Millions of Americans who are at risk of cardiovascular disease because of common conditions, such as obesity and high blood pressure, are potential beneficiaries of a polypill, Cannon said. "They should be taking cardiovascular medications, but don't, because they are otherwise healthy," he said. "If there were one, simple pill, they might be open to taking it."
More studies obviously are needed, Cannon said, and physician care would be necessary if the pill became available. "You can't just give it and walk away," he said. "You would have to monitor for side effects, but once you get past that hurdle, one simple pill would help."
Some major regulatory changes by the U.S. Food and Drug Administration would be necessary for the polypill to be available in the United States, Cannon added. "The current mandates of the FDA are that a combination pill would have to be tested for every combination of every drug included in that pill. That obviously would not be feasible in this case. It would require a re-looking at the rules by the FDA, and for that, one needs larger and longer studies."
Even with those hurdles to overcome, a polypill would be "a major step forward in trying to simplify and broaden the applicability of all the medications that reduce cardiovascular risk," Cannon said.
The next step would be a major trial of the polypill among people with clear risk of cardiovascular disease, Teo said. If such a trial succeeded, the hope is that a drug company would pick up the idea, he said.
"The concept is important, and we are testing the concept," Teo said. "Once the concept is proved, we hope that a company in Europe or the United States could see that something can be done with it."
Cardiovascular risk factors (including unavoidable ones such as aging) are listed by the American Heart Association.
SOURCES: Christopher P. Cannon, M.D., associate professor, medicine, Harvard Medical School, Boston; Koon Teo, M.D., professor, medicine, McMaster University, Hamilton, Ontario, Canada; March 30, 2009, Lancet; March 30, 2009, presentation, American College of Cardiology annual meeting, Orlando, Fla.