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Many Questions Still Unanswered in the Polypill Debate

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Anyone reading the papers this week might have come away with the impression that all over 50s should be hot-footing it down to their local pharmacy and demanding a polypill.

The rash of stories was prompted by a new study published in the journal PLoS One which saw researchers give the polypill to people over the age of 50, with no history of cardiovascular disease. Over a twelve week period, the participants showed a 12 percent reduction in blood pressure and a 39 percent reduction in LDL cholesterol. These results are similar to those from a BHF-funded trial some years ago.

So over the short term the polypill does what is says on the tin - it lowers blood pressure and it lowers cholesterol. But this is not quite the same as saying that if prescribed to the whole population over the long term it would translate into the expected reduction in heart attacks and strokes.

What's in a polypill?
For those who aren't aware, the polypill is a four-in-one tablet containing 3 blood pressure lowering medications along with a statin for lowering cholesterol.

The polypill has had a long and chequered history. There are several in production, each with slightly different combinations of ingredients. The polypill initially devised by these investigators contained two ingredients that aren't in the current version - aspirin and folic acid. They removed these because large scale studies showed that folic acid, whilst doing no harm, did not improve cardiovascular outcomes. Aspirin was also taken out because, for people at relatively low risk of a heart attack or stroke, the bleeding risk associated with it outweighs any cardioprotective benefits it may have. The overriding principle for a polypill is that it should do more good than harm and not all polypills are the same, so it's very important to know exactly what a particular polypill contains.

How would I get a polypill?
It's very much in the early stages of trials and you can't actually get your hands on the polypill just yet, but people are very interested in what could turn out to be a revolution in treatment.

Issuing a drug based on age alone to people with 'normal' blood pressures and cholesterol levels is a different approach to the one you'll encounter in General Practices around the UK. Currently, a whole range of risk factors are taken into consideration to predict your risk of a heart attack or stroke over the next ten years. Only if that risk is more than 1 in 5 will the doctor write you a prescription.

So why, you might be wondering, are we not adopting this 'one size fits all' approach straight away? If the polypill helps to reduce blood cholesterol and blood pressure, two common risk factors for heart attacks and strokes, surely it would do wonders for the nation's heart health?

If my patients ask me about the polypill, I'm always keen to tell them both sides to the story:

Why it's potentially exciting
As many people will know, the simpler your medication routine is, the easier it is to fit in around your everyday life. The polypill is appealing because people are much more likely to stick to taking one pill a day, rather than a collection of tablets at different times for different conditions.

Also, the cost of producing and distributing a single pill would be much lower than multiple meds, so the polypill is a cheaper alternative.

Why we need to curb our enthusiasm for now
This latest research only studied a very small number of people for a short period of time. In order for the changes in blood pressure and cholesterol to translate into fewer heart attacks and strokes these changes need to be sustained over many years. So we need to see further large scale trials over a longer period of time to see if this really happens.

Also, all drugs can have side effects that cause the patient to stop taking them. It is notable that eight times as many people reported sided effects (albeit mild ones) when taking the polypill than when taking the placebo. Whilst people may well be prepared to put up with an irritating side effect for 12 weeks in a clinical study, they may be less inclined to do so in the long term.

Thirdly, the polypill would only be prescribed for younger people deemed to be at too low risk for conventional treatment. We don't yet know the implications of asking a 'normal' population to take a daily tablet. For example, how will the life insurance industry react? Will it accept that the polypill lowers risk or will they load your premium on the basis that if you are taking a drug you must be at increased risk?

Hopefully we won't have to wait too long to get some of the answers we need. There are several other large scale polypill studies going on around the world. If I were a betting man I would say that the polypill will reduce cardiovascular events, but will be less effective than the current study predicts. Only time will tell.

In the meantime anyone worried about their heart health can still do something about it. We know that heart and circulatory disease is largely preventable and that eating a healthy diet and not drinking too much alcohol, staying physically active, and avoiding smoking are all crucial for protecting your heart.

Around the Web

Polypill - Wikipedia, the free encyclopedia

'Polypill' Could Be Available In Two Years

First Polypill trial in people selected on age alone (50 and over ...

Polypill: Does it treat heart disease? - MayoClinic.com