Effectiveness of fixed dose combination medication ('polypills') compared with usual care in patients with cardiovascular disease or at high risk: A prospective, individual patient data meta-analysis of 3140 patients in six countries

Int J Cardiol. 2016 Feb 15;205:147-156. doi: 10.1016/j.ijcard.2015.12.015. Epub 2015 Dec 14.

Abstract

Aims: To conduct a prospective, individual participant data (IPD) meta-analysis of randomised controlled trials comparing a polypill-based approach with usual care in high risk individuals.

Methods and results: Three trials comparing polypill-based care with usual care in individuals with CVD or high calculated cardiovascular risk contributed IPD. Primary outcomes were self-reported adherence to combination therapy (anti-platelet, statin and ≥ two blood pressure (BP) lowering agents), and difference in mean systolic BP (SBP) and LDL-cholesterol at 12 months. Analyses used random effects models. Among 3140 patients from Australia, England, India, Ireland, New Zealand and The Netherlands (75% male, mean age 62 years), median follow-up was 15 months. At baseline, 84%, 87% and 61% respectively were taking a statin, anti-platelet agent and at least two BP lowering agents. At 12 months, compared to usual care, participants in the polypill arm had higher adherence to combination therapy (80% vs. 50%, RR 1.58; 95% CI, 1.32 to 1.90; p < 0.001), lower SBP (-2.5 mmHg; 95% CI, -4.5 to -0.4; p = 0.02) and lower LDL-cholesterol (-0.1 mmol/L; 95% CI, -0.2 to 0.0; p = 0.04). Baseline treatment levels were a major effect modifier for adherence and SBP (p-homog < 0.0001 and 0.02 respectively) with greatest improvements seen among those under-treated at baseline.

Conclusions: Polypill therapy significantly improved adherence, SBP and LDL-cholesterol in high risk patients compared with usual care, especially among those who were under-treated at baseline.

Keywords: Cardiovascular disease; Meta-analysis; Polypill; Secondary prevention.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antihypertensive Agents / administration & dosage
  • Australia / epidemiology
  • Cardiovascular Agents / administration & dosage*
  • Cardiovascular Diseases / drug therapy*
  • Cardiovascular Diseases / epidemiology*
  • Databases, Factual* / standards
  • Drug Combinations
  • England / epidemiology
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage
  • India / epidemiology
  • Ireland / epidemiology
  • Netherlands / epidemiology
  • New Zealand / epidemiology
  • Platelet Aggregation Inhibitors / administration & dosage
  • Prospective Studies
  • Randomized Controlled Trials as Topic / methods
  • Risk Factors
  • Treatment Outcome

Substances

  • Antihypertensive Agents
  • Cardiovascular Agents
  • Drug Combinations
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Platelet Aggregation Inhibitors

Associated data

  • ANZCTR/ACTRN12612000980831