A daily pill combining four cholesterol and blood pressure medications taken with low-dose aspirin cut the risk of heart attacks, strokes, and heart-related deaths by nearly a third in a large international study, leading to this “polypil” Wide use is expected. the vision.
For more than a decade, doctors have been testing whether inexpensive, all-in-one combo pills can make it easier to prevent heart disease, the top killer worldwide. Friday’s results reflect their value – not just for poor countries.
“This is for all sensible countries,” Dr. McMaster University in Hamilton, Ontario. Salim Yusuf said. “If rich countries do not want to benefit, it is their prerogative.”
He helped lead the study and gave the result at an American Heart Association conference. They were also published by the New England Journal of Medicine.
At least half a dozen companies sell polypils outside the United States, including many in Europe, but they are not widely used or marketed. Doctors have been reluctant partly because no large, international studies have shown that they can reduce heart attacks and deaths – not just risk factors such as high blood pressure.
“I think it will change with our results,” Joseph said.
An independent expert agreed.
The study on polypils is very important and “the best data we have ever had”, University of Washington cardiologist Dr. Said Eugene Yang, who heads the 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 access to care problems, he said. A small study last year in Alabama suggested benefits.
The new study tested Polycap, a pill from India-based Cadila Pharmaceuticals Ltd., containing three blood pressure medications (atenolol, ramipril and “water pill” hydrochlorothiazide) and a cholesterol-lowering statin. It sells about 33 centimeters 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 must be at least 50 years old and women must be at least 55 years old. All were at moderate risk of heart problems due to high blood pressure, diabetes or other conditions.
They were divided into groups and were given either low-dose aspirin (75 mg), polypil alone, polypil plus aspirin, or placebo tablets. A group was assigned to receive vitamin D, but those results are not yet available. Neither the participants nor their doctors knew what they were taking until the study ended.
The study was run for five years and included 7,000 people, but drug delivery problems and the coronovirus epidemic forced researchers to reduce it. After only four years on average, aspirin alone did not make much of a difference and Polypil alone showed a trend toward modest gains.
However, polypil plus aspirin showed a clear value, reducing heart-related problems and deaths by 31%. Approximately 4% of the people in this group died or suffered one of the heart problems with about 6% on placebo pills.
The side effects were minimal. About 1.5% of polypill users had more dizziness or lower blood pressure, but if it did, they could be switched to lower doses.
“We now have direct evidence” from several studies with clearly consistent results and no safety concerns about the value of polypills, said another expert with no role in the work, Anushka Patel, in Sydney, Australia A cardiologist at the Royal Prince Alfred Hospital.
“Public health effects … can be overwhelming,” she 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 Polypil companies would need to get the approval of regulators to sell the pills in different countries, and that generic drug manufacturers could offer therapy in conjunction with large insurers. He is hoping that guidelines committees and groups such as the Wellcome Trust, World Health Federation and World Health Organization will advocate this approach. Many have already promoted the concept in medical journals.