Objective The aim of this study was to determine the effect of polypill-based care on the achievement of 2016 European Society of Cardiology (ESC) guideline targets for blood pressure (BP), low-density lipoprotein (LDL) cholesterol and antiplatelet therapy.
Methods We conducted an individual participant data meta-analysis of three randomised clinical trials that compared a strategy using a polypill containing aspirin, statin and antihypertensive therapy with usual care in patients with a prior cardiovascular disease (CVD) event or who were at high risk of their first event. Overall, the trials included 3140 patients from Australia, England, India, Ireland, the Netherlands and New Zealand (75% male, mean age 62 years and 76% with a prior CVD event). The primary outcome for this study was the proportion of people achieving ESC guideline targets for BP, LDL and antiplatelet therapy.
Results Those randomised to polypill-based care were more likely than those receiving usual care to achieve recommended targets for BP (62% vs 58%, risk ratio (RR) 1.08, 95% CI 1.02 to 1.15), LDL (39% vs 34%, RR 1.13, 95% CI 1.02 to 1.25) and all three targets for BP, LDL and adherence to antiplatelet therapy (the latter only applicable to those with a prior CVD event) simultaneously (24% vs 19%, RR 1.27, 95% CI 1.10 to 1.47) at 12 months. There was no difference between groups in antiplatelet adherence (96% vs 96%, RR 1.00, 95% CI 0.98 to 1.01). There was heterogeneity by baseline treatment intensity such that treatment effects increased with the fewer the number of treatments being taken at baseline: for patients taking 3, 2 and 0–1 treatment modalities the RRs for reaching all three guideline goals simultaneously were 1.10 (95% CI 0.94 to 1.30, 22% vs 20%), 1.62 (95% CI 1.09 to 2.42, 27% vs 17%) and 3.07 (95% CI 1.77 to 5.33, 35% vs 11%), respectively.
Conclusions Polypill-based therapy significantly improved the achievement of all three ESC targets for BP, LDL and antiplatelet therapy compared with usual care, particularly among those undertreated at baseline.
- cardiac risk factors and prevention
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Contributors All authors are members of SPACE trial steering committees and as such made substantial contributions to the acquisition of the data for the work. RW is the coordinator, AR is the chair and AP is the deputy chair of the SPACE Collaboration. Analyses were undertaken by SS. The first draft of this paper was written by VS and all authors revised the article critically for important intellectual content. All authors provided final approval of the work to be published and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding RW is funded by an NHMRC early career fellowship. The authors have received grants from several research charities and national funding agencies for research on cardiovascular polypills, and from Dr Reddy’s Laboratories for coordination of the SPACE program (www.spacecollaboration.org). The polypills used in the SPACE trials were manufactured and supplied by Dr Reddy’s Laboratories free of charge. Some authors received funding from Dr Reddy’s Laboratories to attend investigator meetings related to the polypill (VS, RW, AP, ST, CRE, NR, AW, AR). All authors are independent from trial funders. All authors accept full responsibility for the conduct of the study, had access to the data and controlled the decision to publish.
Disclaimer None of the funders or Dr Reddy’s Laboratories had any role in study design, the collection, analysis or interpretation of data, the writing of the article or the decision to submit the article for publication.
Competing interests Support for the submitted work: RW is funded by an NHMRC early career fellowship. The authors have received grants from several research charities and national funding agencies for research on cardiovascular polypills, and from Dr Reddy’s Laboratories for coordination of the SPACE programme (www.spacecollaboration.org). The polypills used in the SPACE trials were manufactured and supplied by Dr Reddy’s Laboratories free of charge. Some authors received funding from Dr Reddy’s Laboratories to attend investigator meetings related to the polypill (VS, RW, AP, ST, NR, AW and AR). George Health Enterprises, the social enterprise arm of The George Institute for Global Health (employer of some coauthors) has received investment for the development of fixed dose combination therapy containing statin, aspirin and blood pressure lowering medications.
Patient consent Not required.
Ethics approval Each SPACE trial complied with the Declaration of Helsinki. Local ethical and regulatory approval was obtained for each SPACE trial. Trial participants gave informed consent before taking part.
Provenance and peer review Not commissioned; externally peer reviewed.
Author note Institutions where work performed: (1) International trial coordinating centre: The George Institute for Global Health, University of New South Wales, Australia. (2) National trial coordinating centres: Centre for Chronic Disease Control, New Delhi, India; International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, UK; Julius Center for Health Sciences and Primary Care / Julius Global Health, University Medical Center Utrecht, Utrecht, The Netherlands; National Institute for Health Innovation, University of Auckland, New Zealand; Royal College of Surgeons in Ireland, Dublin, Ireland; The George Institute for Global Health, University of New South Wales, Australia and Hyderabad, India.
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