Tourian Karen A, Leurent Claire, Graepel Jay, Ninan Philip T
Wyeth Research, Collegeville, Pennsylvania ; and Wyeth Research, Paris, France . Drs Tourian and Leurent are currently with Wyeth, a company of the Pfizer Group, Paris, France, and Drs Graepel and Ninan are currently with Pfizer Inc, Collegeville, Pennsylvania.
Prim Care Companion J Clin Psychiatry. 2010;12(1):PCC.08m00746. doi: 10.4088/PCC.08m00746blu.
To characterize weight change during short- and longer-term treatment with desvenlafaxine (administered as desvenlafaxine succinate) for major depressive disorder (MDD).
Data from 9 short-term, double-blind, placebo-controlled studies and 1 longer-term relapse-prevention trial conducted between September 2002 and January 2007 were analyzed. Adult outpatients with a primary diagnosis of MDD using criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition received fixed- or flexible-dose desvenlafaxine or placebo for 8 weeks in the short-term studies. In the longer-term study, responders to 12 weeks of open-label desvenlafaxine treatment were randomly assigned to double-blind treatment with desvenlafaxine or placebo for 6 months. Mean weight changes and incidence of potentially clinically important changes were evaluated.
In the short-term studies (desvenlafaxine: n = 1,834; placebo: n = 1,116), mean decreases in weight associated with desvenlafaxine were small but statistically significant compared with baseline (P < .05) and with placebo (final evaluation: -0.82 kg desvenlafaxine vs + 0.05 kg placebo; P < .001). Likewise, during the 12-week, open-label phase of the relapse-prevention study (n = 594), a small but statistically significant mean decrease in weight from baseline (-0.8 kg; P < .001) occurred. Small mean increases in weight (< 1 kg) were observed with both desvenlafaxine (n = 190) and placebo (n = 185) throughout the relapse-prevention phase, with no statistical difference between desvenlafaxine- and placebo-treated patients at the final evaluation. Less than 1% of desvenlafaxine-treated patients experienced a clinically meaningful weight change.
Desvenlafaxine was not associated with clinically significant weight change during short- or longer-term treatment.
描述去甲文拉法辛(以琥珀酸去甲文拉法辛形式给药)用于治疗重度抑郁症(MDD)的短期及长期治疗期间的体重变化情况。
分析了2002年9月至2007年1月期间开展的9项短期、双盲、安慰剂对照研究以及1项长期预防复发试验的数据。根据《精神疾病诊断与统计手册》第四版标准,初步诊断为MDD的成年门诊患者在短期研究中接受固定剂量或灵活剂量的去甲文拉法辛或安慰剂治疗8周。在长期研究中,对接受12周开放标签去甲文拉法辛治疗的缓解者随机分配接受去甲文拉法辛或安慰剂双盲治疗6个月。评估平均体重变化以及具有潜在临床重要意义的变化发生率。
在短期研究中(去甲文拉法辛组:n = 1834;安慰剂组:n = 1116),与去甲文拉法辛相关的体重平均下降幅度较小,但与基线相比具有统计学意义(P <.05),与安慰剂相比也具有统计学意义(最终评估:去甲文拉法辛组为 -0.82 kg,安慰剂组为 +0.05 kg;P <.001)。同样,在预防复发研究的12周开放标签阶段(n = 594),体重较基线出现了虽小但具有统计学意义的平均下降(-0.8 kg;P <.001)。在整个预防复发阶段,去甲文拉法辛组(n = 190)和安慰剂组(n = 185)均观察到体重有小幅度的平均增加(<1 kg),在最终评估时,去甲文拉法辛治疗患者与安慰剂治疗患者之间无统计学差异。接受去甲文拉法辛治疗的患者中,体重出现具有临床意义变化的比例不到1%。
在短期或长期治疗期间,去甲文拉法辛与具有临床意义的体重变化无关。