Lufkin Edward G, Sarkar Somnath, Kulkarni Pandurang M, Ciaccia Angelina V, Siddhanti Suresh, Stock John, Plouffe Leo
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA.
Curr Med Res Opin. 2004 Mar;20(3):351-7. doi: 10.1185/030079904125003071.
Standard pharmacological antiresorptive therapy for the prevention and/or treatment of postmenopausal osteoporosis now consists of four categories of drugs: estrogens, a selective estrogen receptor modulator (SERM), bisphosponates, and calcitonin. All of these drugs have been studied in randomized controlled trials, but meaningful comparisons of the efficacy of drugs have been difficult due to differences in baseline risks for fracture and differences in study design, including calcium and vitamin D supplementation, definition of fracture, and discontinuation rates. The current paper reviews results from pivotal studies of antiresorptive therapies with fracture as a primary endpoint, as well as head-to-head trials comparing these therapies using surrogate markers of fracture risk, and introduces the first head-to-head trial with fracture as a primary endpoint. The Evista Alendronate Comparison (EVA) trial, a multi-center, double-blind, double-dummy, randomized trial with two active treatment arms is currently underway to compare directly the osteoporotic fracture risk reduction efficacy of raloxifene and alendronate in postmenopausal women with osteoporosis as defined by bone mineral density. The results from this trial will permit more informed judgment by practitioners and provider groups concerning the relative clinical utility of these two drugs.
目前，用于预防和/或治疗绝经后骨质疏松症的标准药物抗吸收疗法包括四类药物：雌激素、选择性雌激素受体调节剂（SERM）、双膦酸盐和降钙素。所有这些药物均已在随机对照试验中进行了研究，但由于骨折的基线风险不同以及研究设计存在差异，包括钙和维生素D补充、骨折的定义以及停药率等，因此很难对药物疗效进行有意义的比较。本文回顾了以骨折为主要终点的抗吸收疗法关键研究的结果，以及使用骨折风险替代指标比较这些疗法的直接对比试验，并介绍了首个以骨折为主要终点的直接对比试验。依维斯他与阿仑膦酸盐对比（EVA）试验是一项多中心、双盲、双模拟、随机试验，设有两个活性治疗组，目前正在进行中，旨在直接比较雷洛昔芬和阿仑膦酸盐对根据骨密度定义的绝经后骨质疏松症女性降低骨质疏松性骨折风险的疗效。该试验的结果将使从业者和医疗服务提供方能够就这两种药物的相对临床效用做出更明智的判断。
