RT Journal Article
SR Electronic
T1 Effectiveness of polypill for primary and secondary prevention of cardiovascular disease: a pragmatic cluster-randomised controlled trial (PolyPars)
JF Heart
JO Heart
FD BMJ Publishing Group Ltd and British Cardiovascular Society
SP 940
OP 946
DO 10.1136/heartjnl-2023-323614
VO 110
IS 14
A1 Malekzadeh, Fatemeh
A1 Gandomkar, Abdullah
A1 Poustchi, Hossein
A1 Etemadi, Arash
A1 Roshandel, Gholamreza
A1 Attar, Armin
A1 Abtahi, Firoozeh
A1 Sadeghi Boogar, Shahrokh
A1 Mohammadkarimi, Vahid
A1 Fattahi, Mohammad Reza
A1 Mohagheghi, Abbas
A1 Malekzadeh, Reza
A1 Sepanlou, Sadaf G
YR 2024
UL http://heart.bmj.com/content/110/14/940.abstract
AB 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.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.