Angiotensin-Converting Enzyme Inhibitor Associated Cough: Deceptive Information from the Physicians' Desk Reference
Angiotensin-Converting Enzyme Inhibitor Associated Cough: Deceptive Information from the Physicians' Desk Reference
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DOI：
10.1016/j.amjmed.2010.06.014
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发表时间：
2010-11-01
影响因子：
5.9
通讯作者：
Messerli, Franz H.
中科院分区：
文献类型：
--
作者：
Bangalore, Sripal;Kumar, Sunil;Messerli, Franz H.
背景：干咳是所有血管紧张素转换酶(ACE)抑制剂常见的、令人讨厌的不良反应。本研究旨在将文献中报告的咳嗽发生率与医生案头参考(PDR)/药物标签中报告的咳嗽发生率进行比较。方法：我们检索了MEDLINE/EMBASE/CENTER从1990年到现在发表的关于ACE抑制剂的随机临床试验(RCT)的文章，样本量至少有100名患者在ACE抑制剂组中进行了至少3个月的随访，并报告了因咳嗽而导致的发生率或撤药率。结果：符合我们纳入标准的125项研究纳入了198,130名患者。依那普利的合并加权咳嗽发生率为11.48%(95%可信区间，9.54%至13.41%)，比PDR/药品标签中报告的发生率(1.3%)高9倍。依那普利因咳嗽导致的合并加权撤药率为2.57%(95%可信区间，2.40-2.74)，是PDR/药品标签中报告的撤药率(0.1%)的31倍。在过去的20年里，随着数据的积累，咳嗽的发病率逐渐增加，但与RCT相比，PDR中的咳嗽发病率一直在下降几倍。大多数其他ACE抑制剂的结果与此相似。结论：与PDR/药物标签中的报道相比，文献中ACE抑制剂相关咳嗽的发生率和因咳嗽而停药的比率(更客观的指标)显著更高，在现实世界中，与随机对照试验的数据相比，可能更高。从文献中获得的数据与呈现给消费者(开处方的医生和病人)的数据之间存在差距。(C)2010 Elsevier Inc.保留所有权利。圈出美国医学杂志(2010)123,1016-1030
BACKGROUND: Dry cough is a common, annoying adverse effect of all angiotensin-converting enzyme (ACE) inhibitors. The present study was designed to compare the rate of coughs reported in the literature with reported rates in the Physicians' Desk Reference (PDR)/drug label.METHODS: We searched MEDLINE/EMBASE/CENTRAL for articles published from 1990 to the present about randomized clinical trials (RCTs) of ACE inhibitors with a sample size of at least 100 patients in the ACE inhibitors arm with follow-up for at least 3 months and reporting the incidence or withdrawal rates due to cough. Baseline characteristics, cohort enrolled, metrics used to assess cough, incidence, and withdrawal rates due to cough were abstracted.RESULTS: One hundred twenty-five studies that satisfied our inclusion criteria enrolled 198,130 patients. The pooled weighted incidence of cough for enalapril was 11.48% (95% confidence interval [CI], 9.54% to 13.41%), which was ninefold greater compared to the reported rate in the PDR/drug label (1.3%). The pooled weighted withdrawal rate due to cough for enalapril was 2.57% (95% CI, 2.40-2.74), which was 31-fold greater compared to the reported rate in the PDR/drug label (0.1%). The incidence of cough has increased progressively over the last 2 decades with accumulating data, but it has been reported consistently several-fold less in the PDR compared to the RCTs. The results were similar for most other ACE inhibitors.CONCLUSION: The incidence of ACE inhibitor-associated cough and the withdrawal rate (the more objective metric) due to cough is significantly greater in the literature than reported in the PDR/drug label and is likely to be even greater in the real world when compared with the data from RCTs. There exists a gap between the data available from the literature and that which is presented to the consumers (prescribing physicians and patients). (C) 2010 Elsevier Inc. All rights reserved. circle The American Journal of Medicine (2010) 123, 1016-1030