The polypill is back: Should everyone over 50 be given a pill to prevent cardiovascular disease?

Heart disease remains the leading cause of death in the United States. According to an opinion piece published in early March in the prestigious scientific journal The BMJ, thousands of these deaths could be prevented. How? By providing all citizens over 50 — including many who wouldn’t typically be classified as at risk — with a polypill that combines a statin and three blood pressure-lowering medications.

The authors of the article — three professors of epidemiology and preventive medicine from University College London and the University of Birmingham — urged the British healthcare system to implement this measure. According to their estimates, if just 8% of people over 50 accepted it, the health benefits would surpass those of current monitoring and screening systems.

The researchers based this call on two key arguments. First, complex risk prediction tools are ineffective and may be overlooking many potential victims. “Most heart attacks and strokes occur in people with average levels of risk,” said co-author Professor Aroon Hingorani. On the other, it is a “simple, effective, and potentially cost-effective” strategy, he continued, as its components are no longer patented and have minimal side effects.

“Rather than being a ‘medicalization’ of a large section of the population, a polypill program is a preventative strategy designed to avoid a person becoming a patient,” said Nicholas Wald in a press release. “It can be compared to public health programs such as vaccinations, reducing salt in food, and adding folic acid to flour,” added Wald, who has been studying the polypill’s effectiveness as a primary prevention tool since 2003.

Cardiologist Valentín Fuster is director of the Carlos III National Center for Cardiovascular Research (CNIC) in Madrid and one of the world’s leading experts in the field of cardiovascular preventive medicine. He told EL PAÍS: “I believe in Wald’s concept, and he should be congratulated. But I still think that giving a polypill simply to prevent it to people who, for example, don’t have high cholesterol or high blood pressure, is attacking a system that isn’t necessarily sick. If it was proposed 20 years ago and hasn’t gone ahead, we have to ask ourselves why.”

For Fuster, in fact, the very idea of implementing a polypill for disease prevention is “absurd.” “But it’s the reality of the world we live in. The ideal would be for people to take care of themselves and not get sick,” he said.

His opinion is shared by Armando Oterino, a member of the Preventive Cardiology Association of the Spanish Society of Cardiology (SEC), who believes that the priority — before implementing the polypill or any other pharmacological therapy — should be controlling risk factors through health and lifestyle measures (such as physical exercise, the Mediterranean diet, quitting smoking, etc.):

“I am in favor of building the house from the bottom up, not from the roof down,” said Oterino. “Before any medication, the first measures recommended by all the guidelines are health and dietary measures. And if these measures fail or the risk is above a certain value, the medication should be prescribed with the simplest dosage, of course, to improve adherence.”

Oterino also emphasizes the importance of correctly identifying the risk factors for all patients. “Controlling triglycerides and LDL cholesterol, managing blood pressure, and addressing smoking — these are all risk factors. We can screen for all of this using tools and scales that help us determine each patient’s risk and take the appropriate measures. Can improvements be made in this area? Absolutely, and that will allow us to stay ahead of the curve and save lives,” he adds.

Polypill for patients with history of cardiovascular events

In 2022, Dr. Valentín Fuster’s team published a study in the New England Journal of Medicine, concluding that a polypill containing aspirin, atorvastatin, and ramipril could offer a simple solution for secondary prevention and managing complications after a myocardial infarction. The study’s results indicated that this polypill, designed by Fuster himself, reduced cardiovascular deaths in heart attack patients by 33%, largely due to improved patient adherence.

This is crucial after an acute myocardial infarction, as better adherence implies longer treatment, which in turn reduces the risk of further cardiovascular events. Ultimately, as Oterino points out, it’s easier to get a patient to take one pill than three. In fact, according to the expert, adherence rates for statins — the gold standard for controlling cholesterol — rarely exceed 50%.

Today, Fuster’s polypill, developed at the CNIC, has been approved by the European Medicines Agency (EMA), is available in 30 countries, and is seeking approval from the U.S. Food and Drug Administration (FDA). What’s more, in 2023, the World Health Organization (WHO) included it on its list of essential medicines, which highlights drugs that all health systems should have on hand. “For the WHO to tell you that your drug is an essential medication is the most powerful achievement in the field of pharmaceuticals and drug development,” said Fuster.

The cardiologist also notes that the polypill, initially designed for patients who have already experienced a cardiovascular event, is now being recommended in clinical guidelines by organizations like the European Society of Cardiology for coronary patients with poor medication adherence, whether or not they have had a heart attack.

“For me, the future of the polypill in primary prevention is challenging; I’ve always said that. That’s why we’re focusing on secondary prevention,” says Fuster. Time seems to have proven him right.

On March 11, at the request of Nature Cardiovascular Research, Fuster wrote an article about the journey of his polypill — from its conception in 2007 to its recognition as an essential medicine by the WHO in 2023. “Fifteen years ago, we set off to develop a polypill for secondary prevention as a vehicle to improve treatment accessibility and adherence,” he wrote. “Despite many challenges, the polypill has managed to transition from a mere conceptual discussion to a tangible therapeutic option, based on solid scientific grounds, which could substantially raise standards of preventive cardiovascular care worldwide.”

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