All very hopeful but still no double blind studies of vascular disease incidence in humans. The similar "polymeal" concept seems to have petered out
A new 10p-a-day ‘polypill’ containing aspirin and statins halves the risk of heart disease and stroke, according to the world’s first international trial of the drug.
A research team found "sizeable reductions" in blood pressure and levels of 'bad' LDL cholesterol among those who took the polypill over 12 weeks, compared to those who took a placebo. Separate pills are already prescribed to millions of people worldwide to lower their chances of heart attack and stroke.
But scientists have been looking at the prospect of a combined pill, which they believe will encourage more people to take the medications more reliably.
Eight years ago Prof Sir Nichlas Wald, who demonstrated that passive smoking causes cancer, proposed the polypill in an article in the British Medical Journal.
He wrote that such an easy-to-take pill could significantly reduce the burden of cardiovascular disease, which is Britain's biggest killer, accounting for almost 200,000 deaths a year.
Taking such a preventive pill should be as automatic as "brushing your teeth", he later suggested.
Now the first international polypill study, published last night and part funded by the Wellcome Trust, has suggested it could be extremely effective.
The researchers examined data from 378 people with a raised risk of cardiovascular disease. Half were given the polypill and half the placebo. About a third of the participants were British, a third Dutch and a third Indian.
Specifically, systolic blood pressure was reduced from a pre-trial average of 134 mmHg to 124; while 'bad' LDL cholesterol came down from 3.7 mmol/L to 2.9.
Doctors use mmHg as a standard unit for measuring blood pressure, while mmol/L - millimoles per litre - is used as a measurement unit for very low concentrations of substances in blood.
Cardiologists know that having high blood pressure and cholesterol raises the chances of cardiovascular events, and are able to estimate how much reducing these factors decreases that risk.
The researchers calculated that the polypill would roughly halve the incidence of major cardiovascular events in people with similar risk profiles to the participants.
Writing in the journal Public Library of Science One, they concluded that the benefits to those at a high risk would be even greater: "Overall about one in four high risk people would be predicted to avoid a major event over five years."
Prof Anthony Rodgers of the George Institute for Global Health in Australia, who led the study, said: "The results show a halving in heart disease and stroke can be expected for people taking this polypill long-term. "We are really excited about this - it is a step closer to providing the polypill to patients."
It has long been known that taking aspirin and statins separately reduces the risk of cardiovascular disease, but this is one of the first studies examining taking them in a combined pill.
It contains 75mg aspirin, 20mg simvastatin, 10mg lisinopril and 12.5mg hydrochlorothiazide. Aspirin prevents blood getting too 'sticky', which can lead to clots that cause heart attacks; statins lower cholesterol; while the latter two drugs lower blood pressure.
There were fears that the drugs could react in a pill while being stored, and cancel each other out, but the trial proved these were unfounded.
All four drugs are off-patent, meaning any drugs company can manufacture them. Prof Simon Thom, of Imperial College London, said the Indian pharmaceutical firm Dr Reddys had committed to make the polypill "as dirt cheaply as possible".
The cost issue is particularly important in poorer and middle income countries, which are facing growing epidemics of 'lifestyle' diseases due to changing diets and people getting less exercise.
About 17 million people die of cardiovascular disease every year, 80 per cent of them in developing countries.
Prof Thom said in such countries the cost could be just £1.20 a month, with richer countries which were able to shoulder the economic burden paying more. Even so, the cost in Britain could be as low as £3 a month.
The case for the polypill has been given a powerful boost by British-led research, published in The Lancet last winter, showing that regularly taking low-dose aspirin reduces the risk of certain cancers, including bowel cancer, by up to 50 per cent.
Prof Rodgers commented: "These benefits would take several years to 'kick in', but of course one of the hopes with a polypill is it helps people take medicines long-term."
This polypill is likely to be available in India soon. However, the Department of Health is more cautious.
Two years ago Prof Roger Boyle, England's heart disease 'czar', told MPs that he liked the "concept" but there were questions marks over safety. He also said there was a "fine line" between preventive medicine and "medicalising" the population.
Side effects are a big issue. Aspirin is known to aggravate the intestine and can cause internal bleeding, although most cases are minor.
This trial found that about one in 20 people stopped taking the polypill because of side effects, mainly due to such bleeding but also due to light-headedness caused by too low blood pressure.
Prof Rodgers said it was highly unlikely that all middle aged and elderly people would be offered a polypill in the future, but that it could be allocated to those with a higher risk of heart disease, stroke and certain cancers.
That could feasibly be one in five people over 30, perhaps more.
Prof Thom, who led the UK arm of the trial, said: "We now need to conduct larger trials to test whether these medicines are best provided in the form of a polypill, or as separate medicines, and whether this combination strategy improves patient adherence to cardiovascular medication."
Dr Lorna Layward, from The Stroke Association, said: "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. It's also extremely early days and a lot more research needs to be carried into this pill to ensure its safety."
A Department of Health spokesman said: "We welcome any evidence that contributes to providing the best treatment for people with cardiovascular disease."
He added: "It is also important to remember that changes made to a person's lifestyle such as stopping smoking, eating healthily and taking regular exercise have far reaching health benefits that will not be reaped from medication, including reduction in the risk of developing diabetes and cancer."