'Polypill' No Heart Risk Magic Bullet for Now

March 30, 2009— -- What do you get when you combine three blood-pressure-lowering drugs, a cholesterol-busting statin, and aspirin into a single pill?

The answer is a "kitchen sink" approach that proponents say could reduce blood pressure and cholesterol levels -- two well-known heart disease risk factors -- significantly for some, according to research presented today at the American College of Cardiology's 58th annual scientific session in Orlando.

But heart experts cautioned that the pill is no magic bullet. And they said that for now, at least, it is unlikely that most of those at risk of heart disease in the United States would benefit from the pill -- termed the "polypill" -- whose low dosages of its component medications fall short of heart treatments that are tailored specifically to individual patients' needs.

Still, study investigator Dr. Koon Teo, a cardiologist and professor of medicine at McMaster University and Hamilton Health Sciences in Ontario, Canada, told ABCNews.com that the pill may, in the future, represent a paradigm shift in terms of the way heart patients take their medicines.

"I think the evidence from the use of these medicines is already in; the question is, how do we best deliver it," Teo said. "If we put these drugs into one capsule, patients will be more compliant, as they will just take one pill daily."

And in a press release, principal investigator Salim Yusuf of the Population Health Research Institute at McMaster University and Hamilton Health Sciences in Ontario, Canada, said the pill showed promise in the Indian Polycap Study, which compared the effects of the pill against eight other approaches on more than 2,000 study participants in India.

"The thought that people might be able to take a single pill to reduce multiple cardiovascular risk factors has generated a lot of excitement; it could revolutionize heart disease prevention as we know it," Yusuf said in the statement, adding that the polypill represented the first attempt to put five such medications into a single pill. "Side effects with the polypill were no different than when taking one or two medications."

Developing Nations' Hearts Could Benefit From Polypill

Despite the positive findings, heart doctors said that the pill is unlikely to be the best choice for all heart patients. Dr. Robert Bonow, past president of the American Heart Association and co-director of the Bluhm Cardiovascular Institute at Northwestern University in Chicago, said that while the pill might be better than nothing for many who would otherwise receive no care, a one-size-fits-all approach would likely fall short in the United States.

"This study was done in India, and I believe that this is where this kind of approach on a population basis could pay off," Bonow said. He added that such inexpensive and potentially widely available strategies could be an important weapon against heart disease in countries that adopt the unhealthy lifestyle habits that often come part and parcel with industrialization.

But, he noted, the number of medications included in the pill makes tailored treatment impossible.

"This is not a tailored treatment, and it's low doses," he said. "So maybe in people with high blood pressure, it is not enough to lower their blood pressure. Or in people with high cholesterol, it is not enough to get them to the target cholesterol levels that their physicians would like to see."

For example, the pill contains just 20 milligrams of simvastatin, the active ingredient in the widely-used pill Zocor. By comparison, Zocor tablets can contain as little as 5 milligrams or as much as 80 milligrams of simvastatin.

And Dr. Domenic Sica, head of the section of clinical pharmacology and hypertension at the Medical College of Virginia in Richmond, agreed that there could be problems with this nontailored, combination approach.

"The most important issue is: Who would be the target population for this therapy, in that patients with more substantive elevations in LDL-cholesterol and blood pressure would require more aggressive therapy than what might be available from the components of the preparation?" Sica said.

Teo, however, noted that in the future, polypills could be tailored for different patient groups, offering a more individualized type of treatment.

"I don't think that there is going to be just one polypill," he said. "I could imagine that a polypill for someone who has had a heart attack could be different. In a way, you could have tailored polypills for groups of people with different conditions."

Still, Bonow said, much more research is needed. The study only measured two indicators of heart health -- low blood cholesterol, and low blood pressure. And these factors were measured only over the course of 12 weeks. The design of the study, therefore, did not track the number of people who were either saved by the pill or died from heart-related causes.

"People may begin emphasizing this pill, but that is not what we need to do," Bonow said. "There's no magic bullet."

And even though no significant side effects were reported in this most recent study, Sica added that with five drugs comes five sets of possible side effects and drug interactions.

"In reality, the only way that the polypill works is if there are no side effects to all five components," he said. "I do not see this as likely."

Best 'Polypill' May Be Healthy Lifestyle

Still, Bonow said that further research may indeed uncover a strategy for treating at least a segment of U.S. heart patients. Specifically, he said that in patients who have already had a heart attack -- a group known for not taking their medications -- taking a single pill daily could be a much easier proposal that taking a number of pills.

But for everyone else, he said, the best solution may not reside in their medicine cabinets.

"We already have a 'polypill,' and it's called exercise," he said. "Exercise does everything that the 'polypill' supposedly does."