A retrospective evaluation of congestive heart failure and myocardial ischemia events in 14 237 patients with type 2 diabetes mellitus enrolled in 42 short-term, double-blind, randomized clinical studies with rosiglitazone
A retrospective evaluation of congestive heart failure and myocardial ischemia events in 14 237 patients with type 2 diabetes mellitus enrolled in 42 short-term, double-blind, randomized clinical studies with rosiglitazone
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DOI：
10.1002/pds.1615
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发表时间：
2008-08-01
影响因子：
2.6
通讯作者：
Koch, Gary
中科院分区：
文献类型：
--
作者：
Cobitz, Alexander;Zambanini, Andrew;Koch, Gary
目的回顾性研究罗格列酮与充血性心力衰竭(CHF)和心肌缺血事件的潜在相关性。方法采用Logistic回归模型，对42项罗格列酮与安慰剂或活性糖尿病药物的短期、双盲、随机研究中的14 237人的数据进行分析。结果罗格列酮组CHF发生率为0~1.27%(SAEs)和0.12~2.42%(AEs)，对照组CHF发生率为0.07~0.75%和0.25~1.36%。使用磺脲类药物和含有胰岛素的组合的CHF SAE的优势比(95%CI)更高：罗格列酮单一治疗与安慰剂相比，0.25(
Purpose Retrospectively investigate potential associations between rosiglitazone and congestive heart failure (CHF) and, separately, events of myocardial ischemia.Methods Data from 14 237 individuals in 42 short-term, double-blind, randomized studies of rosiglitazone versus placebo or active diabetes medications were analyzed across seven treatment comparisons using an exact logistic regression model, adjusted for number of major cardiovascular risk factors and duration of exposure.Results CHF incidence ranged 0-1.27% (SAEs) and 0.12-2.42% (all AEs) with rosiglitazone versus 0.07-0.75% (SAEs) and 0.25-1.36% (all AEs) with control. Higher odds ratios (95%CI) were observed for CHF SAEs with sulfonylurea- and insulin-containing combinations: rosiglitazone monotherapy versus placebo, 0.25 (