A polypill strategy to improve adherence: results from the FOCUS project

Area of Science:

• Cardiology
• Pharmacology
• Public Health

Background:

• Adherence to cardiovascular medications post-acute myocardial infarction (MI) declines significantly after six months.
• Fixed-dose combinations (FDCs) are known to improve treatment adherence and risk factor control.
• No prior randomized trials have assessed polypill impact on adherence in post-MI patients.

Purpose of the Study:

• To identify factors influencing medication adherence in post-MI patients.
• To evaluate the efficacy of a polypill versus separate medications on adherence, blood pressure, and LDL cholesterol in secondary cardiovascular prevention.

Main Methods:

• Phase 1: Cross-sectional analysis of 2,118 patients across five countries to identify adherence barriers.
• Phase 2: Randomized controlled trial involving 695 patients comparing a polypill (aspirin, simvastatin, ramipril) to individual drug formulations.
• Primary endpoint: Adherence measured by Morisky-Green questionnaire (MAQ) and pill count at 9-month follow-up.

Main Results:

• Lower adherence was associated with younger age, depression, complex regimens, poor insurance, and low social support.
• The polypill group demonstrated significantly higher adherence (50.8% vs. 41% ITT; 65.7% vs. 55.7% PP) compared to separate medications.
• No significant differences were observed in blood pressure, LDL cholesterol, serious adverse events, or mortality between groups.

Conclusions:

• Younger age, depression, and complex treatment plans are linked to poor adherence post-MI.
• Higher insurance coverage and social support correlate with improved medication adherence.
• A polypill strategy is effective in enhancing adherence for secondary cardiovascular prevention after acute MI.