An integrated analysis of the efficacy and safety of desvenlafaxine in the treatment of major depressive disorder

被引:15
|
作者
Carrasco, Jose L. [1 ]
Kornstein, Susan G. [3 ,4 ]
McIntyre, Roger S. [8 ]
Fayyad, Rana [5 ]
Prieto, Rita [2 ]
Salas, Maribel [5 ,6 ,7 ]
Mackell, Joan [5 ]
Boucher, Matthieu [9 ]
机构
[1] Univ Complutense Madrid, CIBERSAM, Madrid, Spain
[2] SLU, Pfizer GEP, Madrid 28223, Spain
[3] Virginia Commonwealth Univ, Dept Psychiat, Richmond, VA USA
[4] Virginia Commonwealth Univ, Inst Womens Hlth, Richmond, VA USA
[5] Pfizer Inc, New York, NY USA
[6] Univ Penn, Ctr Clin Epidemiol & Biostat, Philadelphia, PA 19104 USA
[7] Univ Penn, Ctr Pharmacoepidemiol Res & Training, Philadelphia, PA 19104 USA
[8] Univ Toronto, Toronto, ON, Canada
[9] Pfizer Canada Inc, Kirkland, PQ, Canada
关键词
clinical trials; depressive disorder; desvenlafaxine; efficacy; major; outpatients; randomized; safety; RANDOMIZED CONTROLLED-TRIALS; CANMAT CLINICAL GUIDELINES; PLACEBO-CONTROLLED TRIAL; STAR-ASTERISK-D; DOUBLE-BLIND; 50; MG/DAY; FUNCTIONAL IMPROVEMENT; POSTMENOPAUSAL WOMEN; EXTERNAL VALIDITY; WORK PRODUCTIVITY;
D O I
10.1097/YIC.0000000000000121
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The chronic course of major depressive disorder (MDD) often impedes the ability of patients to achieve full remission. Return of full functioning is a critical goal of antidepressant pharmacotherapy as the presence of residual depressive symptoms is associated with an increased risk of relapse. Treatment guidelines recommend selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, or atypical antidepressants as first-line treatment for moderate to severe MDD. Desvenlafaxine, administered as desvenlafaxine succinate, is an serotonin-norepinephrine reuptake inhibitor approved for the treatment of adults with MDD at the recommended dose of 50mg/day. The aim of this integrated analysis was to assess the efficacy and safety of desvenlafaxine 50 and 100mg/day compared with placebo in adult outpatients with MDD. The analysis used data from nine fixed-dose, short-term, placebo-controlled studies in adult outpatients diagnosed with MDD who had depressive symptoms for at least 30 days. Data from 4279 and 4317 patients were pooled for the efficacy and safety analyses, respectively. Statistically significant improvements were observed with desvenlafaxine 50 and 100mg/day versus placebo for all efficacy endpoints assessed, including improvements in depressive symptoms, response and remission rates, as well as functional and cognitive outcomes. Treatment with desvenlafaxine 50 and 100mg/day was generally safe and well tolerated. The findings of this integrated analysis of data from a large population of patients with MDD confirmed the antidepressant efficacy of both desvenlafaxine doses and add to previous evidence supporting the efficacy of desvenlafaxine.
引用
收藏
页码:134 / 146
页数:13
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