Treatment with a polypill containing aspirin, ramipril, and atorvastatin within six months after myocardial infarction resulted in a significantly lower risk of major adverse cardiovascular events compared with usual care, according to findings from the SECURE study presented Aug. 26 during ESC Congress 2022 in Barcelona, and simultaneously published in the New England Journal of Medicine.

The phase 3 clinical trial, coordinated by the Spanish National Center for Cardiovascular Research (CNIC), randomized 2,499 patients at 113 centers in Spain, Italy, France, Germany, Poland, Hungary and the Czech Republic to either a polypill-based strategy (n=1,237) or usual care (n=1,229). All patients had experienced a myocardial infarction within the previous six months and were older than 75 years of age or at least 65 years of age with one or more risk factors, including diabetes mellitus, mild or moderate kidney dysfunction, previous myocardial infarction, previous coronary revascularization, or previous stroke. The median follow-up was 36 months.

Overall results found the primary composite outcome of cardiovascular death, nonfatal type 1 myocardial infarction, nonfatal ischemic stroke, or urgent revascularization occurred in 118 patients (9.5%) in the polypill group and in 156 patients (12.7%) in the usual-care group (hazard ratio, 0.76; 95% confidence interval [CI], 0.60 to 0.96; P=0.02). The secondary endpoint – a composite of cardiovascular death, nonfatal type 1 myocardial infarction, or nonfatal ischemic stroke – 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).

José María Castellano, MD, and colleagues noted that the "results were consistent regardless of country, age, sex, or the presence or absence of diabetes, chronic kidney disease, or previous revascularization." Additionally, adverse events were similar across both groups. Also of note, the study authors highlighted that medication adherence as reported by the patients was higher in the polypill group than in the usual-care group. "Adherence to treatment after an acute myocardial infarction is essential for effective secondary prevention," said Castellano.

Based on the study findings, Valentín Fuster, MD, PhD, MACC, principal investigator of study and CNIC General Director, suggests the polypill could become an integral element of strategies to prevent recurrent cardiovascular events in patients who have had a heart attack. "By simplifying treatment and improving adherence, this approach has the potential to reduce the risk of recurrent cardiovascular disease and death on a global scale," he said.

In a related editorial, Thomas J. Wang, MD, FACC, looks at what has been learned in the 20 years since the introduction of the polypill concept. "We now know that using fixed-dose combination pills for cardiovascular prevention is safe and promotes greater use of guideline-concordant medications," he writes. However, he cautions that "whether mass administration of a polypill is warranted remains an important unanswered question" due largely to a "variety of practical barriers to implementation" that remain. Looking ahead, he suggests that "moving the polypill forward will likely require public and private partnerships, as exemplified by the SECURE trial" and that "doing so in the context of secondary prevention may be a good place to start."

Clinical Topics: Dyslipidemia, Prevention, Nonstatins, Novel Agents, Statins

Keywords: ESC Congress, ESC22, Secondary Prevention, Drug Combinations, Hydroxymethylglutaryl-CoA Reductase Inhibitors

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