Angiotensin-Converting Enzyme Inhibitor Associated Cough: Deceptive Information from the Physicians' Desk Reference - 19/08/11
Reprint requests should be addressed to Franz H. Messerli, MD, FACC, Hypertension Program, Division of Cardiology, St. Luke's-Roosevelt Hospital, Columbia University College of Physicians and Surgeons, 1000 10th Avenue, Suite 3B-30, New York, NY 10019Abstract |
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).
El texto completo de este artículo está disponible en PDF.Keywords : Angiotensin-converting enzyme inhibitors, Clinical trials, Cough, Incidence, Withdrawal
Esquema
| Funding: This study was supported by a grant from Boehringer Ingelheim. |
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| Conflict of Interest: Drs. Bangalore and Kumar do not have any potential conflicts of interest to disclose. Dr. Messerli is on the speaker's bureau or ad hoc consulting for Pfizer, Abbott, Takeda, Nicox, Boehringer Ingelheim, Merck, Novartis, and Daiichi-Sankyo. |
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| Authorship: All authors have read and approved the manuscript. All authors met the criteria for authorship, had access to data, and played an important role in writing the manuscript. All activities and decisions involved in the meta-analysis and preparation of the manuscript were performed completely independently with no input or review by Boehringer Ingelheim. |
Vol 123 - N° 11
P. 1016-1030 - novembre 2010 Regresar al número
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