罗西格利塔与心血管事件的长期风险:一个元分析
Sonal Singh1, Yoon K Loke, Curt D Furberg
1Department of Medicine, Wake Forest University School of Medicine, Winston-Salem, NC 27157, USA. sosingh@wfubmc.edu
JAMA
|September 13, 2007
概括
在2型糖尿病患者中使用罗西格利塔显著增加了心脏病发作和心力衰竭的风险. 在长期研究的这次元分析中,心血管死亡风险没有显著增加.
科学领域:
- 心脏病学 心脏病学
- 内分泌学 在内分泌学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 由于报告的不良事件,人们对罗西格利塔用于治疗2型糖尿病的安全性存在担忧.
- 罗西格利塔的危害与益处的证据需要进行彻底的风险评估.
研究的目的:
- 系统地审查和分析与罗西格利塔相关的长期心血管风险.
- 研究的主要风险包括心肌梗塞,心力衰竭和心血管死亡率.
主要方法:
- 对相关研究进行了多个数据库 (MEDLINE,临床试验登记册,FDA) 的系统搜索.
- 包括的研究是罗西格利塔的随机对照试验 (RCT),至少12个月的随访,重点关注心血管事件.
- 对4个RCT (n=14,291) 进行了固定效应元分析,以估计相对风险.
主要成果:
- 罗西格利塔使用与心肌梗塞风险显著增加有关 (RR,1.42;P=.02).
- 观察到心力衰竭风险显著增加 (RR,2.09;P<.001).
- 没有发现心血管死亡风险显著增加 (RR,0.90;P=.53).
结论:
- 长期使用罗西格利塔 (≥12个月) 对葡萄糖耐受性降低或2型糖尿病的患者,与心肌梗塞和心力衰竭的风险增加有关.
- 该研究发现,使用罗西格利塔时,心血管死亡风险没有显著增加.
- 这些发现强调了需要权衡罗西格利塔治疗的益处与心血管风险的必要性.
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