SECURE will evaluate whether Trinomia® will reduce the rate of death from cardiovascular (CV) causes, nonfatal myocardial infarction (MI), stroke, and hospitalisation requiring revascularisation when compared to treatments where the patients have to take several drugs separately, in patients over 65, in several European countries with different rates of adherence and CV events (Spain, Italy, France, Hungary, Poland, Germany and the Czech Republic). Through pharmacoeconomic measures SECURE will also aim to prove that the FDC polypill is a cost- effective strategy in the prevention of cardiovascular disease (CVD). Additionally, regional differences in terms of adherence rates, risk factor control and CV events will also be studied in order to aid the different stakeholders in making appropriate decisions that are specific for each region.