It’s taken 15 years, but evidence is available now that the polypill saves lives, says Denis Xavier at St John’s Medical College and Research Institute, on findings from an international study that has a large India imprint in terms of participation and benefit for heart patients.
“Heart attacks, strokes and other cardiovascular incidents can be cut by 20-40 per cent through use of a polypill, which combines three blood pressure and one lipid-lowering medications, taken alone or with aspirin,” the study said.
This is the third study on this polypill, says Xavier, professor at St John’s in Bengaluru and head of the division of clinical research. Describing it as “the final frontier”, he says the study provided evidence that the combination medication, that has been around for about 10 years, saved lives.
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Benefits of polypill
Although the formulation of different polypills may vary, the polypill used in this study included 40 mg simvastatin; 100 mg of atenolol; 25mg of hydrochlorothiazide, and 10 mg of ramipril. It can be combined with 75 mg of aspirin a day, a note on the study said.
Xavier hoped the study would help expand its use by reducing the pill-burden (number of pills taken by a person) from five to one, making it easier for people to stick to their treatment regimen. And this, in turn, benefited people prone to heart diseases, especially in India where the risk was higher than Europe or America, he added.
The combination-drug harks back to the time of pharma-industry doyens like Anji Reddy, founder of Dr Reddy’s Laboratories and IA Modi, founder of Cadila Pharma, who were keen on the product due to its “benefit to society”, recalls Xavier.
The study involved over 5,700 patients across 89 centres. India contributed almost half the number, with 2,700 patients across 39 centres, Xavier told BusinessLine. The medication was provided by Cadila Pharma. The international study was done by St John’s in collaboration with Canada’s Population Health Research Institute (PHRI) of McMaster University and Hamilton Health Sciences.With about taken eight years to complete the study globally, participants took the medication for an average of 4.5 years. The study has been published in the New England Journal of Medicine.
“A polypill is not only effective, it is likely to be cost effective since it is based on using commonly used generic drugs,” observed Prem Pais, co-principal investigator of the study and professor at St. John’s.
Pointing out that the adverse events were minimal, Xavier said that most people could take the medication in the fixed-dose combination. Some cardiac doctors had pointed out that a fixed dose made it inconvenient for doctors to vary the dosage for different patients.
Salim Yusuf, co-principal investigator for the study and professor of medicine at McMaster University in Canada, said, “This is the start of a transformational approach to preventing heart disease, we could save millions of people from experiencing serious heart disease or stroke each year with effective use of the polypill and aspirin.”
Balram Bhargava, Director General, Indian Council of Medical Research observed that the polypill was worth considering for widespread use. “Costs can be further reduced for our people if and when it enters our national programs.”
The study was supported by agencies including Wellcome Trust UK, Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada and Hamilton Health Sciences Research Institute, Canada, the note said.
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