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

Vanessa Selak, Chris Bullen, Sandrine Stepien, Bruce Arroll, Michiel Bots, Dale Bramley, Alan Cass, Diederick Grobbee, Graham S. Hillis, Barbara Molanus, Bruce Neal, Anushka Patel, Natasha Rafter, Anthony Rodgers, Simon Thom, Andrew Tonkin, Tim Usherwood, Angela Wadham, Ruth Webster

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Aim: 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. 

Methods: 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. 

Results: 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/m2, 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. 

Discussion: 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.

Original languageEnglish
Pages (from-to)1393-1400
Number of pages8
JournalEuropean Journal of Preventive Cardiology
Volume23
Issue number13
DOIs
Publication statusPublished - 1 Sep 2016

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Meta-Analysis
Life Style
Cardiovascular Diseases
Patient Care
Confidence Intervals
Hydroxymethylglutaryl-CoA Reductase Inhibitors
New Zealand
Ireland
England
Netherlands
Antihypertensive Agents
Aspirin
India
Body Mass Index
Guidelines
Exercise
Pharmaceutical Preparations
Therapeutics

Cite this

Selak, Vanessa ; Bullen, Chris ; Stepien, Sandrine ; Arroll, Bruce ; Bots, Michiel ; Bramley, Dale ; Cass, Alan ; Grobbee, Diederick ; Hillis, Graham S. ; Molanus, Barbara ; Neal, Bruce ; Patel, Anushka ; Rafter, Natasha ; Rodgers, Anthony ; Thom, Simon ; Tonkin, Andrew ; Usherwood, Tim ; Wadham, Angela ; Webster, Ruth. / 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. In: European Journal of Preventive Cardiology. 2016 ; Vol. 23, No. 13. pp. 1393-1400.
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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 = "Aim: 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. Methods: 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. Results: 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/m2, 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. Discussion: 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.",
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author = "Vanessa Selak and Chris Bullen and Sandrine Stepien and Bruce Arroll and Michiel Bots and Dale Bramley and Alan Cass and Diederick Grobbee and Hillis, {Graham S.} and Barbara Molanus and Bruce Neal and Anushka Patel and Natasha Rafter and Anthony Rodgers and Simon Thom and Andrew Tonkin and Tim Usherwood and Angela Wadham and Ruth Webster",
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Selak, V, Bullen, C, Stepien, S, Arroll, B, Bots, M, Bramley, D, Cass, A, Grobbee, D, Hillis, GS, Molanus, B, Neal, B, Patel, A, Rafter, N, Rodgers, A, Thom, S, Tonkin, A, Usherwood, T, Wadham, A & Webster, R 2016, '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', European Journal of Preventive Cardiology, vol. 23, no. 13, pp. 1393-1400. https://doi.org/10.1177/2047487316638216

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. / Selak, Vanessa; Bullen, Chris; Stepien, Sandrine; Arroll, Bruce; Bots, Michiel; Bramley, Dale; Cass, Alan; Grobbee, Diederick; Hillis, Graham S.; Molanus, Barbara; Neal, Bruce; Patel, Anushka; Rafter, Natasha; Rodgers, Anthony; Thom, Simon; Tonkin, Andrew; Usherwood, Tim; Wadham, Angela; Webster, Ruth.

In: European Journal of Preventive Cardiology, Vol. 23, No. 13, 01.09.2016, p. 1393-1400.

Research output: Contribution to journalArticleResearchpeer-review

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T1 - 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

AU - Selak, Vanessa

AU - Bullen, Chris

AU - Stepien, Sandrine

AU - Arroll, Bruce

AU - Bots, Michiel

AU - Bramley, Dale

AU - Cass, Alan

AU - Grobbee, Diederick

AU - Hillis, Graham S.

AU - Molanus, Barbara

AU - Neal, Bruce

AU - Patel, Anushka

AU - Rafter, Natasha

AU - Rodgers, Anthony

AU - Thom, Simon

AU - Tonkin, Andrew

AU - Usherwood, Tim

AU - Wadham, Angela

AU - Webster, Ruth

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N2 - Aim: 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. Methods: 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. Results: 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/m2, 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. Discussion: 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.

AB - Aim: 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. Methods: 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. Results: 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/m2, 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. Discussion: 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.

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KW - lifestyle factors

KW - meta-analysis

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