess depression and extrapyramidal symptoms, respectively. All 40 patients had at least one postbaseline measurement, and 38 patients completed the trial. Patients in the memantine group showed a significantly greater improvement on negative subscale than the placebo group at end point (P < 0.001). The same effect was observed for the total score (P < 0.001) and the general psychopathology subscale score (P = 0.002). There was no significant difference in reduction of positive symptoms score between the 2 groups (P = 0.757). Changes in the Hamilton Depression Rating Scale and the Extrapyramidal Symptom Rating Scale scores and frequency of adverse effects did not differ between the 2 groups. Our study showed that memantine is a tolerable and efficacious add-on treatment for primary negative symptoms of schizophrenia.

Rezaei F; Mohammad-Karimi M; Seddighi S; Modabbernia A; Ashrafi M; Salehi B; Hammidi S; Motasami H; Hajiaghaee R; Tabrizi M; Akhondzadeh S

2013-06-01

295

Memantine add-on to risperidone for treatment of negative symptoms in patients with stable schizophrenia: randomized, double-blind, placebo-controlled study.  

Science.gov (United States)

We aimed to evaluate the efficacy of memantine add-on in the treatment of primary negative symptoms of patients with stable schizophrenia. In a double-blind placebo-controlled clinical trial, 40 patients with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) who were stabilized on risperidone for a minimum of 8 weeks were randomized to either memantine (20 mg) or placebo in addition to risperidone, 6 mg/d, for eight weeks. Assessment was done using the Positive and Negative Syndrome Scale at baseline, week 4, and week 8. The Hamilton Depression Rating Scale and the Extrapyramidal Symptom Rating Scale at baseline and week 8 were used to assess depression and extrapyramidal symptoms, respectively. All 40 patients had at least one postbaseline measurement, and 38 patients completed the trial. Patients in the memantine group showed a significantly greater improvement on negative subscale than the placebo group at end point (P memantine is a tolerable and efficacious add-on treatment for primary negative symptoms of schizophrenia. PMID:23609382

Rezaei, Farzin; Mohammad-Karimi, Maryam; Seddighi, Sahar; Modabbernia, Amirhossein; Ashrafi, Mandana; Salehi, Bahman; Hammidi, Siran; Motasami, Hamid; Hajiaghaee, Reza; Tabrizi, Mina; Akhondzadeh, Shahin

2013-06-01

296

Efficacy and safety of haloperidol versus atypical antipsychotic medications in the treatment of delirium.  

UK PubMed Central (United Kingdom)

CONCLUSIONS: Haloperidol, risperidone, olanzapine, and quetiapine were equally efficacious and safe in the treatment of delirium. However, age is a factor that needs to be considered when making a choice of antipsychotic medication for the treatment of delirium.Trial registration: Clinical Research Information Service, Republic of Korea, (http://cris.nih.go.kr, Registered Trial No. KCT0000632).

Yoon HJ; Park KM; Choi WJ; Choi SH; Park JY; Kim JJ; Seok JH

2013-09-01

297

Risperidone irreversibly binds to and inactivates the h5-HT7 serotonin receptor.  

Science.gov (United States)

Risperidone displays a novel mechanism of antagonism of the h5-HT7 receptor. Pretreatment of the cells with 5 or 20 nM risperidone, followed by removal of the drug from the media, renders the 5-HT7 receptors unresponsive to 10 microM 5-HT for at least 24 h. Thus, risperidone seems to be producing a rapid, long-lasting inactivation of the h5-HT7 receptor. Whole-cell radioligand binding studies indicate that risperidone interacts in an irreversible or pseudo-irreversible manner with the h5-HT7 receptor, thus producing the inactivation. Internalization of the h5-HT7 receptor was not detected by monitoring green fluorescent protein-labeled fluorescent forms of the h5-HT7 receptor exposed to 20 nM risperidone. Ten other antagonists were tested for h5-HT7-inactivating properties, and only 9-OH-risperidone and methiothepin were found to demonstrate the same anomalous properties as risperidone. These results indicate that the h5-HT7 receptor may possess unique structural features that allow certain drugs to induce a conformation resulting in an irreversible interaction in the intact membrane environment. This may indicate that the h5-HT7 receptor is part of a subfamily of G-protein-coupled receptors (GPCRs) possessing this property or that many GPCRs have the potential to be irreversibly blocked, but only select drugs can induce this effect. At the very least, the possibility that highly prescribed drugs, such as risperidone, are irreversibly antagonizing GPCR function in vivo is noteworthy. PMID:16870886

Smith, Carol; Rahman, Tariq; Toohey, Nicole; Mazurkiewicz, Joseph; Herrick-Davis, Katharine; Teitler, Milt

2006-07-26

298

Polipectomía endoscópica de colon: efectividad y seguridad de la técnica de inyectar y cortar/ Efficacy and safety of the inject and cut technique for endoscopic colonic polypectomy  

Scientific Electronic Library Online (English)

Full Text Available Abstract in spanish La polipectomía de colon es el más importante instrumento para detener la secuencia adenoma-cáncer. La técnica de inyectar y cortar ha demostrado eficacia y seguridad en estudios realizados en otros países. En nuestro país no se han reportado datos sobre el desempeño de esta técnica por lo que se hace necesario describir la experiencia de una unidad de gastroenterología de un centro universitario. Objetivos: Describir las características demográficas y operativ (more) as de la polipectomía endoscópica de colon por medio de la técnica de inyectar y cortar. Materiales y métodos: Se incluyeron todos los pacientes a quienes se les realizó polipectomía endoscópica colon en la unidad de gastroenterología de la Clínica Fundadores de Bogotá, desde enero de 2003 hasta septiembre de 2011; los datos se procesaron en el paquete estadístico PASW statistics 18 versión 18,8 (SPSS-IBM). Resultados: A 420 pacientes se les realizó polipectomía con un total de 548 pólipos resecados. Promedio de edad 56,3años (14-93), 201 masculinos y 219 femeninos. Localización más común en colon izquierdo (238/64,4%), promedio de tamaño 1,6 cm, 83,8% pediculados, 13,3% sésiles y 2,85% planos. Hubo sangrado intraprocedimiento en 36 casos (8,6%). No hubo relación entre esta complicación y el tamaño de los pólipos ( Abstract in english Colonic polypectomy is the most important tool for stopping adenoma-cancer, and the inject and cut technique has demonstrated efficacy and safety in studies conducted in other countries. Since in our country there are no reported data on performance of this technique, it is necessary to describe the experience of a gastroenterology unit of a university. Objectives: The objectives of this study were to describe operational characteristics of endoscopic colonic polypectomy (more) using the inject and cut technique and to describe demographic characteristics of patients undergoing this procedure. Materials and Methods: We included all patients who underwent endoscopic colonic polypectomies in the gastroenterology unit of the Clínica Fundadores in Bogotá from January 2003 to September 2011. Data were processed using SPSS version 18 18.8 (SPSS-IBM) statistical package. Results: 420 patients underwent polypectomies which resected a total of 548 polyps. Mean patient age was 56.3 years (range 14 to 93), 201 patients were male, and 219 were female. Polyps were most commonly located in the left colon (238/64.4%). Average size was 1.6 cm. 83.8% were pedunculated, 13.3% were sessile, and 2.85% were flat. Intraoperative bleeding occurred in 36 cases (8.6%). There was no relationship between this complication and the size of polyps (

Otero R, William; Concha M, Alejandro; Gómez Z, Martín

2013-03-01

299

Relapse in patients with schizophrenia: a comparison between risperidone and haloperidol  

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Full Text Available OBJECTIVES: To compare rates of rehospitalization and time to relapse in risperidone vs. haloperidol-treated schizophrenic patients discharged from the hospital. METHODS: Randomized controlled trial comparing risperidone and haloperidol regarding relapse in patients with schizophrenia treated with flexible doses during one year. RESULTS: Twenty patients were assigned to risperidone and 13 to haloperidol. One patient from each group withdrew consent and one patient in the risperidone group was lost for follow-up. Six (30.0%) patients in the risperidone group and 3 (23.1%) in the haloperidol group relapsed (p=1.00). However, time to relapse was shorter in the later (logrank =4.2; p=.04). When rehospitalized, patients in the risperidone group stayed 34.5 days (median) at hospital as compared to the haloperidol group (median of 61 days) (p=.61). CONCLUSION: The proportion of schizophrenic patients who relapsed was similar in both groups; However, time to relapse was shorter in the haloperidol-treated patients.

