A polypill strategy for lipid lowering and anti-platelet therapy after acute coronary syndrome: A pilot randomized controlled trial

Abstract

Background

Medication non-adherence following acute coronary syndrome (ACS) is common, especially among underserved populations. The use of fixed-dose combination pills (polypills) may improve both adherence and prescription practices.

Methods

This open-label, two-center pilot RCT enrolled adults within 30 days of ACS with stent placement and randomized them 1:1 to a once-daily polypill (aspirin 81 mg, rosuvastatin 40 mg, and clopidogrel 75 mg or prasugrel 10 mg) versus usual care. Key endpoints were follow-up LDL-C levels and platelet reactivity, measured by impedance aggregometry (ohms [Ω]; lower=worse aggregation/better inhibition) at 30 days. Medication adherence was assessed with the Morisky Medication Adherence Scale (range 0–8, higher=better adherence). Treatment effects were reported as least squares means (LSM) differences using baseline-adjusted linear regression models.

Results

Among 140 randomized participants (median age 58 years, 29 % female, 14 % Black, 63 % Hispanic), 128 (91 %) completed follow-up. Index ACS events were STEMI (29 %), NSTEMI (51 %), and unstable angina (19 %). There was no significant difference between polypill and usual care in LDL-C (LSM difference: -4.58 mg/dL, 95 % CI -12.68 to 3.52, p = 0.27) and platelet reactivity (-0.08Ω, 95 % CI -0.96, 1.11, p = 0.88) at 30 days. Similarly, medication adherence was similar between groups at 30 days (MMAS-8 LSM difference: 0.13, 95 % CI -0.23 to 0.49, p = 0.47). Composite emergency department visits and hospitalizations over 30 days were similar between groups (polypill vs usual care: 0.14 vs 0.18 events/participant, p = 0.67).

Conclusions

This pilot RCT demonstrated the feasibility of a polypill strategy incorporating P2Y12 inhibitors, aspirin, and high-intensity statin in the post-ACS period. Larger, longer-duration trials are needed to evaluate clinical effects.