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| |  Tolerability of Desvenlafaxine in Major Depressive Disorder Is Dose Dependent: Presented at CINP By Bryan DeBusk, PhD MUNICH, Germany -- July 16, 2008 -- A review of multiple desvenlafaxine trials shows the drug is effective for major depressive disorder (MDD) across a range of doses currently in use, but tolerability is dose dependent, according to research presented here at the 26th Collegium Internationale Neuro-Psychopharmacologicum (CINP) Congress. Bruno Pitrosky, PhD, Neuroscience Research Division, Wyeth Research, Paris, France, presented the results in a poster session on July 14. "In the course of reviewing data on this antidepressant emerging over the past 5 years, I was impressed by several aspects of the performance of the drug in these studies," explained lead author Michael Thase, MD, Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, in an interview regarding the findings. The information presented focused on the performance of desvenlafaxine in studies evaluating the safety and efficacy of the drug in 5 double-blind, placebo-controlled trials. Dr. Thase and colleagues pooled data from 5 studies in which 1,973 participants with MDD were randomised to placebo (n = 631) or desvenlafaxine 50, 100, 200, or 400 mg per day (n = 1,342) and were followed for 8 weeks. The investigators evaluated the efficacy of treatment using the 17- and 6-item Hamilton Rating Scales for Depression (HAM-D17 and HAM-D6, respectively) and the Montgomery Asberg Depression Rating Scale (MADRS). Rates of response were defined as Clinical Global Impression-Improvement [CGI-I] score of <=2 or a decrease of >=50% in HAM-D17 or MADRS scores from baseline. Remission was defined as HAM-D17 score of <=7. Efficacy as measured by HAM-D17 was comparable among the different dosages of desvenlafaxine versus placebo (adjusted mean differences: pooled data for all dosages, -2.3; 50 mg, -2.2; 100 mg, -2.4; 200 mg, -2.2; 400 mg, -2.3; P < .001 for all). Rates of response were higher in the pooled data set compared with placebo as measured by HAM-D17 (55% vs 42%, P < .001), MADRS (55% vs 40%, P < .001), and CGI-I (61% vs 46%, P < .001). Higher rates of remission were also observed in patients receiving desvenlafaxine as measured by HAM-D17 (34% vs 25%, P < .001), HAM-D6 (-1.6, P < .001), and MADRS (-3.4, P < .001). When evaluated individually, each dosing regimen also resulted in statistically significant improvements compared with placebo. Despite comparable efficacy among the dosing regimens, discontinuation rates were not comparable. Among patients receiving desvenlafaxine 50 mg per day, 4% discontinued the study due to adverse events, whereas discontinuations due to adverse events occurred in 9% of patients on 100 mg per day, 15% of patients on 200 mg per day, and 18% of patients on 400 mg per day. "Desvenlafaxine succinate is an effective antidepressant across the doses studied, and whereas there is no dose-response relationship for efficacy, there is a clear dose-response relationship for tolerability," Dr. Thase concluded. "That is, lower doses are reliably better tolerated than higher doses." Funding for this study was provided by Wyeth Research. [Presentation title: Efficacy of Desvenlafaxine Compared With Placebo in Patients With Major Depressive Disorder: A Pooled Analysis. Abstract P-04-97]
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