Polypill Strategy in Secondary Cardiovascular Prevention
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BACKGROUND A polypill that includes key medications associated with improved outcomes (aspirin, angiotensin-converting–enzyme [ACE] inhibitor, and statin) has been proposed as a simple approach to the secondary prevention of cardiovascular death and complications after myocardial infarction. METHODS In this phase 3, randomized, controlled clinical trial, we assigned patients with myocardial infarction within the previous 6 months to a polypill-based strategy or usual care. The polypill treatment consisted of aspirin (100 mg), ramipril (2.5, 5, or 10 mg), 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 end point was a composite of cardiovascular death, nonfatal type 1 myocardial infarction, or nonfatal ischemic stroke. RESULTS A total of 2499 patients underwent randomization and were followed for a median of 36 months. 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. CONCLUSIONS Treatment with a polypill containing aspirin, ramipril, and atorvastatin within 6 months after myocardial infarction resulted in a significantly lower risk of major adverse cardiovascular events than usual care.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | New England Journal of Medicine |
| Vol/bind | 387 |
| Udgave nummer | 11 |
| Sider (fra-til) | 967-977 |
| Antal sider | 11 |
| ISSN | 0028-4793 |
| DOI | |
| Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:
The trial was funded by the European Union Horizon 2020. Ferrer International provided the polypill that was used in the trial; the company had no other role in the trial. Appropriate approvals were provided by the ethics committee at each trial site. All the patients provided written informed consent.
Funding Information:
Supported by a grant (633765) from the European Union Horizon 2020 research and innovation program. Centro Nacional de Investigaciones Cardiovasculares (CNIC), a nonprofit public institution, is supported by Instituto de Salud Carlos III, the Ministerio de Ciencia e Innovación, and the Pro CNIC Foundation and is a Severo Ochoa Center of Excellence (grant CEX2020-001041-S funded by MICIN/AEI/10.13039/501100011033). CNIC receives royalties for the sales of the polypill from Ferrer International. In Spain, project management and monitoring was performed the Spanish Clinical Research Network, a public network funded by Instituto de Salud Carlos III (grant numbers PTC20/00018 and PT17/0017); the State Plan for Research, Development, and Innovation 2013–16; the State Plan for Scientific and Technical Research and Innovation 2017–20; and the Subdirectorate General for Evaluation and Promotion of Research, with cofunding from the European Regional Development Fund.
Funding Information:
Supported by a grant (633765) from the European Union Horizon 2020 research and innovation program . Centro Nacional de Investigaciones Cardiovasculares (CNIC), a nonprofit public institution, is supported by Instituto de Salud Carlos III, the Ministerio de Ciencia e Innovación, and the Pro CNIC Foundation and is a Severo Ochoa Center of Excellence (grant CEX2020-001041-S funded by MICIN/AEI/10.13039/501100011033). CNIC receives royalties for the sales of the polypill from Ferrer International. In Spain, project management and monitoring was performed the Spanish Clinical Research Network, a public network funded by Instituto de Salud Carlos III (grant numbers PTC20/00018 and PT17/0017); the State Plan for Research, Development, and Innovation 2013–16; the State Plan for Scientific and Technical Research and Innovation 2017–20; and the Subdirectorate General for Evaluation and Promotion of Research, with cofunding from the European Regional Development Fund.
Publisher Copyright:
Copyright © 2022 Massachusetts Medical Society.
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