The objective of SECURE is to evaluate whether Trinomia® will reduce the rate of death from CV causes, nonfatal 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 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 (Table 1).
The polypill is an innovative strategy that has moved from concept to reality as a strategy to contain the CVD pandemic. It has successfully proven in different clinical settings it is an effective, safe and cost-effective strategy to significantly increase adherence and improve risk factor profile. The polypill in CV prevention is a relatively novel concept, which was introduced as a conceptual means to contain the CVD burden for the first time in 2002. Given the current state-of-the-art in the CV prevention arena using this strategy, the next logical clinical study to fill in the current evidence gaps must necessarily include hard outcomes. SECURE would become the first study to investigate the effects of a polypill strategy on hard endpoints and go beyond (but also include as secondary objectives) adherence and risk factor control, specifically in the elderly population.
The World Health Organization (WHO) estimates that worldwide there are 100 million people with either ischemic heart or cerebrovascular disease.2 Although tailored treatment to correct risk factors is advocated by many physicians, the efficacy of such an approach is limited. First, more than four-fifths of CV deaths occur in developing countries where accessibility to drugs and medical care is very restricted. Implementation of healthy lifestyles and a cost-effective polypill strategy in selected patients from these countries would avoid a number of deaths.
The rapidly increasing global burdens of CVD call for interventions that have a population-wide effect, as well as interventions that identify and protect individual patients who have a high risk of major adverse events (AEs). Such actions are especially needed in LMIC, which can ill afford the huge losses in human and financial resources that will result from unchecked development of clinical disease. The findings from SECURE can be extrapolated to LMIC to apply a simple, novel strategy to increase adherence, accessibility and affordability of CVD prevention.