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      Zofenopril and incidence of cough: a review of published and unpublished data

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          Abstract

          Objective

          Cough is a typical side effect of angiotensin-converting enzyme (ACE) inhibitors, though its frequency quantitatively varies among the different compounds. Data on the incidence of cough with the lipophilic third-generation ACE inhibitor zofenopril are scanty and never systematically analyzed. The purpose of this paper is to give an overview on the epidemiology, pathophysiology, and treatment of ACE inhibitor-induced cough and to assess the incidence of cough induced by zofenopril treatment.

          Methods

          Published and unpublished data from randomized and postmarketing zofenopril trials were merged together and analyzed.

          Results

          Twenty-three studies including 5794 hypertensive patients and three studies including 1455 postmyocardial infarction patients exposed for a median follow-up time of 3 months to zofenopril at doses of 7.5–60 mg once-daily were analyzed. The incidence of zofenopril-induced cough was 2.6% (range 0%–4.2%): 2.4% in the hypertension trials (2.4% in the double-blind randomized studies and 2.4% in the open-label postmarketing studies) and 3.6% in the doubleblind randomized postmyocardial infarction trials. Zofenopril-induced cough was generally of a mild to moderate intensity, occurred significantly ( P < 0.001) more frequently in the first 3–6 months of treatment (3.0% vs 0.2% 9–12 months), and always resolved or improved upon therapy discontinuation. Zofenopril doses of 30 mg and 60 mg resulted in significantly ( P = 0.042) greater rate of cough (2.1% and 2.6%, respectively) than doses of 7.5 mg and 15 mg (0.4% and 0.7%, respectively). In direct comparison trials (enalapril and lisinopril), incidence of cough was not significantly different between zofenopril and other ACE inhibitors (2.4% vs 2.7%).

          Conclusion

          Evidence from a limited number of studies indicates a relatively low incidence of zofenopril-induced cough. Large head-to-head comparison studies versus different ACE inhibitors are needed to highlight possible differences between zofenopril and other ACE inhibitors in the incidence of cough.

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          Author and article information

          Journal
          Ther Clin Risk Manag
          Therapeutics and Clinical Risk Management
          Therapeutics and Clinical Risk Management
          Dove Medical Press
          1176-6336
          1178-203X
          2011
          2011
          29 November 2011
          : 7
          : 459-471
          Affiliations
          [1 ]Italian Institute of Telemedicine, Varese, Italy
          [2 ]Department of Internal Medicine, Aging, and Kidney Diseases, University Hospital of Bologna, Bologna, Italy
          Author notes
          Correspondence: Stefano Omboni, Italian Institute of Telemedicine, Via Colombera 29, 21048 Solbiate Arno (Varese), Italy, Tel +39 0331 984 529, Fax +39 0331 984 530, Email stefano.omboni@ 123456iitelemed.org
          Article
          tcrm-7-459
          10.2147/TCRM.S25976
          3233529
          22162922
          © 2011 Omboni and Borghi, publisher and licensee Dove Medical Press Ltd.

          This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

          Categories
          Review

          Medicine

          zofenopril, ace inhibitor, arterial hypertension, heart failure, myocardial infarction, cough

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