Polypill together with aspirin can reduce heart attacks and strokes by 40%: study

The International Polycap Study 3 (TIPS-3) was conducted in 89 centers in nine countries, including 39 centers in India.The study took approximately 8 years to complete globally with participants taking medication for an average of 4 ,5 years

India, November 16, 2020 Heart attacks, strokes and other cardiovascular accidents can be reduced by 20 to 40% through the use of a polypill that combines three blood pressure medications and a lipid lowering agent taken alone or with aspirin .

TIPS-3, an international study in people with no previous heart disease, but at intermediate risk, found that the polypill alone can reduce the risk of heart attack, stroke, revascularization procedures (such as angioplasty or heart surgery) or other cardiovascular accidents of about 20 percent. The combination of polypill and aspirin can reduce these cardiovascular events by up to 40%.

A polypill is not only effective, it is likely to be cost-effective as it relies on the use of commonly used generic drugs, said Prem Pais, lead co-researcher on the study and professor at 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 into one pill and is taken once a day, which should improve adherence.

This is the beginning of a transformative approach to preventing heart disease, we could save millions of people from serious heart disease or stroke every year with effective use of the polypill and aspirin, said Salim Yusuf, principal co-investigator of the study. and professor of medicine at McMaster University in Canada.

As the most common serious disease globally, cardiovascular disease causes approximately 18 million deaths each year, of which over 80% in low- and middle-income countries. More than 40 million people worldwide are affected by cardiovascular events every year, including those recovering from a heart attack or stroke.

Professor (Dr.) Balram Bhargava, Director General of the Indian Council of Medical Research (ICMR) said this result is very encouraging and I am so pleased that the Indian investigators led by Dr Prem Pais and Dr Denis Xavier at St John’s made an important global contribution. This is another example of India’s contribution to global science. The polypill strategy is worth considering for widespread use. Costs can be further reduced for our people if and when they enter our national programs.

The study was conducted in 89 centers in nine countries, including 39 centers in India, and was coordinated globally by McMaster University’s Population Health Research Institute (PHRI) and Hamilton Health Sciences in Canada. In India it was coordinated by the St. John’s Medical College and Research Institute in Bangalore.

This study took approximately 8 years to complete globally with participants taking medication for an average of 4.5 years. Studies of this nature are very difficult to conduct as they involve many centers and participants must be followed at least twice a year. In India we recruited 49% of the total sample size. This has been possible for us as we have built a collaboration for over two decades and most of the investigators are close friends of ours who are passionate about the scientific question, said Denis Xavier, a professor at St. John’s and head of the clinical research division.

Today, the study was published in the New England Journal of Medicine and presented by lead co-researchers at the American Heart Association scientific sessions in 2020.

The study of 5,714 people from nine countries, most notably India and the Philippines, looked at the polypill alone versus a placebo; aspirin alone versus a placebo and polypill plus aspirin versus a double placebo. The men in the study were 50 or older and the women 55 or older.

Although the formulation of different polypills may vary, the polypill used in this study included 40 mg of simvastatin; 100 mg of atenolol; 25 mg of hydrochlorothiazide and 10 mg of ramipril. It can be combined with 75 mg of aspirin per day.

The next generation of polypills will likely have a greater reduction in risk factors and thus may be even more effective in reducing heart disease with improved polypill formulations, Yusuf said.

The study found that only 4.4% of those who took the polypill alone had a heart attack, stroke, revascularization procedure, or died from cardiovascular problems compared with 5.5% who took the placebo. Of those who took aspirin alone the incidence was 4.1% compared to 4.7% of those on placebo.

The benefits of the combined polypill plus aspirin in those who continued taking the drugs without interruption were greater, and their use was associated with a 40% risk reduction. Among those who took the polypill along with aspirin, 4.1% had a severe cardiovascular event, compared with 5.8% of those who had double placebo.

Diana Tay, senior partner in innovations at Wellcome Trust UK, said: We are delighted with the results of the TIPS-3 study, supported by Wellcome.

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.