Sena Eduardo Pondé de; Santos-Jesus Rogério; Miranda-Scippa Ângela; Quarantini Lucas de Castro; Oliveira Irismar Reis de

2003-01-01

300

Risperidone treatment in a steroid-induced psychosis case  

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Full Text Available Steroids have been used effectively for many years to treat a wide variety of both acute and chronic medical conditions. Despite some well-known side effects, the association of psychiatric disorders with the use of these drugs has not been well established and documented. We describe a case of a 46-year-old man with a recent diagnosis of optic neuritis, who has psychotic symptoms which appear to be induced by steroids. Psychiatric symptoms emerged after the first dose of steroid and diagnosis of steroid-induced psychosis was made. After discontinuation of steroid therapy, psychiatric symptoms did not improve. But after four weeks of risperidone treatment, he recovered completely. This case adds to small but progressive body of evidence supporting the incidence of steroid-induced psychiatric symptoms in patients with optic neuritis. We suggest that the prevalence of this phenomenon might be considerably higher than what has been reported in the current literature.

Aysel Milanl?o?lu; Mustafa Güleç

2011-01-01

 
 
 
 
301

Early onset of treatment effects with oral risperidone  

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Full Text Available Abstract Background The dogma of a delayed onset of antipsychotic treatment effects has been maintained over the past decades. However, recent studies have challenged this concept. We therefore performed an analysis of the onset of antipsychotic treatment effects in a sample of acutely decompensated patients with schizophrenia. Methods In this observational study, 48 inpatients with acutely decompensated schizophrenia were offered antipsychotic treatment with oral risperidone. PANSS-ratings were obtained on day 0, day 1, day 3, day 7 and day 14. Results Significant effects of treatment were already present on day 1 and continued throughout the study. The PANSS positive subscore and the PANSS total score improved significantly more than the PANSS negative subscore. Conclusion Our results are consistent with the growing number of studies suggesting an early onset of antipsychotic treatment effects. However, non-pharmacological effects of treatment also need to be taken into consideration.

Raedler Thomas J; Schreiner Andreas; Naber Dieter; Wiedemann Klaus

2007-01-01

302

Insulin secretion in patients receiving clozapine, olanzapine, quetiapine and risperidone.  

UK PubMed Central (United Kingdom)

BACKGROUND: Second-generation antipsychotics (SGAs) increase the risk of type 2 diabetes. The mechanism is thought to center on drug-induced weight gain, which starts the dysmetabolic cascade of insulin resistance, increased insulin production and pancreatic beta-cell failure. An independent effect of SGAs on insulin secretion has been suggested in animal models, but has not been demonstrated in clinical samples. OBJECTIVE: To determine the post-challenge insulin secretion in patients treated with SGAs. METHOD: We identified 520 non-diabetic individuals treated with clozapine (N=73), olanzapine (N=190), quetiapine (N=91) or risperidone (N=166) in a consecutive, single-site cohort of 783 adult psychiatric inpatients who underwent a comprehensive metabolic assessment. Insulin secretion was measured as the area under the curve (AUC(insulin)) generated by levels recorded at baseline, 30, 60 and 120 min after the intake of 75 g of glucose. The independent predictors of insulin secretion were determined with regression analysis in the entire sample and separately in patients with normal glucose tolerance (NGT) and prediabetes. RESULTS: The post-challenge AUC(insulin) was independently predicted by AUC(glucose), waist circumference, triglyceride levels and younger age (p<0.0001); non-smoking status (p=0.0012); and treatment with clozapine (p=0.021). The model explained 33.5% of the variance in insulin secretion (p<0.0001). The clozapine effect was present in the NGT group, but not in prediabetics. CONCLUSIONS: Clozapine, but not olanzapine, quetiapine and risperidone, is an independent predictor of post-challenge insulin secretion in non-diabetics, particularly in those with normal glucose tolerance. The findings suggest that the diabetogenic risk of clozapine may persist even after weight reduction.

Manu P; Correll CU; Wampers M; van Winkel R; Yu W; Shiffeldrim D; Kane JM; De Hert M

2013-02-01

303

The efficacies of pure LICAM(C) and DTPA on the retention of plutonium-238 and americium-241 in rats after their inhalation as nitrate and intravenous injection as citrate.  

UK PubMed Central (United Kingdom)

The pure carboxylated catechoyl amide LICAM(C) and the calcium and zinc salts of diethylenetriaminepenta-acetic acid (DTPA), were tested for efficacy for removing 238Pu and 241Am from rats after inhalation of the nitrate or intravenous injection of the citrate. The results were compared with the efficacy of methylated LICAM(C) used in previous experiments. It was shown that: (1) after inhalation of 238Pu nitrate, DTPA was far superior to pure LICAM(C); (2) after intravenous injection of 238Pu citrate, the infusion of DTPA plus LICAM(C) was only marginally more effective than DTPA alone; and (3) after inhalation or intravenous injection of 238Pu plus 241Am, the efficacy of pure LICAM(C) was only marginally more effective than the methylated form and neither form was effective for the decorporation of 241Am. It was concluded that DTPA, at present, remains the chelating agent of choice for treating persons accidentally contaminated with transportable forms of Pu and Am.

Stradling GN; Stather JW; Gray SA; Moody JC; Ellender M; Hodgson A; Volf V; Taylor DM; Wirth P; Gaskin PW

1989-10-01

304

A placebo-controlled study of tropisetron added to risperidone for the treatment of negative symptoms in chronic and stable schizophrenia.  

UK PubMed Central (United Kingdom)

RATIONAL: A growing body of evidence illustrates that 5-HT3 receptor antagonist drugs may be of benefit in the treatment of negative symptoms in schizophrenia. OBJECTIVE: The objective of this study was to assess the efficacy and tolerability of tropisetron add-on to risperidone on negative symptoms in patients with chronic stable schizophrenia. METHODS: In a double-blind, placebo-controlled 8-week trial, 40 patients with chronic schizophrenia who were stabilized on risperidone were randomized into tropisetron or placebo add-on groups. Psychotic symptoms were measured using the Positive and Negative Syndrome Scale (PANSS) every 2 weeks. Furthermore, extrapyramidal and depressive symptoms as well as side effects were assessed. The primary outcome measure was the difference in change from baseline of negative subscale scores between the two groups at week 8. RESULTS: Tropisetron resulted in greater improvement of the total PANSS scores [F(1.860,70.699)?=?37.366, p?risperidone improves the primary negative symptoms of patients with chronic stable schizophrenia.

Noroozian M; Ghasemi S; Hosseini SM; Modabbernia A; Khodaie-Ardakani MR; Mirshafiee O; Farokhnia M; Tajdini M; Rezaei F; Salehi B; Ashrafi M; Yekehtaz H; Tabrizi M; Akhondzadeh S

2013-08-01

305

Effects of risperidone on conduct and disruptive behavior disorders in children with subaverage IQs.  

