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 been prescribed for decades throughout life after a heart attack – “provide no benefit” to the majority of these patients, those who maintain the heart’s pumping ability.
“We’re talking about tens or hundreds of millions of people around the world; it’s staggering,” says Ibáñez, in a room at Spain’s National Center for Cardiovascular Research (CNIC) overlooking northern Madrid. The researchers’ conclusions, however, were met with some skepticism. The number two in the Spanish Ministry of Health, family doctor Javier Padilla, went so far as to say that there are “contradictory articles in this field” and even criticized “the siren song of discoveries that can be very surprising”.
The controversy concerns millions of people who take one or two of these tablets every day. Beta-blockers can save the lives of those suffering from arrhythmias, chronic heart failure, or cardiac dysfunction. These drugs dilate blood vessels, lowering blood pressure and heart rate, but 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, which this time 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: ubiquitous beta-blockers are not necessary for patients who, after surviving a heart attack, maintain adequate cardiac contractile function.
Ibáñez does the math. He estimates that in Spain alone there are 1.2 million people who take beta-blockers daily unnecessarily, but points out that there are another 500,000 patients for whom these drugs are actually recommended. No one should stop treatment without first consulting their cardiologist, warn Ibáñez and Fuster. Their results, presented Sunday in New Orleans at the annual meeting of the American Heart Association, were published in the specialized journal The New England Journal of Medicine.
Valentín Fuster directs the CNIC in Madrid and also presides over the Mount Sinai Fuster Heart Hospital in New York, which has borne his name for two years. The renowned cardiologist says he stopped prescribing beta-blockers to his patients with uncomplicated heart attacks ten years ago. It wasn’t an easy decision, he explains. Fuster, 82, is a disciple of Desmond Julian, the British doctor who half a century ago led 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 wire mesh tubes that prevent blockage of arteries after a heart attack – became popular.
“I worked with Desmond Julian, so I saw firsthand the development of the concept of beta-blockers. For a few years it was practically gospel: after a heart attack you had to prescribe beta-blockers, no exceptions. I stopped prescribing them 10 years ago, but that decision was highly criticized,” Fuster recalls.
His team is now calculating the savings this could generate for public healthcare. Beta-blockers are drugs from the 1970s whose patent has now expired, such as bisoprolol, developed by the pharmaceutical company Merck, and metoprolol, historically associated with AstraZeneca. A pack of 40 tablets costs around 4 euros in Spain. They cost little, but if one million patients stopped buying the daily capsule, according to an initial estimate by Ibáñez, the savings could reach around 35 million euros (35.5 million dollars) each year. “We will save millions for the public health system,” he says.
The new analysis includes nearly 18,000 volunteers, mainly from Spain, Sweden, Norway, Denmark, Italy and Japan. All had had a heart attack, but retained their heart’s pumping ability. 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: About 8 percent of participants suffered a serious cardiovascular event, whether heart failure, another heart attack or even death. Whether or not I took beta blockers made no difference. “These data are conclusive,” Fuster says.
Their previous study, called REBOOT and conducted in a hundred hospitals in Spain and Italy, produced worrying results in women. For every 100 patients treated with beta-blockers, there was an adverse outcome – death, reinfarction or hospitalization – attributable to the drugs themselves, the authors explained at the time. The publication of the Italian-Spanish research coincided with another similar study, but with fewer patients, conducted in Denmark and Norway. The results seemed contradictory. The Nordic study, conducted on 5,600 volunteers, found that beta-blockers slightly reduced the risk of death or serious cardiovascular events. When all the data were analyzed together, the supposed beneficial effect disappeared and the possible harmful impact for some women was no longer considered statistically significant.
In 2014, the European Society of Cardiology commissioned Borja Ibáñez to develop its guidelines for the treatment of myocardial infarction, a condition that affects two million people every year across Europe. The cardiologist explains that he has found a complete lack of evidence on the current effectiveness 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 surprised no one.”
Ibáñez and Fuster predict an immediate change in heart attack treatment guidelines around the world. The lead authors of the new study include Danish cardiologist Eva Prescott, Japanese cardiologist Neiko Ozasa and Spanish cardiologist Xavier Rosselló. Even the president of the Spanish Society of Cardiology, Ignacio Fernández Lozano, believes that this international analysis “resolves” all doubts. “Currently, 70% of patients recover without significant long-term effects or harm after a heart attack, with heart function preserved, and they do not benefit from beta-blockers, so there is 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 treatment without first consulting their doctor.
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