巴泽多昔芬在绝经后亚洲女性中的疗效和安全性。
Efficacy and safety of bazedoxifene in postmenopausal Asian women.
机构信息
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, #1 Shuaifuyuan, Wangfujing, Beijing, 100730, People's Republic of China.
出版信息
Osteoporos Int. 2011 Feb;22(2):559-65. doi: 10.1007/s00198-010-1259-5. Epub 2010 Jun 10.
UNLABELLED
This 6-month study examined the efficacy and safety of bazedoxifene 20 mg in postmenopausal Asian women. Bazedoxifene showed statistically significant improvements over placebo in bone mineral density at all skeletal sites evaluated. Bazedoxifene significantly reduced bone turnover and had favorable effects on lipid parameters. Bazedoxifene was safe and well tolerated.
INTRODUCTION
This 6-month, randomized, double-blind, placebo-controlled phase 3 study conducted in China, Korea, and Taiwan evaluated the efficacy and safety of bazedoxifene in postmenopausal Asian women.
METHODS
Generally, healthy postmenopausal Asian women (N=487; mean age, 57.2 years; mean lumbar spine bone mineral density [BMD], -1.1) were randomized to daily therapy with bazedoxifene 20 mg or placebo; all subjects received daily supplemental calcium carbonate 600 mg. The changes from baseline in BMD at the lumbar spine (primary end point) and at other skeletal sites, bone turnover markers, and lipid parameters were evaluated at 6 months. Safety assessments included adverse event (AE) reporting and physical/gynecologic examination.
RESULTS
At 6 months, women who received bazedoxifene 20 mg had significantly greater BMD compared with those receiving placebo at the lumbar spine (0.41% vs -0.32%, P<0.01), femoral neck (-0.08% vs -0.69%, P=0.014), trochanter (0.50% vs -0.23%, P=0.010), and total hip (-0.03% vs -0.77%, P<0.001), respectively. Bazedoxifene 20 mg was also associated with significant differences from placebo in median percent reductions from baseline in serum C-telopeptide (-21.8%, P<0.001) and osteocalcin (-12.9%, P<0.001) levels and total (-5.0%, P<0.001) and low-density lipoprotein cholesterol (-9.5%, P<0.001) levels. The incidence of AEs was not different between subjects treated with bazedoxifene and those who received placebo.
CONCLUSION
Bazedoxifene was generally safe and effective in preventing bone loss in this short-term study of postmenopausal Asian women.
目的
本为期 6 个月的研究旨在评估巴多昔芬 20mg 在绝经后亚洲女性中的疗效和安全性。巴多昔芬在所有评估的骨骼部位的骨密度方面均显著优于安慰剂。巴多昔芬显著降低了骨转换，并对脂质参数有有利影响。巴多昔芬安全且耐受良好。
引言
本项在中国、韩国和中国台湾进行的为期 6 个月、随机、双盲、安慰剂对照的 3 期研究评估了巴多昔芬在绝经后亚洲女性中的疗效和安全性。
方法
一般来说，健康的绝经后亚洲女性（N=487；平均年龄 57.2 岁；平均腰椎骨密度（BMD）-1.1）被随机分为每日接受巴多昔芬 20mg 或安慰剂治疗；所有患者均每日接受碳酸钙 600mg 补充治疗。在 6 个月时评估腰椎（主要终点）和其他骨骼部位、骨转换标志物和脂质参数的基线变化。安全性评估包括不良事件（AE）报告和体格/妇科检查。
结果
在 6 个月时，接受巴多昔芬 20mg 治疗的女性与接受安慰剂治疗的女性相比，腰椎（0.41%对-0.32%，P<0.01）、股骨颈（-0.08%对-0.69%，P=0.014）、转子间（0.50%对-0.23%，P=0.010）和全髋（-0.03%对-0.77%，P<0.001）的 BMD 均显著更高。巴多昔芬 20mg 还与血清 C 端肽（-21.8%，P<0.001）和骨钙素（-12.9%，P<0.001）水平以及总胆固醇（-5.0%，P<0.001）和低密度脂蛋白胆固醇（-9.5%，P<0.001）水平的基线中位数降低百分比从安慰剂相比具有显著差异。接受巴多昔芬治疗的受试者与接受安慰剂治疗的受试者的不良事件发生率无差异。
结论
在这项针对绝经后亚洲女性的短期研究中，巴多昔芬总体上安全有效，可预防骨丢失。
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