UK PubMed Central (United Kingdom)

OBJECTIVE: To determine whether risperidone is effective in reducing symptoms of disruptive behaviors (such as aggression, impulsivity, defiance of authority figures, and property destruction) associated with conduct disorder, oppositional defiant disorder, and disruptive behavior disorder-not otherwise specified in children with subaverage IQs. METHOD: The trial consisted of a 1-week, single-blind, placebo run-in period and was followed by a 6-week, double-blind, placebo-controlled period. One hundred ten children (aged 5-12 years inclusive) with an IQ of 36-84 with a disruptive behavior disorder and a score of at least 24 on the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (NCBRF) were enrolled. Eighty percent of subjects had comorbid attention-deficit/hyperactivity disorder (ADHD). Risperidone doses ranged from 0.02 to 0.06 mg/kg per day. Subjects were rated on the NCBRF, Aberrant Behavior Checklist, Behavior Problems Inventory, Clinical Global Impressions (CGI), modified California Verbal Learning Test (CVLT), and a continuous performance task (CPT). RESULTS: The intention-to-treat analysis of risperidone-treated subjects showed a significant (p < .001) reduction in mean scores (from 33.4 at baseline to 17.6 at end point; 47.3% reduction) versus placebo-treated subjects (mean baseline of 32.6 to 25.8 at end point; 20.9% reduction) on the Conduct Problem subscale of the NCBRF. Between-group differences in favor of risperidone were seen as early as week 1 and were significant at all post-baseline visits. Other subscales showed significant improvement with risperidone compared with placebo. CGI scale ratings of improvement showed highly significant gains for risperidone over placebo. A subanalysis demonstrated that the effect of risperidone was unaffected by diagnosis, presence/absence of ADHD, psychostimulant use, IQ status, and somnolence. Risperidone produced no changes on the cognitive variables (CPT/modified CVLT). The most common side effects included somnolence, headache, appetite increase, and dyspepsia. Side effects related to extrapyramidal symptoms were reported in 7 (13.2%) and 3 (5.3%) of the subjects in the risperidone and placebo groups, respectively (p = .245). CONCLUSIONS: Risperidone appears to be an adequately tolerated and effective treatment in children with subaverage IQs and severe disruptive behaviors such as aggression and destructive behavior.

Snyder R; Turgay A; Aman M; Binder C; Fisman S; Carroll A

2002-09-01

306

Double-blind randomized trial of risperidone versus divalproex in pediatric bipolar disorder.  

UK PubMed Central (United Kingdom)

OBJECTIVE: To determine the relative effects of risperidone and divalproex in pediatric mania. METHODS: This is a double-blind, randomized, outpatient clinical trial with 66 children and adolescents (mean age= 10.9 ± 3.3 years; age range= 8-18 years) with mania who were randomly assigned to either risperidone (0.5-2 mg/day, n= 33) or divalproex (60-120 ?g/mL, n= 33) for a six-week period. Measures included the Young Mania Rating Scale (YMRS) and Child Depression Rating Scale-Revised (CDRS-R). RESULTS: Mixed-effects regression models, with interaction between time and the active drug as predictors, found that the risperidone group had more rapid improvement than the divalproex group (p < 0.05), although final scores did not differ significantly between groups. Mixed models using only those subjects who completed the six-week study found similar results. The response rate on YMRS was 78.1% for risperidone and 45.5% for divalproex (p < 0.01). The remission rate for risperidone was 62.5%, compared with 33.3% for divalproex (p < 0.05). Improvement on the CDRS-R was significantly higher for the risperidone group relative to the divalproex group (p < 0.05). There were no significant differences between groups in safety, but subject retention was significantly higher at study endpoint in the risperidone group (p < 0.01). Dropout rate was 24% in the risperidone group and 48% in the divalproex group, with increased irritability being the most common reason for dropout in the latter. There was no significant weight gain in either group. CONCLUSION: Results suggest that risperidone was associated with more rapid improvement and greater reduction in manic symptoms compared to divalproex. Although the results suggest that both drugs are safe, risperidone's lower attrition rate and lower rate of adverse events may suggest better toleration. Clinical trials with larger samples are required to confirm these preliminary findings.

Pavuluri MN; Henry DB; Findling RL; Parnes S; Carbray JA; Mohammed T; Janicak PG; Sweeney JA

2010-09-01

307

Potential bias in testing for hyperprolactinemia and pituitary tumors in risperidone-treated patients: a claims-based study  

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Full Text Available Abstract Background A reporting association of risperidone with pituitary tumors has been observed. Because such tumors are highly prevalent, there may be other reasons why they were revealed in association with risperidone treatment. We assessed two potential explanations: disproportionately more prolactin assessment and head/brain imaging in risperidone-treated patients vs patients treated with other antipsychotics. Methods Treatment episodes with risperidone, clozapine, olanzapine, quetiapine, ziprasidone, aripiprazole, haloperidol, perphenazine and 'other typical' antipsychotics were identified in two databases (large commercial, Medicaid). Comparisons used proportional hazards regression to determine whether prolactin testing was disproportionate with risperidone, regardless of prior potentially prolactin-related adverse events (PPAEs). Logistic regression determined whether magnetic resonance imaging (MRI)/computed tomography (CT) were disproportionate in risperidone-treated patients vs other patients, regardless of hyperprolactinemia or PPAEs. In each regression, the 'other typical' antipsychotic category served as the comparator. Regression models controlled for age, gender, and other factors. Results Altogether, 197,926 treatment episodes were analyzed (63,878 risperidone). Among patients with or without preceding PPAEs, risperidone treatment was associated with a significantly greater likelihood of prolactin assessment (hazard ratio (HR) 1.34, 95% confidence interval (CI) = 1.09 to 1.66, p = 0.007). Among patients with hyperprolactinemia or PPAEs, those treated with risperidone (odds ratio (OR) 1.66, 95% CI 1.23 to 2.23, p = 0.001) or ziprasidone (OR 1.66, 95% CI 1.06 to 2.62, p = 0.028) had a higher likelihood of MRI/CT. Conclusion Risperidone-treated patients are more likely to undergo prolactin assessment regardless of prior PPAEs, and more likely to undergo MRI/CT in association with hyperprolactinemia or PPAEs. Thus, a predisposition for more evaluations in risperidone-treated patients may contribute to disproportionate identification and reporting of prevalent pituitary adenoma.

Gianfrancesco Frank D; Pandina Gahan; Mahmoud Ramy; Wu Jasmanda; Wang Ruey H

2009-01-01

308

A pilot study on risperidone metabolism: the role of cytochromes P450 2D6 and 3A.  

UK PubMed Central (United Kingdom)

BACKGROUND: The limited available information on plasma risperidone levels shows a stable relationship between daily doses of risperidone and total plasma concentration (risperidone plus its active metabolite 9-hydroxyrisperidone). The ratio between risperidone and 9-hydroxyrisperidone characterizes cytochrome P450 2D6 (CYP2D6) status. According to the manufacturer, the CYP2D6 genotype or drugs that influence CYP2D6 or other cytochrome P450 isoenzyme activity are not expected to be clinically significant. One case report suggests that CYP3A participates in the metabolism of risperidone. METHOD: A case series of 13 risperidone patients (the initial case and 12 new cases) who were genotyped for CYP2D6 were followed, and another 20 risperidone patients from a case-control study for the CYP2D6 genotype were reviewed. RESULTS: The CYP2D6 poor metabolizers, who are enzyme deficient (2/13 in the case series and 3/20 in the case-control study), did not appear to tolerate risperidone well. Drugs affecting CYP3A, in particular powerful inducers and inhibitors, resulted in at least a 2-fold decrease or increase in plasma risperidone levels. CONCLUSION: The anecdotal nature of this study is clearly a limitation. Drugs influencing CYP3A and CYP2D6 metabolic activity may significantly affect risperidone levels. Thus, plasma level monitoring of risperidone in a clinical setting may be useful, especially if patients are taking multiple medications or a CYP2D6 deficiency is suspected. New prospective studies under more controlled conditions are needed to verify these hypotheses.

Bork JA; Rogers T; Wedlund PJ; de Leon J

1999-07-01

309

Effects of risperidone on energy balance in female C57BL/6J mice.  

