An inexpensive polypill is probably one of the best ways to solve the world’s heart problems, prominent cardiologists say.
Never heard of a polypill? You’re not alone. This approach to medication for heart disease, which experts say could save millions of lives and spare millions more from heart problems, is not available in the United States. And in places where it is used, it’s underutilized, some experts say.
The term “polypill” generally refers to a combination of medicine that can lower blood pressure, a statin that lowers cholesterol, a medication that can make the heart beat with less force, and sometimes aspirin. It’s kind of like a multivitamin for your heart. Other kinds of polypills are made to treat HIV, glaucoma and other diseases.
In a commentary published Tuesday in the medical journal the Lancet, Drs. Fausto Pinto, president of the World Health Federation, and Salim Yusuf, executive director of the Population Health Research Institute, write that the time is now for companies to make more of these pills and for more doctors to prescribe them.
‘A global tragedy’
Heart disease is the No. 1 killer in the world. About 18 million people die from heart problems every year. Around 54 million people live with heart disease.
In the US alone, nearly half of adults have some form of cardiovascular disease, and one person dies of it every 34 seconds, according to the US Centers for Disease Control and Prevention.
With risk factors such as obesity and diabetes on the rise, heart problems will continue to grow, particularly in communities that are already disproportionately affected by health issues, like the Black community, and in families that have limited access to health care, like those who live in rural areas or in poor communities.
For almost two decades, doctors have argued that a polypill would be a cheap and easy way to prevent heart problems. But few companies make them, and even when they are available, few people take them, the commentary says.
“This systemic failure is a global tragedy as many premature deaths from cardiovascular diseases could be avoided,” Pinto and Yusuf write.
They point to a growing body of evidence that suggests that a polypill can prevent heart problems with few side effects. Studies also show that when people can take only one pill, as opposed to many, they are significantly more likely to do so.
Another advantage is that the polypill may be made with generic ingredients, so it can be inexpensive.
In recent independent long-term trials, the commentary says, there was “clear and resounding” evidence that this pill really worked for primary prevention, meaning a person could take it even if they hadn’t had a heart attack or stroke, and as secondary prevention, after a heart attack.
Data from these three trials also showed that the polypill reduced the risk of heart problems by nearly 40%. There was also a nearly 50% relative risk reduction when scientists included an aspirin in the medicine. Positive results were seen in people with a wide range of underlying risk factors like high blood pressure and high cholesterol.
By Pinto and Yusuf’s own estimate, even if only half of the people who may be at risk for heart problems take a polypill, it could prevent about 2 million deaths a year from heart disease and keep 4 million people from developing heart problems.
“The evidence for the benefits of the polypill is now substantial,” they wrote. “It is time to use the polypill widely to save millions of lives each year.”
Polypills are not included in the World Health Organization’s Essential Medicines List of the drugs considered to be the most effective and safe to meet the most important needs in a health system. Such an addition would prompt governments and insurance companies to encourage doctors to recommend them, Pinto and Yusuf said.
Debate over who should get polypills
Dr. Donald Lloyd-Jones, a cardiologist at Northwestern’s Feinberg School of Medicine and immediate past president of the American Heart Association, notes that a significant body of evidence suggests that polypills can be safe and can prevent heart attacks and strokes.
“If you have an unhealthy population and you want to address a kind of one-size-fits-all scenario, particularly in populations with limited resources where you can’t have an easy access to health care or doctor’s appointments, these kind of one-size-fits-all solutions can be quite cost-effective,” he said.
Diet and exercise can do a lot to keep hearts healthy, but some people may not have access to healthy food or may live in neighborhoods where it isn’t safe to take a walk outside.
“For some, we haven’t designed the system to help people succeed with lifestyle alone. So we may well need this kind of approach to curb the epidemic of cardiovascular disease, which is alive and well as an epidemic,” Lloyd-Jones said. “We’re likely to see this deployed far more often as a strategy.”
Dr. Dariush Mozaffarian, a cardiologist and dean for policy and the Jean Mayer Professor of Nutrition at the Friedman School of Nutrition Science and Policy at Tufts University, doesn’t like the idea of making a polypill available population-wide, even in vulnerable communities.
“I think the idea of putting drugs in the water, so to speak, to help everyone is just not supported by the evidence,” he said.
Mozaffarian said he’s been in some debates with other scientists about this topic. For most people, there should be a polyhealth approach instead of a polypill, he said: Make healthy food more accessible and a healthy lifestyle more achievable.
“These are the treatments we should be investing in for primary prevention,” he said.
He supports the use of a polypill as secondary prevention, after a heart attack, or in other people who are at high risk. “Putting it together in one pill it makes compliance easier. It makes it simpler for the patient and for the clinician.”
But there’s no real financial incentive for a pharmaceutical company to make these kinds of pills at low cost, he said. Governments and international organizations should work with the companies to provide that incentive.
Seeking FDA approval
Dr. Valentín Fuster, director of Mount Sinai Heart and general director of the National Center for Cardiovascular Investigation in Madrid, Spain, published the results of a large trial of a polypill in the New England Journal of Medicine last month.
He agrees that more companies should make them, but it isn’t necessarily easy to do, he said. His team tried 50 variations before they came up with the combination of medications that seemed to work the best.
“I do think [a polypill] is a significant advance,” Fuster said.
His team’s polypill is a combination of an ACE inhibitor to lower blood pressure, a statin to reduce cholesterol and aspirin. His late-stage trial resultsshowed that people who had had a heart attack and took the pill had a relative risk reduction of 33% for cardiovascular death. It also helped prevent other problems, like stroke and subsequent heart attacks.
The results were so positive, Fuster said, he is submitting them to the US Food and Drug Administration for approval of his team’s polypill.
Some combination drugs widely used to treat blood pressure combine an ACE inhibitor and a diuretic, Lloyd-Jones said, but the FDA has not approved any polypills that address multiple heart issueslike this.
Fuster believes that polypills should be given only to people who have had a heart attack rather than used as a preventive medicine.
“I don’t have any idea what the person on the street needs. This is not a pill for people walking in the streets. This is for people who had a heart attack already,” he said.
Fuster said his team has been working on a polypill for the past 15 years.
He got interested in the idea when he learned how few people take their medicine for heart issues, even after having one heart attack, which raises their risk of another. One study found that less than half were taking the appropriate pills.
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He thought a simple change, like a single pill, would lead more people to take their medicine.
“Adherence, I’m sure, plays a very important role,” Fuster said. “The fact that the polypill was used more often than the people using the pills separately, we are very, very pleased with the result, and hopefully this can be generalized for people after heart attacks or even people at a very high risk with a stroke. At the same time, it is much more affordable for countries that are in need of this better secondary treatment.”
