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Polypill Strategy at 20: Role in Secondary Cardiovascular Prevention 

Compared with usual care, a polypill with aspirin, ramipril, and atorvastatin significantly lowered the risk of major adverse cardiovascular events in 2.499 patients with myocardial infarction within the prior 6 months.

In the phase 3 SECURE trial, the once-daily polypill contained 100 mg of aspirin; 2.5, 5, or 10 mg of ramipril; and atorvastatin 20 or 40 mg. The primary composite outcome was cardiovascular death, nonfatal type 1 myocardial infarction, nonfatal ischemic stroke, or urgent revascularization. The key secondary endpoint was a composite of cardiovascular death, nonfatal type 1 myocardial infarction, or nonfatal ischemic stroke.

Over a 36-month treatment period, patients had these outcomes: “A primary-outcome event occurred in 118 of 1237 patients (9.5%) in the polypill group and in 156 of 1229 (12.7%) in the usual-care group (hazard ratio, 0.76; 95% confidence interval [CI], 0.60 to 0.96; P = 0.02). A key secondary-outcome event occurred in 101 patients (8.2%) in the polypill group and in 144 (11.7%) in the usual-care group (hazard ratio, 0.70; 95% CI, 0.54 to 0.90; P = 0.005). The results were consistent across prespecified subgroups. Medication adherence as reported by the patients was higher in the polypill group than in the usual-care group. Adverse events were similar between groups.”

Editorial: “What have we learned in the two decades since the introduction of the polypill concept?” writes an editorialist. “We now know that using fixed-dose combination pills for cardiovascular prevention is safe and promotes greater use of guideline-concordant medications. Arguably, it would be sufficient to know that the use of polypills leads to outcomes that are similar to those with conventional medications, given the benefits of simplification. However, a growing body of evidence indicates that polypills actually lead to better outcomes than usual care in multiple clinical settings.”

Source: New England Journal of Medicine