UK PubMed Central (United Kingdom)

OBJECTIVE: To investigate the effect of risperidone on energy expenditure and weight gain in female C57BL/6J mice. DESIGN AND METHODS: Body weight and composition, food intake, energy expenditure, and activity were determined weekly. mRNA expression of uncoupling protein 1 in brown adipose tissue, orexin and brain-derived neurotrophic factor in the hypothalamus were quantified by Real-Time PCR. RESULTS: Risperidone tended to induce a greater body weight gain (P=0.052) and significantly higher food intake (P=0.038) relative to the placebo-treated group. Risperidone-treated mice had a higher resting energy expenditure (P=0.001), and total energy expenditure (P=0.005) than the placebo group. There were no effects of treatment, time, and treatment by time on NREE between groups. Risperidone-treated mice showed a significantly lesser locomotor activity than placebo-treated mice over 3 weeks (P<0.001). Risperidone induced a higher UCP1 mRNA (P=0.003) and a lower orexin mRNA (P=0.001) than placebo. DISCUSSION: Risperidone-induced weight gain is associated with hyperphagia and a reduction in locomotor activity in C57BL/6J mice. Additionally, higher total and resting energy expenditure were accompanied by higher levels of UCP1 mRNA in BAT. The increased total energy expenditure could not offset the total intake of energy through risperidone-induced hyperphagia, therefore resulting in weight gain in female C57BL/6J mice.

Li X; Johnson MS; Smith DL Jr; Li Y; Kesterson RA; Allison DB; Nagy TR

2013-02-01

310

A Randomized Open Label Comparison of the Effects ofRisperidone and Haloperidol on Sexual Function  

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Full Text Available "n Objective: "nSexual dysfunction in patients who take antipsychotics causes adecline in their quality of life and medication acceptance. Considering the restrictions in cross sectional design of many earlier researches, we used a clinical trial aimed at assessing sexual dysfunction by substituting Risperidone, an atypical antipsychotic drug, with Haloperidol, a typical one . "n "n "nMethod: This clinical trial was conducted on 51 patients who had been using Risperidone with a minimum dose of 2 mg/daily for at least 2 months. The patients were randomly divided into 2 groups. The first group continued taking Risperidone, whereas the second group was given Haloperidol. Sexual function prior to and after the drug substitution was assessed using a sexual questionnaire designed to assess four stages of sexual function . "nResults: Compared to those who changed their medication to Haloperidol, the patients who remained on Risperidone therapy suffered from more sexual dysfunction, especially in their tendency towards having sexual activities (P= 0.01), post menstrual sexual activity (P= 0.002), and reaching orgasm in their sexual activities (P= 0.04); however in the Haloperidol group, no significant difference was observed before and after the change in medication . "nConclusion: Although Risperidone and Haloperidol can both disturb patients'sexual function, the side effects of Risperidone are stronger. Hence toprevent the decline of medication acceptance or irregular consumption by patients which may lead to possible relapse, substitution of Risperidone withanother drug with fewer side effects on sexual activities is definitely to the advantage of the patients .

Narges Beyraghi; Mona Ershadi; Mahyar Azar; S. Jaber Mousavi

2009-01-01

311

Comparative pharmacokinetics and bioequivalence of two tablet formulations of 2 mg risperidone in healthy Thai male volunteers.  

UK PubMed Central (United Kingdom)

BACKGROUND: Risperidone is an atypical antipsychotic drug with potent serotonin and moderate dopamine antagonistic properties. It possesses good bioavailability following oral administration. Risperidone is primarily converted by the cytochrome P450 2D6 (CYP2D6) and 3A4 (CYP3A4) enzymes to 9-hydroxyrisperidone, its active metabolite with equivalent potency to the parent compound. OBJECTIVE: This study aimed to compare the pharmacokinetics and determine bioequivalence of two risperidone immediate release oral tablets, a test formulation (Risperidone GPO® or "Test") and a reference formulation (Risperdal® or "Reference"). METHOD: A single-dose, randomized, fasting, 2-period, 2-sequence, crossover study design with a 2-week washout period was conducted in 23 healthy Thai male volunteers. Blood samples were collected predose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 and 96 h following an oral administration of 2 mg risperidone. The plasma concentrations of risperidone and 9-hydroxyrisperidone were determined by using a validated HPLC method. Pharmacokinetic parameters of Test and Reference were obtained by noncompartmental analysis. Results: The 90% confidence intervals for Test/Reference ratios of the pharmacokinetic parameters (Cmax, AUC0-t and AUC0-?) of both risperidone and its active metabolite (9-hydroxyrisperidone) fell within the acceptable bioequivalence range (80 - 125%) according to ASEAN guideline. CONCLUSION: The two risperidone formulations are bioequivalent. The test formulation may be used for generic substitution where applicable.

Khorana N; Maphanta S; Lohitnavy O; Srichaiya A; Sayasathid J

2011-06-01

312

Risperidone Augmentation for Treatment-Resistant Aggression in Attention-Deficit/Hyperactivity Disorder: A Placebo-Controlled Pilot Study  

Science.gov (United States)

Objective: To evaluate the effects of risperidone augmentation for treatment-resistant aggression in children with attention-deficit/hyperactivity disorder (ADHD). Method: Twenty-five children (ages 7-12 years) with attention-deficit/hyperactivity disorder(ADHD) and significant aggressive behaviors were randomized to risperidone or placebo for 4…

Armenteros, Jorge L.; Lewis, John E.; Davalos, Marisabel

2007-01-01

313

Risperidone in psychotic combat-related posttraumatic stress disorder: an open trial.  

UK PubMed Central (United Kingdom)

RATIONALE: Psychotic symptoms that frequently occur in combat-related posttraumatic stress disorder (PTSD) complicate its pharmacotherapy. We hypothesized that war veterans with psychotic PTSD, resistant to prior antidepressant treatment, would respond well to 6 weeks of treatment with the atypical antipsychotic risperidone, given as a monotherapy. METHOD: Twenty-six male war veterans with psychotic PTSD (DSM-IV) completed the 6-week inpatient treatment with risperidone (2-4 mg/day) during the period from November 1999 through December 2002. The primary outcome measure was change from baseline to endpoint (6 weeks) in Positive and Negative Syndrome Scale (PANSS) total and subscale scores. Secondary outcome measures were changes in PTSD Interview (PTSD-I) and Clinical Global Impressions-Severity of Illness scale (CGI-S) total and subscale scores. Clinical improvement was assessed by CGI-S, CGI-Improvement scale, and Patient Global Impression of Improvement scale, while adverse events were recorded by Drug-Induced Extrapyramidal Symptoms Scale. RESULTS: Treatment with risperidone for either 3 or 6 weeks in an open trial significantly reduced total and subscales scores on the PANSS and on the PTSD-I and CGI-S when compared to baseline scores in patients with psychotic PTSD. CONCLUSION: Our preliminary data from the open trial indicate that risperidone decreased most of the psychotic and PTSD symptoms. Psychotic PTSD patients, unresponsive to antidepressant treatment, improved significantly after treatment for either 3 or 6 weeks with risperidone.

Kozari?-Kovaci? D; Pivac N; Mück-Seler D; Rothbaum BO

2005-07-01

314

[Differences in cerebral blood flow following risperidone treatment in children with autistic disorder].  

UK PubMed Central (United Kingdom)

OBJECTIVE: Functional changes in the brains of autistic children due to risperidone treatment and theirs relationship to the symptom clusters are yet unknown. In this autistic disorder case series we aimed to comparatively evaluate the clinical findings before and after risperidone treatment, and regional cerebral blood flow (rCBF) findings with 99mTc-hexamethylpropyleneamine oxime (HMPAO) brain SPECT. METHOD: Eleven autistic patients (age range: 6-7 years; 4 girls, 7 boys) received risperidone therapy (1.5-2.5 mg d(-1)) and were followed-up for 3 months. All the patients underwent neurologic examinations, psychometric examinations, and SPECT imaging, both at the start of risperidone treatment and 3 months after the treatment started. Clinical observations, and the observations of parents and teachers were recorded. These results were compared with cerebral perfusion indices obtained from SPECT data. RESULTS: After 3 months of treatment changes in rCBF were observed in various regions and to varying degrees. We observed relationships between clinical symptoms and pre-therapy rCBF findings, and between clinical improvement and rCBF changes. CONCLUSION: Findings in the present case series are the first to demonstrate a relationship between clinical improvement and regional perfusion patterns after risperidone treatment. We think that these findings may contribute to the understanding of the neurofunctional mechanisms and hypothetical models of autism.

