title: Do polypills lead to neglect of lifestyle risk factors? Findings from an individual participant data meta-analysis among 3140 patients at high risk of cardiovascular disease.
abstract: The aim of this study was to investigate whether polypill-based care for the prevention of cardiovascular disease (CVD) is associated with a change in lifestyle risk factors when compared with usual care, among patients with CVD or high calculated cardiovascular risk.
  
  
  
  We conducted an individual participant data meta-analysis of three trials including patients from Australia, England, India, Ireland, the Netherlands and New Zealand that compared a strategy using a polypill containing aspirin, statin and antihypertensive therapy with usual care in patients with a prior CVD event or who were at high risk of their first event. Analyses investigated any differential effect on anthropometric measures and self-reported lifestyle behaviours.
  
  
  
  Among 3140 patients (75% male, mean age 62 years and 76% with a prior CVD event) there was no difference in lifestyle risk factors in those randomised to polypill-based care compared with usual care over a median of 15 months, either across all participants combined, or in a range of subgroups. Furthermore, narrow confidence intervals (CIs) excluded any major effect; for example differences between the groups in body mass index was -0.1 (95% CI -0.2 to 0.1) kg/m(2), in weekly duration of moderate intensity physical activity was -2 (-26 to 23) minutes and the proportion of smokers was 16% vs 17% (RR 0.98, 0.84 to 1.15) at the end of trial.
  
  
  
  This analysis allays concern that polypill-based care may lead to neglect of lifestyle risk factors, at least among high-risk patients. Maximally effective preventive approaches should address lifestyle factors alongside pharmaceutical interventions, as recommended by major international guidelines.
authors.affiliation: Department of Epidemiology and Biostatistics, University of Auckland, New Zealand v.selak@auckland.ac.nz.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Selak
authors.affiliation: National Institute for Health Innovation, University of Auckland, New Zealand.
authors.forename: Chris
authors.initials: C
authors.lastname: Bullen
authors.affiliation: The George Institute for Global Health, University of Sydney, Australia.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Stepien
authors.affiliation: Department of General Practice and Primary Health Care, University of Auckland, New Zealand.
authors.forename: Bruce
authors.initials: B
authors.lastname: Arroll
authors.affiliation: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, the Netherlands.
authors.forename: Michiel
authors.initials: M
authors.lastname: Bots
authors.affiliation: Waitemata District Health Board, New Zealand.
authors.forename: Dale
authors.initials: D
authors.lastname: Bramley
authors.affiliation: Menzies School of Health Research, Charles Darwin University, Australia.
authors.forename: Alan
authors.initials: A
authors.lastname: Cass
authors.affiliation: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, the Netherlands.
authors.forename: Diederick
authors.initials: D
authors.lastname: Grobbee
authors.affiliation: Department of Cardiology, Royal Perth Hospital, Australia.
authors.forename: Graham S
authors.initials: GS
authors.lastname: Hillis
authors.affiliation: South Australian Health and Medical Research Institute, Australia.
authors.forename: Barbara
authors.initials: B
authors.lastname: Molanus
authors.affiliation: The George Institute for Global Health, University of Sydney, Australia.
authors.forename: Bruce
authors.initials: B
authors.lastname: Neal
authors.affiliation: The George Institute for Global Health, University of Sydney, Australia.
authors.forename: Anushka
authors.initials: A
authors.lastname: Patel
authors.affiliation: National Institute for Health Innovation, University of Auckland, New Zealand Department of Epidemiology and Public Health Medicine, Royal College of Surgeons in Ireland, Ireland.
authors.forename: Natasha
authors.initials: N
authors.lastname: Rafter
authors.affiliation: The George Institute for Global Health, University of Sydney, Australia.
authors.forename: Anthony
authors.initials: A
authors.lastname: Rodgers
authors.affiliation: International Centre for Circulatory Health, Imperial College London, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Thom
authors.affiliation: Department of Epidemiology and Preventive Medicine, Monash University, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Tonkin
authors.affiliation: Department of General Practice, University of Sydney Westmead, Australia.
authors.forename: Tim
authors.initials: T
authors.lastname: Usherwood
authors.affiliation: National Institute for Health Innovation, University of Auckland, New Zealand.
authors.forename: Angela
authors.initials: A
authors.lastname: Wadham
authors.affiliation: The George Institute for Global Health, University of Sydney, Australia.
authors.forename: Ruth
authors.initials: R
authors.lastname: Webster
mesh_terms: D002317:Cardiovascular Agents / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000517:prevention & control / Q000523:psychology; D004338:Drug Combinations; D014943:Global Health; D006801:Humans; D008019:Life Style; D009017:Morbidity / Q000639:trends; D011322:Primary Prevention / Q000379:methods*; D012307:Risk Factors
chemical_list: D002317:Cardiovascular Agents; D004338:Drug Combinations
keywords: Polypill; fixed dose combination; lifestyle factors; meta-analysis; risk factors