Is the life-saving polypill for over-55s a reality?

A five-in-one polypill could prevent 100,000 premature deaths from heart conditions in the UK every year, according to media reports.

UK researchers claim that the pill, which would be given to everyone over the age of 55 regardless of risk profile, could prevent 80 per cent of heart attacks and strokes.

The pill has been in development for five years but the first samples were only made available last week by its maker Cipla, an Indian pharmaceutical company.

Despite this, the drug has received the backing of Professor Roger Boyle, the DoH's heart czar, who has called for it to be prescribed on the NHS.

Reports said the pill consisted of a statin, three types of medicine to lower BP and folic acid, and could cost as little as £1 a day.

Clinical trials have already shown that taking the medications separately can prevent heart disease and strokes.

If trials on the polypill are successful, it could become licensed and available to patients within years, say the papers.

What is the research?
The principle of a polypill came from a meta-analysis of 750 published trials, involving 40,000 patients over 55.

Researchers examined the effects of each component drug - simvastatin (40mg); a combination of thiazide, a beta-blocker and an ACE inhibitor each at half standard dose; and folic acid (0.8mg) - on reducing risk factors for IHD and stroke compared with placebo.

The use of simvastatin reduced LDL cholesterol by an average of 1.8mmol/l. This accounted for a 61 per cent reduction in IHD incidence and a 17 per cent reduction in stroke.

The use of the three BP medications in combination lowered diastolic BP by 11mmHg, resulting in a 46 per cent reduction in IHD cases and a 63 per cent fall in stroke.

On average, folic acid use lowered serum homocysteine by 3micromol/l. This reduced the risk of IHD by 32 per cent and strokes by 16 per cent.

A separate meta-analysis of data from 15 studies examining the effects of low dose aspirin (50-125mg daily) on reducing platelet activation showed that aspirin reduced the number of IHD events by 32 per cent and strokes by 16 per cent.

Changing all four measured risk factors - LDL cholesterol, BP, serum homocysteine and platelet activation - cumulatively cut the risk of IHD events by 88 per cent and stroke by 80 per cent. The researchers estimate that the polypill will benefit a third of users. On average, each would gain 11-12 years of life free from MI or stroke.

Combining the adverse effects of the components showed that the polypill would cause adverse symptoms in 8-15 per cent of the population.

Aspirin was the most dangerous component, causing haemorrhage. Although this research was completed five years ago, the story has re-emerged in the press after manufacturers have released samples of the polypill for chemical and stability tests.

What do the researchers say?
Lead researcher Professor Nicholas Wald, director of the Wolfson Institute of Preventive Medicine in London, said: 'The polypill will allow doctors to help prevent heart attacks and strokes in people before they develop.

'It should be given to all patients over the age of 55. We know that over 95 per cent of strokes and heart attacks occur in this age group.

'Patients under the age of 55 may also benefit from the pill but it would not be cost effective to prescribe it for them.'

On the whole, the pill should be affordable on the NHS as it is made up of drugs that are all off-patent, such as simvastatin, said Professor Wald. Adverse side-effects would be rare with the polypill, he added.

'The biggest safety concern would come from the use of aspirin but this will no longer be added to the polypill,' he said.

'Final safety tests are now being performed on the polypill ahead of an application for a product licence and testing in human patients,' added Professor Wald. 'But we cannot yet say when the drug will become available for patients.'

What do other experts say?
A spokeswoman for the DoH said: 'All medicinal products in this country have to be licensed for use. Polypills would have to go through these procedures.'

Richard Hobbs, professor of primary care at Birmingham University and a member of the Primary Care Cardiovascular Society, warned the polypill would need to be tested in clinical trials before introduction.

'The researchers have extrapolated data taken from trials of each individual drug,' he said. 'It needs to be demonstrated in practice that the polypill can reduce risk of heart attacks by 88 per cent.'

There is little direct evidence to support the use of folic acid in reducing the risk of heart disease, added Professor Hobbs.

sanjay.tanday@haymarket.com

BMJ 2003; 326: 1,419-24

Informing Patients

  • Taking a daily polypill could reduce the risk of heart attacks by 88 per cent and strokes by 80 per cent in the over-55s.
  • Aspirin will no longer be added to the polypill because of safety concerns.
  • The pill needs to be tested in humans and licensed before it can be made available to patients.
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