Relief of vasomotor symptoms with the tissue-selective estrogen complex containing bazedoxifene/conjugated estrogens: a randomized, controlled trial
Relief of vasomotor symptoms with the tissue-selective estrogen complex containing bazedoxifene/conjugated estrogens: a randomized, controlled trial
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DOI：
10.1097/gme.0b013e3181a7df0d
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发表时间：
2009-11-01
影响因子：
2.7
通讯作者：
Pickar, James H.
中科院分区：
文献类型：
--
作者：
Pinkerton, JoAnn V.;Utian, Wulf H.;Pickar, James H.
目的：本研究的目的是在选择性雌激素绝经和治疗反应2试验中评估巴泽多昔芬(BZA)/偶联雌激素（CE）治疗中重度血管舒缩症状的安全性和有效性。方法：这是一项在美国进行的门诊、多中心、双盲、随机、安慰剂对照的3期研究。健康绝经后妇女（N = 332，年龄40-65岁）中度至重度潮热（>= 7/d或50/周）随机分为BZA 20 mg/CE 0.45 mg、BZA 20 mg/CE 0.625 mg或安慰剂组，每天1次，持续12周。在第4周和第12周评估中度和重度潮热的平均每日次数和每日严重程度评分的基线变化；记录不良事件。结果：BZA/CE显著降低了第4周和第12周的潮热次数和严重程度（P < 0.001）。在第12周，BZA 20 mg/CE 0.45 mg和BZA 20 mg/CE 0.625 mg从基线减少潮热次数分别为74%（10.3次[基线]vs 2.8次[第12周]）和80%（10.4次vs 2.4次），而安慰剂组为51%（10.5次vs 5.4次）。在第12周，与安慰剂相比，BZA 20 mg/CE 0.45 mg（61%）和BZA 20 mg/CE 0.625 mg（73%）的参与者潮热至少减少75% （27%;P < 0.001）。BZA/CE和安慰剂的安全性相似，没有意外的安全性发现报告。结论：BZA 20 mg联合CE 0.45或0.625 mg治疗绝经后妇女血管舒缩症状有效且短期安全。
Objective: The aim of this study was to assess the safety and efficacy of bazedoxifene (BZA)/conjugated estrogens (CE) treating moderate to severe vasomotor symptoms in the Selective Estrogen Menopause and Response to Therapy 2 trial.Methods: This was an outpatient, multicenter, double-blind, randomized, placebo-controlled, phase 3 study conducted in the United States. Healthy postmenopausal women (N = 332; aged 40-65 y) with moderate to severe hot flushes (>= 7/d or 50/wk) were randomized to BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, or placebo once daily for 12 weeks. Changes from baseline in the average daily number of moderate and severe hot flushes and daily severity score were assessed at weeks 4 and 12; adverse events were recorded.Results: BZA/CE significantly reduced the number and severity of hot flushes at weeks 4 and 12 (P < 0.001). At week 12, BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg reduced hot flushes from baseline by 74% (10.3 hot flushes [baseline] vs 2.8 [week 12]) and 80% (10.4 vs 2.4), respectively, compared with 51% (10.5 vs 5.4) for placebo. More participants at week 12 had at least a 75% decrease in hot flushes with BZA 20 mg/CE 0.45 mg (61%) and BZA 20 mg/CE 0.625 mg (73%) versus placebo (27%; P < 0.001). The safety profile was similar between BZA/CE and placebo, and no unexpected safety findings were reported.Conclusions: BZA 20 mg paired with CE 0.45 or 0.625 mg is effective, with short-term safety, for treating vasomotor symptoms in postmenopausal women.