New pill could transform the fight against heart disease

A five-year study of the so-called polypill suggests the medication could slash the risk of strokes or heart attacks

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Imagine being able to slash your chances of dying from a heart attack or stroke just by popping one pill daily.

Imagine no longer. Just such a possibility has moved a step closer following the biggest-ever study of the so-called polypill, which could transform the fight against cardiovascular disease (CVD), the leading cause of premature death worldwide.

Containing a combination of inexpensive drugs already widely-used to combat CVD, the polypill has the potential to rival vaccinations in its impact on global health.

Now an international team has reported the findings of a pioneering five-year study involving nearly 7,000 participants. And the results are dramatic.

Among those given the polypill, the risk of falling victim to CVD plunged by one-third compared to those given the usual advice about lifestyle changes. The impact on heart attacks and strokes was even more remarkable, with the risk falling by up to 40 per cent.

Published in the prestigious journal The Lancet, the success of the study has particular resonance in the Emirates, which has one of the highest rates of CVD in the world, despite relentless health campaigns.

Public health experts know they face an uphill battle in getting people to stick to the usual mantras of taking more exercise, eating healthily, and stopping smoking.

But as the popularity of health supplements shows, people would much prefer to just pop a pill and get on with their lives.

This reality is a key motivator of the polypill concept. First mooted almost 20 years ago, the idea is simple: get people to take a daily pill combining cheap but clinically-proven drugs each known to cut the risk of CVD.

Researchers quickly identified a shortlist of drugs suitable for a polypill: so-called beta-blockers, ACE inhibitors and thiazide diuretics which reduce blood pressure, along with statins to cut cholesterol. Also in the mix was folic acid, linked to reduced CVD risk, plus the nearest thing medical science has to a cure-all: aspirin.

Based on their individual success-rates, early estimates suggested that a polypill combining these drugs might cut CVD risk by up to 80 per cent, transforming the lives of millions globally.

But like so many simple ideas, the polypill also raised some hard questions. What should the dosage be – and was it safe to simply use the same dose with vast numbers of people?

Most controversial of all is the idea of handing out the polypill to people regardless of whether or not they are at risk of CVD.

For those in good health, the drugs might not bring any benefit at all, and instead put them at risk of potentially dangerous side-effects.

For example, even low doses of aspirin have been linked to an increased risk of bleeding in the gut or brain, with potentially fatal consequences such as – ironically – heart attacks and strokes.

The other drugs have also been linked to a range of side-effects, from tiredness and nausea to dizziness.

For years the polypill concept remained an idea kicked around by researchers, with no hard evidence that it would do more good than harm.

Early studies of their use confirmed people preferred the pill-popping approach to reducing their risk of CVD. But the studies were too small and too brief to reveal the true benefits – especially for those with no obvious risk of CVD.

Hence the excitement over the success of the new trial. It was big enough and long enough to give the polypill the chance to reveal its potential. And it did not disappoint.

Public health experts have faced an uphill battle in getting people to stick to the usual mantras of taking more exercise, eating healthily, and stopping smoking. Courtesy LuxuryProperty.com
Public health experts have faced an uphill battle in getting people to stick to the usual mantras of taking more exercise, eating healthily, and stopping smoking. Courtesy LuxuryProperty.com

As well as the impressive drop in CVD risk, only 1 in 8 of those given the polypill stopped taking it before the end of the trial, a startlingly low drop-out rate. Most of those who quit did so because of concerns about side-effects of the polypill.

But don’t expect your doctor to be putting you on a polypill just yet. As with all pioneering medical trials, this one has still left unresolved some key issues about risks and benefits.

For a start, the polypill used a mix and dosage of drugs thought optimal when the trial was designed over a decade ago: a statin, two blood-pressure drugs and low dose aspirin.

Since then research has moved on – and along with it opinions about the best combination. Folic acid, once thought a key ingredient of a polypill, was left out, but there is some evidence this might have been a mistake. Better cholesterol-busting statins are also now available.

On the other hand, there’s growing concern about giving aspirin to elderly patients with no history of CVD, though in the trial, those at major risk of bleeds were excluded.

But most important of all, the trial focused on precisely the people most likely to benefit from the polypill strategy: those aged 50 to 75 living in a rural area of a low to middle income country. In Iran, where the study was carried out, CVD has reached epidemic proportions and combating it is a major challenge.

In contrast, the world’s richest nations have seen CVD rates decline dramatically since the 1990s, while those who do develop it get treatment tailored to them.

As such, the benefits of the one-size-fits-all polypill would be relatively small – and might even be cancelled out by drug side-effects.

The trial also threw up some mysteries. For example, despite including two drugs specifically for the purpose, the polypill produced negligible declines in blood-pressure.

One possibility is that it contained too low a dosage. A more radical explanation is that blood pressure isn’t as strongly linked to CVD as widely thought.

Whatever the truth, the trial has found intriguing evidence that the world’s number one killer could be tackled using a single, cheap pill taken daily - at least in less wealthy nations.

But it’s also clear that more research is needed before the polypill is ready for global prime-time.

Until then, the best advice is to stay healthy while the scientists figure out exactly what to put into this would-be silver bullet.

Robert Matthews is Visiting Professor of Science at Aston University, Birmingham, UK