The controversial all-in-one polypill – a cocktail of drugs to fight heart disease – has come through its biggest clinical trial so far with flying colours.
Two thousand middle-aged and elderly people in India took part in the trial. The results, published online by the Lancet, show that a polypill with five active ingredients works almost as well as the sum of its individual components. And the combination causes no unexpected side-effects.
Salim Yusuf of McMaster University in Canada and his Indian colleagues, who organised the trial, estimate that middle-aged people could roughly halve the chance of suffering a “cardiovascular event” – heart attack or stroke – by taking polypills regularly. For those at high risk, the benefits would be greater.
The polypill used in the Indian study contains a statin (simvastatin) to reduce cholesterol, aspirin to thin the blood and three antihypertensives (atenolol, ramipril and thiazide) to lower blood pressure. It is similar to the polypill originally advocated by two UK professors, Malcolm Law and Nick Wald, in the British Medical Journal in 2003.
Although there is nothing to stop a doctor prescribing the five polypill ingredients individually to patients, there is a strong psychological obstacle to taking so many pills at once every day. Much better to swallow them as a single capsule.
All the ingredients are off-patent, cheap and easy to produce. Indeed Indian generic drug companies are already gearing up to manufacture polypills.
Some experts have been concerned that adverse reactions between the ingredients might seriously reduce their effectiveness or even lead to new side-effects. The Indian study has allayed most of these fears, though more clinical evidence will be required before GPs – and regulators such as the US Food and Drug Administration – are convinced of the merits of the polypill. Issues such as dosing also need to be resolved.
A Lancet commentary by Christopher Cannon of Harvard Medical School, accompanying the research paper, raises another question: “Would the availability of a single magic bullet for the prevention of heart disease lead people to abandon exercise and appropriate diet? Would this make two of the major root causes of heart disease worse?” The medical profession would need to make sure that the answer is No.