Methods:

There were two phases to the FOCUS study. Phase 1 was a cross-sectional analysis to characterize factors associated with patients’ adherence to treatment in five different countries (Argentina, Brazil, Italy, Paraguay, and Spain). Although the inclusion criteria were initially limited to patients with an acute MI in the preceding 2 years, this was amended to allow for inclusion of patients with any history of acute MI. In phase 1, the authors determined adherence to guideline-based medical therapy (aspirin, angiotensin-converting enzyme inhibitor, beta-blocker, and statin) based on responses to the self-reported Morisky-Green medication adherence questionnaire (MAQ) and identified factors contributing to inadequate adherence to treatment. Phase 2 was a randomized, open label, active-controlled, two-group parallel trial of patients who participated in Phase 1. Patients were randomized to the polypill (aspirin 100 mg, simvastatin 40 mg, and ramipril at three different doses of 2.5, 5, and 10 mg), or the three medications given separately. Both polypill and control groups received medications at no cost and had an identical visit plan. In Phase 2, adherence was determined through responses on the self-reported MAQ and pill count. The primary outcome was percentage of patients taking medication adequately at 9 months in each arm, assessed by attendance at the final 9-month follow-up visit and the MAQ and pill counts. Risk factor control (blood pressure and low-density lipoprotein cholesterol levels at 1 and 9 months) was also assessed in each arm.