Mannucci E, Monami M, Lamanna C, Gensini G F, Marchionni N
Department of Cardiovascular Medicine, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy.
Diabetes Obes Metab. 2008 Dec;10(12):1221-38. doi: 10.1111/j.1463-1326.2008.00892.x. Epub 2008 May 26.
The aim of this meta-analysis of randomized clinical trials (RCT) was to assess whether pioglitazone is also associated with increased cardiovascular risk, as recently reported for rosiglitazone.
RCT of pioglitazone were retrieved from Medline (any date up to 31 August 2007; English language only). Unpublished RCT were identified through http://www.clinicaltrials.gov or http://www.fda.gov websites, and results on cardiovascular outcomes were retrieved from investigators and/or sponsors, whenever possible. RCT were included in meta-analysis if pioglitazone was compared with other treatments (placebo, active comparators or no treatment) for at least 4 weeks. Ninety-four trials, 10 of which were unpublished, were retrieved; those included in the analysis, which excluded PROspective PioglitAzone Clinical Trial In MacroVascular Events (PROACTIVE), enrolled 11 268 and 9912 patients in the pioglitazone and comparator groups respectively. Data for analysis, extracted independently by two observers, included all-cause and cardiovascular mortality and incidence of non-fatal coronary events and heart failure. Proportions of outcome measures across treatment groups were compared by odds ratios (ORs) and 95% confidence interval.
Pioglitazone was associated with reduced all-cause mortality [OR 0.30 (0.14-0.63); p < 0.05], with no relevant effect on non-fatal coronary events. The observed increase in incidence of non-fatal heart failure was not statistically significant [OR 1.38 (0.90-2.12)].
The use of pioglitazone does not appear to be harmful in terms of cardiovascular events and all-cause deaths.
本随机临床试验（RCT）的荟萃分析旨在评估吡格列酮是否也如最近报道的罗格列酮那样会增加心血管疾病风险。
从Medline数据库（截至2007年8月31日的任何日期；仅英文文献）检索吡格列酮的RCT。通过http://www.clinicaltrials.gov或http://www.fda.gov网站识别未发表的RCT，并尽可能从研究者和/或申办者处获取心血管结局的结果。如果吡格列酮与其他治疗（安慰剂、活性对照药或不治疗）比较至少4周，则将该RCT纳入荟萃分析。共检索到94项试验，其中10项未发表；纳入分析的试验（排除吡格列酮大血管事件前瞻性临床试验（PROACTIVE））中，吡格列酮组和对照组分别纳入了11268例和9912例患者。由两名观察者独立提取的分析数据包括全因死亡率和心血管死亡率以及非致命性冠状动脉事件和心力衰竭的发生率。通过比值比（OR）和95%置信区间比较各治疗组间结局指标的比例。
吡格列酮与全因死亡率降低相关[OR 0.30（0.14 - 0.63）；p < 0.05]，对非致命性冠状动脉事件无显著影响。观察到的非致命性心力衰竭发生率增加无统计学意义[OR 1.38（0.90 - 2.12）]。
就心血管事件和全因死亡而言，使用吡格列酮似乎并无危害。
