Effects of Treatment with Zofenopril in Men and Women with Acute Myocardial Infarction: Gender Analysis of the SMILE Program |
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Authors: | Flavia Franconi Stefano Omboni Ettore Ambrosioni Giorgio Reggiardo Ilaria Campesi Claudio Borghi |
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Affiliation: | 1. Laboratory of Gender Medicine, National Institute of Biostructures and Biosystems and Department of Biomedical Sciences, University of Sassari, Sassari, Italy.; 2. Clinical Research Unit, Italian Institute of Telemedicine, Varese, Italy.; 3. Unit of Internal Medicine, Policlinico S. Orsola, University of Bologna, Bologna, Italy.; 4. Mediservice, Milano, Italy.; University of Perugia, Italy, |
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Abstract: | Backgroundthe 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.Methodsthe 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.Resultswomen 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.Conclusionspost-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. |
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