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For evaluation of response rate for the comparisons between placebo and olanzapine buy promethazine in united states online allergy cold, immediate-release quetiapine promethazine 25 mg allergy testing des moines, risperidone generic 25 mg promethazine otc allergy drops austin, and ziprasidone, respectively, we included meta-analysis results from 2 382, 383 systematic reviews. The date of publication for the published trial was subsequent to our second search and, consequently, will not be considered for inclusion until the next update of this review. The manufacturer provided trial synopses for both trials, but their detail was insufficient for assessment of internal validity due to a lack of information about important prognostic factors at baseline. For evaluation of maintenance treatment of manic or mixed episodes, we included 386 387 388 placebo-controlled trials of asenapine, aripiprazole, olanzapine, immediate-release 389-391 392 quetiapine, and long-acting risperidone injection. In placebo-controlled trials, immediate-release quetiapine was the only atypical antipsychotic that has been evaluated both as 389 390, 391 monotherapy and in combination with lithium and divalproex for maintenance treatment. Trials of aripiprazole and olanzapine involved their use as monotherapy only. Trials of asenapine and long-acting risperidone injection involved their use as adjunctive therapies. Asenapine was 386 used in combination with lithium or divalproex and long-acting risperidone injection was used 392 in combination with any number of antidepressants, mood stabilizers, or anxiolytics. Duration 387 of maintenance treatment ranged from 26 weeks for aripiprazole to 104 weeks for immediate- 389, 391 release quetiapine. Gender distribution varied across the trials, with proportion of females ranging from 28% in the trial of long-acting 392 387 risperidone injection to 67% in the trial of aripiprazole. Episode type also varied across the trials, with proportion of patients with an index manic episode ranging from 24% in a trial of 390 387 immediate-release quetiapine to 70% in the trial of aripiprazole. Trials of immediate-release 389-391 392 quetiapine and long-acting risperidone injection included 28% to 31% of patients with an index episode of depression whereas the trials of aripiprazole, asenapine, and olanzapine excluded such patients. For evaluation of depressive episodes, we included placebo-controlled trials of 393 394, 395 396-399 aripiprazole, olanzapine, immediate-release quetiapine, and extended-release 400 397 quetiapine. One trial of immediate-release quetiapine was rated good quality. Immediate- release quetiapine was the only atypical antipsychotic for which we found a placebo-controlled 401 trial of maintenance treatment for depressive episodes. More females than males were enrolled in all the trials of bipolar depression (range, 58% to 64%). We found no trial that was prospectively designed exclusively for evaluating an atypical antipsychotic in adults with rapid cycling bipolar disorder (≥ 4 manic or mixed episodes within the past year). The only evidence available came from subgroup analyses of larger placebo- 359 402-404 controlled trials of aripiprazole or olanzapine. Atypical antipsychotic drugs Page 87 of 230 Final Report Update 3 Drug Effectiveness Review Project Finally, for evaluation of immediate control of acute agitation associated with bipolar 405 disorder, we included placebo-controlled trials of intramuscular forms of aripiprazole or 406 olanzapine. Effectiveness Hospitalization Significant differences between atypical antipsychotics were found in 2 retrospective 352, 356 observational studies based on large commercial health plan databases. One retrospective, nonrandomized database study found a lower risk of hospitalization for monotherapy with immediate-release quetiapine 160 mg than for monotherapy with risperidone 1. Estimated hazard ratios for risk of mental health-related hospitalization within a treatment period at least 60 days long were 1. Comparisons between these atypical antipsychotics and ziprasidone 70 mg or conventional antipsychotics were not statistically significant. In contrast, in patients with bipolar disorder (N=6162) who were treated with a mood stabilizer, adjunctive treatment (mean maximal doses) with aripiprazole 12. Persistence Results were mixed across 2 retrospective claims database studies that directly compared 282, 353 persistence outcomes among different atypical antipsychotics. Adherence and persistence outcomes were similar for patients on risperidone, olanzapine, and immediate-release quetiapine based on analyses of claims data for 825 patients with bipolar disorder identified from a 282 Medicaid database during the period of 1999 to 2001 (Evidence Tables 10 and 11). Over a 12- month follow-up period, ratios of total days supplied to total days observed (medication possession ratio) were 0. Average number of days before therapy