Ozdemir DF; Karabacak NI; Akka? B; Akdemir O; Unal F; Senol S

2009-01-01

315

Quality of life and adverse effects of olanzapine versus risperidone therapy in patients with schizophrenia.  

UK PubMed Central (United Kingdom)

This cross-sectional study aimed to compare the effects of treatment with an atypical antipsychotic drug (olanzapine or risperidone) on quality of life (QoL) and to document adverse effects in 115 patients diagnosed with schizophrenia who attended the ambulatory service of Hospital Dr. João Machado, Natal, Rio Grande do Norte, Brazil. Socioeconomic, sociodemographic, and clinical variables were compared. The QoL Scale validated for Brazil (QLS-BR) was used to evaluate QoL, and adverse effects were assessed using the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale. Data were analyzed using the ?(2) test and Student's t test, with a significance level of 5 %. Patients in both drug groups showed severe impairment in the occupational domain of the QLS-BR. Global QLS-BR scores indicated impairment among risperidone users and severe impairment among olanzapine users. The most significant side effects were associated with risperidone, including asthenia/lassitude/fatigue, somnolence/sedation, paresthesia, change in visual accommodation, increased salivation, diarrhea, orthostatic posture, palpitations/tachycardia, erythema, photosensitivity, weight loss, galactorrhea, decreased sexual desire, erectile/orgasmic dysfunction, vaginal dryness, headache, and physical dependence. QoL was impaired in patients using olanzapine and in those using risperidone. Risperidone use was associated with psychic, neurological, and autonomous adverse effects and other side effects.

Chaves KM; Serrano-Blanco A; Ribeiro SB; Soares LA; Guerra GC; do Socorro Costa Feitosa Alves M; de Araújo Júnior RF; de Paula Soares Rachetti V; Filgueira Júnior A; de Araújo AA

2013-03-01

316

Serum concentrations and side effects in psychiatric patients during risperidone therapy  

DEFF Research Database (Denmark)

Steady state serum concentrations of risperidone and 9-hydroxyrisperidone (9-OH-risperidone), the active moiety, were measured in 42 patients. The concentration-to-dose ratios (C/D) varied by a factor of 20, from 1.8 to 36.8 (nmol/l)/(mg/24 hours), and 90% of the active moiety was constituted of 9-OH-risperidone. No correlation between the serum concentration of the active moiety and the side effects evaluated by the UKU Side Effect Scale was found. The absence of CYP2D6 (poor metabolizers) or the coadministration of drugs other than benzodiazepines increased the ratio between parent compound and metabolite but did not significantly influence the C/D of the total active moiety. A therapeutic range for serum risperidone has not been established, but 6 mg/day is considered the optimum dose for most patients. The authors found that in 90% of 22 patients administered 6 mg/day risperidone, the serum levels were within 50 to 150 nmol/l.

Olesen, O V; Licht, R W

1998-01-01

317

Quality of life and adverse effects of olanzapine versus risperidone therapy in patients with schizophrenia.  

Science.gov (United States)

This cross-sectional study aimed to compare the effects of treatment with an atypical antipsychotic drug (olanzapine or risperidone) on quality of life (QoL) and to document adverse effects in 115 patients diagnosed with schizophrenia who attended the ambulatory service of Hospital Dr. João Machado, Natal, Rio Grande do Norte, Brazil. Socioeconomic, sociodemographic, and clinical variables were compared. The QoL Scale validated for Brazil (QLS-BR) was used to evaluate QoL, and adverse effects were assessed using the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale. Data were analyzed using the ?(2) test and Student's t test, with a significance level of 5 %. Patients in both drug groups showed severe impairment in the occupational domain of the QLS-BR. Global QLS-BR scores indicated impairment among risperidone users and severe impairment among olanzapine users. The most significant side effects were associated with risperidone, including asthenia/lassitude/fatigue, somnolence/sedation, paresthesia, change in visual accommodation, increased salivation, diarrhea, orthostatic posture, palpitations/tachycardia, erythema, photosensitivity, weight loss, galactorrhea, decreased sexual desire, erectile/orgasmic dysfunction, vaginal dryness, headache, and physical dependence. QoL was impaired in patients using olanzapine and in those using risperidone. Risperidone use was associated with psychic, neurological, and autonomous adverse effects and other side effects. PMID:22806578

Chaves, Katarina Melo; Serrano-Blanco, Antoni; Ribeiro, Susana Barbosa; Soares, Luiz Alberto Lira; Guerra, Gerlane Coelho Bernardo; do Socorro Costa Feitosa Alves, Maria; de Araújo Júnior, Raimundo Fernandes; de Paula Soares Rachetti, Vanessa; Filgueira Júnior, Antônio; de Araújo, Aurigena Antunes

2013-03-01

318

Low-dose risperidone as adjunctive therapy for irritable aggression in posttraumatic stress disorder.  

UK PubMed Central (United Kingdom)

Increased aggressive behavior can occur in association with posttraumatic stress disorder (PTSD). This study tested the hypothesis that low-dose risperidone reduces aggression and other PTSD-related symptoms in combat veterans. Subjects were male combat veterans with PTSD who scored 20 or higher on cluster D (hyperarousal) of the Patient Checklist for PTSD-Military Version (PCL-M). Subjects were randomly assigned to either risperidone or placebo treatment groups. Drugs were administered over a 6-week treatment period in a double-blind manner. Subjects received either risperidone (0.5 mg/day; n = 7) or matched placebo (n = 8) tablets during the first 2 weeks of the treatment period. The dose of risperidone could then be increased up to 2.0 mg/day on the basis of response. Prerandomization psychotropic regimens were continued. Subjects were evaluated with the PCL-M and the Overt Aggression Scale-Modified for Outpatients (OAS-M). In comparison with placebo treatment, reductions in scores between baseline and the last week of treatment were significantly greater for OAS-M irritability and PCL-M cluster B (intrusive thoughts) subscales and on the PCL-M total scale. These results suggest that low-dose risperidone administration reduces irritability and intrusive thoughts in combat-related PTSD.

Monnelly EP; Ciraulo DA; Knapp C; Keane T

2003-04-01

319

A case of neuroleptic malignant syndrome induced by risperidone in a schizophrenic woman.  

UK PubMed Central (United Kingdom)

OBJECTIVE: We report a case of neuroleptic malignant syndrome in a woman who assumed risperidone for schizoaffective disorders. CASE SUMMARY: A 45-year-old woman affected by schizoaffective disorders was admitted to Infectious Disease unit of Crotone Hospital because of a diagnosis of a fever of unknown origin. Clinical evaluation documented confusion and dysphoria, whereas chemical blood evaluation revealed acidosis and liver dysfunction. After few days she was transferred to the Operative Unit of Internal Medicine of San Giovanni in Fiore Hospital because of an increase in liver transaminases. Clinical evaluation showed the persistence of fever (38.8 degrees Celsius), with an increase in CPK, and liver enzymes. Pharmacological evaluation indicated a probable relationship between risperidone and NMS and led to a diagnosis of neuroleptic malignant syndrome associated with risperidone in a woman with schizophrenia. About seven days later, we recorded a complete resolution of her psychiatric symptoms. DISCUSSION: We postulate a possible interaction between risperidone and neuroleptic malignant syndrome and we suggest to use risperidone with caution in both young and middle aged people.

Gallelli L; Spagnuolo V; Palleria C; De Sarro G; Ferraro M

2009-05-01

320

[Injection lipolysis].  

