title: Effects of treatment with zofenopril in men and women with acute myocardial infarction: gender analysis of the SMILE Program.
abstract: 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.
authors.affiliation: Laboratory of Gender Medicine, National Institute of Biostructures and Biosystems and Department of Biomedical Sciences, University of Sassari, Sassari, Italy.
authors.forename: Flavia
authors.initials: F
authors.lastname: Franconi
authors.affiliation: Clinical Research Unit, Italian Institute of Telemedicine, Varese, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Omboni
authors.affiliation: Unit of Internal Medicine, Policlinico S. Orsola, University of Bologna, Bologna, Italy.
authors.forename: Ettore
authors.initials: E
authors.lastname: Ambrosioni
authors.affiliation: Mediservice, Milano, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Reggiardo
authors.affiliation: Laboratory of Gender Medicine, National Institute of Biostructures and Biosystems and Department of Biomedical Sciences, University of Sassari, Sassari, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Campesi
authors.affiliation: Unit of Internal Medicine, Policlinico S. Orsola, University of Bologna, Bologna, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Borghi
mesh_terms: D000368:Aged; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002216:Captopril / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000401:mortality; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D012307:Risk Factors; D012737:Sex Factors; D016896:Treatment Outcome
chemical_list: D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; C044958:zofenopril; D002216:Captopril