One Size Fits All? New Pill Combines Heart Drugs
If you could take five heart medications in one cheap pill to reduce your risk of heart disease and stroke without risking more side effects, wouldn't you?
That's what a pharmaceutical company in India is hoping.
The pill contains aspirin to prevent blood clots that can cause heart attacks, a statin to lower cholesterol, and three blood pressure medications.
The single capsule, taken daily by people at risk of heart disease, could cut their risk about as much as taking each pill taken separately, according to a study presented at the American College of Cardiology meeting in Orlando this week.
An All-In-One Way To Reduce Risk
Dr. Salim Yusuf, who headed the study, says that means the polypill could reduce the risk of heart disease by 60 percent and strokes by 50 percent in this population.
The real appeal, in both the developing world and the modern medical system in the U.S., may be increased compliance.
It's a lot easier to remember to take one pill than five pills.
And since all five components are generic drugs, if the drug comes to market, it's not likely to be very expensive, says Christopher Cannon, head of the cardiovascular division at Brigham and Women's Hospital in Boston in a commentary published along with the study in The Lancet.
However, the drawback in combining medications into one pill may be that everyone gets the same dose of each ingredient, whether it's needed or not.
Polypill's Initial Success Merits Further Study
Researchers from McMaster University in Canada, St. John's Research Institute in Banagalore, India, and several other institutions tested the polypill and various combinations of its separate components on 2,000 men and women in India at risk of heart disease because of high blood pressure, obesity, high cholesterol, diabetes or a history of smoking.
After three months, the researchers looked for changes in blood pressure and various blood fats such as cholesterol. The polypill proved as effective as taking three separate blood pressure medications. It lowered lipids 25 percent, a few percentage points less than a statin alone. Side effects were no more than if each drug had been taken separately.
The study was funded by Cadila Pharmaceuticals in Ahmedabad, India.
The polypill is not approved for use in the U.S.
Cardiologists say the positive results of the preliminary trial warrant a bigger and longer trial to look for long-term side effects.
"We have to see if it works as advertised in reducing cardiovascular risk over the simpler approach of simply just treating one risk factor at a time," says cardiologist and health policy expert Mark Hlatky of Stanford University.
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RENEE MONTAGNE, host:
For people who are tired of lining up all their pills next to their morning coffee and drowning them one by one, researchers from Canada and India may have a solution: a single pill made of five drugs, each of which is used to combat heart disease. The idea is to be both convenient and effective, although more work needs to be done, as NPR's Joanne Silberner reports.
JOANNE SILBERNER: A lot of people at risk of heart disease take one or two or even all five of the following drugs: aspirin to prevent blood clots, a statin to lower blood lipids and three blood pressure medications that work in different ways.
The idea of combining these five drugs into a single pill has been around for a long time, says Yusuf Salim of McMaster University in Canada. He set out to develop a single medication called a polypill. And so far, things are looking good. The polypill lowered cholesterol almost as much as the statin alone. It lowered blood pressure like the blood pressure medications and improved other risk factors as well.
Dr. YUSUF SALIM (McMaster University, Canada): When we put all the things together, we estimated that the polypill will likely reduce heart disease by about 60 percent and strokes by 50 percent.
SILBERNER: The data come from a study Salim and colleagues conducted in India with the support of a drug company. They divided 2,000 people at risk of heart disease into nine groups. Four hundred people took the polypill. The other groups took various combinations.
Salim wanted to give the drug to people with just one or two risk factors for heart disease: diabetes or high blood pressure or obesity or smoking or cholesterol. But he worried about the safety of drugs within the combination that people may not need. There might be someone with high cholesterol, for example, but normal blood pressure.
Dr. SALIM: If you take people with normal blood pressure and give them three blood pressure-lowering drugs, will their blood pressures fall (unintelligible), and will they all collapse?
SILBERNER: They didn't. Then there's the problem that people often discontinue taking drugs when they encounter side effects.
Dr. SALIM: So are the rates of discontinuation five times as worse in people who take the polypill with five drugs compared to somebody who only takes one drug?
SILBERNER: In fact, the side effects were no worse than taking a single pill alone. That's not to say the five-in-one pill is a done deal. Doctors at the American College of Cardiology meeting where the research was presented are cautiously optimistic.
Cardiologist Christopher Cannon of Brigham and Women's Hospital says just like with the individual drugs, people who take the polypill need to be monitored for serious side effects.
Dr. CHRISTOPHER CANNON (Brigham and Women's Hospital): So you have to have the follow-up blood work to check the kidneys and check the liver, test for the statin.
SILBERNER: Cannon wants to see a longer study. This one was only three months.
Dr. CANNON: And ideally one to show that it, in fact, does lower the risk of heart attack. It's been calculated that it would likely do that, but to do a large study to really prove that would make this ready for prime time.
SILBERNER: That study could cost tens of millions of dollars. There's no guarantee a drug company that spends it will be able to get a patent so it could recoup research costs, since these are five generic drugs. But Yusuf Salim says the company that supported his work is interested and will do further testing.
If it all works out, it would make life simpler for people with risk factors for heart disease. But even so, no free lunch, say cardiologists. Weight loss and exercise and no smoking is still the best medicine.
Joanne Silberner, NPR News. Transcript provided by NPR, Copyright National Public Radio.
