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Modest Association of Long-Term ACE Inhibitor Treatment With Lung Cancer: The Promise and Pitfalls of Epidemiological Drug-Safety Analyses
Journal of Cardiovascular Pharmacology and Therapeutics ( IF 2.6 ) Pub Date : 2021-03-25 , DOI: 10.1177/10742484211000521
Kathleen A Fairman 1
Affiliation  

Results of the carefully executed Evaluation of Treatment with Angiotensin Converting Enzyme Inhibitors and the Risk of Lung Cancer (ERACER) study, reported in this issue, echo those of several previous observational analyses of the association of long-term angiotensin-converting enzyme (ACE) inhibitor use with incident lung cancer. These epidemiological drug-safety analyses merit cautious interpretation. First, the number needed to harm (NNH) of 6667 reported in ERACER for ACE inhibitors compared with angiotensin-2 receptor blockers (ARBs) after approximately 12 years of follow-up should be balanced against therapeutic benefits. Previously reported meta-analyses of randomized controlled trials (RCTs) over a mean 4.3-year follow-up suggested number needed to treat (NNT) of 67 for all-cause mortality, 116 for cardiovascular mortality, and 86 for a composite of myocardial infarction (MI) and stroke for ACE inhibitors, compared with nonsignificant benefits for ARBs on the mortality outcomes and NNT of 157 for ARBs on the MI/stroke composite. Second, confounding by indication is possible because until 2013, ACE inhibitors, not ARBs, were first-line medications for heart failure, which is associated with incident lung cancer. Third, findings may be compromised by detection bias due to investigation of ACE inhibitor-induced cough, or by residual confounding due to influential factors not measurable in the available data, such as socioeconomic status (SES) or smoking history. The important questions raised by ERACER and similar drug-safety analyses should be addressed in long-term RCTs or in enhanced large-database pharmacoepidemiological analyses, measuring both NNH and NNT and controlling for SES, indication, medication, and dosage.



中文翻译:

长期ACE抑制剂治疗与肺癌的适度关联:流行病学药物安全分析的前景和陷阱

本期报道的血管紧张素转换酶抑制剂治疗评估和肺癌风险 (ERACER) 研究的仔细执行的结果与之前关于长期血管紧张素转换酶 (ACE) 关联的几项观察性分析的结果相呼应抑制剂与偶发肺癌的使用。这些流行病学药物安全分析值得谨慎解释。首先,在大约 12 年的随访后,与血管紧张素-2 受体阻滞剂 (ARB) 相比,ERACER 中报告的 6667 例 ACEI 所需的伤害数量 (NNH) 应与治疗获益进行权衡。先前报道的随机对照试验 (RCT) 的荟萃分析在平均 4.3 年的随访中建议全因死亡率为 67,心血管死亡率为 116,和 86 的心肌梗死 (MI) 和卒中复合使用 ACEI,而 ARB 对死亡率结果的无显着益处和 ARB 对 MI/卒中复合的 NNT 为 157。其次,可能会因适应症而混淆,因为直到 2013 年,ACE 抑制剂,而不是 ARB,是心力衰竭的一线药物,心力衰竭与肺癌发生相关。第三,由于对 ACEI 引起的咳嗽的调查,或由于社会经济地位 (SES) 或吸烟史等现有数据中无法衡量的影响因素造成的残留混杂,结果可能会受到影响。ERACER 和类似药物安全性分析提出的重要问题应在长期 RCT 或增强型大数据库药物流行病学分析中解决,

更新日期:2021-03-25
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