American journal of preventive cardiology · 2026
A polypill strategy for lipid lowering and anti-platelet therapy after acute coronary syndrome: A pilot randomized controlled trial.
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Coellar Juan David, Keshvani Neil, Jain Anand K, Usman Muhammad Shariq, Segar Matthew W, Miller James W, Bustillo-Rubio Myriam, Kumbhani Dharam J, Sathyamoorthy Mohanakrishnan, Butler Javed, Banerjee Subhash, Yates Sean, Wang Thomas J, Pandey Ambarish
Аннотация
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.
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.