May 25, 2011
A four-in-one combination pill which can halve the predicted risk of heart disease and stroke. Photograph: Wellcome Trust/PA
A once-a-day tablet containing four common drugs to lower cholesterol and blood pressure has been shown to halve the risk of heart disease and stroke in those who take it, opening the way to a simple form of global mass preventative medication.
The polypill has been a gleam in scientists’ eyes for more than a decade. In 2001, the World Health Organisation and the Wellcome Trust – which funded the trial – convened a meeting to discuss the possibility of producing a single combination pill which would be a potent weapon in the battle against chronic diseases.
A single pill, the meeting concluded, would make it more likely that those at risk of heart disease, stroke or diabetes would stick to their medication and would be much cheaper than taking several drugs.
Results from the first international trial of a polypill containing drugs to lower cholesterol and blood pressure – and also aspirin – show that it could make a major difference to the toll of chronic disease, even though they are not as good as the original polypill pioneers hoped.
Professors Sir Nicholas Wald and Malcolm Law, in a seminal article in 2003, anticipated that the polypill could cut the risk of heart disease and strokes by 80% with few side-effects.
In practice, in the trial which took place in the UK, Australia, Brazil, India, New Zealand, the Netherlands and the US, reported in the open access journal PLoS One, the predicted risk was cut by 50%, not 80%. And there were more side-effects than expected, affecting about one in six of those who took part in the trial. Most of the side-effects were mild but about one participant in 20 stopped taking the polypill as a result.
Professor Anthony Rodgers of the George Institute for Global Health, who led the trial, said he thought the results were “more realistic than the original hope, which I think now people are realising was more like hype”. He described the results as “very good, but not the panacea it was originally thought to be”.
Most side-effects were caused by the aspirin in the pill, which is known to cause gastric bleeding in some people. But aspirin has also been shown to cut the risk of cancer, which gives the polypill a further dimension. “We know from other trials that long-term there would also be a 25-50% lower death rate from colon cancer, plus reductions in other major cancers, heart failure and renal failure,” said Rodgers.
The polypill could be most suitable for those people who have already suffered a heart attack or stroke and are therefore at risk of another one. They would normally be put on a cocktail of pills but some might be more likely to stick to medication if only required to take one a day.
The other group likely to be offered it are those who are at risk because they are clearly overweight or have high blood pressure and cholesterol readings. At one time it was thought that everybody over the age of 55 should be offered the polypill, but the side-effects make that unlikely.
The main value in the UK would be in encouraging adherence to medication, but in the developing world, where other trials are going on, the low cost may be a significant issue. Professor Simon Thom of Imperial College, London, who led the UK arm of the trial, said the Indian company making the polypill, which it calls the Red Heart pill, is aiming for a price in India of £13 per patient per year. “We anticipate the cost being somewhat more in developed countries. The poorer countries will be subsidised by the surcharge in the wealthier countries,” he said.
Natasha Stewart, senior cardiac nurse at the British Heart Foundation, said: “While the concept of taking one pill rather than many sounds appealing, this was a small study and we’d need to see results from much larger trials to determine the validity of its potential benefits. While medicines could help to reduce risk, they’re not a substitute for living a healthy lifestyle, which will always remain a vital part of keeping your heart in good shape.”
Dr Lorna Layward, from the Stroke Association, said: “Anyone at risk of stroke should be supported in reducing their risk through lifestyle changes and medication. Many people with high blood pressure and high cholesterol are required to take multiple pills every day in order to reduce their risk. Calculating when each pill needs to be taken can often be confusing and so combining the pills into one could make taking the medication much simpler.
“However, it’s important to note that this pill might not be suitable for everyone and it may have side-effects so every patient should be assessed and treated on an individual basis.
The polypill will be available in the UK within a couple of years after it has gone through regulatory approval, the scientists expect, but sooner in India.