Heart attacks, strokes, and other cardiovascular incidents can be cut by 20 to 40% through the use of a polypill, which combines three blood pressure and one lipid-lowering medication taken alone or with aspirin.
TIPS-3, an international study of people with no previous heart disease but intermediate risk, found the polypill alone may reduce the risk of heart attack, stroke, revascularization procedures such as angioplasty or heart surgery other cardiovascular incidents by about 20%. The combination of the polypill and aspirin may reduce those cardiovascular events by up 40%.
“A polypill is not only effective, it is 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.”
“This is the start of a transformational approach to preventing heart disease, we could save millions of people from experiencing serious heart disease or stroke each year with effective use of the polypill and aspirin,” said Salim Yusuf, co-principal investigator for the study and professor of medicine at McMaster University in Canada.
As the most common serious illness globally, cardiovascular diseases account for about 18 million deaths each year, with more than 80% of those in low-income and middle-income countries. More than 40 million people worldwide are impacted by cardiovascular events each year if those who recover from a heart attack or stroke are included.
Balram Bhargava, director-general of the Indian Council of Medical Research (ICMR), said, “This result is very encouraging, and I am so pleased that Indian investigators led by Prem Pais and Denis Xavier at St John’s have made a major 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 it enters our national programs.”
The study was conducted in 89 centers from nine countries, including 39 centers in India. 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.
This study took about eight 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 it involves many centers and participants have to be followed up at least twice a year. We in India recruited 49% of the total sample size. This was possible for us as we had built a collaboration over two decades and most of the investigators are our close friends who are keen on the scientific question”, said Denis Xavier, Professor at St John’s and head of the division of clinical research.
On 16 November 2020, the study was published in The New England Journal of Medicine and presented by the co-principal investigators at the 2020 American Heart Association scientific sessions.
The study of 5,714 people from nine countries, particularly India and the Philippines, looked at 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.
Although the formulation of different polypills may vary, the polypill used in this study included 40 mg simvastatin, 100 mg of atenolol, 25mg of hydrochlorothiazide, and 10 mg ramipril. It can be combined with 75 mg of aspirin a day.
“The next generation of polypills will likely have greater reductions in risk factors and so can be even more effective at cutting heart disease as the formulations of polypills improve,” said Yusuf.
The study found that only 4.4% of those who took the polypill alone had a heart attack, stroke, revascularization procedure, or died of cardiovascular problems compared to 5.5% who took the placebo. Of those who took just the aspirin, the incidence was 4.1% compared to 4.7% of those with the placebo.
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% reduction in risk. Among those who took the polypill and aspirin, 4.1% experienced a severe cardiovascular event, compared to 5.8% of those who had a double placebo.
Diana Tay, senior partner in innovations at Wellcome Trust UK, said, “We are delighted by the findings from the TIPS-3 study, which was 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.