Servier's Procoralan Cuts Heart-Failure Death, Hospital Stays, Study Shows
Les Laboratoires Servier’s Procoralan, used to treat chest pain in Europe, reduced hospital stays and deaths from heart failure in high-risk patients, according to a study published in the journal The Lancet.
Researchers tracked more than 6,500 people with severe heart failure, including those who had a recent hospitalization, poor cardiac pumping power and a heart rate of at least 70 beats per minute at rest. Patients getting Procoralan in addition to standard therapy were 18 percent less likely to die from cardiovascular causes or be admitted to the hospital for worsening symptoms than those on placebo after almost two years.
Heart failure occurs when the muscle is too damaged to pump enough blood through the body. About 5.7 million Americans have the condition, for which there is no cure, according to the U.S. National Institutes of Health. Servier’s drug, known chemically as ivabradine, latches on to part of the electrical system that causes the heart to contract, slowing the heart rate, according to the company-funded study. A high heartbeat at rest is a known risk for heart failure patients, with a faster rate tied to a worse outcome.
“It is very good news for patients and doctors that, even when using the best current drug treatment available, ivabradine further reduces the risk of death or hospitalization,” said Michel Komajda, the lead researcher and head of the cardiovascular and surgical departments at the Pitie Salpetriere Hospital in Paris. “The trial has demonstrated, for the first time, that reducing heart rate alone is beneficial for patients with heart failure.”
Patients with a higher heart rate at the start of the study reaped more benefit from the drug, according to the findings presented today at the European Society of Cardiology meeting in Stockholm. The trial, dubbed Shift, was the first to examine the impact of lowering the heart rate in heart failure. Patients taking Procoralan had an average reduction of 15 beats per minute in the study.
Decline in Deaths
The decline in deaths and hospitalizations from heart failure became apparent after three months of treatment, and continued throughout the trial, the researchers said. Fewer serious side effects occurred in patients getting Procoralan, though they were more likely to develop a heart rate that was too slow, a condition known as bradycardia.
It’s too soon to draw clear conclusions from the trial, wrote John Teerlink, director of the heart failure clinic at the San Francisco Veterans Affairs Medical Center and the University of California, San Francisco, in an editorial in The Lancet.
Less than one in four patients were getting the recommended dose of standard heart failure drugs and less than 3 percent had medical devices like defibrillators to shock a stopped heart back into rhythm, Teerlink wrote. The numbers raise questions about whether optimal heart failure therapies were given to the patients, the majority of whom came from eastern Europe, he said.
“It is not clear that Shift successfully tested the hypothesis that ivabradine provided additional benefit to patients with heart failure treated with contemporary optimal heart-failure therapies,” according to Teerlink, who said additional studies are needed. “Ivabradine should only be considered for patients truly intolerant to or on maximally tolerated heart-failure therapies.”
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