INTRODUCTION:Two global, double-blind, placebo- and active-controlled, phase-3 studies (2-year prevention (n = 1583) and 3-year treatment (n = 7492)) have shown that bazedoxifene (BZA) is safe and effective for prevention and treatment of postmenopausal osteoporosis. OBJECTIVE:To evaluate the efficacy/safety of BZA according to baseline kidney function. METHODS:Data for the BZA 20- and 40-mg and placebo groups from both studies were integrated for assessment of bone turnover markers (BTMs), bone mineral density (BMD), and fracture incidence (treatment study only). Safety was assessed using integrated data for the BZA, placebo, and raloxifene 60-mg groups from both studies. Baseline glomerular filtration rate (GFR) was estimated by the Modification of Diet in Renal Disease Study equation; among subjects with baseline GFR, renal function categories were defined by GFR (ml/min per 1.73 m(2)): normal (GFR ≥ 90; n = 1982), mild impairment (60 ≤ GFR < 90; n = 6032), or moderate/severe impairment (GFR < 60; n = 723). RESULTS:Demographics were similar across treatment groups and within GFR subgroups. Across GFR subgroups, BZA 20 and 40 mg reduced BTM levels and improved lumbar spine and total hip BMD versus placebo. At month 24, there were significant treatment-by-GFR (p = 0.003) and treatment-by-serum creatinine (p = 0.034) interactions for the increase in lumbar spine BMD versus placebo. Fracture incidence was lower with BZA than placebo across all GFR categories, with no treatment-by-GFR interaction. There were no significant differences among treatment groups in incidences of overall, serious, or renal-related adverse events across GFR subgroups. CONCLUSIONS:Mild to moderate kidney impairment did not affect the efficacy and safety of BZA in postmenopausal women.

译文

简介:两项全球,双盲,安慰剂和活性药物对照的3期研究(2年预防(n = 1583)和3年治疗(n = 7492))表明,巴多昔芬(BZA)是安全的对防治绝经后骨质疏松症有效。
目的:根据基线肾脏功能评估BZA的疗效/安全性。
方法:将两项研究中BZA 20 mg和40 mg以及安慰剂组的数据进行整合,以评估骨转换标志(BTM),骨矿物质密度(BMD)和骨折发生率(仅治疗研究)。使用来自两项研究的BZA,安慰剂和雷洛昔芬60 mg组的综合数据评估安全性。基线肾小球滤过率(GFR)通过“饮食中肾脏疾病研究方程的修正”来估算。在具有基线GFR的受试者中,肾功能类别由GFR(每分钟1.73 m(2 / ml / min))定义:正常(GFR≥90; n = 1982),轻度损伤(60≤GFR <90; n = 6032),或中度/重度损伤(GFR <60; n = 723)。
结果:治疗组之间和GFR亚组内的人口统计学相似。在所有GFR亚组中,与安慰剂相比,BZA 20和40 mg降低了BTM水平,改善了腰椎和全髋BMD。在第24个月时,与安慰剂相比,腰椎BMD的升高,分别有明显的GFR治疗(p = 0.003)和血清肌酐治疗(p = 0.034)相互作用。在所有GFR类别中,BZA的骨折发生率均低于安慰剂,并且没有按GFR进行治疗的相互作用。在治疗组之间,GFR亚组的总体,严重或与肾脏相关的不良事件的发生率无显着差异。
结论:轻度至中度肾功能损害并未影响绝经后妇女BZA的疗效和安全性。

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