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首页> 外文期刊>American journal of cardiovascular drugs: drugs, devices, and other interventions >Thiazolidinediones and risk of heart failure in patients with or at high risk of type 2 diabetes mellitus: a meta-analysis and meta-regression analysis of placebo-controlled randomized clinical trials.
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Thiazolidinediones and risk of heart failure in patients with or at high risk of type 2 diabetes mellitus: a meta-analysis and meta-regression analysis of placebo-controlled randomized clinical trials.

机译：噻唑烷二酮类药物与2型糖尿病或高危2型糖尿病患者的心力衰竭风险：安慰剂对照的随机临床试验的荟萃分析和荟萃回归分析。

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Background: Recent meta-analyses of randomized clinical trials (RCTs) demonstrated a higher risk of heart failure (HF) with the use of thiazolidinediones (TZDs). However, this effect may have been diluted by including active controls. Also, it is uncertain whether the risk of HF is similar with rosiglitazone and pioglitazone. Objectives: This study quantified the risks of HF with the use of TZDs in patients with or at high risk of developing type 2 diabetes mellitus (DM), and evaluated differential effects by type of TZD. Secondarily, we evaluated risks of peripheral edema. Methods: We performed a systematic review and meta-analysis of placebo-controlled RCTs evaluating the effect of rosiglitazone or pioglitazone on investigator-reported HF and edema. Articles published before 31 December 2009 were searched in MEDLINE, The Web of Science, and Scopus, and the data were extracted by three investigators. RCTs with >/=100 patients and >/=3 months of follow-up were included. We quantified the effect of TZDs as odds ratios (ORs) by using the Mantel-Haenzel and alternative models. We further evaluated the risk of serious/severe HF, and the effect of several trial characteristics on HF risk by subgroup analysis and meta-regression analysis. Results: 29 trials (n = 20 254) were evaluated. TZDs were significantly associated with HF (TZD 360/6807 [5.3%] vs placebo 234/6328 [3.7%], OR 1.59; 95% CI 1.34, 1.89; p < 0.00001). The risk of HF was higher with rosiglitazone than with pioglitazone (2.73 [95% CI 1.46, 5.10] vs 1.51 [1.26, 1.81]; p = 0.06). TZDs were associated with a similar risk of serious/severe HF (OR 1.47; 95% CI 1.16, 1.87; p = 0.002). Use of TZDs was also associated with edema (OR 2.04; 95% CI 1.85, 2.26; p < 0.00001). HF and edema risks were consistent using Peto and random effects models. Risks of HF were significantly high for the subgroups of trials including patients with or at high risk for type 2 DM, and for the subgroup of trials with >/=12 months of follow-up. Meta-regression analysis showed that trials with lower overall baseline risk had higher HF risks. Conclusion: In placebo-controlled trials of adult patients with or at high risk for type 2 DM, TZD therapy is significantly and consistently associated with a higher risk of HF. The risk of serious/severe HF is also increased with the use of TZDs. HF risks are similar to those of meta-analyses combining active- and placebo-controlled trials. The benefit/risk profile of TZDs should be considered when treating diabetic patients with or without prior HF.
机译：背景：最近对随机临床试验（RCT）进行的荟萃分析显示，使用噻唑烷二酮（TZD）会增加心脏衰竭（HF）的风险。但是，此效果可能已经通过包含主动控件而被淡化了。此外，尚不确定罗格列酮和吡格列酮的HF风险是否相似。目的：本研究量化了在患有2型糖尿病（DM）或处于2型糖尿病高危患者中使用TZD引起的HF的风险，并评估了TZD类型的不同作用。其次，我们评估了周围水肿的风险。方法：我们对安慰剂对照的RCT进行了系统评价和荟萃分析，评估了罗格列酮或吡格列酮对研究者报告的心衰和水肿的影响。在MEDLINE，The Web of Science和Scopus中检索了2009年12月31日之前发表的文章，并由三位研究人员提取了数据。包括> / = 100名患者且> / = 3个月的随访的RCT。通过使用Mantel-Haenzel模型和替代模型，我们将TZD的影响量化为优势比（OR）。我们通过亚组分析和Meta回归分析进一步评估了严重/严重HF的风险，以及几种试验特征对HF风险的影响。结果：评估了29个试验（n = 20 254）。 TZD与HF显着相关（TZD 360/6807 [5.3％] vs安慰剂234/6328 [3.7％]，OR 1.59; 95％CI 1.34，1.89; p <0.00001）。罗格列酮治疗HF的风险高于吡格列酮治疗（2.73 [95％CI 1.46，5.10] vs 1.51 [1.26，1.81]; p = 0.06）。 TZD与发生严重/重度HF的风险相似（OR 1.47; 95％CI 1.16，1.87; p = 0.002）。 TZDs的使用也与水肿有关（OR 2.04; 95％CI 1.85，2.26; p <0.00001）。使用Peto和随机效应模型，HF和浮肿风险保持一致。对于包括2型DM风险或处于2型DM高风险患者的试验亚组，以及随访时间≥/ = 12个月的试验亚组，HF的风险均很高。荟萃回归分析显示，总体基线风险较低的试验具有较高的心力衰竭风险。结论：在对患有2型DM或处于2型DM高风险的成年患者进行的安慰剂对照试验中，TZD治疗显着且始终如一地与更高的HF风险相关。使用TZD还会增加严重/重度HF的风险。 HF风险类似于将主动和安慰剂对照试验相结合的荟萃分析的风险。在治疗患有或未患有心力衰竭的糖尿病患者时，应考虑TZD的获益/风险特征。

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