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Polypill Strategy in Secondary Cardiovascular Prevention.

Jose M Castellano1, Stuart J Pocock1, Deepak L Bhatt1

  • 1From Centro Nacional de Investigaciones Cardiovasculares (J.M.C., S.J.P., A.J.Q., A.F.-O., J.M.F.A., V.A., H.B., J.F.F., B.I., V.F.), Centro Integral de Enfermedades Cardiovasculares, Hospital Universitario Monteprincipe, Grupo HM Hospitales (J.M.C.), Hospital Clínico San Carlos, Universidad Complutense (A.F.-O., D.V.), Centro de Investigacion Biomedica en Red de Enfermedades Cardiovasculares (A.F.-O., P.L.S., F.M.O., J.M.V.R., V.A., H.B., A.C., B.I.), Unidad de Investigación Clínica y Ensayos Clínicos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (A.D.-F.), Health Research Institute, October 12 Hospital (H.B.), Fundación Jiménez Díaz University Hospital (J.F.F., B.I.), and Universidad Autonóma de Madrid (J.F.F.), Madrid, the Department of Cardiology, Hospital Universitario Salamanca, Salamanca (P.L.S.), Servicio de Cardiología, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia (F.M.O.), Servicio de Cardiología, Hospital Universitario A Coruña, Instituto de Investigación Biomédica A Coruña, La Coruña (J.M.V.R.), Servicio de Cardiología, Hospital Universitario de Cabueñes, Gijón (I.L.), the Cardiovascular Area and Coronary Unit, University Clinical Hospital of Santiago de Compostela, Santiago (M.R.-M.), the Department of Neurology, Hospital Universitario Rey Juan Carlos, Getafe (J.F.F.), and Servicio de Neurología, Hospital General Universitario de Alicante (N.L.), and the Department of Cardiology, Hospital Universitario de San Juan (A.C.), Alicante - all in Spain; the Department of Medical Statistics (S.J.P., R.O., T.C.) and the Centre for Global Chronic Conditions (P. Perel), London School of Hygiene and Tropical Medicine, and Imperial College NHS Trust (A.A.G.), London, and Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool (M.P.) - all in the United Kingdom; Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School (D.L.B.) - both in Boston; the Laboratory of Cardiovascular Prevention (M.C.R., M.B., A.F., L.O.-F.) and Laboratorio di Malattie Neurologiche, Dipartimento di Neuroscienze (E.B.), Istituto di Ricerche Farmacologiche Mario Negri, IRCCS, the Geriatric Unit, IRCCS Istituti Clinici Scientifici Maugeri (M.P.), and the Department of Clinical Sciences and Community Health, University of Milan (M.P.), Milan, and the Clinical and Rehabilitation Cardiology Unit, Emergency Department, San Filippo Neri Hospital, Rome (F.C., S.A.D.F.) - all in Italy; Berlin Institute of Health-Center for Regenerative Therapies, the Department of Internal Medicine and Cardiology (Virchow Klinikum), German Center for Cardiovascular Research, and the Center for Stroke Research Berlin, Charité Universitätsmedizin - all in Berlin (W.D., A.M.); the Department of Cardiology, University Hospital Besançon (F.S., F.E.), and University of Burgundy Franche-Comté (F.S., F.E.), Besançon, the Department of Clinical Pharmacology-Clinical Research Platform, Assistance Publique-Hôpitaux de Paris, Hôpital Saint Antoine, French Alliance for Cardiovascular Trials, Sorbonne Université, Paris (T.S.), the Department of Neurology, University Hospital of Dijon Burgundy (Y.B.), the Medical School of Dijon, University of Burgundy (Y.B.), and Hôpital François Mitterrand (Y.B.), Dijon - all in France; the 2nd Department of Medicine, Department of Cardiovascular Medicine of the 1st Faculty of Medicine, Charles University, and General University Hospital - both in Prague (A.L., J.-C.L.); Semmelweis Egyetem Városmajori Szív És Érgyógyászati Klinika, Budapest (G.B., B.M.); the Department of Heart Disease, Medical University, Wrocław, Poland (P. Ponikowski, M.K.); the Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium (F.V.W.); the Department of Cardiology, Zealand University Hospital, Roskilde, Denmark (M.M.S.); and the Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (V.F.).

The New England Journal of Medicine
|August 26, 2022
PubMed
Summary

A polypill combining aspirin, an ACE inhibitor, and a statin significantly reduced major adverse cardiovascular events in post-myocardial infarction patients. This polypill strategy offers a simpler approach to secondary cardiovascular prevention.

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Area of Science:

  • Cardiology
  • Pharmacology
  • Clinical Trials

Background:

  • A polypill containing aspirin, an angiotensin-converting-enzyme (ACE) inhibitor, and a statin is a proposed strategy for secondary prevention of cardiovascular events post-myocardial infarction.
  • This approach aims to simplify treatment regimens and improve patient adherence.

Purpose of the Study:

  • To evaluate the efficacy of a polypill-based strategy compared to usual care for secondary prevention in patients following myocardial infarction.
  • To assess the impact of the polypill on major adverse cardiovascular events.

Main Methods:

  • A phase 3, randomized, controlled clinical trial involving 2499 patients within six months of myocardial infarction.
  • Patients were assigned to either a polypill regimen (aspirin, ramipril, atorvastatin) or usual care.
  • The primary outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, or urgent revascularization.

Main Results:

  • The polypill group showed a significantly lower incidence of the primary composite outcome (9.5% vs. 12.7%; hazard ratio, 0.76; P=0.02).
  • A key secondary outcome composite also demonstrated a significant reduction in the polypill group (8.2% vs. 11.7%; hazard ratio, 0.70; P=0.005).
  • Medication adherence was higher in the polypill group, with similar adverse event rates between groups.

Conclusions:

  • A polypill containing aspirin, ramipril, and atorvastatin significantly reduces major adverse cardiovascular events in patients treated within six months after myocardial infarction.
  • The polypill-based strategy represents an effective and simpler alternative to usual care for secondary cardiovascular prevention.