Science.gov (United States)

A new treatment variation in the spectrum of aesthetic medicine has been investigated worldwide since 2004: so-called injection lipolysis. Advances in knowledge regarding the efficacy and mechanism of action have been achieved especially in Germany because most users are found in Germany when compared on an international level. The reason for this is that the combination of phosphatidylcholine and deoxycholic acid as active substances has been approved for i.v. treatment of fat embolisms. It is thus readily available, but the subcutaneous injection of the drug Lipostabil N® is considered as off-label use. Meanwhile injection lipolysis has become an integral component for many in the practice of aesthetic medicine. The international association of physicians performing lipolysis in the so-called NETWORK-Lipolysis (with more than 2,000 members worldwide) has in particular called for the development of internationally recognized treatment standards and protocols. When the indication for its use adheres to strict criteria and the physicians applying the method have participated in intensive training, subcutaneous injection of phosphatidylcholine/deoxycholic acid represents a meaningful addition to the scope of minimally invasive aesthetic medicine. PMID:20878380

Hoffmann, K

2010-10-01

 
 
 
 
321

[Injection lipolysis].  

UK PubMed Central (United Kingdom)

A new treatment variation in the spectrum of aesthetic medicine has been investigated worldwide since 2004: so-called injection lipolysis. Advances in knowledge regarding the efficacy and mechanism of action have been achieved especially in Germany because most users are found in Germany when compared on an international level. The reason for this is that the combination of phosphatidylcholine and deoxycholic acid as active substances has been approved for i.v. treatment of fat embolisms. It is thus readily available, but the subcutaneous injection of the drug Lipostabil N® is considered as off-label use. Meanwhile injection lipolysis has become an integral component for many in the practice of aesthetic medicine. The international association of physicians performing lipolysis in the so-called NETWORK-Lipolysis (with more than 2,000 members worldwide) has in particular called for the development of internationally recognized treatment standards and protocols. When the indication for its use adheres to strict criteria and the physicians applying the method have participated in intensive training, subcutaneous injection of phosphatidylcholine/deoxycholic acid represents a meaningful addition to the scope of minimally invasive aesthetic medicine.

Hoffmann K

2010-10-01

322

Dose-dependent effect of risperidone treatment in a case of 22q13.3 deletion syndrome.  

UK PubMed Central (United Kingdom)

We describe a 18-year-old female with 22q13.3 deletion syndrome characterized by an alteration of SHANK3/PROSAP2 and severe mental retardation, intense psychomotor agitation and aggressive behaviour. When the patient was given risperidone, different therapeutic results were observed: at a 6 mg dose, risperidone had no therapeutic effect and the patient's behavioural problems increased; at a low dose (1mg), risperidone treatment resulted in rapid improvement of mood and behaviour. Recent findings suggest that risperidone exerts dose-dependent effects on Glu receptors in developing rats. An altered preset of the glutamate receptors, due to the presence of a haploinsufficiency of SHANK3/PROSAP2, could explain the different results of risperidone therapy observed in our patient with 22q13.3 deletion syndrome.

Pasini A; D'Agati E; Casarelli L; Curatolo P

2010-05-01

323

Dose-dependent effect of risperidone treatment in a case of 22q13.3 deletion syndrome.  

Science.gov (United States)

We describe a 18-year-old female with 22q13.3 deletion syndrome characterized by an alteration of SHANK3/PROSAP2 and severe mental retardation, intense psychomotor agitation and aggressive behaviour. When the patient was given risperidone, different therapeutic results were observed: at a 6 mg dose, risperidone had no therapeutic effect and the patient's behavioural problems increased; at a low dose (1mg), risperidone treatment resulted in rapid improvement of mood and behaviour. Recent findings suggest that risperidone exerts dose-dependent effects on Glu receptors in developing rats. An altered preset of the glutamate receptors, due to the presence of a haploinsufficiency of SHANK3/PROSAP2, could explain the different results of risperidone therapy observed in our patient with 22q13.3 deletion syndrome. PMID:19428206

Pasini, Augusto; D'Agati, Elisa; Casarelli, Livia; Curatolo, Paolo

2009-05-09

324

CYP2D6 poor metabolizer status might be associated with better response to risperidone treatment.  

UK PubMed Central (United Kingdom)

The variability in the antipsychotic response is, to some extent, genetically determined. Several studies have attempted to establish a role for genetic variation in genes coding pharmacokinetic and pharmacodynamic targets, but to date, no definite genetic predictive marker has been identified. We aimed to explore the putative role of 19 genetic variants and risperidone clinical improvement in 76 White schizophrenic inpatients, measured as change in Positive and Negative Syndrome Scale (PANSS). CYP2D6 poor metabolism was significantly associated with greater clinical improvement in total PANSS and a trend was also found for MDR1 3435C>T to higher total PANSS scores in 3435T carriers. This study suggests the importance that genetic variability on pharmacokinetic factors may have in risperidone response and gives evidence for the need for further investigation in order to establish the actual predictive value and clinical utility that CYP2D6 genotyping might have in risperidone therapy management.

Almoguera B; Riveiro-Alvarez R; Lopez-Castroman J; Dorado P; Vaquero-Lorenzo C; Fernandez-Piqueras J; Llerena A; Abad-Santos F; Baca-García E; Dal-Ré R; Ayuso C

2013-09-01

325

Hyperprolactinemia associated with risperidone: a case report and review of literature.  

UK PubMed Central (United Kingdom)

This case report describes a 19-year-old Caucasian woman who presented to a state psychiatric facility with symptoms of depression and auditory hallucinations. She was diagnosed with schizoaffective disorder, depressed type, and was treated with risperidone and sertraline. Soon after initiation of drug therapy, the patient developed galactorrhea and dysmenorrhea, and her prolactin level was 171.6ng/mL (normal level 2.8-29.2ng/mL in adult women). Upon discontinuation of risperidone, the prolactin level dropped to 17.2ng/mL within one week. The patient was treated with quetiapine and titrated up to 800mg daily. Repeated prolactin levels continued to be normal during treatment with quetiapine. This case report and others from literature suggest that risperidone is associated with hyperprolactinemia, and that quetiapine is less likely to be associated with hyperprolactinemia.

Aboraya A; Fullen JE; Ponieman BL; Makela EH; Latocha M

2004-11-01

326

Hyperprolactinemia associated with risperidone: a case report and review of literature.  

Science.gov (United States)

This case report describes a 19-year-old Caucasian woman who presented to a state psychiatric facility with symptoms of depression and auditory hallucinations. She was diagnosed with schizoaffective disorder, depressed type, and was treated with risperidone and sertraline. Soon after initiation of drug therapy, the patient developed galactorrhea and dysmenorrhea, and her prolactin level was 171.6ng/mL (normal level 2.8-29.2ng/mL in adult women). Upon discontinuation of risperidone, the prolactin level dropped to 17.2ng/mL within one week. The patient was treated with quetiapine and titrated up to 800mg daily. Repeated prolactin levels continued to be normal during treatment with quetiapine. This case report and others from literature suggest that risperidone is associated with hyperprolactinemia, and that quetiapine is less likely to be associated with hyperprolactinemia. PMID:21191524

Aboraya, Ahmed; Fullen, Jennifer E; Ponieman, Barbara L; Makela, Eugene H; Latocha, Melissa

2004-11-01

327

A comparative study of the efficacy of intralesional verapamil versus normal saline injection in a novel Peyronie disease animal model: assessment of immunohistopathological changes and erectile function outcome.  

UK PubMed Central (United Kingdom)

PURPOSE: While intralesional injections improve penile curvature and decrease plaque volume, the exact mechanism of action on Peyronie disease is unknown. We evaluated penile curvature, immunohistology and erectile function outcomes after intralesional injections of verapamil and normal saline in a previously described Peyronie disease animal model. MATERIALS AND METHODS: Peyronie plaque was induced in 12 adult male rats using an established Peyronie disease animal model. At 4 weeks the rats were divided into group 1-5 with 0.1 mg/0.1 ml intralesional verapamil injected every second day for 2 weeks, group 2-5 with 0.1 ml intralesional normal saline injection and group 3-2 that served as controls. At weeks 6 and 8 penile pressure was measured and serial immunohistochemical staining of penile tissue sections was done. RESULTS: Intralesional injection of verapamil and normal saline resulted in macroscopic and microscopic changes to penile curvature and Peyronie plaque size. Decreased collagen and elastin fibers were measured with a significant reduction in smooth muscle ?-actin (p <0.05). Changes were greater in group 1 than group 2 (p <0.05). Intralesional verapamil injection was associated with greater recovery of electrostimulated penile pressure, a surrogate of erectile function, than in the saline and control groups. CONCLUSIONS: To our knowledge this novel study offers for the first time histological evidence of cellular changes and improvement in penile pressure studies in rats with Peyronie plaque after intralesional verapamil injection therapy in a Peyronie disease animal model.

