Mount Sinai School of Medicine, New York, NY;
Zena and Michael A. Wiener Cardiovascular Institute, the Marie-Josée and Henry R. Kravis Center for Cardiovascular Health, New York, NY;
Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain
Cardiovascular disease (CVD) is a global epidemic and the largest cause of noncommunicable disease–related death worldwide. The concept of a combination pill, or “polypill,” composed of aspirin, antihypertensives, and a statin has been suggested to simplify and improve the prevention and treatment of CVD. Individually, these medications have been shown to effectively modify risk factors of CVD, and a single pill composed of these medications has the potential to conveniently and cost effectively provide additive benefits in relative risk reduction. In particular, the polypill concept presents significant potential for reducing the impact of cardiovascular disease in low- and middle-income countries where populations account for >80% of all CVD-related deaths worldwide. Using a polypill as the primary way to prevent CVD has been proposed as a broad “vaccination” strategy to treat asymptomatic individuals based solely on age or the presence of risk factors.
Several clinical trials have shown that combination pills are well tolerated and have lower relative risk by as much as 60–70% by moderately reducing blood pressure and LDL-cholesterol. However, uncertainty remains in regards to long-term adherence, cost effectiveness, and “medicalization” of asymptomatic individuals, who account for a large percentage of the world's population. Furthermore, more data regarding CVD outcomes is required to evaluate the widespread use of a polypill in primary prevention.
The use of a combination pill in individuals with overt CVD provides the potential to reduce the “treatment gap” that exists in the secondary prevention of CVD by simplifying treatment algorithms, reducing nonadherence, and improving access to medications in countries lacking adequate healthcare infrastructure. The promising results of completed clinical trials have lead to the approval of polypill formulations (e.g., Polycap, Trinomia®, or Zycad) and several large clinical trials are posed to present new data regarding outcomes and adherence.