New study confirms combo pill alone and with aspirin lowers heart disease risk

November 13, 2020

Embargoed until 12:10 p.m. CT/1:10 p.m. ET, Friday, Nov. 13, 2020

DALLAS, Nov. 13, 2020 -- A single, daily pill combining blood pressure and cholesterol medications, along with the addition of a daily dose of aspirin, reduced cardiovascular disease events in people at risk for heart disease, according to late-breaking research presented today in a late-breaking clinical trial presentation at the American Heart Association's Scientific Sessions 2020. The virtual conference, held Friday, November 13 - Tuesday, November 17, 2020, is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science for health care worldwide. The manuscript of this study is simultaneously published today in The New England Journal of Medicine.

The medicine tested in this study is a fixed-dose combination therapy (or a "polypill") combining blood pressure and cholesterol lowering medications. Researchers assessed the polypill's effects on cardiovascular disease events - such as heart attack, stroke and cardiovascular death - when given alone or with aspirin, in patients considered at intermediate risk of cardiovascular disease. They also examined the effects of aspirin alone.

The International Polycap Study (TIPS)-3 is a large, randomized, placebo-controlled trial conducted in nine countries. The study included 5,700 people considered at intermediate risk of developing heart disease. The average age of the participants was 64 years, and 47% were male.

Participants were randomly assigned to different interventions: 1) 75 mg daily of aspirin; 2) a polypill combining blood pressure and cholesterol medication daily; 3) polypill and 75 mg aspirin daily; or 4) vitamin D 5,000 IU daily. Each intervention included a control group who received a matching placebo. The medications in the polypill were atenolol 100mg, ramipril 10mg, hydrochlorothiazide 25 mg, and simvastatin 40 mg.

Over the follow-up period of nearly five years, participants were monitored for the first occurrence of a major cardiovascular event, such as non-fatal heart attack, non-fatal stroke, heart failure, resuscitated cardiac arrest or cardiovascular death.

The analysis of all patient groups found: "Aspirin should be prescribed with a polypill in primary prevention for patients at intermediate risk of heart disease," said Salim Yusuf, M.D., B.S., D. Phil., a co-author of the study and professor of medicine at McMaster University School of Medicine in Toronto, Canada. "Our study results provide important data regarding the role of the polypill in preventing the development of heart disease."

Co-author Prem Pais, M.B.B.S., M.D., a professor in the division of clinical research and training at St. John's Research Institute in Bangalore, India, added, "We were also interested in evaluating if combining blood pressure and cholesterol reduction medications in a single pill would be effective for this population. This is a cost-effective strategy that could help meet global targets of reducing CVD by 30% by 2030."

"Use of a polypill plus aspirin can avert 3 - 5 million cardiovascular deaths globally," said Yusuf. "Future polypills, with newer statins, may reduce LDL cholesterol and blood pressure to a greater extent and could reduce cardiovascular disease risk greater than 50%."
Co-authors are Philip Joseph, M.D.; Antonio L Dans, M.D.; Jackie Bosch, Ph.D.; Denis Xavier, M.D., M.Sc.; Patricio Lopez-Jaramillo, M.D., Ph.D.; Khalid Yusoff, M.B.B.S.; Anwar Santoso, M.D., Ph.D.; Shamim Talukder, M.B.B.S., M.Phil.; Habib Gamra, M.D.; Karen Yeates, M.D.; Paul Camacho Lopez, M.D.; Jessica Tyrwhitt, B.Sc.; Peggy Gao, M.Sc. and Koon Teo, M.D. Author disclosures are in the abstract. The study is funded through unrestricted grants by the Wellcome Trust, Canadian Institutes for Health Research (#259128), Cadila pharmaceuticals, the Population Health Research Institute (PHRI), Heart and Stroke Foundation of Ontario (#000448), Philippines Council for Health Research and Development, Secretaria de Salud del Departamento de Santander (Colombia) and St. John's Research Institute (India).

Session: LBS.02. Bending the Curve for CV Disease - Precision or Polypill?

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