Convenient for patients as it combines several effective drugs in a single pill and is taken once a day.
Heart attacks, strokes, and other cardiovascular events can be reduced by 20 to 40 percent by using a polypill, three blood pressure medications, and a lipid-lowering drug taken alone or with aspirin.
An international study of people without a history of heart disease or stroke, but who are at moderate risk, found that the polypill alone can reduce the risk of heart attack, stroke, revascularization procedures (such as angioplasty or cardiac surgery), or other cardiovascular incidents by about 20 percent and that Combination of polypill and aspirin can reduce these cardiovascular events by up to 40 percent.
“This is the beginning of a transformative approach to heart disease prevention. With the effective use of polypill and aspirin, we could save millions of people from serious heart disease or stroke each year, ”said Salim Yusuf, co-principal investigator for the study and professor of medicine at McMaster University in Canada.
Cardiovascular disease, the most common serious illness in the world, causes around 18 million deaths annually, more than 80 percent of them in low and middle income countries. Cardiovascular events affect more than 40 million people around the world each year, including those who are recovering from a heart attack or stroke.
“A polypill is not only effective, but also likely inexpensive because it is based on the use of commonly used generic drugs,” said Prem Pais, co-principal investigator on the study and professor at St. John’s Medical College and Research Institute in Bangalore, India. “A polypill is convenient for patients because it combines several effective drugs in a single pill and is taken once a day, which should improve adherence.”
The study was conducted in 89 centers in nine countries and coordinated worldwide by the Population Health Research Institute (PHRI), a joint institute of McMaster University and Hamilton Health Sciences.
“In addition to quitting smoking, high blood pressure and high cholesterol are the most modifiable risk factors for cardiovascular disease. So we wanted to test a polypill with aspirin, which has been shown to be of value in people with established vascular disease,” said Yusuf, Executive Director of PHRI and cardiologist at Hamilton Health Sciences.
Today the study was published in The New England Journal of Medicine The Co-Principal Investigators are expected to present the results of the study at the 2020 American Heart Association scientific sessions.
“The results of the study have an impact on reducing the burden of cardiovascular disease worldwide. Even if only a third of eligible people are given a polypill, its use is likely to be avoided by millions of people with serious cardiovascular disease worldwide, “Pais said. “It also opens the way for a community-based approach where health workers work under medical supervision and the pill can reach large numbers of people.”
“The widespread use of the polypill will benefit people in both rich and poor countries as there are large treatment gaps in the population around the world,” said Philip Joseph, co-author of the study, associate professor of medicine at McMaster. Researcher at PHRI and cardiologist at Hamilton Health Sciences.
The information comes from the TIPS-3 study (International Polycap Study 3), which followed participants for an average of 4.6 years.
The study, involving 5,714 people from nine countries, particularly India and the Philippines, looked at the polypill alone versus a placebo. Aspirin alone versus a placebo and the polypill plus aspirin versus a double placebo. The men in the study were 50 years or older and the women were 55 years or older.
Although the formulation of different polypills may vary, the polypill used in this study contained 40 mg simvastatin; 100 mg of atenolol; 25 mg hydrochlorothiazide and 10 mg ramipril. It can be combined with 75 mg aspirin per day.
“The next generation of polypills is likely to have greater reductions in risk factors, and therefore may be even more effective in reducing heart disease if the formulations of polypills improve,” said Yusuf.
The polypill tested in this study is currently available in India and some countries in Africa. Various polypills are available in Europe, South America and South Korea, and new polypills are being developed in North America and China.
The study found that only 4.4 percent of those who took the polypill alone had a heart attack, stroke, revascularization procedure, or died of cardiovascular problems, compared with 5.5 percent who took the placebo. Of those who took aspirin only, the incidence was 4.1 percent compared with 4.7 percent of those who took placebo.
The benefits of the combined polypill plus aspirin were greater in those who continued to take the medication without interruption, and its use was associated with a 40 percent reduction in risk. 4.1 percent of patients who took the polypill with aspirin had a major cardiovascular event, compared with 5.8 percent of those who took double the placebo.
The TIPS-3 study is supported by several agencies including Wellcome Trust UK, Canadian Health Research Institutes, the Heart and Stroke Foundation of Canada, the Hamilton Health Sciences Research Institute, and Cadila Pharmaceuticals.
Diana Tay, Senior Partner for Innovation at Wellcome Trust, said: “We are pleased with the results of the TIPS-3 study, which Wellcome supported as part of our previous Affordable Healthcare funding program in India, to test whether the polypill was used for reduction of cardiovascular disease can contribute in populations at risk.
“We hope that the results of the study will stimulate the polypill to prevent cardiovascular events, which remain a major cause of death worldwide.”
Several senior Canadian cardiology researchers congratulated on the study.
John Cairns, Dean Emeritus of the University of British Columbia Medical School and cardiologist, said, “We have long recognized that primary prevention is important to reduce heart attacks and strokes. These researchers have taken a brilliant step ahead with the factorial design testing the polypill with and without aspirin, and the study contains enough power to know that the results are very compelling, especially regarding the use of the polypill with aspirin . ”
Gilles Dagenais, clinical investigator, Quebec Heart and Lung Institute Research Center; The professor emeritus at Laval University and an author of the study said, “The influence of the polypill with aspirin on reducing cardiovascular risk in TIPS-3 and the low cost of these combined drugs are an important addition to primary prevention of cardiovascular stress – Decrease diseases. ”
Michael Farkouh, professor and vice chairman of the Department of Medicine and director of the Richard Lewar Center of Excellence in Heart and Stroke at the University of Toronto, said, “Polypill intervention addresses the challenges associated with adhering to our most effective primary prevention strategies. Frontline doctors now have significant evidence that they can virtually improve our care and save countless lives in Canada and abroad. ”
Reference: November 13, 2020, New England Journal of Medicine.
Funding: Wellcome Trust UK, Canadian Health Research Institutes, Canadian Heart and Stroke Foundation, Hamilton Health Sciences Research Institute, and Cadila Pharmaceuticals.