Polypill Strategy in Secondary Cardiovascular Prevention.

Angiotensin-Converting Enzyme Inhibitors / adverse effects Aspirin / adverse effects Atorvastatin / adverse effects Cardiovascular Diseases / etiology Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects Ischemic Stroke / prevention & control Myocardial Infarction / complications Platelet Aggregation Inhibitors / adverse effects Ramipril / adverse effects Secondary Prevention / methods

Journal

The New England journal of medicine

ISSN: 1533-4406

Titre abrégé: N Engl J Med

Pays: United States

ID NLM: 0255562

Informations de publication

Date de publication:
15 09 2022

Historique:

pubmed: 27 8 2022

medline: 17 9 2022

entrez: 26 8 2022

Statut: ppublish

Résumé

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. 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. 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. 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. (Funded by the European Union Horizon 2020; SECURE ClinicalTrials.gov number, NCT02596126; EudraCT number, 2015-002868-17.).

Sections du résumé

BACKGROUND

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. (Funded by the European Union Horizon 2020; SECURE ClinicalTrials.gov number, NCT02596126; EudraCT number, 2015-002868-17.).

Identifiants

DOI: 10.1056/NEJMoa2208275 PMID: 36018037

pubmed: 36018037

doi: 10.1056/NEJMoa2208275

doi:

Substances chimiques

Angiotensin-Converting Enzyme Inhibitors 0

Hydroxymethylglutaryl-CoA Reductase Inhibitors 0

Platelet Aggregation Inhibitors 0

Atorvastatin A0JWA85V8F

Ramipril L35JN3I7SJ

Aspirin R16CO5Y76E

Banques de données

ClinicalTrials.gov

['NCT02596126']

EudraCT

['2015-002868-17']

Types de publication

Clinical Trial, Phase III Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

Pagination

967-977

Investigateurs

Helene Abergel (H)

Jeremie Abtan (J)

Emma Actis Perinetto (EA)

Najia Adjeroud (N)

Jaume Agüero (J)

Raquel Ajo (R)

Fernando Alfonso (F)

Antoine Alix (A)

Manuel Almendro Delia (M)

Javier Alonso (J)

David Alonso (D)

Marta Álvarez (M)

Elisabete Alzola (E)

Rut Andrea (R)

Pierre Ardouin (P)

Vicente Arrarte (V)

Raphaële Arrouasse (R)

Fausto Avanzini (F)

Valeria Azzini (V)

Ermentina Bagni (E)

Pawel Bajon (P)

Paula Balboa (P)

Gema Ballesteros (G)

Jordi Bañeras (J)

Marlena Baranowska (M)

Araceli Barcena (A)

Gyorgy Barczi (G)

Rocío Barquero Gordillo (R)

Jose Antonio Barrabés (JA)

María Isabel Barrio López (MI)

Mateusz Barycki (M)

Teresa Bastante (T)

Delphine Baudouy (D)

Silvia Bayona (S)

František Bednář (F)

Joanna Bednarska (J)

Steffen Behrens (S)

Jan Bělohlávek (J)

Sergej Belozerov (S)

Piotr Berkowski (P)

Klára Berta (K)

Alessandra Bertoletti (A)

Farzin Beygui (F)

Florence Bichat (F)

Mathieu Bignon (M)

Dalila Bitari (D)

Katrien Blanchart (K)

Ana Blazquez Galán (A)

Christelle Boczek (C)

Michał Bohdan (M)

Javier Borrego (J)

Thiébaud Boucher (T)

Thiebancel Boucher (T)

Catherine Bouffard (C)

Marian Branny (M)

Ines Bressem (I)

Marek Bronisz (M)

Marta Brzostowicz (M)

Hamza Bhugaloo (H)

Mariagrazia Buratti (M)

Christian Butter (C)

José Cabrera (J)

Pierpaolo Cannarile (P)

Maria Teresa Cano Mozo (MT)

Olga Cañavate (O)

Andrey Cararzana (A)

Evelyn Cardenas (E)

Crisitina Carmona (C)

Maria Angeles Carmona (MA)

Muriel Carvalho (M)

Gabriella Cataldi (G)

Eva María Cebrián Salgado (EM)

Marco Centola (M)

Ángel Cequier (Á)

Ondřej Čermák (O)

Jindrich Černý (J)

Alba Cerveró (A)

Clémence Charlon (C)

Mihai Chiorean (M)

Grzegorz Chorzempa (G)

Giovanni Cioffi (G)

Joanna Ciosek (J)

Anne Clairet (A)

Fiorenza Clerici (F)

Tiziana Coco (T)

Furio Colivicchi (F)

Charles Cornet (C)

Álvaro Corral Alaejos (Á)

Elena Corrada (E)

Alejandro Cortes (A)

Yves Cottin (Y)

Alix Courouau (A)

Amélie Cransac (A)

Emese Csulak (E)

Ester Cunha (E)

Alejandro Curcio (A)

Jolanta Ćwikła (J)

Dóra Czenke (D)

Valerie Daniel (V)

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