Scientific research can sometimes have a beneficial impact on the daily lives of millions of people, explain cardiologists Valentín Fuster and Borja Ibáñez. A few months ago, his team published the results of a clinical trial of 8,500 volunteers that showed that beta-blockers (drugs that have been prescribed for life after a heart attack) “offer no benefit” to the majority of patients whose hearts keep pumping. “We’ve been talking about millions of people around the world for decades, and it’s barbaric,” Ibáñez summed up in a room at the Center for Cardiovascular Investigations (CNIC) overlooking northern Madrid. However, there was some skepticism about his conclusions. Javier Padilla, the health ministry’s chief physician, said there were “contradictory articles in this field” and even criticized “the siren song of Halasgos, which can be very inflammatory.”
This controversy affects millions of people who spend their day or two using these tablets. If you have arrhythmia, chronic heart failure, or cardiac dysfunction, beta-blockers can be lifesaving. These drugs dilate blood vessels and lower blood pressure and heart rate, but often have undesirable effects such as fatigue and decreased sex drive. It should only be taken if there is a truly medical reason. The Spanish team will present new results this Sunday, but this time they are “irrefutable,” said Subraya Ibáñez, CNIC’s scientific director. The authors analyzed data from five clinical trials in eight countries involving 18,000 participants and substantiated their previous conclusions. Patients who survive a heart attack and whose heart maintains proper contractile activity do not need ubiquitous beta-blockers.
Mr. Ibáñez says: The study calculates that in Spain alone there may be 1.2 million people taking beta-blockers every day without needing them, but claims there are a further 500,000 patients for whom these drugs are only recommended. Nadi warned Ibáñez and Faster that they should have stopped the treatment without consulting a cardiologist. The results will be presented this Sunday at the congress of the Estado Unidense del Corazon in Nueva Orléans (EE UU) and published in a professional journal. New England Medical Journal.
Valentín Fuster heads the CNIC in Madrid, as well as the Cardiaco Monte Sinai Fuster hospital in New York, which for many years bears his name. The renowned cardiologist says he has been prescribing beta-blockers to patients with complex heart attacks for 10 years. It wasn’t an easy decision, he explains. Dr Faster is a protégé of British doctor Desmond Julian, who conducted an ambitious clinical trial demonstrating the benefits of beta-blockers after a heart attack. However, the usefulness of these drugs has declined since 2005. stent Coronary arteries, metal tubes that prevent blockages in arteries that can cause heart attacks.
“I was involved in the development of the concept of beta-blockers for a long time and worked with Desmond Julien. For several years, it was like gospel. After a heart attack, you had to take beta-blockers. I stopped taking beta-blockers 10 years ago, but I had a lot of questions,” recalls Fuster, 82, born in Barcelona. Your team is currently working on calculating the savings provided by public health. Beta-blockers are off-patent medicines developed in the 1970s, such as bisoprolol, developed by Merck Pharmaceuticals, and metoprolol, historically associated with AstraZeneca. A box of 40 tablets costs 4 euros. These are very cheap, but Ibáñez’s initial estimates suggest that if 1 million patients stopped buying their daily capsules, the cost would be around 35 million euros a year. “We are going to save millions of people from public health,” he declares.
The new analysis includes approximately 18,000 volunteers, primarily from Spain, Sweden, Norway, Denmark, Italy and Japan. Everyone has suffered a heart attack, but the heart’s ability to pump has not been lost. Most patients received beta-blockers, but the other half received no beta-blockers. After four years of follow-up, doctors observed similar results in both groups. About 8% of participants had a major cardiovascular event, leading to heart failure, another heart attack, or even death. Take a beta blocker or no change at all. “These data are conclusive,” Faster said.
His previous study, called REBOOT, was conducted in 100 hospitals in Spain and Italy and had alarming results among women. As the authors explained, for every 100 patients treated with a beta-blocker, the drug itself results in death, reinfarction, or hospitalization. The publication of the Spanish and Italian studies coincided with other similar studies conducted in Denmark and Norway with smaller numbers of patients. The results seem contradictory. A Scandinavian study involving 5,600 volunteers found that beta-blockers only slightly reduced the risk of death or serious cardiovascular events. When all data were analyzed together, the expected beneficial effect disappeared. The potential for harmful effects for some women is also now considered statistically significant.
In 2014, the European Society of Cardiology commissioned Borja Ibáñez to create a treatment guide for myocardial infarction. Myocardial infarction affects millions of people on the continent every year, including 70,000 in Spain. The cardiologist reports that there is a total lack of evidence about the effectiveness of current beta-blockers for uncomplicated heart attacks, despite the fact that millions of people take beta-blockers every day. So the idea was born to test them. “The results are revolutionary,” says Ibáñez, but he understands the skepticism of recent months. “Humanity in general, and the medical community as well, has great fear of this change, but among heart attack experts these data are not surprising to Nadi,” he opines.
Ibáñez and Fuster predict that heart attack treatment guidelines will soon change around the world. The new study’s lead authors include Danish cardiologist Eva Prescott, Japanese Yasuko Ozasa, and Spaniard Xavier Rosselló. Ignacio Fernández Lozano, president of the Spanish Society of Cardiology, also believes that the international analysis has put aside doubts. “Currently, there is no reason to give beta-blockers because 70% of patients suffer heart attacks without many sequelae, with preserved heart function, and do not benefit from beta-blockers,” he summarizes. The cardiologist at Madrid Public Hospital Puerta de Hierro Majadahonda insists that he never interrupts treatment without consulting his doctor.
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