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Researchers tout multipurpose heart pill

A British study suggests one "polypill" combining several drugs could reduce cardiovascular risk for everyone older than 55; others say it might not suit all.

By Victoria Stagg Elliott, AMNews staff. July 21, 2003.

Statins lower cholesterol. Other medications lower blood pressure. Aspirin acts on the platelets. They all reduce the risk of cardiovascular events.

What if a patient could get all these benefits by taking just one pill?

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According to several papers in the June 28 issue of the British Medical Journal, a "polypill" combining a statin, a thiazide, a beta-blocker, an ACE inhibitor, folic acid and aspirin has the potential to lower cardiovascular disease by 80% if taken by everyone older than 55. Those with other risk factors such as diabetes should be on the polypill even earlier.

"It's very much a change in approach, and it's a little bit like vaccination," said Dr. Nicholas Wald, an author of the papers and professor at the University of London. "The toxicity is low. The majority could take it, and the gains are really quite large."

To reach this conclusion, Dr. Wald and other university physicians analyzed hundreds of studies on the varying polypill ingredients, finding that the combination would mean one-third of those older than 55 would live an average of 11 more years free of heart attack or stroke.

Such a polypill could improve patient compliance with cardiovascular risk reduction therapy and might be cheaper than the multiple pills some take now, responded some American physicians.

"There's a lot of attractiveness to the idea," said Gregory Sachs, MD, governor of the New Jersey chapter of the American College of Cardiology and a senior cardiologist at Summit Medical Group.

But some doctors were by no means convinced that the benefits of such a pill, taken by everyone, would outweigh the risks. A polypill might be a useful tool for some, particularly those with limited access to health care, but not necessarily for all.

"You can take all these drugs together, but not everybody can," said Richard Milani, MD, vice chair of the cardiology department at the Ochsner Clinic Foundation in New Orleans. "There are people over 55 who have reasonably normal blood pressure. We're going to harm them. And there are going to be people with very high blood pressure that the polypill will not be sufficient to correct. And if you have a side effect to one of the ingredients, the whole thing is shot."

But polypill proponents said the concept eliminates some of the guesswork behind figuring out who needs primary prevention. According to their research, everyone older than 55 needs at least a little bit of prevention. Only one-third might benefit, and two-thirds probably won't. But those who don't benefit are, for the most part, not harmed by the intervention. According to the paper, as many as 15% would experience some adverse events, although they might not be significant enough to stop taking the drug.

"There is no satisfactory way of distinguishing the one who will benefit from the other two who won't," said Dr. Wald. "And it has become clear that whatever your blood pressure is now, if it were lowered a bit, your risk would go down a bit. Whatever your LDL cholesterol is, if it were lowered a bit, your risk would go down. If lower is better, why limit the extent to which you would lower these things?"

Just last month, there was what many experts consider commercial and government action in the direction of an eventual polypill. The Food and Drug Administration approved "Pravigard PAC," a package that includes the cholesterol-lowering drug pravastatin sodium and buffered aspirin in the same wrapping, albeit not in the same pill.

"In many ways, this is a first step to this polypill," Dr. Milani said. "But you can't do the polypill that has been proposed. The disadvantages outweigh the advantages, but the goal is a noble one. It doesn't mean we shouldn't try to do these things, but you need to be able to mix, choose and combine."

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Copyright 2003 American Medical Association. All rights reserved.

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