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

Ruth Webster, Anushka Patel, Vanessa Selak, Laurent Billot, Michiel L. Bots, Alex Brown, Chris Bullen, Alan Cass, Sue Crengle, C. Raina Elley, Diederick E. Grobbee, Bruce Neal, David Peiris, Neil Poulter, Dorairaj Prabhakaran, Natasha Rafter, Alice Stanton, Sandrine Stepien, Simon Thom, Tim Usherwood & 2 others Angela Wadham, Anthony Rodgers

    Research output: Contribution to journalArticleResearchpeer-review

    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.
    Original languageEnglish
    Pages (from-to)147-156
    Number of pages10
    JournalInternational Journal of Cardiology
    Volume205
    DOIs
    Publication statusPublished - 2016

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    Meta-Analysis
    Patient Care
    Cardiovascular Diseases
    LDL Cholesterol
    Blood Pressure
    Hydroxymethylglutaryl-CoA Reductase Inhibitors
    Blood Platelets
    Therapeutics
    New Zealand
    Ireland
    England
    Netherlands
    India
    Randomized Controlled Trials

    Cite this

    Webster, Ruth ; Patel, Anushka ; Selak, Vanessa ; Billot, Laurent ; Bots, Michiel L. ; Brown, Alex ; Bullen, Chris ; Cass, Alan ; Crengle, Sue ; Raina Elley, C. ; Grobbee, Diederick E. ; Neal, Bruce ; Peiris, David ; Poulter, Neil ; Prabhakaran, Dorairaj ; Rafter, Natasha ; Stanton, Alice ; Stepien, Sandrine ; Thom, Simon ; Usherwood, Tim ; Wadham, Angela ; Rodgers, Anthony. / 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. In: International Journal of Cardiology. 2016 ; Vol. 205. pp. 147-156.
    @article{02123678e29a44688dfaddad8dea3262,
    title = "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",
    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.",
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    author = "Ruth Webster and Anushka Patel and Vanessa Selak and Laurent Billot and Bots, {Michiel L.} and Alex Brown and Chris Bullen and Alan Cass and Sue Crengle and {Raina Elley}, C. and Grobbee, {Diederick E.} and Bruce Neal and David Peiris and Neil Poulter and Dorairaj Prabhakaran and Natasha Rafter and Alice Stanton and Sandrine Stepien and Simon Thom and Tim Usherwood and Angela Wadham and Anthony Rodgers",
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    Webster, R, Patel, A, Selak, V, Billot, L, Bots, ML, Brown, A, Bullen, C, Cass, A, Crengle, S, Raina Elley, C, Grobbee, DE, Neal, B, Peiris, D, Poulter, N, Prabhakaran, D, Rafter, N, Stanton, A, Stepien, S, Thom, S, Usherwood, T, Wadham, A & Rodgers, A 2016, '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', International Journal of Cardiology, vol. 205, pp. 147-156. https://doi.org/10.1016/j.ijcard.2015.12.015

    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. / Webster, Ruth; Patel, Anushka; Selak, Vanessa; Billot, Laurent; Bots, Michiel L.; Brown, Alex; Bullen, Chris; Cass, Alan; Crengle, Sue; Raina Elley, C.; Grobbee, Diederick E.; Neal, Bruce; Peiris, David; Poulter, Neil; Prabhakaran, Dorairaj; Rafter, Natasha; Stanton, Alice; Stepien, Sandrine; Thom, Simon; Usherwood, Tim; Wadham, Angela; Rodgers, Anthony.

    In: International Journal of Cardiology, Vol. 205, 2016, p. 147-156.

    Research output: Contribution to journalArticleResearchpeer-review

    TY - JOUR

    T1 - Effectiveness of fixed dose combination medication ('polypills') compared with usual care in patients with cardiovascular disease or at high risk

    T2 - A prospective, individual patient data meta-analysis of 3140 patients in six countries

    AU - Webster, Ruth

    AU - Patel, Anushka

    AU - Selak, Vanessa

    AU - Billot, Laurent

    AU - Bots, Michiel L.

    AU - Brown, Alex

    AU - Bullen, Chris

    AU - Cass, Alan

    AU - Crengle, Sue

    AU - Raina Elley, C.

    AU - Grobbee, Diederick E.

    AU - Neal, Bruce

    AU - Peiris, David

    AU - Poulter, Neil

    AU - Prabhakaran, Dorairaj

    AU - Rafter, Natasha

    AU - Stanton, Alice

    AU - Stepien, Sandrine

    AU - Thom, Simon

    AU - Usherwood, Tim

    AU - Wadham, Angela

    AU - Rodgers, Anthony

    PY - 2016

    Y1 - 2016

    N2 - 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.

    AB - 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.

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