University of Virginia Health System, Charlottesville, VA 22903, USA.
Menopause. 2013 Jan;20(1):28-37. doi: 10.1097/gme.0b013e31826421a8.
The aim of this study was to assess the 12-week efficacy of desvenlafaxine in treating moderate to severe vasomotor symptoms and the clinical relevance of improvements in postmenopausal women experiencing 50 or more moderate to severe hot flashes per week.
Participants were randomized to placebo or desvenlafaxine 100 mg/day in the 12-week efficacy substudy of a year-long, multicenter, parallel-group, double-blind study. Coprimary outcomes were changes from baseline in the daily number and severity of hot flashes on weeks 4 and 12. The percentage of women achieving the minimal clinically important difference (MCID) in the number of hot flashes on week 12 was determined.
The efficacy substudy modified intent-to-treat population included 365 women (desvenlafaxine, n = 184; placebo, n = 181). Desvenlafaxine 100 mg/day significantly reduced the number and severity of hot flashes versus placebo on week 4 (P < 0.001) and week 12 (P < 0.001). On week 12, desvenlafaxine reduced the number of moderate and severe hot flashes by 7.3 (62%) per day (placebo, -4.5 [38%] per day) and the severity score by 0.59 (25%) per day (placebo, -0.28 [12%] per day). MCID-a reduction of 5.35 moderate and severe hot flashes per day-was achieved by 64% of desvenlafaxine-treated women (placebo, 41%; P < 0.001). In all, 17.2% (67/390) of participants discontinued, 10.0% (20/200) of participants taking desvenlafaxine and 3.7% (7/190) of participants taking placebo discontinued because of adverse events (P = 0.016), and 2.5% (5/200) of participants taking desvenlafaxine and 8.4% (16/190) of participants taking placebo discontinued because of lack of efficacy (P = 0.012).
Postmenopausal women with moderate to severe hot flashes who are treated with desvenlafaxine achieve rapid symptom reduction that is clinically relevant based on MCID.
本研究旨在评估去甲文拉法辛治疗中重度血管舒缩症状的 12 周疗效，以及改善每周经历 50 次或更多中重度潮热的绝经后妇女的临床相关性。
参与者被随机分配至安慰剂或去甲文拉法辛 100mg/天，进行为期 12 周的疗效亚研究，这是一项为期 1 年的多中心、平行组、双盲研究。主要疗效终点为第 4 周和第 12 周时每日潮热次数和严重程度的变化。还确定了第 12 周时达到潮热次数最小临床重要差异（MCID）的女性比例。
疗效亚研究的意向治疗人群包括 365 名女性（去甲文拉法辛组，n=184；安慰剂组，n=181）。与安慰剂相比，去甲文拉法辛 100mg/天在第 4 周（P＜0.001）和第 12 周（P＜0.001）时显著减少了潮热的次数和严重程度。第 12 周时，去甲文拉法辛使每日中度和重度潮热次数减少 7.3（62%）（安慰剂组为减少 4.5 [38%]），严重程度评分降低 0.59（25%）（安慰剂组为降低 0.28 [12%]）。MCID-每日减少 5.35 次中度和重度潮热-被 64%的去甲文拉法辛治疗女性实现（安慰剂组为 41%；P＜0.001）。共有 17.2%（67/390）的参与者停药，10.0%（20/200）接受去甲文拉法辛治疗的参与者和 3.7%（7/190）接受安慰剂治疗的参与者因不良事件停药（P=0.016），2.5%（5/200）接受去甲文拉法辛治疗的参与者和 8.4%（16/190）接受安慰剂治疗的参与者因缺乏疗效停药（P=0.012）。
接受去甲文拉法辛治疗的中重度潮热绝经后女性可迅速减轻症状，且基于 MCID 观察到的缓解具有临床相关性。
