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Cardiac risk factors and prevention
Original research
Effectiveness of polypill for primary and secondary prevention of cardiovascular disease: a pragmatic cluster-randomised controlled trial (PolyPars)
  1. Fatemeh Malekzadeh1,
  2. Abdullah Gandomkar2,
  3. Hossein Poustchi1,
  4. Arash Etemadi3,
  5. Gholamreza Roshandel4,
  6. Armin Attar5,
  7. Firoozeh Abtahi5,
  8. Shahrokh Sadeghi Boogar6,
  9. Vahid Mohammadkarimi7,
  10. Mohammad Reza Fattahi6,
  11. Abbas Mohagheghi8,
  12. Reza Malekzadeh1,
  13. Sadaf G Sepanlou1
  1. 1Digestive Disease Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran
  2. 2Non-Communicable Disease Research Center, Shiraz University of Medical Sciences, Shiraz, Fars, Iran
  3. 3Metabolic Epidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland, USA
  4. 4Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Sciences, Gorgan, Iran
  5. 5Department of Cardiology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Fars, Iran
  6. 6Gastroenterohepatology Research Center, Shiraz University of Medical Sciences, Shiraz, Fars, Iran
  7. 7Hematology Research Center and Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, Fars, Iran
  8. 8Department of Cardiology, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
  1. Correspondence to Dr Sadaf G Sepanlou, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran 14117-13135, Iran (the Islamic Republic of); sepanlou{at}yahoo.com

Abstract

Background We aimed to investigate the effectiveness of fixed-dose combination therapy (polypill) for primary and secondary prevention of major cardiovascular diseases in a typical rural setting.

Methods The PolyPars Study is a two-arm pragmatic cluster-randomised trial nested within the PARS cohort study, including all residents aged over 50 years in the entire district in southern Iran. The 91 villages underwent random allocation into two arms: the control arm, encompassing 45 clusters, was subjected to non-pharmacological intervention (educational training on healthy lifestyle), whereas the intervention arm, comprising 46 clusters, received the non-pharmacological interventions in conjunction with a once-daily polypill tablet. This tablet comprised two antihypertensive agents, a statin and aspirin. The primary outcome was the first occurrence of major cardiovascular events defined as a composite of hospitalisation for acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, non-fatal and fatal stroke, sudden death and heart failure. The Cox regression model, with shared frailty, was used to account for clustering effect.

Results During December 2015–December 2016, a total of 4415 participants aged 50–75 years were recruited (2200 participants in the intervention arm and 2215 participants in the control arm). The overall median of follow-up duration was 4.6 years (interquartile interval 4.4–4.9). The achieved adherence rate to polypill in intervention arm was 86%. In the control group, 176 (8.0%) of 2215 participants developed primary outcome, compared with 88 (4.0%) of 2200 participants in the polypill group. We found substantial reduction in risk of primary outcome both in relative and absolute scales (HR 0.50, 95% CI 0.38 to 0.65; absolute risk reduction 4.0%, 95% CI 2.5% to 5.3%). No difference in serious adverse events was observed between the two groups.

Conclusions The fixed-dose combination therapy using polypill can safely halve the risk of major cardiovascular diseases at the population level.

Trial registration number NCT03459560.

  • Epidemiology
  • Pharmacology, Clinical

Data availability statement

Data are available upon reasonable request. The PolyPars Study data including patients' demographic data, outcome data, covariates data and a data dictionary will be available to other researchers after publication of the main paper. Only de-identified data will be available. The PolyPars data are stored in the internal server of the Digestive Diseases Research Institute at Tehran University of Medical Sciences (Tehran, Iran) and the Shiraz University of Medical Sciences. Data will be provided to researchers according to a research proposal. After approval of the research proposal by the principal investigators of the study, the data will be provided to the researcher after signing of a data access agreement.

https://doi.org/10.1136/heartjnl-2023-323614

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    Data availability statement

    Data are available upon reasonable request. The PolyPars Study data including patients' demographic data, outcome data, covariates data and a data dictionary will be available to other researchers after publication of the main paper. Only de-identified data will be available. The PolyPars data are stored in the internal server of the Digestive Diseases Research Institute at Tehran University of Medical Sciences (Tehran, Iran) and the Shiraz University of Medical Sciences. Data will be provided to researchers according to a research proposal. After approval of the research proposal by the principal investigators of the study, the data will be provided to the researcher after signing of a data access agreement.

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    Footnotes

    • Contributors FM, HP, AE, SGS and RM—conception and design, analysis and interpretation of data. FM, SGS and RM—drafting of the manuscript. AG, GR, AA, FA, SSB, VM, MRF and AM—acquisition of the data and revising the manuscript for important intellectual content. All authors gave final approval and agreed to be accountable for all aspects of the work ensuring integrity and accuracy. SGS and RM are the guarantors of the study.

    • Funding The PolyPars was funded by the joint collaboration of Digestive Diseases Research Institute in Tehran University of Medical Sciences and the Non-Communicable Diseases Research Center in Shiraz University of Medical Sciences (grant number 910210).

    • Disclaimer Funders had no role in design, implementation and reporting the results of the study.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.