Large-scale study confirms that millions of people are taking a heart attack drug unnecessarily

Rarely does a scientific study have such a beneficial impact on the daily lives of so many millions of people, explain cardiologists Valentín Fuster and Borja Ibáñez. A couple of months ago, their team presented the results of a clinical trial with 8,500 volunteers that showed that beta-blockers — drugs that have for decades been prescribed for life after a heart attack — “provide no benefit whatsoever” to the majority of these patients, those who retain their heart’s pumping capacity.

“We’re talking about tens or hundreds of millions of people worldwide; it’s staggering,” says Ibáñez, in a room at Spain’s National Center for Cardiovascular Research (CNIC) overlooking northern Madrid. The researchers’ conclusions, however, met with some skepticism. The number two at the Spanish Ministry of Health, family physician Javier Padilla, went so far as to say that there were “contradictory articles in this field” and even criticized “the siren songs of findings that may be very striking.”

The controversy affects the millions of people who take one or two of these tablets every day. Beta-blockers can be lifesaving for those with arrhythmias, chronic heart failure, or heart dysfunction. These drugs dilate blood vessels, which lowers blood pressure and heart rate, but they often have unwanted side effects, such as constant fatigue and decreased libido. They should only be taken if there is a genuine medical reason. The Spanish team announced new results on Sunday, and this time they are “irrefutable,” according to Ibáñez, scientific director of the CNIC. The authors analyzed data from five clinical trials in eight countries, with nearly 18,000 participants, and confirmed their previous conclusion: the ubiquitous beta-blockers are not necessary for patients who, after surviving a heart attack, retain proper heart contractile function.

Ibáñez does the math. He estimates that, in Spain alone, there may be 1.2 million people taking beta-blockers daily unnecessarily, but points out that there are another 500,000 patients for whom these drugs are indeed recommended. No one should stop their treatment without first consulting their cardiologist, warn Ibáñez and Fuster. Their findings, presented on Sunday in New Orleans at the American Heart Association Annual Meeting, were published in the specialized journal The New England Journal of Medicine.

Valentín Fuster directs the CNIC in Madrid and also chairs the Mount Sinai Fuster Heart Hospital in New York, which has borne his name for the past two years. The renowned cardiologist says he stopped prescribing beta-blockers to his patients with uncomplicated heart attacks a decade ago. It wasn’t an easy decision, he explains. Fuster, 82, is a disciple of Desmond Julian, the British physician who half a century ago spearheaded the ambitious clinical trial that demonstrated the benefits of beta-blockers after a heart attack. The usefulness of these drugs, however, declined after 2005, when the implantation of coronary stents — the small metal mesh tubes that prevent the arteries from becoming blocked after a heart attack — became widespread.

“I worked with Desmond Julian, so I witnessed the development of the beta-blocker concept firsthand. For a few years, it was practically gospel: you had to prescribe beta-blockers after a heart attack, no exceptions. I stopped prescribing them 10 years ago, but that decision was heavily criticized,” recalls Fuster.

His team is now calculating the savings this could generate for public healthcare. Beta-blockers are medications from the 1970s that are now off-patent, such as bisoprolol, developed by the pharmaceutical company Merck, and metoprolol, historically associated with AstraZeneca. A box of 40 tablets costs about €4 ($4.60) in Spain. They are very inexpensive, but if one million patients stop buying their daily capsule, the savings could reach around €35 million ($35.5 million) each year, according to an initial estimate by Ibáñez. “We are going to save millions for the public healthcare system,” he says.

The new analysis includes nearly 18,000 volunteers, primarily from Spain, Sweden, Norway, Denmark, Italy, and Japan. All had suffered a heart attack, but retained their heart’s pumping capacity. Half of the patients received beta-blockers, and the other half did not. After nearly four years of follow-up, doctors observed similar results in both groups: around 8% of participants suffered a major cardiovascular event, whether heart failure, another heart attack, or even death. Taking beta-blockers or not made no difference. “These data are conclusive,” says Fuster.

Their previous study, called REBOOT and conducted in a hundred hospitals in Spain and Italy, produced concerning results in women. For every 100 patients treated with beta-blockers, there was one adverse outcome — death, reinfarction, or hospitalization — attributable to the drugs themselves, the authors explained at the time. The publication of the Spanish-Italian research coincided with another similar study, but with fewer patients, conducted in Denmark and Norway. The results seemed contradictory. The Nordic study, with 5,600 volunteers, had detected that beta-blockers slightly reduced the risk of death or a serious cardiovascular event. When all data were analyzed together, the supposed beneficial effect disappeared, and the possible harmful impact to some women is no longer considered statistically significant.

In 2014, the European Society of Cardiology commissioned Borja Ibáñez to develop its treatment guidelines for myocardial infarction, a condition that affects two million people annually across Europe. The cardiologist explains that he found a complete lack of evidence regarding the current efficacy of beta-blockers in uncomplicated heart attacks, despite millions of people taking them daily. This led to the idea of testing them. “The result is revolutionary,” says Ibáñez, who understands the skepticism of two months ago. “People in general, and the medical community is no exception, are very afraid of change, but among heart attack experts, these findings haven’t surprised anyone.”

Ibáñez and Fuster predict an immediate change in heart attack treatment guidelines worldwide. The lead authors of the new study include Danish cardiologist Eva Prescott, Japanese cardiologist Neiko Ozasa, and Spanish cardiologist Xavier Rosselló. The president of the Spanish Society of Cardiology, Ignacio Fernández Lozano, also believes this international analysis “settles” any doubts. “Currently, 70% of patients recover without significant long-term effects or damage after a heart attack, with their heart function preserved, and they don’t benefit from beta-blockers, so there’s no reason to prescribe them,” he says. This cardiologist, from the Puerta de Hierro Majadahonda public hospital in Madrid, insists that no one should stop their treatment without consulting their doctor first.

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