A polypill strategy to improve adherence

José M. Castellano, Ginés Sanz, José L. Peñalvo, Sameer Bansilal, Antonio Fernández-Ortiz, Luz Alvarez, Luis Guzmán, Juan Carlos Linares, Fernando García, Fabiana D'Aniello, Joan Albert Arnáiz, Sara Varea, Felipe Martínez, Alberto Lorenzatti, Iñaki Imaz, Luis M. Sánchez-Gómez, Maria Carla Roncaglioni, Marta Baviera, Sidney C. Smith, Kathryn TaubertStuart Pocock, Carlos Brotons, Michael E. Farko, Valentin Fuster

Research output: Contribution to journalArticlepeer-review


BACKGROUND: Adherence to evidence-based cardiovascular (CV) medications after an acute myocardial infarction (MI) is low after the first 6 months. The use of fixed-dose combinations (FDC) has been shown to improve treatment adherence and risk factor control. However, no previous randomized trial has analyzed the impact of a polypill strategy on adherence in post-MI patients. OBJECTIVES: The cross-sectional FOCUS (Fixed-Dose Combination Drug for Secondary Cardiovascular Prevention) study (Phase 1) aimed to elucidate factors that interfere with appropriate adherence to CV medications for secondary prevention after an acute MI. Additionally, 695 patients from Phase 1 were randomized into a controlled trial (Phase 2) to test the effect of a polypill (containing aspirin 100 mg, simvastatin 40 mg, and ramipril 2.5, 5, or 10 mg) compared with the 3 drugs given separately on adherence, blood pressure, and low-density lipoprotein cholesterol, as well as safety and tolerability over a period of 9 months of follow-up. METHODS: In Phase 1, a 5-country cohort of 2,118 patients was analyzed. Patients were randomized to either the polypill or 3 drugs separately for Phase 2. Primary endpoint was adherence to the treatment measured at the final visit by the self-reported Morisky-Green questionnaire (MAQ) and pill count (patients had to meet both criteria for adherence at the in-person visit to be considered adherent). RESULTS: In Phase 1, overall CV medication adherence, defined as an MAQ score of 20, was 45.5%. In a multivariable regression model, the risk of being nonadherent (MAQ

Original languageEnglish
Pages (from-to)2071-2082
Number of pages12
JournalJournal of the American College of Cardiology
Issue number20
Publication statusPublished - 2014


  • Adherence
  • Polypill
  • Secondary prevention

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)


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