modification was 194. Compared with risperidone, the adjusted hazard ratios of modifying therapy within the first 250 days was 1. In the other study of medication claims data, number of days on therapy was evaluated 353 for olanzapine, immediate-release quetiapine, risperidone, and ziprasidone. A total of 1516 patients who initiated an atypical antipsychotic during the period of 2003 to 2004 were identified from the Phar Metrics Integrated Database and all were followed for 12 months following the index prescription. Based on adjusted results from both linear regression and propensity score- adjusted bootstrapping, olanzapine (73. Conversely, patients treated with an atypical antipsychotic plus other bipolar medications used Atypical antipsychotic drugs Page 88 of 230 Final Report Update 3 Drug Effectiveness Review Project ziprasidone (118. Quality of life Direct evidence No significant differences were found in quality-of-life outcomes either for the comparison of 349 346 risperidone and olanzapine or for the comparison of asenapine and olanzapine. The trial that compared risperidone and olanzapine was 3 weeks in duration and measured quality of life using the Medical Outcomes Study Short-Form 12-Item Health Survey, SF-12. The comparison of asenapine and olanzapine was based on SF-36 outcome data from a 9-week extension study and only included patients who consented to continue taking study medication after completing an 346 initial 3-week study. Therefore, the results may not be broadly applicable. Indirect evidence For acute treatment of manic and mixed episodes of bipolar disorder, olanzapine had significantly greater improvements than placebo on 5 of 9 subscales of the Lehman Brief Quality-of-Life Interview (QLI) (general, daily activities, living situation, family contact, social 407 relations) when taken in combination with lithium or valproic acid and only on the physical 408 functioning domain of the SF-36 when taken as monotherapy. For acute treatment of bipolar depression, no atypical antipsychotic has been found to consistently demonstrate significant improvements over placebo in quality of life outcomes. Immediate-release quetiapine 300 mg demonstrated a significant improvement over placebo in 398, 409 396, 398, 409 the Q-LES-Q total score in 2 of 3 trials, as did immediate-release quetiapine 600 398 396, 398, 409 mg in 1 of 3 trials. Functional capacity Direct evidence Direct evidence of the comparative effectiveness of atypical antipsychotics for improving functional capacity was not found. Indirect evidence For acute treatment of bipolar depression, immediate-release quetiapine 600 mg demonstrated a 397, significant improvement over placebo in the Sheehan Disability Scale (SDS) total score in 2 409 396, 397, 409 of 3 trials whereas immediate-release quetiapine 300 mg demonstrated a significant 397 396, 397, 409 improvement over placebo in only 1 of 3 trials. Atypical antipsychotic drugs Page 89 of 230 Final Report Update 3 Drug Effectiveness Review Project Efficacy Response and remission Direct evidence In head-to-head trials, no statistically significant differences in response or remission outcomes were found between olanzapine and risperidone or between olanzapine and asenapine. However, data on the comparison of response and remission rates between asenapine and olanzapine came from patients who participated in extension studies. Thus, these results are likely limited to those who experienced symptom improvements during the initial 3-week treatment phase and are 346 therefore not broadly applicable. For asenapine, initially adults with bipolar I disorder experiencing manic or mixed 410, 411 episodes were enrolled in two 3-week trials (Ares 7501004, Ares 7501005). Both included an olanzapine arm, but results were limited to comparisons between each atypical antipsychotic and placebo, respectively. In Ares 7501004 (N=488), the Young Mania Rating Scale (YMRS) response rate and remission rate for asenapine (43% and 35%, respectively) were not significantly different from placebo (34% and 31%, respectively) whereas rates were significantly greater for olanzapine compared with placebo (55%; P=0. In Ares 7501005 (N=489), response and remission rates were significantly greater for both asenapine (42% and 40%; both P<0. Whereas asenapine and olanzapine were not compared with each other in the initial 3- week trials, direct comparison of the 2 atypical antipsychotics were reported based on data from 346, 347 subsets of patients who participated in subsequent extension studies. A total of 504 patients who completed Ares 7501004 and 7501005 (51% of the original 977 randomized) immediately entered an extension study in which their double-blind treatment was continued. Pooled results 346 after 9 weeks have been published and the manufacturer provided unpublished results for the 218 patients who participated in an additional 40-week continuation phase (22% of original 347 group).
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