Randomized controlled trials (RCTs) examining the outcomes of "polypill" therapy in cardiovascular disease prevention have yielded mixed results. We performed an electronic search through January 2023 for RCTs that examined the use of polypills for cardiovascular disease primary or secondary prevention. The primary outcome was the incidence of major adverse cardiac and cerebrovascular events (MACCEs). The final analysis included 11 RCTs with 25,389 patients; 12,791 patients were in the polypill arm, and 12,598 patients were in the control arm. The follow-up period ranged from 1 to 5.6 years. Polypill therapy was associated with a lower risk of MACCE (5.8% vs 7.7%; risk ratio [RR] 0.78, 95% confidence interval [CI] 0.67 to 0.91). The reduction of MACCE risk was consistent in both primary and secondary prevention. Polypill therapy was associated with a lower incidence of cardiovascular mortality (2.1% vs 3%; RR 0.69, 95% CI 0.55 to 0.87), myocardial infarction (2.3% vs 3.2%; RR 0.72, 95% CI 0.61 to 0.84) and stroke (0.9% vs 1.6%; RR 0.62, 95% CI 0.42 to 0.90). Polypill therapy was associated with a higher degree of adherence. There was no difference between both groups in the incidence of serious adverse events (16.1% vs 15.9%; RR 1.12, 95% CI 0.93 to 1.36). In conclusion, we found that a polypill strategy was associated with a lower incidence of cardiac events and higher adherence, without an increased incidence of adverse events. This benefit was consistent for both primary and secondary prevention.
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