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For more than a decade, doctors have been testing whether cheap all-in-one combination pills could help prevent heart and cardiovascular disease and death.
This November 2020 photo provided by McMaster University shows 75mg aspirin pills, left, and policaps from India-based Cadila Pharmaceuticals, containing one cholesterol drug and three blood pressure drugs, used in the Study. International Polycap 3 (TIPS-3). (AP)
A daily pill combining four cholesterol and blood pressure medications taken with low-dose aspirin has reduced the risk of heart attacks, strokes, and heart-related deaths by nearly a third in a large international study expected to lead to a wider use of this “polypill” “Get closer.
For more than a decade, doctors have been testing whether cheap all-in-one combination pills could make it easier to prevent heart disease, the leading cause of death worldwide. Friday’s results show its value, and not just for poor nations.
“It’s for all sensitive countries,” said Dr. Salim Yusuf of McMaster University in Hamilton, Ontario. “If the rich countries do not want the benefit, that is their prerogative.”
He helped lead the study and gave results at an American Heart Association conference. They were also published by the New England Journal of Medicine.
At least half a dozen companies sell polypills outside the United States, including several in Europe, but they are not widely used or marketed. Doctors have been reluctant in part because there are no large international studies that have shown that they can reduce heart attacks and deaths, not just risk factors like high blood pressure.
“I think this will change with our results,” Yusuf said.
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This November 2020 photo provided by McMaster University shows Dr. Salim Yusuf, principal investigator of the TIPS-3 study and director of the Institute for Population Health Research at McMaster University and Hamilton Health Sciences in Hamilton, Ontario, Canada. (AP)
33 cents per polypill
The study is very important and “the best data we have so far” on polypills, said Dr. Eugene Yang, a cardiologist at the University of Washington who leads a heart disease prevention panel at the American College of Cardiology.
In the United States, “I could definitely see” the use of a polypill in places with huge health disparities and problems with access to care, he said. A small study last year in Alabama suggested a benefit.
The new study tested Polycap, a pill from India-based Cadila Pharmaceuticals Ltd., containing three blood pressure medications (atenolol, ramipril, and the “water pill” hydrochlorothiazide) plus a cholesterol-lowering statin. It is sold in India for about 33 cents a pill.
The researchers enrolled more than 5,700 people, mainly in India and the Philippines, in addition to Colombia, Canada, Malaysia, Indonesia, Bangladesh, Tanzania and Tunisia. The men had to be at least 50 years old and the women at least 55. All had a moderate risk of heart problems due to high blood pressure, diabetes or other conditions.
They were divided into groups and were given low-dose aspirin (75 milligrams), the polypill alone, the polypill plus aspirin, or placebo pills. A group was assigned to get vitamin D, but those results are not yet available. Neither the participants nor their doctors knew who was taking what until the study ended.
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Polypill + aspirin
The study was supposed to last five years and have included 7,000 people, but drug administration problems and the coronavirus pandemic forced researchers to halt it. After just over four years on average, aspirin alone did not make a significant difference and the polypill alone showed a trend toward modest benefit.
However, the polypill plus aspirin showed a clear value, reducing heart-related problems and deaths by 31 percent. About 4 percent of the people in this group died or suffered from one of the heart problems that are being tracked compared to nearly 6 percent of those who took placebo pills.
The side effects were minimal. About 1.5 percent more of the polypill users had dizziness or low blood pressure, but could be switched to a lower dose if that happened, Yusuf said.
“We now have direct evidence” from several studies with clearly consistent results and no safety concerns about the value of polypills, said another paperless expert in this paper, Anushka Patel, a cardiologist at Royal Prince Alfred Hospital in Sydney, Australia.
“The impact on public health … could be huge,” he said.
The study was funded by the Wellcome Trust, a British charity that supports research, Cadila Pharmaceuticals and other public and private research organizations.
Yusuf said that polypill companies would need to get approval from regulators to sell the pills in several countries, and that generic drug makers could partner with large insurers to offer the therapy. He hopes that committees and guiding groups such as the Wellcome Trust, the World Health Federation and the World Health Organization will advocate for this approach. Many have already promoted the concept in medical journals.
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Source: AP
