Gender comparison of efficacy and safety of ranolazine for chronic angina pectoris in four randomized clinical trials.

More women than men with myocardial infarction have previous stable angina pectoris. Women also have an increased incidence of angina after percutaneous coronary intervention and coronary artery bypass grafting. Data from 1,737 patients with stable angina pectoris in 4 international trials (Monotherapy Assessment of Ranolazine In Stable Angina [MARISA], Combination Assessment of Ranolazine In Stable Angina [CARISA], Ranolazine Versus Atenolol Comparison in Chronic Angina [RAN080], and Efficacy of Ranolazine in Chronic Angina [ERICA]) were used to compare efficacy and safety of ranolazine therapy for angina in women and men. MARISA, CARISA, and RAN080 included exercise testing; CARISA, RAN080, and ERICA assessed angina frequency and nitroglycerin consumption; and ERICA included quality-of-life assessment using the Seattle Angina Questionnaire. MARISA, CARISA, and ERICA used the extended-release formulation of ranolazine; RAN080 used ranolazine immediate release. All 4 studies showed overall efficacy and safety of ranolazine. In subgroup analyses, women showed less improvement than men in exercise testing. However, similar improvements for women and men were noted in angina frequency and nitroglycerin consumption, and in ERICA, in the angina frequency dimension of the Seattle Angina Questionnaire. In conclusion, explanations for the gender treatment differences for exercise parameters but comparable effects on decrease in angina frequency and nitroglycerin use are uncertain, but may include differences in patient demographics, reasons for stopping exercise, and type of exercise protocol used.

RCT Entities:   Population Interventions Outcomes