Big study supports cheap combo pill to reduce heart risk



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A daily pill combining four cholesterol and blood pressure medications taken with low-dose aspirin reduced the risk of heart attack, stroke and cardiac death by nearly a third in one. large international study which should lead to wider use of this “polypill” approach.

For more than a decade, doctors have been testing whether inexpensive all-in-one combination pills could help prevent heart disease, the world’s leading killer. Friday’s results show their value – and not just for poor countries.

“It’s for all sane countries,” said Dr. Salim Yusuf of McMaster University in Hamilton, Ont. “If the rich countries don’t want it, that’s their prerogative.”

He helped lead the study and delivered results at an American Heart Association conference. They have also been published by the New England Journal of Medicine.

At least half a dozen companies sell polypills outside of the United States, including several in Europe, but they are not widely used or marketed. Doctors have been reluctant in part because no large international study has shown that they can reduce heart attacks and death – not just risk factors like high blood pressure.

“I think that will change with our results,” Yusuf said.

An independent expert agreed.

The study is very important and “the best data we have so far” on polypills, said Dr Eugene Yang, a heart specialist at the University of Washington who heads a heart disease prevention panel for the American College of Cardiology.

In the United States, “I could definitely see” using a polypill in places with large health disparities and problems accessing care, he said. A small study last year in Alabama suggested an advantage.

The new study tested Polycap, a pill from Indian company Cadila Pharmaceuticals Ltd. which contains three blood pressure medications (atenolol, ramipril and the hydrochlorothiazide “water pill”) as well as a cholesterol-lowering statin. It sells for around 33 cents a pill in India.

The researchers recruited more than 5,700 people, mainly from India and the Philippines as well as Colombia, Canada, Malaysia, Indonesia, Bangladesh, Tanzania and Tunisia. Men had to be at least 50 years old and women at least 55 years old. All had a moderate risk of heart problems due to high blood pressure, diabetes or other conditions.

They were divided into groups and received either low-dose aspirin (75 milligrams), polypill alone, polypill plus aspirin, or placebo pills. One group has been assigned to vitamin D, but these results are not yet available. Neither the participants nor their doctors knew who was taking what until the study was over.

The study was supposed to last five years and include 7,000 people, but issues with drug delivery and the coronavirus pandemic forced researchers to cut it short. After a little over four years on average, aspirin alone did not make a significant difference, and polypill alone showed a trend of modest benefit.

However, polypill plus aspirin showed a clear value, reducing heart problems and deaths by 31%. About 4% of people in this group died or suffered from one of the heart problems followed compared to almost 6% of those who took placebo pills.

The side effects were minimal. About 1.5% of the more polypill users had dizziness or low blood pressure, but they might switch 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 expert without a role in this work, Anushka Patel, cardiologist at the Royal Prince Alfred Hospital in Sydney. , in Australia.

“The impact on public health … could be huge,” she said.

The study was funded by the Wellcome Trust, a UK charity that supports research; Cadila Pharmaceuticals; and other public and private research organizations.

Yusuf said polypill companies would need to seek approval from regulators to sell the pills in various countries, and generic drug makers could partner with big insurers to offer the treatment. He hopes committees and steering 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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The Associated Press’s Department of Health and Science receives support from the Department of Science Education at the Howard Hughes Medical Institute. The AP is solely responsible for all content.

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