MONDAY, March 30, 2009 (HealthDay News) -- Create a single pill that contains a statin, three blood pressure drugs and aspirin, and you have an inexpensive medication that can reduce the risk of heart attack, stroke and other cardiovascular problems.
Or so researchers hope.
A first trial of the polypill (which already has a brand name, Polycap), has been successful, according to a report that was to be presented Monday at the American College of Cardiology annual meeting in Orlando, Fla., and online in The Lancet.
The polypill contains generic versions of the blood pressure medications atenolol, hydrochlorothiazide and rampiril, as well as simvastatin (Zocor) and aspirin. It is designed to attack three major risk factors of cardiovascular disease -- high blood pressure, high blood cholesterol and formation of artery-blocking blood clots. It is being tested by an Indian company, Cadila Pharma.
The idea was originated by a group of physicians trained in India and now at McMaster University in Canada, said Dr. Koon Teo, a professor of medicine at McMaster and a member of the research team.
"We know that there are many medications that are beneficial," Teo said. "But often people don't like to take many pills, and doctors don't give patients all the pills they might need."
The first trial enrolled 2,053 people with one risk factor, such as high blood pressure, but no cardiovascular disease. They were divided into nine groups, one taking the polypill, the others various combinations of the medications.
The study, done at 50 centers in India, was designed to answer several questions:
Would the five-drug polypill deliver the same effect as individual pills? What reduction in blood pressure and cholesterol could it achieve? Would there be harmful interactions between the ingredients? Would aspirin reduce the blood-pressure-lowering effect?
The answers were favorable. The polypill reduced systolic blood pressure (the higher of the 120/80 reading) by 7.4 points and diastolic blood pressure by 5.6 points, better than the reduction produced by individual medications. LDL cholesterol reductions were almost as great as those produced by individual doses of simvastatin, the statin in the polypill. Readings showed a reduction in urinary levels of a clot-associated molecule. There was no indication of harmful interactions for those taking the polypill.
The blood pressure reduction caused by the polypill would lower the risk of heart disease by 24 percent and lower stroke risk by 33 percent, the researchers estimated. The cholesterol-lowering effect would reduce heart disease risk by 27 percent and stroke risk by 8 percent, they estimated.
And putting those benefits into one pill would increase the possibility that healthy people would actually take the medications needed to keep them healthy, they said.
"I think this is a good idea, in that even though all these drugs are available in separate pills, people don't take them for lots of reasons -- logistics, costs, availability," said Dr. Christopher P. Cannon, an associate professor of medicine at Harvard Medical School, who wrote an accompanying commentary in The Lancet. "If one had a simple, inexpensive pill, it could open cardiovascular protection to many people."
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.