A Review of Fixed-Dose Combination Therapy for Secondary Prevention of Adverse Cardiovascular Events and the Preliminary Results of the Persianpolypill Randomized Clinical Trial

This article is an update on our previous review of clinical studies on the role of polypills in the secondary prevention of cardiovascular diseases (CVD). We also present the preliminary results of the Persian Polypill study.

Persian Polypill is a randomized clinical trial with two parallel arms on hospitalized patients due to acute myocardial infarction (AMI). It is planned that 1100 patients will be randomly assigned to one of the two arms of Polypill or usual care and will be followed up for 34 months. The primary outcome will be a composite clinical outcome of major adverse cardiovascular events (MACE), and the secondary outcome will be the cost-effectiveness of polypill treatment.

We identified ten completed studies and two ongoing trials in which at least 10% of participants had CVD. The evaluation of these studies showed the lack of research in low- and middle-income countries about the role of polypill in secondary prevention of CVD and limited information about cost-effectiveness resulting from clinical trials. In Persian Polypill, so far, 624 patients admitted to three hospitals due to AMI have been included in the study. The average age of patients is 60.9 ± 8.7 and 506 are male (81.1%). Overall, 94.4% of the patients underwent percutaneous coronary intervention in the hospital, and 26.3% had hospital complications.

The final results of this study can compensate for the gap in the past studies. They may confirm the role of polypill in the initial management of AMI and long-term secondary prevention in these patients.