One daily pill combined with four cholesterol and blood pressure medications taken with low doses of aspirin reduced the risk of heart attack, stroke and heart-related death in an international study, leading to widespread use of this “polypil” in international studies. Approach
For more than a decade, doctors have been testing whether cheap, single combo pills can make heart disease easier to prevent, the top killer worldwide. Friday’s results show their value – and not just for poor countries.
“It’s for all sensible countries,” said Dr. Salim Youssef of MM Commaster University in Hamilton, Ontario. “If rich countries don’t want to benefit, that’s their prerequisite.”
He helped lead the study and gave results at a conference of the American Heart Association. They were also published by the New England Journal of Medicine.
At least half a dozen companies sell polypil outside the United States, including some in Europe, but they are not widely used or in marketing. Doctors have been reluctant in part because no large, international studies have shown they can reduce heart attacks and deaths – not just risk factors such as high blood pressure.
Yusuf said, “I think this will change with our results.
An independent expert agreed.
The study on polypills is very important and “we have the best data so far,” said Dr. John H. Snyder, of the University of Washington, who specializes in heart disease prevention panels at the American College of Cardiology. Said Eugene Yang.
In the United States, he said, “I can definitely see” the use of polypills in places with access to large health inequalities and care problems. A small study Indicated benefits in Alabama last year.
The new study tested a pill, apical tested, from India-based Cadila Pharmaceuticals Ltd., which contained three blood pressure drugs (ten tenolol, ripipril and a “water pill” hydrochlorothiazide) as well as a cholesterol-lowering statin. It sells for about 33 cents a tablet in India.
The researchers enrolled more than 5,700 people, mainly in India and the Philippines plus Colombia, Canada, Malaysia, Indonesia, Bangladesh, Tanzania and Tunisia. Men should be at least 50 years old and women at least 55 years old. Everyone had a moderate risk of heart problems due to high blood pressure, diabetes or other conditions.
They were divided into groups and given either low-dose aspirin (75 mg), a single polypil, a polypil plus aspirin, or a placebo pill. One group was assigned to receive vitamin D, but the results are not yet available. Neither the participants nor their doctors knew who was taking what until the study was completed.
The study was to run for five years and involve 7,000 people, but drug distribution problems and a coronavirus epidemic forced researchers to shorten it. After an average of four years, there was no significant difference in aspirin alone, and polypil alone showed a trend toward modest gain.
However, polypil plus aspirin has a clear value, reducing heart-related problems and deaths by 31%. About 4% of people in this group died or suffered from one of the heart problems, compared to 6% of people on placebo pills.
The side effects were minimal. The U.S.F. said about yp. 1.5% of Polypill users had dizziness or low blood pressure, but if that happened they could turn up in small amounts, Yusuf said.
Anushka Patel, a cardiologist at the Royal Prince Alfred Hospital in Sydney, Australia, said there was no role in the work.
“The impact on public health … could be huge,” he said.
The study was funded by the Wellcome Trust, a British charity that supports the research; Cadila Pharmaceuticals; And other public and private research institutions.
Yusuf said polypil companies have to seek regulatory approval to sell pills in different countries, and general drug manufacturers can team up with large insurance companies for treatment. He hopes that steering committees and 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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