Rosiglitazone, Myocardial Ischemic Risk, and Recent Regulatory Actions
Rosiglitazone, Myocardial Ischemic Risk, and Recent Regulatory Actions
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DOI：
10.1345/aph.1q400
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发表时间：
2012-02-01
影响因子：
2.9
通讯作者：
Phillips, Beth Bryles
中科院分区：
文献类型：
--
作者：
Bourg, Catherine A.;Phillips, Beth Bryles
目的：回顾有关罗格列酮和缺血性心血管风险的证据，并讨论美国食品和药物管理局 (FDA) 修改安全信息和限制使用该药物的决定。 数据来源：通过 MEDLINE（1950 年至 2012 年 1 月）、PubMed（1966 年至 2012 年 1 月）和国际药物文摘（1970 年至 2011 年 12 月）进行文献检索，使用搜索词罗格列酮和心血管风险。对 FDA 和药物评价与研究中心的监管文件以及已确定的出版物的参考引文进行了审查。 研究选择和数据提取：对从数据源中确定的所有英文文章进行了纳入评估。 数据综合：有关罗格列酮和缺血性心血管风险的文献显示了不一致的结果。 FDA、葛兰素史克和几个独立研究小组的荟萃分析表明，心肌梗塞 (MI) 的风险增加，而其他研究小组则没有。并非旨在评估心血管结局的长期对照试验并未发现心血管事件显着增加，并且总体事件发生率较低。 RECORD（罗格列酮口服药物联合治疗 2 型糖尿病的心血管结局评估）试验是迄今为止唯一旨在评估罗格列酮心血管结局的前瞻性随机试验；由于研究设计和事件裁决的问题，结果是有限的。罗格列酮和吡格列酮之间唯一的直接比较是观察性研究，其中吡格列酮具有更有利的心肌梗死风险特征。结论：涉及罗格列酮和缺血性心血管风险相关性的数据得出了不同的结果。 FDA 于 2010 年 9 月决定限制罗格列酮的使用，要求葛兰素史克提交风险评估和缓解策略 (REMS)。药品标签于2011年2月进行修订，罗格列酮REMS计划于2011年11月全面生效。
OBJECTIVE: To review the evidence surrounding rosiglitazone and ischemic cardiovascular risk and discuss the Food and Drug Administration (FDA) decision to revise safety information and restrict access to the drug.DATA SOURCES: A literature search was conducted through MEDLINE (1950-January 2012), PubMed (1966-January 2012), and International Pharmaceutical Abstracts (1970-December 2011) using the search terms rosiglitazone and cardiovascular risk. Regulatory documents from the FDA and the Center for Drug Evaluation and Research, as well as reference citations from publications identified, were reviewed.STUDY SELECTION AND DATA EXTRACTION: All articles in English identified from the data sources were evaluated for inclusion.DATA SYNTHESIS: Literature regarding rosiglitazone and ischemic cardiovascular risk has shown inconsistent results. Meta-analyses by the FDA, GlaxoSmithKline, and several independent research groups suggest an increased risk for myocardial infarction (MI), while others have not. Long-term, controlled trials not designed to evaluate cardiovascular outcomes did not find a significant increase in cardiovascular events and had low event rates overall. The RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes) trial is the only prospective randomized trial to date designed to evaluate cardiovascular outcomes of rosiglitazone; the results were limited because of issues with study design and event adjudication. The only direct comparisons between rosiglitazone and pioglitazone are observational studies in which pioglitazone had a more favorable MI risk profile.CONCLUSIONS: Data involving rosiglitazone and an association with ischemic cardiovascular risk have yielded variable results. The FDA made the decision to restrict access to rosiglitazone in September 2010 by requiring GlaxoSmithKline to submit a risk evaluation and mitigation strategy (REMS). Drug labeling was revised in February 2011, and the rosiglitazone REMS program took full effect in November 2011.