Chung E; Garcia F; Young LD; Solomon M; Brock GB

2013-01-01

328

Risperidone, QTc interval prolongation, and torsade de pointes: a systematic review of case reports.  

UK PubMed Central (United Kingdom)

RATIONALE: A recent publication asserted that even low-dose risperidone may induce corrected QT (QTc) interval prolongation up to 500 ms without drug-induced IKr blockade. We seek to better understand the complexity of any link between risperidone-induced/associated QTc interval prolongation and torsade de pointes (TdP). OBJECTIVES: The objective of this study is to systematically analyze all available case reports of risperidone, QTc interval prolongation, and/or TdP. METHOD: We identify case reports using PubMed, Medline, EMBASE, and Cochrane. RESULTS: Of the 15 cases found, nine were adult women (ages 31, 33, 34, 37, 47, "elderly", 77, 84, and 87 years) and one was a teenager. There were four men (ages 28, 29, 29, and 46 years) and one preadolescent boy. Besides risperidone administration or overdose, traditional risk factors for QTc interval prolongation and TdP included female sex (n?=?10), older age (n?=?4), heart disease (n?=?3), hypokalemia (n?=?2), bradycardia (n?=?1), liver disease (n?=?1), QTc interval prolonging drugs other than risperidone (n?=?8), and metabolic inhibitors (n?=?2). TdP occurred in four cases. Six patients died, and three deaths were probably related to TdP. CONCLUSION: Risperidone (when properly prescribed in patients free of other risk factors for QTc interval prolongation and TdP) is a relatively safe drug. Conventional statistics can neither predict the individual patient who will experience TdP nor determine the relationship of drug dose to QTc interval prolongation and TdP. Narrative medicine using a case report format appears to be an alternative and valuable additional approach to advance our understanding of this relationship and to reduce risks.

Vieweg WV; Hasnain M; Hancox JC; Baranchuk A; Digby GC; Kogut C; Crouse EL; Koneru JN; Deshmukh A; Pandurangi AK

2013-08-01

329

Iron deficiency in pediatric patients in long-term risperidone treatment.  

UK PubMed Central (United Kingdom)

OBJECTIVE: Atypical antipsychotics, increasingly used in children and adolescents, modulate brain dopamine. Iron plays a critical role in dopaminergic signaling. Therefore, we explored whether body iron status is related to psychiatric symptom severity, treatment response, and tolerability following extended antipsychotic therapy. METHODS: Between November 2005 and August 2009, medically healthy 7-17-year-old risperidone-treated participants enrolled in a cross-sectional study examining the long-term safety of this antipsychotic. Anthropometric measurements were obtained. Psychiatric symptom severity and dietary intake were assessed. Serum ferritin, transferrin receptor, and prolactin concentrations were measured. Linear multivariable regression analysis tested the association among body iron, symptom severity, the dose of risperidone and psychostimulants, and serum prolactin concentration. RESULTS: The sample consisted of 115 patients (87% males) with a mean (±SD) age of 11.6 (±2.8) years. The majority had externalizing disorders, and they had taken risperidone for 2.4 (±1.7) years. Body iron was low, with 45% having iron depletion and 14% having iron deficiency. Iron status was inversely associated with weight gain during risperidone treatment and with interleukin-6. Body iron was neither associated with psychiatric symptom severity nor with the daily dose of risperidone and psychostimulants. It was, however, inversely associated with prolactin concentration, which was nearly 50% higher in the iron-deficient group. CONCLUSIONS: Iron depletion and deficiency are prevalent in children and adolescents chronically treated with risperidone. Iron deficiency accentuates the antipsychotic-induced elevation in prolactin. Future studies should confirm this finding and investigate the potential benefit of iron supplementation in antipsychotic-treated patients.

Calarge CA; Ziegler EE

2013-03-01

330

Correlates of weight gain during long-term risperidone treatment in children and adolescents  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background Most clinical trials of antipsychotics in children are brief, failing to address their long-term safety, particularly when taken concurrently with other psychotropics. This hypothesis-generating analysis evaluates potential correlates of weight gain in children receiving extended risperidone treatment. Methods Medically healthy 7–17?year-old patients treated with risperidone for six months or more were enrolled. Anthropometric measurements were conducted. Developmental and medication history was obtained from the medical record. Information related to birth weight, dietary intake, physical activity, and parental weight was collected. Mixed regression analyses explored the contribution of various demographic and clinical factors to age- and sex-adjusted weight and body mass index (BMI) z scores over the treatment period. Results The sample consisted of 110 patients (89% males) with a mean age of 11.8?years (sd?=?2.9) upon enrollment. The majority had an externalizing disorder and received 0.03?mg/kg/day (sd?=?0.02) of risperidone, for 2.5?years (sd?=?1.7), to primarily target irritability and aggression (81%). Polypharmacy was common with 71% receiving psychostimulants, 50% selective serotonin reuptake inhibitors (SSRIs), and 32% ?2-agonists. Weight and BMI z score were positively correlated with baseline weight at the start of risperidone, treatment duration, and the weight-adjusted dose of risperidone but inversely associated with the weight-adjusted dose of psychostimulants and the concurrent use of SSRIs and ?2-agonists. The effect of risperidone dose appeared to attenuate as treatment extended while that of psychostimulants became more significant. The rate of change in weight (or BMI) z score prior to and within the first 12?weeks of risperidone treatment did not independently predict future changes neither did birth weight, postnatal growth, dietary intake, physical activity, or parental weight. Conclusions This comprehensive analysis exploring correlates of long-term weight (or BMI) change in risperidone-treated youths revealed that pharmacotherapy exerts significant but complex effects. Trial Registration Not applicable.

Calarge Chadi; Nicol Ginger; Xie Diqiong; Zimmerman Bridget

2012-01-01

331

First generation antipsychotics switch with Risperidone in the treatment of chronic schizophrenic patients.  

UK PubMed Central (United Kingdom)

BACKGROUND: Schizophrenia is a severe chronic psychiatric disorder for which treatment compliance is important in the prevention of relapse. Second generation antipsychotics (SGA), such as Risperidone, have been found to be more effective in the treatment of such patients than the high potency first generation antipsychotics (FGA). This is an open study where the same group of patients was first treated with FGA and then were switched to Risperidone, in controlled hospital conditions, after a wash- out period. The aim of the study was to examine whether patients with schizophrenia who were judged to be stable on long-term treatment with FGA would further benefit from a switch to an atypical antipsychotic drug. SUBJECTS AND METHODS: Eighty hospitalized patients suffering from Schizophrenia or Schizoaffective disorder (male 54, female 26) were first treated with Haloperidol (N=60) or Fluphenazine (N=20), and then were switched to Risperidone. Their clinical state was monitored using the PANSS scale for Schizophrenia, measuring the Total PANSS score. The KLAWANS scale for assessment of extrapyramidal syndrome (EPS) was also used. Administration and dosage of Trihexiphenidil (THF) was recorded. The study lasted for 8 weeks, with 4 screenings (Visit 0-baseline- FGA, Visits 1-3 Risperidone on Day 14, 28 and 56, respectively). RESULTS: The average age was 38. Patients usually suffered the paranoid form of Schizophrenia (55%). The duration of illness was more than 5 years (38.8%). During the eight- week trial on Risperidone, using the PANSS total scores, we observed clinical improvement where the therapy switch had caused an initial worsening (p<0.05). Also, the compared baseline (FGA) and last visit showed a low, but statistically significant benefit in favor of Risperidone (t=5.45, df=79, p<0.005). Intensity of EPS measured by KLAWANS scores significantly decreased during time (F=4.115; p=0.016; Partial Eta Square=0.058). Average Trihexiphenidil doses followed Risperidone in a dose dependent manner (r=0.748, r=0.661, respectively, p<0.01) with the consequent decrease of patients needing THF corrective therapy (68.8% at the baseline toward 22.5% on last visit). CONCLUSION: Switch to Risperidone medication provided significant additional improvement in symptom severity, extrapyramidal side effects and need for anticholinergic medication. This suggests that one might expect better compliance in future treatment in this population of chronic schizophrenic patients.

