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GPs go forth

Should the UK introduce a polypill?

It's hard to argue that we should use lifestyle interventions across the population but not highly effective medication, says Professor David Taylor. But Dr Terry McCormack argues the polypill is cheap and cheerful medicine but lacks the flexibility we expect in the developed world, or the evidence base for its individual components

It's hard to argue that we should use lifestyle interventions across the population but not highly effective medication, says Professor David Taylor. But Dr Terry McCormack argues the polypill is cheap and cheerful medicine but lacks the flexibility we expect in the developed world, or the evidence base for its individual components

The idea of using fixed-dose combination medicines for cardiovascular conditions is by no means new. In the context of secondary prevention, for delaying the progression of established disease, using various forms of multicomponent polypill could at the very least improve adherence rates, as they offer simplified therapeutic regimens and are relatively easy for patients to take. They might also help some prescribers to avoid recommending suboptimal drug and dose combinations.

However, recent proposals by Professor Malcolm Law and Professor Nicholas Wald to use a statin-antihypertensive combination1 to reduce cardiovascular risk in people with no diagnosed illness are more radical. These investigators have offered evidence that giving three half-standard doses of antihypertensives with differing modes of action would optimise reductions in blood pressure while reducing side-effects. And that could mean polypills being recommended across a population rather than on an individual basis.

In societies such as modern Britain, every 'healthy' person aged over 55 or 60 years can be regarded as being at an unacceptably high risk of developing vascular disease. This is regardless of whether their blood pressures or LDL cholesterol levels are above some arbitrarily defined 'pathological' level. Population-level pharmaceutical intervention would mean that the default position for older adults not already receiving treatment would be to offer a polypill as a protective agent. Only those who developed unwanted side-effects would be subject to additional investigation, over and above the norm.

The proponents of such an approach argue that now safe and effective medicines to reduce vascular disease risk are off-patent, or very shortly to become so, providing polypills offers an affordable route to further reducing rates of heart disease and stroke. If polypills could be supplied as pharmacy medicines or prescription-only medicines but prescribed by pharmacists or nurses, this would help prevent excessive workload being imposed on GPs. Against this, some critics counter that such a mass-medication strategy would in essence be immoral. Others question the wisdom and probity of supplying powerful medicines to people who have no clearly defined disease and may not even have the level of personal risk they have been assigned.

I believe it is difficult to rationally argue that reducing health risks through lifestyle modification is ethically more desirable than achieving equal or greater gains by alternative routes such as pharmaceutical intervention. I do not think encouraging population-wide use of a primary prevention polypill would necessarily discourage people from stopping smoking, taking daily moderate exercise and keeping their weight down. In relation to hazards such as those of lung cancer and type 2 diabetes, it should normally be possible to communicate that healthy lifestyles offer benefits that lowering blood pressure and lipid levels alone cannot.

Alongside additional services targeted at individuals in need of specific treatments, there is good reason to believe primary prevention polypills should play an increasingly significant part in reducing disease risks. A number of the world's best epidemiologists believe we are still failing to offer potentially beneficial medicines to enough of those who would gain from them - even taking the risk of side-effects into account. Accepting a polypill-based approach would offer GPs who wish to contribute to better public health more opportunity to do so effectively.

Professor David Taylor is professor of pharmaceutical and public health policy at the University of London

The original polypill concept developed by Professor Nicholas Wald and Professor Malcolm Law is now being worked up into a realistic entity, the Polycap1. Recently, research has been published that shows this polypill to be effective in lowering blood pressure and cholesterol, as well as providing antiplatelet cover, while also being safe and well tolerated2. The Indian Polycap Study (TIPS) was conducted in a part of the world where preventive cardiovascular medicine is not available to the great majority of the population.

The intention is to use the polypill on a 'fire and forget' basis, with patients selected on the basis of a single risk factor - their age. But here in the UK we have a level of sophistication in cardiovascular prescribing that allows tailored individual treatment regimes. Adopting the polypill would be, for us, a retrograde move.

The Polycap, as described in the TIPS study1, consists of a mixture of aspirin 100mg, simvastatin 20mg, atenolol 50mg, ramipril 5mg and hydrochlorothiazide 12.5mg. Some polypill formulations differ from this but doses are fixed in all. The main problem this brings is a lack of versatility.

The evidence to include aspirin is based on a meta-analysis of trials in high-risk patients. But a number of recent studies have cast doubt on its use in primary prevention.

A study in Scotland, for instance, questioned its use in primary prevention for patients with diabetes3,4. The problem with aspirin is that risk may outweigh benefit for some individuals.

Simvastatin is an obvious choice, but the dose should be 40mg - and what happens when atorvastatin goes off-patent in 2011/12? Some people are statin-resistant and need higher doses or different agents. Without follow-up testing of cholesterol, we cannot identify these individuals.

Many people, such as those with asthma, cannot take ß-blockers, and many more will suffer side-effects. The benefit of atenolol has also been questioned as an antihypertensive and it is now only indicated in ischaemic heart disease5. An angiotensin inhibitor is a good idea, but why ramipril, with its relatively short half-life - and what about monitoring kidney function? Thiazide diuretics, and particularly hydrochlorothiazide, are under scrutiny with the recent publication of the ACCOMPLISH study6. And all this on a 'fire and forget' basis. I personally would still want my blood pressure monitored and controlled to the optimum level.

UK doctors have not traditionally been big users of fixed-dose combinations in cardiovascular medicine. We have several combinations available that will control blood pressure, with two or three medications in a single tablet, but they account for about only 2% of prescriptions for hypertension. So why would anyone think we would change our habits?

I actually like the idea of using fixed-dose combinations, especially in patients who want to reduce the sheer number of tablets they take, and I do believe such an approach does aid compliance. But I want that mix to include a choice of compounds and variable doses. The polypill does not offer that choice. It is a cheap and cheerful pill that is being evaluated in the massive arena of India. Economics and cultural differences may make it desirable there, but unless this recession gets even worse I cannot see a role for it here.

Dr Terry McCormack is a GP in Whitby, North Yorkshire, and one of the three editors of the British Journal of Cardiology

yes no Would having a polypill to treat cardiovascular conditions aid compliance or be a retrograde move?

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