Heart attacks, strokes and other cardiovascular incidents can be cut by 20 to 40 per cent through the use of a polypill which combines three blood pressure and one lipid-lowering medications taken alone or with aspirin, finds The International Polycap Study 3 (TIPS-3).
The study was published in The New England Journal of Medicine and presented at the 2020 American Heart Association scientific sessions.
TIPS-3 is an international study of people with no prior heart disease, but intermediate risk. The study included 5,714 participants from nine countries, particularly India and the Philippines. It was conducted in 89 centres, including 39 centres in India recruiting about 49% of the total sample size.
The polypill used in this study included 40 mg simvastatin; 100 mg of atenolol; 25mg of hydrochlorothiazide, and 10 mg of ramipril. It can be combined with 75 mg of aspirin a day.
The study investigated the polypill alone compared to a placebo; aspirin alone versus a placebo, and the polypill plus aspirin versus double placebo. The men in the study were 50 or older and the women were 55 or older.
The study found that only 4.4 per cent of those who took the polypill alone had a heart attack, stroke, revascularization procedure or died of cardiovascular problems compared to 5.5 per cent who took the placebo. Among those who took the polypill along with aspirin, 4.1 per cent experienced a serious cardiovascular event, compared to 5.8 per cent of those who had the double placebo.
The findings showed that the polypill alone may reduce the risk of heart attack, stroke, revascularization procedures (such as angioplasty or heart surgery) or other cardiovascular incidents by about 20 per cent. The benefits of combined polypill plus aspirin in those who continued to take the medications without interruption were larger and their use was associated with a 40 per cent reduction in risk.
“A polypill is not only effective, but it is also likely to be cost-effective since it is based on using commonly used generic drugs,” said Prem Pais, co-principal investigator of the study and professor of St. John’s Medical College and Research Institute in Bangalore, India. “A polypill is convenient for patients to use as it combines several effective drugs in a single pill and is taken once a day, which would be expected to improve adherence.”
The study took about 8 years to complete globally with participants taking medication for an average of 4.5 years. It was coordinated globally by the Population Health Research Institute (PHRI) of McMaster University and Hamilton Health Sciences in Canada. In India it was coordinated by St. John’s Medical College and Research Institute in Bangalore.
The TIPS-3 study is supported by several agencies including Wellcome Trust UK, Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, Hamilton Health Sciences Research Institute, Canada, St. John’s Research Institute, Bangalore and Cadila Pharmaceuticals.