If there's one thing medical science knows for sure about the preventive medications many of us use to ward off heart disease and stroke, it's that we are lousy about taking them.
Generally, people take daily pills like aspirin, blood-pressure medication and cholesterol-lowering statins properly little more than half the time. "We think, 'How is that possible?'" says Dr. Christopher Cannon, a cardiologist and professor at Harvard Medical School. "These are simple medications. Most of them are generic. Yet only 60 percent of people take their drugs properly."
To help people better manage multiple medications that address risk factors for heart disease, Cannon and some other experts advocate a single daily "polypill." Much like a multivitamin, the polypill would meet several needs, lowering both LDL ("bad") cholesterol and blood pressure while providing the anti-clotting benefits of aspirin. "The concept is simplifying care," he says.
Targeting Borderline Patients
Combination pills are not new. Treatments for various conditions, including HIV/AIDS, high blood pressure and diabetes, have combined two or even three medications into a single pill. What makes the polypill different is that it would combine as many as four or five medicines for the purpose of treating asymptomatic patients in middle age and beyond who have what Cannon calls "borderline" risk factors for heart disease, like diabetes, obesity or elevated cholesterol or blood pressure.
The combined effects of the individual drugs in the pill, Cannon says, could help reduce one's risk of heart disease or stroke by as much as 80 percent. "These are proven therapies and real medicines," Cannon says. "One could simply take one pill in the morning that would address all of these risk factors."
Doctors would need to monitor patients' progress on the polypill, Cannon says, so that if someone's blood pressure spiked while taking the medication, for example, they could return to traditional prescriptions. "If the polypill works for a while, great," he says, "but then if you need more intensity of one therapy, you can switch over to that individual pill."
The polypill for heart-disease prevention is likely a couple of years away from being widely available and the regulatory path may be complicated, even though each element of the polypill has long been approved by regulators. The Food and Drug Administration has tended to require that combination pills be offered in a variety of strengths, covering all possible doses of each drug in the cocktail. For the polypill, that could mean producing as many as 100 separate versions of the medication. "The simplicity of the polypill in that situation is lost," Cannon says. In trials, the pill has been offered in a single strength.
Other questions focus on whether the combined drugs will prove to be as effective in the long-term as they have been when taken separately, and whether a polypill might heighten the side effects of any of the medications involved, such as the muscle pain that is often associated with statins.
In tests so far, results have been encouraging, although large-scale trials have yet to take place. A recent study in India, in which three blood-pressure medications, a cholesterol-lowering statin and an aspirin were combined in a polypill, found that the medication helped patients significantly lower their blood pressure and LDL cholesterol. In one test group, however, the statin did not reduce cholesterol as much as it did as a stand-alone drug.
One Treatment for All
Patients in the Indian trial needed to present only one major risk factor for heart disease, like obesity, hypertension or smoking, Cannon wrote in an editorial for the science journal The Lancet. But each of the subjects took the same polypill, designed to treat multiple risk factors. "So a smoker without a history of high blood pressure or high cholesterol was nonetheless treated for both," he wrote, "and was able to tolerate the treatment. This approach illustrates the feasibility of the principle that one can treat patients with multiple classes of drugs for cardiovascular risk factors, even if the patients do not have some of these risk factors."
People who successfully manage multiple preventive medications already, or whose risk factors would only lead them to one prescription, would have less use for a polypill. But those whose medication compliance is low could benefit from the convenience, and the greatest potential patient pool for the pill may be in developing countries where people who have risk factors for heart disease but limited access to physicians and medications could take advantage of the opportunity to get preventive treatment in a simple, economical way. "This approach has obvious appeal and vast implications for global health," Cannon wrote in The Lancet, "because heart disease is the leading cause of death worldwide."
Following a trial of the polypill conducted by British researchers, Nicholas Wald, director of the Wolfson Institute of Preventive Medicine at the University of London and an inventor of the medication, estimated that if half of all Britons over 50 began taking the pill daily, that country could prevent 94,00 heart attacks each year.
Critics of the polypill, though, are concerned that large-scale trials of potential side effects have not been completed, and that in the rush to adopt a single, daily medication, people may lose sight of the most proven strategies to reduce their risk of heart disease — maintaining a healthy weight, eating heart-healthy foods, staying active, exercising regularly and avoiding smoking.
"I don't think the answers to these problems lie in a pill," Dr. Margaret McCartney, author of The Patient Paradox, told London's Telegraph newspaper after the recent British trial, adding that she feared "the people least likely to benefit from the polypill — the healthy — will probably be the most likely to take it."
Cannon has expressed this concern as well. "Would the availability of a single magic bullet for the prevention of heart disease lead people to abandon exercise and appropriate diet?" he wrote in the Lancet. "Would this make two of the major root causes of heart disease worse? Hopefully not, but the medical profession would need to help ensure that this would not happen."
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