A Super Pill to Thwart Heart Attacks and Stroke?

Researchers contend it can be created

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By
HealthDay Reporter

(HealthDay is the new name for HealthScoutNews.)

THURSDAY, June 26, 2003 (HealthDayNews) -- A pill aimed at reducing heart attacks and stroke by more than 80 percent is currently on the drawing board in England.

Conceived as a once-a-day, megavitamin-like pill, it would contain six active components to combat the main risk factors associated with heart disease.

According to the authors of an article on the pill, called Polypill, in the June 28 issue of the British Medical Journal, if everyone over the age of 55 and everyone with existing cardiovascular disease took the super pill, "it would be acceptably safe and…have a greater impact on the prevention of disease in the Western world than any other single intervention."

The six components of the pill would include aspirin (for blood platelet levels), a cholesterol-lowering drug, and three blood pressure-lowering drugs at half the standard dose. It also would contain folic acid for lowering levels of the amino acid homocysteine, which may contribute to blockages in the arteries.

"It's more than just an idea -- there's evidence behind it," says Dr. Nicholas Wald, lead author of the article and a professor of environmental medicine at the University of London. "Technically [developing the drug] is straightforward. We've had discussions with pharmacists, and the concept is simple and powerful and there's an enormous amount of information already available."

Dr. Edgar Lichstein, chairman of the department of medicine at Maimonides Medical Center in New York City, calls Wald's proposal "an interesting concept."

"It's certainly not brand new," Lichstein adds. "We put fluoride in drinking water. We put calcium in orange juice, iodine in salt. That part isn't new. Doing it for cardiovascular disease is new, and I think these authors are to be applauded. It's thinking out of the box."

While the thinking may be out of the box, it's still largely just thinking at this point -- even though the authors have already filed a patent for the combination pill as well as a trademark application for the name Polypill.

If the pill does become reality, some say it's likely to be of greater value to developing nations, which have limited health care.

"Clearly, there's a fairly large issue as to whether in our society it makes sense," says Dr. Richard Stein, associate chairman of medicine at Beth Israel Hospital in New York City and a spokesman for the American Heart Association. "They're proposing it really for developing countries where testing [for heart disease] is not available or is too expensive."

Heart disease is a worldwide scourge. The American Heart Association estimates that in the United States alone, 61.8 million people had some form of cardiovascular disease in 2000 and that almost 1 million people died from it.

Coronary heart disease, which is caused by narrowing of the coronary arteries, is the single leading cause of death in the United States and was responsible for more than 500,000 deaths in 2000. Almost 13 million Americans have a history of heart attack, angina or both, and more than 1 million Americans will have a heart attack this year.

Four risk factors are of particular concern: low-density lipoprotein (LDL or "bad") cholesterol, blood pressure, homocysteine levels and platelet function.

The authors of the journal article looked at data from more than 750 trials involving 400,000 participants. Completed randomized trials showed that drugs to lower three risk factors -- LDL levels, blood pressure and platelet function -- reduced the incidence of ischemic heart disease (lack of blood flow to the heart muscle) and stroke. Nonrandomized trials showed that lowering homocysteine levels also reduced the risk of these diseases.

Using statistical methods, the authors calculated that a Polypill combining existing drugs potentially could prevent 88 percent of all heart attacks and 80 percent of strokes. About one in three people would directly benefit, each gaining about 11 or 12 years of life without a heart attack or stroke.

But all this is a long way off, if indeed it ever materializes.

"I understand it will actually be a considerable challenge," Dr. Anthony Rodgers, author of an accompanying editorial and co-director of the Clinical Trials Research Unit at the University of Auckland in New Zealand, said in an e-mail to HealthDay.

"The key requirement is to ensure that all the 'ingredients' do not affect each other's chemical activity," Rodgers says. "Long-term stability and activity tests are required, monitoring all of the breakdown products, and these become more and more complex as the number of active components increases. Requirements from the FDA [U.S. Food and Drug Administration] and other regulatory authorities are likely to be stringent."

Even if the pill made it over all these hurdles, there may be other considerations.

For instance, there are side effects to weigh, especially if there is no active monitoring of patients. "We need to be concerned about side effects," Lichstein says. "The one I'm most worried about are ACE inhibitors (used to treat high blood pressure) with people with kidney diseases. We would need some screening."

Says Wald: "The notion of all adults over 55 being eligible to have this and taking it is something that really is quite new. There are some effects of the drugs which are reasonably well known, so what will have to be determined is the extent to which this will be acceptable in a general population."

In the end, it may come down to balancing the needs of a society versus the individual.

"Basically, it's a trade-off between treating a lot of people semieffectively versus treating a small group of people really well," Lichstein says. "Right now we treat patients a lot more aggressively and we probably do better, but we do not give access to this beneficial medicine to a large number of patients. We could include large numbers, but it wouldn't be tailored."

Stein has another idea: a super pill that would be customized for each individual's particular needs.

"In general, for a lot of my patients I will use some combination of these medications and I will have to give them four or five pills instead of one, so that's not so great," he says. "It would be lovely if I could get a patient on a stable preparation of medications and order a custom pill which would be one pill."

More information

The American Heart Association has information on heart attacks, stroke and related topics.

SOURCES: Nicholas Wald, M.D., professor of environmental and preventive medicine, University of London, London, England; Anthony Rodgers, M.D., Clinical Trials Research Unit, The University of Auckland, Auckland, New Zealand; Edgar Lichstein, M.D., chairman, department of medicine, Maimonides Medical Center, New York, N.Y.; Richard Stein, M.D., associate chairman of medicine, Beth Israel Hospital, New York, N.Y., and national spokesman, American Heart Association; June 28, 2003, British Medical Journal

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