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| |  Asenapine as Effective as Olanzapine for Long-Term Treatment of Patients With Bipolar Disorder: Presented at EPA By Jenny Powers MUNICH, Germany -- March 3, 2010 -- Asenapine remained effective throughout 52 weeks of exposure in patients with mania associated bipolar I disorder, according to study results presented here on March 1 at the European Psychiatric Association (EPA) 18th European Congress of Psychiatry. The efficacy and tolerability of asenapine was comparable to olanzapine. Roger S. McIntyre, MD, University of Toronto, Toronto, Ontario, headed an international research team in conducting a long-term efficacy assessment of asenapine and olanzapine. The primary objective of the study was to characterise the long-term efficacy, safety, and tolerability of asenapine and olanzapine (as an active control) in the treatment of acute mania in patients with manic or mixed episodes associated with bipolar I disorder. Patients (n = 218) were enrolled in a 40-week extension trial that maintained previous treatment regimens, except for 32 patients (n = 13 completed) who had received placebo in the efficacy trial who were switched to asenapine BID on day 1 and flexible dosing at 5 or 10 mg BID thereafter, blind unbroken and assessed for safety only. Before the 9-week extension, patients had completed either of the 3-week efficacy trials wherein 19 patients received sublingual asenapine BID on day 1 and flexible dosing at 5 or 10 mg BID thereafter and 107 patients received oral olanzapine 15 mg QD on day 1 and flexible dosing at 5-20 mg QD thereafter. The efficacy endpoint was the change in Young Mania Rating Scale (YMRS) total score from 3-week trial baseline to week 52. At week 52, the mean +- standard deviation (SD) changes in YMRS score population were -28.6 +- 8.1 for asenapine (n = 45) and -28.2 +- 6.8 for olanzapine (n = 76), and both the YMRS response and remission rates were 97.8% and 98.4% for asenapine and olanzapine, respectively. The mean +- SD changes in Montgomery-Asberg Depression Rating Scale scores were -4.8 +- 5.8 for asenapine versus -4.4 +- 5.4 for olanzapine. The overall incidence of treatment-emergent adverse events was 71.9% with placebo/asenapine, 86.1% with asenapine, and 79.4% with olanzapine. The efficacy of flexible-dose asenapine was comparable with that of olanzapine during the 52 weeks of treatment in patients with mania-associated bipolar I disorder. Asenapine was well tolerated over the long-term course of treatment. Funding for this study was provided by Schering-Plough (now Merck and Co, Inc.) and Pfizer, Inc. [Presentation title: Long-Term Asenapine Treatment for Bipolar Disorder: A Double-Blind 40-Week Extension Study. Abstract P01-69]
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