Centre of Community Medicine & HIV Outpatient Clinic, Verona, Italy.
AIDS. 2011 Oct 23;25(16):1993-2004. doi: 10.1097/QAD.0b013e328349c6ee.
The use of abacavir (ABC) has been associated with an increased risk of cardiovascular disease in some cohort studies. However, no excess risk of myocardial infarction (MI) with ABC therapy has been observed in individual randomized clinical trials (RCTs) and in the aggregated clinical trials database maintained by the manufacturer of ABC.
To combine all the evidence from RCTs by means of meta-analysis to estimate the effect of combined antiretroviral therapy (cART) containing ABC on MI and overall major cardiovascular events (CVEs).
Primary outcomes included MI, CVE, adverse events requiring discontinuation of treatment, and overall mortality. We used a conventional Mantel-Haenszel method, with risk ratio and 95% confidence intervals (CIs) or, in the presence of heterogeneity, a random-effect model.
Data were from 28 primary RCTs (9233 participants) comparing ABC-containing cART (4376 participants) to other regimens not containing ABC (4857 controls). MI data were available from 18 trials (31 episodes in 7054 patients) and CVE data from 20 trials (79 episodes in 7899 patients). Compared to the controls, ABC use did not increase significantly the occurrence of MI (risk ratio 0.73, 95% CI 0.39-1.35; P = 0.31), CVE (risk ratio 0.95, 95% CI 0.62-1.44; P = 0.80), overall mortality (risk ratio 1.20, 95% CI 0.63-2.27; P = 0.58), and adverse events requiring discontinuation of treatment (risk ratio 0.82, 95% CI 0.67-1.00; P = 0.05).
This meta-analysis of RCTs does not support the hypothesis that ABC-containing cART regimens carry a greater risk of MI or major cardiovascular events relative to comparator cART.
一些队列研究表明，使用阿巴卡韦（ABC）与心血管疾病风险增加相关。然而，在个别随机临床试验（RCT）和 ABC 制造商维护的汇总临床试验数据库中，并未观察到 ABC 治疗与心肌梗死（MI）风险增加相关。
通过荟萃分析综合所有 RCT 的证据，估计包含 ABC 的联合抗逆转录病毒治疗（cART）对 MI 和总体主要心血管事件（CVE）的影响。
主要结局包括 MI、CVE、需要停药的不良事件和总体死亡率。我们使用传统的 Mantel-Haenszel 方法，计算风险比和 95%置信区间（CI），或在存在异质性时使用随机效应模型。
数据来自 28 项比较包含 ABC 的 cART（4376 名参与者）与不包含 ABC 的其他方案（4857 名对照）的主要 RCT（9233 名参与者）。MI 数据来自 18 项试验（7054 名患者中的 31 例），CVE 数据来自 20 项试验（7899 名患者中的 79 例）。与对照组相比，ABC 治疗并未显著增加 MI 的发生风险（风险比 0.73，95%CI 0.39-1.35；P = 0.31）、CVE（风险比 0.95，95%CI 0.62-1.44；P = 0.80）、总体死亡率（风险比 1.20，95%CI 0.63-2.27；P = 0.58）或需要停药的不良事件（风险比 0.82，95%CI 0.67-1.00；P = 0.05）。
这项 RCT 的荟萃分析不支持包含 ABC 的 cART 方案比对照 cART 方案具有更高的 MI 或主要心血管事件风险的假设。
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