A single pill that contains five life-saving drugs to guard against heart disease and strokes has come closer to reality after passing its first big test.
A team of Indian and Canadian announced that the five-in-one 'polycap', an experimental combo formulated by Cadila Pharmaceuticals of Ahmedabad, was as effective as drugs taken separately, with no greater side effects.
Their study tested the polypill on 2,053 Indians aged 48-80 years at 50 centres across India, who did not have heart disease but had a single risk factor like high blood pressure, diabetes, obesity or smoking. Reductions were seen in both blood pressure and cholesterol without any major side effects.
The study concluded that if the pill was given to this profile of patients, it would reduce risk of heart disease by 62 per cent and stroke by 48 per cent.
The study was led by Salim Yusuf of McMaster University in Hamilton, Ontario, and Prem Pais of St. John's Medical College in Bangalore. The findings were presented on Monday at the cardiology college's conference in Florida and published online by the British medical journal Lancet.
The concept of a polypill for everyone over 55 to cut heart disease by up to 80 per cent was mooted over five years ago, but slow progress has been made since. The polypill used in the latest study combines five active pharmacological ingredients widely available separately - aspirin, a statin to lower cholesterol and three blood pressure-lowering drugs - as well as folic acid.
The approach needs far more testing - as well as approval from the Food and Drug Administration, something that could take years - but it could make heart disease prevention much more common and more effective, doctors say.
Ahead of the competition
Several other teams of scientists are working on the polypill approach, notably A UK team led by Simon Thom of the Imperial College of London. They have been testing a four-in-one polypill called the 'red heart pill, with the backing of the Wellcome Trust and the British Heart Foundation, which could cost as little as 15 euros per person per year.
Thom said it would be at least five years before there was enough data to convince drug regulators to approve a polypill. However, the Polycap is the furthest along, and this is the largest study of such a combination so far.
Formulating a single pill of five drugs that work in five different ways is a complex task - more complex than simply mixing the medicines. Pills have coatings and other ingredients that control the rate at which the medicine is released into the bloodstream. The polypill must be designed so that the five drugs work as intended, and the study seems to show that the Polycap has achieved this.
However, the polypill has its fair share of sceptics. Many doctors in India and abroad say that a quickfix pill would tempt people even with a single risk factor to pop it in lieu of the more important factors of diet and exercise.
In India, however, cheap generics of all the ingredients are available, and it would be better to administer these according to a patient's need rather than a 'one-size-fits-all' pill.
Other Indian doctors say the pill will mostly benefit people in the west where medicines are expensive.