Risk of Myocardial Infarction and Abacavir Therapy: No Increased Risk Across 52 GlaxoSmithKline-Sponsored Clinical Trials in Adult Subjects
Risk of Myocardial Infarction and Abacavir Therapy: No Increased Risk Across 52 GlaxoSmithKline-Sponsored Clinical Trials in Adult Subjects
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DOI：
10.1097/qai.0b013e31819ff0e6
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发表时间：
2009-05-01
影响因子：
3.6
通讯作者：
Lapierre, Didier H.
中科院分区：
文献类型：
--
作者：
Brothers, Cindy H.;Hernandez, Jaime E.;Lapierre, Didier H.
背景资料：最近，抗HIV药物组（D：A：D）不良事件数据收集描述了其33，347名HIV-1感染者的国际观察队列的结果，表明与阿巴卡韦（ABC）治疗相关的心肌梗死（MI）风险意外增加[相对率1.9，95%置信区间（CI）：1.47至2.45; P = 0.0001]。为了回答这个科学问题，我们总结了葛兰素史克HIV临床试验数据，以确定是否出现了类似的信号。方法：我们收集了葛兰素史克申办的临床试验数据，这些试验包括14，174名接受ABC治疗的HIV感染成人，结果：基线人口统计学和HIV疾病特征，包括血脂和血糖值，是相似的。暴露于[n = 16（0.168%; CI：0.096 - 0.273; 2.09/1000人-年）]或未暴露于[n = 11（0.235%; CI：0.118 - 0.421; 2.57/1000人-年）]含ABC治疗的受试者的MI发生率相当。12项随机分配至ABC组或非ABC组的试验结果是一致的（2.15/1000人-年vs. 4.10/1000人-年）。解释：在本汇总总结中，我们观察到总体上很少发生MI事件，ABC治疗没有增加MI的风险。目前尚不清楚为什么该数据集的结果似乎与抗MV药物不良事件数据集的数据收集不一致，特别是因为非ABC MI事件发生率相似。需要进一步的数据来评估ABC和MI风险增加之间的任何关联。
Background: Recently, the Data collection of Adverse events of Anti-HIV Drugs Group (D:A:D) described results from their international observational cohort of 33,347 HIV-1-infected individuals, Suggesting unexpected increased risk of myocardial infarction (MI) associated with abacavir (ABC) therapy [relative rate 1.9, 95% confidence interval (CI): 1.47 to 2.45; P = 0.0001]. To contribute to the scientific question, we summarized GlaxoSmithKline HIV clinical trial data to determine if a similar signal emerged.Methods: We compiled data from GlaxoSmithKline-sponsored clinical trials with >= 24 weeks of combination antiretroviral therapy comprising 14,174 HIV-infected adults who received ABC (n = 9502; 7641 person-years) or not (n = 4672; 4267 person-years).Findings: Baseline demographics and HIV disease characteristics, including lipids and glucose values, were similar. MI rates were comparable among Subjects exposed [n = 16 (0.168%; CI: 0.096 to 0.273; 2.09 per 1000 person-years)] or not [n = 11 (0.235%; CI: 0.118 to 0.421; 2.57 per 1000 person-years)] to ABC-containing therapy. Results of 12 trials with randomization to ABC or not were consistent (2.15 per 1000 person-years vs. 4.10 per 1000 person-years).Interpretations: In this pooled summary, we observed few MI events overall and no excess risk of MI with ABC therapy. It is unclear why results from this data set seem discrepant to the Data collection of Adverse events of Anti-MV Drugs data set, particularly, as the non-ABC MI event rate is similar. Further data are needed to evaluate any association between ABC and increased risk of MI.