他汀类药物不能降低骨折风险

JAMA Internal Medicine杂志12月1日在线发表的一篇报道指出，在一项大规模国际临床试验中，对于C反应蛋白水平升高的老年男性和女性，每日服用瑞舒伐他汀并不会降低骨折的风险。

他汀类药物被认为可以刺激骨形成，升高骨密度，表明该类药物还可以发挥更大的临床效用，而并不仅仅用于预防心血管疾病。一些观察性研究已经表明，与不服用他汀类药物的被研究者相比较，他汀类药物服用者因骨质疏松导致骨折的风险降低。为了明确该类药物的可能的此种作用，JUPITER（他汀类药物用于预防的证明：评价瑞舒伐他汀的干预性研究）实验纳入了17,802例被研究者，所有被研究者男性年龄均超过50岁，女性年龄均超过60岁，被研究者服用瑞舒伐他汀或对应的安慰剂，随访5年（中位随访时间2年）以观察心血管疾病及骨折的发生。纽约蒙特菲尔医疗中心心脏内科医生杰西卡M.佩纳和她的同事们说，该项研究在26个国家的1,315个医学中心中开展。

共有431例参与者发生骨折：其中221例属于服用瑞舒伐他汀组，210例属于服用安慰剂组，差异无统计学意义。相应的骨折发生率是他汀类组每年1.20%，安慰剂组每年1.14%，差异也无统计学意义。无论参与者有无骨折病史，此药物的无保护作用在男性和女性参与者中及所有骨折部位上并无差异。各种敏感度分析的结果是一致的，研究者如是说（JAMA Intern. Med. 2014 Dec. 1 [doi:10.1001/jamainternmed.2014.6388])）。

“我们的研究并不支持服用预防心血管疾病的剂量的他汀类药物可以降低骨折风险”，研究人员声明。

Daily rosuvastatin did not decrease fracture risk in a large international clinical trial involving older men and women who had elevated CRP levels, according to a report published online Dec. 1 in JAMA Internal Medicine.

Statins are thought to stimulate bone formation and increase bone mineral density, suggesting that they may exert clinical benefits beyond cardiovascular disease (CVD) prevention. Several observational studies have reported that statin users show a decreased risk of osteoporotic fractures, compared with nonusers. To examine this possible benefit, the JUPITER (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) trial enrolled 17,802 men older than 50 years and women older than 60 years to receive either rosuvastatin or matching placebo and be followed for up to 5 years (median follow-up, 2 years) for both CVD and fracture events. The study was conducted at 1,315 medical centers in 26 countries, said Dr. Jessica M. Peña of the division of cardiology, Montefiore Medical Center, New York, and her associates.

A total of 431 participants sustained fractures: 221 in the rosuvastatin group and 210 in the placebo group, a nonsignificant difference. The corresponding rate of fracture was 1.20 per 100 person-years with the statin and 1.14 per 100 person-years with placebo, also a nonsignificant difference. The lack of protection associated with the active drug was consistent between men and women, across all fracture sites, and regardless of the participants’ fracture history. It also persisted through several sensitivity analyses, the investigators said (JAMA Intern. Med. 2014 Dec. 1 [doi:10.1001/jamainternmed.2014.6388]).

“Our study does not support the use of statins in doses used for cardiovascular disease prevention to reduce the risk of fracture,” the researchers noted.

Copyright (c) 2014 Frontline Medical News, a Frontline Medical Communications, Inc. company. All rights reserved. This material may not be published, broadcast, copied or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications, Inc.

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