Popovi? I; Ravani? D; Popovi? V; Vladeji? S; Stanojevi? A; Stojanovi? M

2011-12-01

332

Anesthetic efficacy of X-tip intraosseous injection using 2% lidocaine with 1:80,000 epinephrine in patients with irreversible pulpitis after inferior alveolar nerve block: A clinical study.  

UK PubMed Central (United Kingdom)

INTRODUCTION: The inferior alveolar nerve block (IAN) is the most frequently used mandibular injection technique for achieving local anesthesia in endodontics. Supplemental injections are essential to overcome failure of IAN block in patients with irreversible pulpitis. AIM: To evaluate the anesthetic efficacy of X-tip intraosseous injection (2% lidocaine with 1:80,000 epinephrine) in patients with irreversible pulpitis in mandibular posterior teeth when conventional IAN block failed. MATERIALS AND METHODS: Thirty emergency patients diagnosed with irreversible pulpitis in a mandibular posterior tooth received an IAN block and experienced moderate to severe pain on endodontic access or initial instrumentation. The X-tip system was used to administer 1.8 ml of 2% lidocaine with 1:80,000 epinephrine. The success of X-tip intraosseous injection was defined as none or mild pain (Heft-Parker visual analogue scale ratings < 54 mm) on endodontic access or initial instrumentation. RESULTS: Ninety-three percent of X-tip injections were successful and 7% were unsuccessful. Discomfort rating for X-tip perforation: 96.66% patients reported none or mild pain, whereas 3.34% reported moderate to severe pain. For discomfort rating during solution deposition, 74.99% patients reported none or mild pain and 24.92% reported moderate to severe pain. Ninety-six percent of the patients had subjective/objective increase in heart rate. CONCLUSIONS: Supplemental X-tip intraosseous injection using 2% lignocaine with 1:80,000 epinephrine has a statistically significant influence in achieving pulpal anesthesia in patients with irreversible pulpitis.

Verma PK; Srivastava R; Ramesh KM

2013-03-01

333

A comparison of the oral application and injection routes using the Onderstepoort Biological Products Fowl Typhoid vaccine, its safety, efficacy and duration of protection in commercial laying hens : article  

Directory of Open Access Journals (Sweden)

Full Text Available This study was undertaken to establish whether the Onderstepoort Biological Products Fowl Typhoid (OBPft) vaccine registered as an injectable vaccine was effective and safe when administered orally to commercial layers. Its efficacy and duration of protection were compared with application by intramuscular injection. Commercial brown layer hens were used as they were found to be highly susceptible to Salmonella gallinarum infections. In the vaccine safety trial birds were euthanased at timed intervals spanning 4 weeks post-vaccination. Necropsies were performed and samples were taken and tested. No clinical signs or mortalities could be attributed to the OBPft vaccine nor could active shedding of the vaccine strain be detected. Slight pathological changes were noted with both routes of vaccination; however, these changes were transient, returning to normal within the observation period. The injected groups showed a better serological response with the rapid serum plate agglutination (RSPA) test than the orally vaccinated groups. In the duration of protection trial, birds were challenged at 3-8-week intervals post-vaccination. All unvaccinated birds died. Protection 8 and 16 weeks after vaccination was above 60 %, by 24 weeks after challenge, the vaccine protection was below 30 %. It was found that there was no significant difference (P < 0.05) in the protection offered by either the oral or injected route of vaccination with the OBPft vaccine.

C. Purchase; J. Picard; R. McDonald; S.P.R. Bisschop

2012-01-01

334

Butorphanol Injection  

Science.gov (United States)

Butorphanol injection is used to relieve moderate to severe pain. Butorphanol injection is also used to relieve pain during labor ... Butorphanol injection comes as a liquid to be injected into a muscle or vein. When butorphanol injection is used ...

335

Immunohistochemical evidence suggests repeated intravesical application of botulinum toxin A injections may improve treatment efficacy of interstitial cystitis/bladder pain syndrome.  

UK PubMed Central (United Kingdom)

UNLABELLED: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: A single set of botulinum toxin A (BoNT-A) injections relieves clinical symptoms of interstitial cystitis/bladder pain syndrome (IC/BPS), but lacks long-term effect. An inadequate anti-inflammatory effect is likely to cause treatment failure. The study shows that chronic inflammation and apoptotic signalling molecules are significantly reduced after repeated intravesical BoNT-A injection in patients with IC/BPS. It also shows that repeated BoNT-A injections are necessary to achieve greater success in the treatment of IC/BPS. OBJECTIVE: To investigate the mechanisms of action of botulinum toxin A (BoNT-A) treatment on interstitial cystitis/bladder pain syndrome (IC/BPS). PATIENTS AND METHODS: A total of 23 women with IC/BPS who received single intravesical BoNT-A injection were studied. Among them, 11 received three repeated injections every 6 months to improve their symptoms. Bladder biopsy was obtained before each BoNT-A injection and the clinical symptoms and urodynamic variables were recorded. Immunohistochemical (IHC) staining for TUNEL and mast cell activity, and western blotting analysis of tryptase, cytokines, Bax and phospho-p38 (p-p38) were carried out. We compared the clinical results and IHC data among baseline, single or repeated BoNT-A treatments. RESULTS: Single BoNT-A injection improved clinical symptoms, pain score and daytime urinary frequency. Mast cell activity and apoptotic cell count did not decrease significantly, while Bax and p-p38, but not tryptase, decreased significantly after a single BoNT-A injection. The 11 patients who received three repeated BoNT-A injections had significantly lower pain scores than the remaining patients (mean [SD]: 5.80 [2.27] vs. 3.03 [2.30], P = 0), glomerulation degree (mean [SD]: 1.80 [1.06] vs. 1.20 [1.06], P = 0.026) and global response scores (mean [SD]: 0.30 [0.92] vs. 1.20 [1.06], P = 0) after treatment. Tryptase, Bax, p-p38 and apoptotic cell counts all decreased significantly. 25-kD synaptosomal-associated protein also decreased after BoNT-A treatments, which confirmed the therapeutic effect of repeated BoNT-A injections. CONCLUSIONS: Chronic inflammation and apoptotic signalling molecules were significantly reduced after repeated BoNT-A injections in patients with IC/BPS. The IHC improvement was associated with clinical symptom improvement. Repeated BoNT-A injections are necessary to achieve a greater success rate in the treatment of IC/BPS.

Shie JH; Liu HT; Wang YS; Kuo HC

2013-04-01

336

Evaluations of therapeutic efficacy of intravitreal injected polylactic-glycolic acid microspheres loaded with triamcinolone acetonide on a rabbit model of uveitis.  

UK PubMed Central (United Kingdom)

Conventional treatments of uveitis are not ideal because of the short period of therapeutic efficacy. In the present study, biodegradable polylactic-glycolic acid microspheres loaded with triamcinolone acetonide (TA) were prepared to achieve sustained drug release and their therapeutic efficacy was investigated on a rabbit model of uveitis. TA-loaded microspheres (TA-MS) were prepared by the solvent evaporation method and characterized for encapsulation efficiency, particle size, morphology and in vitro release. The therapeutic efficacy was studied on the rabbit experimental uveitis model based on scoring of the inflammation, aqueous leukocyte counting, aqueous protein determination and histological examination. The TA-MS exhibited smooth and intact surfaces with an average diameter of 50.87 ?m. The drug-loading coefficient and encapsulation efficiency were 15.2 ± 0.6 % and 91.24 ± 3.77 %, respectively. The drug release from TA-MS lasted up to 87 days, but only 46 days for TA suspension. The change in surface morphology also showed sustained drug