Palacios S, Arias L, Lavenberg J, Pan K, Mirkin S, Komm B S
a Palacios Institute of Women's Health , Madrid , Spain ;
b Pfizer Inc, Bosques de las Lomas , Mexico ;
Climacteric. 2016 Jun;19(3):261-7. doi: 10.3109/13697137.2016.1146248. Epub 2016 Mar 3.
Introduction Conjugated estrogens/bazedoxifene (CE/BZA) relieves menopausal symptoms and increases bone mineral density (BMD). Objective To evaluate CE/BZA in a Latin American subpopulation from randomized, double-blind, phase-3, multinational trials. Methods Safety data were pooled from three trials from non-hysterectomized postmenopausal Latin American women assigned to CE 0.45 mg/BZA 20 mg (n = 227), CE 0.625 mg/BZA 20 mg (n = 222), or placebo (n = 193). Efficacy outcomes from one study included changes in hot flush frequency at week 12 in women with at least seven moderate/severe hot flushes/day or 50/week at baseline (n = 39), and from baseline to month 12 for BMD (n = 381) and genitourinary syndrome of menopause (GSM) (women with baseline GSM; n = 189). Results At week 12, women taking CE/BZA had four to five fewer moderate/severe hot flushes/day vs. placebo. At month 12, percentage changes in BMD with CE 0.45 mg/BZA 20 mg, CE 0.625 mg/BZA 20 mg, and placebo were 1.2%, 1.6%, and -1.1% for lumbar spine and 1.1%, 1.2%, and -0.3% for total hip. GSM improved with treatment (percentage superficial cells: 4.5, 7.4, vs. 2.0; percentage parabasal cells: -9.3, -27.8 vs. 2.8). There were no new/unexpected safety trends. Conclusion CE/BZA improved vasomotor symptoms, GSM, and BMD in Latin American women, with efficacy/safety similar to the global population.
引言 共轭雌激素/巴多昔芬（CE/BZA）可缓解更年期症状并增加骨矿物质密度（BMD）。目的 评估CE/BZA在拉丁美洲亚人群中的效果，该评估来自随机、双盲、3期、多国试验。方法 安全性数据汇集自三项试验，这些试验的受试者为未接受子宫切除术的绝经后拉丁美洲女性，她们被分配至CE 0.45mg/BZA 20mg组（n = 227）、CE 0.625mg/BZA 20mg组（n = 222）或安慰剂组（n = 193）。一项研究的疗效结果包括基线时每天至少有7次中度/重度潮热或每周50次潮热的女性在第12周时潮热频率的变化（n = 39），以及从基线到第12个月时骨密度（n = 381）和更年期泌尿生殖综合征（GSM）（基线时有GSM的女性；n = 189）的变化。结果 在第12周时，服用CE/BZA的女性每天中度/重度潮热次数比服用安慰剂的女性少4至5次。在第12个月时，CE 0.45mg/BZA 20mg组、CE 0.625mg/BZA 20mg组和安慰剂组的腰椎骨密度百分比变化分别为1.2%、1.6%和 -1.1%，全髋骨密度百分比变化分别为1.1%、1.2%和 -0.3%。GSM随治疗得到改善（表层细胞百分比：4.5、7.4对2.0；副基底层细胞百分比：-9.3、-27.8对2.8）。没有新的/意外的安全趋势。结论 CE/BZA改善了拉丁美洲女性的血管舒缩症状、GSM和骨密度，其疗效/安全性与全球人群相似。
