Evidence map›Paper›PMID 33186492›Full record

Trial reportThe New England journal of medicine2021

Polypill with or without Aspirin in Persons without Cardiovascular Disease.

Salim Yusuf, Philip Joseph, Antonio Dans, Peggy Gao, Koon Teo, Denis Xavier, Patricio López-Jaramillo, Khalid Yusoff, Anwar Santoso, Habib Gamra and 12 more

3 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 96 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
96citing papers in PubMed, 10 pooled it
35.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01646437 phase3completednot on this map

The International Polycap Study 3 (TIPS-3) is a Randomized Double-blind Placebo-controlled Trial for the Evaluation of a Polycap, Low Dose Aspirin and Vitamin D Supplementation in Primary Prevention

TypeinterventionalSponsorPopulation Health Research InstituteRan2012 to 2021Enrolled7,793ConditionsCardiovascular Disease, Fractures, CancersArmsPolycap, Aspirin, Vitamin D, Matching Placebo
NCT05347823 unknown statusnot on this mapstarted 2022, after this paper: background citation

Study of Adherence to Antihypertensive Drugs and Statins in the Population of Subjects With Hypertension Followed at SIIA Centers, Using an Innovative Monitoring Based on Hair Analysis

TypeobservationalSponsorAzienda Ospedaliera Universitaria Integrata VeronaRan2022 to 2023Enrolled200ConditionsArterial Hypertension, Dyslipidemias, Antihypertensive Drugs, StatinsArmsHair analysis for drug concentration
NCT07032389 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

Polypill Strategy for the Treatment of Patients After Acute Coronary Syndromes - A Multicenter Randomized Controlled Trial

TypeinterventionalSponsorUniversity of Texas Southwestern Medical CenterRan2025 to 2030Enrolled1,000ConditionsAcute Coronary SyndromeArmsPolypill
3 · Its place in the literature

Who cites it

96 citing papers in PubMed, 10 syntheses or guidelines pooled it, 260 citations in OpenAlex.

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  11. Low-Dose Telmisartan/Amlodipine in Essential Hypertension: A Phase III Trial.Journal of clinical hypertension (Greenwich, Conn.) · 2026
    Trial
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  20. Comparison of Fixed-Dose Clopidogrel/Asetylsalicylic Acid Combination and Standard Loading Strategy During Percutaneous Coronary Intervention in Chronic Coronary Syndrome.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025
    Observational

36 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 3 institutions in 7 countries.

Salim YusufFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).ORCID 0000-0003-4776-5601
Philip JosephFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
Antonio DansFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
Peggy GaoFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
Koon TeoFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
Denis XavierFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
Patricio López-JaramilloFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
Khalid YusoffFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
Anwar SantosoFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
Habib GamraFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
Shamim TalukderFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
Courtney ChristouFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
Preeti GirishFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
Karen YeatesFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
Freeda XavierFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
Gilles DagenaisFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
Catalina RochaFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
Tara McCreadyFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
Jessica TyrwhittFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
Jackie BoschFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).ORCID 0000-0001-6292-4207
Prem PaisFrom the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
International Polycap Study 3 Investigators
Population Health Research Institute · CAQueen's University · CAUniversity of Monastir · TN

Funding

CIHR 119993Wellcome 089725/B/09/ZWellcome Trust 089725
6 · The paper itself

Abstract

backgroundA polypill comprising statins, multiple blood-pressure-lowering drugs, and aspirin has been proposed to reduce the risk of cardiovascular disease.

methodsUsing a 2-by-2-by-2 factorial design, we randomly assigned participants without cardiovascular disease who had an elevated INTERHEART Risk Score to receive a polypill (containing 40 mg of simvastatin, 100 mg of atenolol, 25 mg of hydrochlorothiazide, and 10 mg of ramipril) or placebo daily, aspirin (75 mg) or placebo daily, and vitamin D or placebo monthly. We report here the outcomes for the polypill alone as compared with matching placebo, for aspirin alone as compared with matching placebo, and for the polypill plus aspirin as compared with double placebo. For the polypill-alone and polypill-plus-aspirin comparisons, the primary outcome was death from cardiovascular causes, myocardial infarction, stroke, resuscitated cardiac arrest, heart failure, or revascularization. For the aspirin comparison, the primary outcome was death from cardiovascular causes, myocardial infarction, or stroke. Safety was also assessed.

resultsA total of 5713 participants underwent randomization, and the mean follow-up was 4.6 years. The low-density lipoprotein cholesterol level was lower by approximately 19 mg per deciliter and systolic blood pressure was lower by approximately 5.8 mm Hg with the polypill and with combination therapy than with placebo. The primary outcome for the polypill comparison occurred in 126 participants (4.4%) in the polypill group and in 157 (5.5%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.63 to 1.00). The primary outcome for the aspirin comparison occurred in 116 participants (4.1%) in the aspirin group and in 134 (4.7%) in the placebo group (hazard ratio, 0.86; 95% CI, 0.67 to 1.10). The primary outcome for the polypill-plus-aspirin comparison occurred in 59 participants (4.1%) in the combined-treatment group and in 83 (5.8%) in the double-placebo group (hazard ratio, 0.69; 95% CI, 0.50 to 0.97). The incidence of hypotension or dizziness was higher in groups that received the polypill than in their respective placebo groups.

conclusionsCombined treatment with a polypill plus aspirin led to a lower incidence of cardiovascular events than did placebo among participants without cardiovascular disease who were at intermediate cardiovascular risk. (Funded by the Wellcome Trust and others; TIPS-3 ClinicalTrials.gov number, NCT01646437.).

Indexed as

AgedAnticholesteremic AgentsAntihypertensive AgentsAspirinAtenololBlood PressureCardiovascular DiseasesCholesterol, LDLDrug CombinationsDrug Therapy, CombinationFemaleHumansHydrochlorothiazideIncidenceMaleMedication AdherenceAnticholesteremic AgentsAntihypertensive AgentsAspirinAtenololCholesterol, LDLDrug CombinationsHydrochlorothiazidePlatelet Aggregation InhibitorsSimvastatin

Identifiers

PMID33186492
PMCPMC7116860
OpenAlexW3101533148

What Socratic holds

Texttitle and abstract
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.