Rarely can a scientific study have 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, his team presented the results of a clinical trial with 8,500 volunteers that showed that beta-blockers – drugs that are prescribed for life after a heart attack for decades – “bring no benefit” to the majority of these patients, those who maintain the heart’s pumping ability. “We are talking about tens or hundreds of millions of people in the world, it is scandalous,” summarizes Ibáñez, in a room of the National Cardiovascular Research Center (CNIC) overlooking the north of Madrid. His conclusions, however, were met with some skepticism. The number two of the Ministry of Health, family doctor Javier Padilla, went so far as to state that there are “contradictory articles in this sector” and even criticized “the siren song of results which can be very surprising”.
The controversy concerns those millions of people who take one or two of these tablets every day. Beta blockers can save your life if you have arrhythmias, chronic heart failure, or cardiac dysfunction. These drugs cause blood vessels to dilate, lowering blood pressure and heart rate, but often have side effects, such as constant tiredness and decreased sexual desire. You should only take them if there really is a medical reason. The Spanish team announces new results this Sunday, this time “irrefutable”, according to Ibáñez, scientific director of the CNIC. The authors analyzed data from five clinical trials in eight countries, with almost 18,000 participants, and certified their previous conclusion: the ubiquitous beta-blockers are not necessary in patients who, after surviving a heart attack, maintain correct contractile activity of the heart.
Ibáñez does the math. He estimates that, in Spain alone, there could be 1.2 million people who take beta-blockers daily without need, but underlines that there will be another 500,000 patients for whom these drugs will be recommended. No one should abandon treatment without first consulting their cardiologist, warn Ibáñez and Fuster. Their results, presented this Sunday in New Orleans (USA) at the American Heart Association congress, are published in the specialized journal The New England Journal of Medicine.
Valentín Fuster directs the CNIC in Madrid and at the same time presides over the Monte Sinaí 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 is a disciple of Desmond Julian, the British doctor who half a century ago promoted 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 it came into force stent coronary arteries, the small wire mesh tubes that prevent arteries from clogging after a heart attack.
“I worked with Desmond Julian, so I experimented a lot with the development of the concept of beta-blockers. For a few years it was like gospel: you had to give beta-blockers after a heart attack, no matter what. I stopped giving them 10 years ago, but this was very much questioned,” recalls Fuster, born in Barcelona 82 years ago. His team is now working to calculate the savings generated for public healthcare. Beta blockers are drugs from the 1970s that are now off-patent, such as bisoprolol, developed by the pharmaceutical company Merck, and metoprolol, historically linked to AstraZeneca. A box of 40 tablets costs around four euros. They cost very little, but if a million patients stopped buying the daily capsule, the savings would amount to around 35 million euros each year, according to an initial estimate by Ibáñez. “We will save millions for public health,” he proclaims.
The new analysis includes nearly 18,000 volunteers, mainly from Spain, Sweden, Norway, Denmark, Italy and Japan. All of them had had a heart attack, but without losing the 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, a new heart attack or even death. Taking or not taking beta blockers didn’t change anything. “This data is definitive,” Fuster says.
Their previous study, called REBOOT and conducted in a hundred hospitals in Spain and Italy, obtained disturbing results in women. For every 100 patients treated with beta-blockers there was one outcome of 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, conducted on 5,600 volunteers, found that beta-blockers slightly reduced the risk of death or serious cardiovascular events. When analyzing all the data together, the supposed beneficial effect disappeared. And even the possible harmful impact on some women is now not considered statistically significant.
In 2014, the European Society of Cardiology commissioned Borja Ibáñez to prepare a therapeutic guide for myocardial infarction, a problem that affects two million people on the continent every year, of which 70,000 in Spain. The cardiologist says he found an absolute lack of evidence on the current effectiveness of beta blockers in uncomplicated heart attacks, despite the fact that millions of people were taking them daily. Thus the idea of putting them to the test was born. “The result is revolutionary,” says Ibáñez, who understands the skepticism of two months ago. “Humans in general, and the medical community is no different, are very afraid of change, but among people who are experts in heart attacks, this data surprised no one,” he says.
Ibáñez and Fuster predict that there will be an immediate change in heart attack treatment guidelines around the world. Among the main authors of the new study are the Danish cardiologist Eva Prescott, the Japanese Neiko Ozasa and the Spaniard Xavier Rosselló. Even the president of the Spanish Society of Cardiology, Ignacio Fernández Lozano, believes that this international analysis “resolves” the doubts. “Now 70% of patients remain without many consequences or damage after a heart attack, with preserved heart function, and do not get benefits from beta-blockers, so there is no reason to administer them,” he summarizes. This cardiologist, from Madrid’s public hospital Puerta de Hierro Majadahonda, insists that no one stops treatment without first consulting their doctor.
