贝特类药物预防2型糖尿病患者心血管疾病：随机对照试验的荟萃分析

Fibrates in the prevention of cardiovascular disease in patients with type 2 diabetes mellitus: meta-analysis of randomised controlled trials.

作者信息

Allemann Sabin, Diem Peter, Egger Matthias, Christ Emanuel R, Stettler Christoph

机构信息

Department of Social and Preventive Medicine, University of Bern, Switzerland.

出版信息

Curr Med Res Opin. 2006 Mar;22(3):617-23. doi: 10.1185/030079906X89865.

DOI:10.1185/030079906X89865

PMID:16574044

Abstract

OBJECTIVE

To assess the impact of lipid lowering treatment with fibrates on cardiovascular endpoints in patients with type 2 diabetes mellitus.

METHODS

MEDLINE (from inception to November 2005) and the Cochrane Controlled Trials Register (including Issue 3, 2005) were searched for randomised controlled trials comparing therapy with fibrates to placebo in patients with type 2 diabetes mellitus. Electronic searches were supplemented by manual searching of reference lists, reviews, conference abstracts and specialist journals. Incidence rate ratios (IRRs) were estimated using a fixed effects model. The primary endpoint was the IRR for coronary heart disease (CHD) events (a combination of non fatal myocardial infarction and death due to CHD). Secondary endpoints included: (1) death due to CHD; (2) fatal and non fatal myocardial infarction; and (3) fatal and non fatal stroke.

RESULTS

Eight trials and 12 249 patients with type 2 diabetes were included in the analyses. A total of 924 CHD events (418 and 506 in the treatment and placebo groups, respectively) occurred during a follow up of 60 395 person-years (30 106 and 30 289 in treatment and placebo groups). The combined IRR for CHD events was 0.84 (95% confidence interval [CI] 0.74-0.96, p = 0.008). The numbers needed to treat (NNTs) to prevent one CHD event over 10 years were nine and 26 for patients with and without pre-existing CHD, respectively. IRRs for death due to CHD, myocardial infarction and stroke were 0.96 (95% CI 0.77-1.20, p = 0.73), 0.88 (95% CI 0.69-1.12, p = 0.30) and 0.87 (95% CI 0.73-1.05, p = 0.14), respectively. Larger benefits were found when restricting the analysis to trials that were not confounded by unequal provision of additional lipid-lowering therapy.

CONCLUSIONS

Fibrates are associated with a substantial reduction of CHD events, but their exact role in lipid lowering treatment of patients with type 2 diabetes mellitus remains to be defined.

摘要

目的

评估贝特类药物降脂治疗对2型糖尿病患者心血管终点事件的影响。

方法

检索MEDLINE（从创刊至2005年11月）和Cochrane对照试验注册库（包括2005年第3期），查找比较贝特类药物治疗与安慰剂治疗2型糖尿病患者的随机对照试验。电子检索辅以手动检索参考文献列表、综述、会议摘要和专业期刊。使用固定效应模型估计发病率比（IRR）。主要终点是冠心病（CHD）事件的IRR（非致命性心肌梗死和CHD死亡的组合）。次要终点包括：（1）CHD死亡；（2）致命和非致命性心肌梗死；（3）致命和非致命性卒中。

结果

分析纳入了8项试验和12249例2型糖尿病患者。在60395人年的随访期间（治疗组和安慰剂组分别为30106和30289人年）共发生924例CHD事件（治疗组和安慰剂组分别为418例和506例）。CHD事件的合并IRR为0.84（95%置信区间[CI]0.74 - 0.96，p = 0.008）。对于有和没有预先存在CHD的患者，10年内预防1例CHD事件所需治疗人数（NNT）分别为9和26。CHD死亡、心肌梗死和卒中的IRR分别为0.96（95%CI 0.77 - 1.20，p = 0.73）、0.88（95%CI 0.69 - 1.12，p = 0.30）和0.87（95%CI 0.73 - 1.05，p = 0.14）。当将分析限制在未因额外降脂治疗提供不均等而产生混淆的试验时，发现了更大的益处。