FOCUS: Fixed-Dose Combination Drug For Secondary CV Prevention
Use of a polypill strategy for adherence for secondary prevention following an acute myocardial infarction (AMI) "significantly increases self-reported and directly measured medication adherence," according to results from the FOCUS trial released Sept. 1 at ESC Congress 2014 and simultaneously published in the Journal of the American College of Cardiology.
Results were presented by Valentin Fuster, MD, PhD, MACC, Icahn School of Medicine at Mount Sinai, New York, NY, who explained that the trial was a five-country cohort of 2,118 patients who were analyzed for factors that interfere with appropriate adherence to cardiovascular medications for secondary prevention after an AMI. In phase two of the trial, 695 patients were randomized into a controlled trial, receiving a polypill containing aspirin 100mg, simvastatin 40mg, and Ramipril 2.5, 5 or 10mg, while another randomized group received the three drugs separately.
Over the nine month period of follow-up, researchers measured the primary endpoint in the final visit by a self-reported Morisky-Green questionnaire (MAQ) and pill count. The group that received the polypill showed an increase in adherence compared to the group receiving the medications separately: 65.7 percent vs. 55.7 percent when using the primary endpoint, MAQ=20 and high pill count (80-110 percent) during the final visit.
The researchers concluded that their results show that "for secondary prevention following AMI, younger age, depression and a complex drug treatment plan are associated with lower medication adherence. Meanwhile, adherence is increased in patients with higher insurance coverage levels and social support. Compared with the three drugs given separately, the use of a polypill strategy met the primary endpoint for adherence for secondary prevention following an AMI."
They also note that the polypill may be a safe cardiovascular strategy for post-MI patients. Moving forward, the researchers plan to evaluate the potential benefit of another polypill for the reduction of major adverse cardiovascular events (death from cardiovascular causes, nonfatal MI, stroke and revascularization) in an adequately powered outcomes trial.
< Back to Listings