Major Study Supports Inexpensive Daily Combination Pill For Lowering Cholesterol, Stroke Risk
A daily pill combining four cholesterol and high blood pressure medications taken with low-dose aspirin reduced the risk of heart attacks, strokes and heart-related death by nearly a third by almost a third. international study which should lead to a 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 the advantage, 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 they can reduce heart attacks and deaths – not just risk factors such as 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 yet” on polypills, said Dr. Eugene Yang, a heart specialist at the University of Washington who heads a heart disease prevention group 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 Alabama suggested the advantage.
The new study tested Polycap, a pill from India-based Cadila Pharmaceuticals Ltd., which contains three blood pressure medications (atenolol, ramipril, and hydrochlorothiazide) plus a cholesterol-lowering statin. It sells for around 33 cents a pill in India.
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 receive 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 drug delivery issues and the coronavirus pandemic forced researchers to end it. After a little over four years on average, aspirin alone did not make a significant difference, and the polypill alone showed a trend for modest benefit.
However, the 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 taking placebo.
The side effects were minimal. About 1.5% more of polypill users had dizziness or low blood pressure, but they 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 regarding 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 team up with big insurers to offer the therapy. He hopes committees and policy 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.