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Effects of treatment with zofenopril in men and women with acute myocardial infarction: gender analysis of the SMILE program

Franconi, Flavia and Omboni, Stefano and Ambrosioni, Ettore and Reggiardo, Giorgio and Campesi, Ilaria and Borghi, Claudio (2014) Effects of treatment with zofenopril in men and women with acute myocardial infarction: gender analysis of the SMILE program. PLoS One, Vol. 9 (11), e111558. eISSN 1932-6203. Article.

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DOI: 10.1371/journal.pone.0111558


Background: the SMILE studies proved the prognostic benefit of zofenopril vs. placebo or other ACE-inhibitors (ACEIs) in post-acute myocardial infarction (AMI). In this retrospective pooled analysis of these studies we assessed whether the zofenopril effect is influenced by gender.
Methods the four double-blind, randomized, parallel-group SMILE studies, compared the efficacy and safety of 6–48 week treatment with zofenopril 60 mg/day with that of placebo, lisinopril 10 mg/day or ramipril 10 mg/day in 3630 AMI patients. This pooled analysis compared treatment efficacy (1-year combined occurrence of death or hospitalization for CV causes) in 2733 men and 897 women.
Results women were older than men, had a higher prevalence of diabetes and of other major CV risk factors. The risk of a major CV event was significantly larger for women (23% vs. 17% men, p<0.001). Between-gender risk difference was more marked for people living in Southern (+54%) than in Northern Europe (+12%). In both genders zofenopril similarly reduced the 1-year risk of CV morbidity and mortality vs. placebo (−39% men, p = 0.0001; −40% women, p = 0.005). The risk reduction was more marked with zofenopril than with the other ACEIs, particularly in men (−27%, p = 0.012; women: −14%, p = 0.479). The drug safety profile was similar between genders in zofenopril-treated patients, while it was worse in women treated with other ACEIs.
Conclusions post-AMI women are at higher risk of CV complications than men, particularly when living in Mediterranean countries. Their response to ACE-inhibition varies according to the type of drug and is usually better in men.

Item Type:Article
ID Code:10282
Uncontrolled Keywords:Zofenopril, myocardial infarction (AMI), gender analysis, SMILE program
Subjects:Area 05 - Scienze biologiche > BIO/14 Farmacologia
Divisions:001 Università di Sassari > 01-a Nuovi Dipartimenti dal 2012 > Scienze Biomediche
Publisher:Public Library of Science
Copyright Holders:© 2014 Franconi et al.
Deposited On:10 Nov 2014 12:13

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