The new study suggests "we should look seriously at this drug in heart failure patients as well," says American Heart Association spokeswoman Mariell Jessup, MD, medical director of the Penn Heart and Vascular Center at the University of Pennsylvania. She was not involved with the work.
The results were presented at the European Society of Cardiology Congress (ESC) and simultaneously published online in the journal The Lancet.
Procoralan Slows Heart Rate in Heart Failure Patients
About 50% of patients die within four years of diagnosis, and about 25% are rehospitalized within three months of their first hospital stay.
Recent research shows that elevated heart rates are associated with poor prognoses, says researcher Michel Komajda, head of the cardiovascular and surgical departments at the Pitie Salpetriere Hospital in Paris.
"So we hypothesized that reducing the heart rate with a novel agent, [Procoralan], would improve the prognosis above what is obtained with best clinical practice," he tells WebMD.
Which is just what happened. After nearly two years of treatment, patients given Procoralan were 18% less likely to die from cardiovascular disease or to be hospitalized for worsening heart failure, compared with patients given placebo.
Specifically, 24% of patients in the Procoralan group were hospitalized or died vs. 29% of patients given placebo, Komajda says.
The benefit was driven mainly by a reduction in hospitalizations for heart failure, he says.
Procoralan Produces Benefits in 3 Months
The study involved people with severe heart failure, whose hearts had serious trouble pumping and who had a heart rate of 70 beats per minute or more at rest -- a rate associated with a particularly poor prognosis, Jessup says.
Participants were given Procoralan or placebo on top of beta-blocker medication, the standard treatment for chronic heart failure.
Fewer serious side effects occurred in patients getting Procoralan. However, they were more likely to develop a condition known as bradycardia, characterized by a dangerously slow heart rate: 5% vs. 1% in the placebo group.
Adding Procoralan produced benefits within just three months and continued throughout the trial, Komajda says.
The trial was considered a big win by the researchers, as the drug failed to reduce heart attacks, hospitalizations, or deaths in the BEAUTIFUL trial, which was reported at ESC in 2008.
Procoralan fastens to the part of the electrical system that causes the heart to contract, slowing the heart rate, he says. It's the first drug to work by specifically slowing the heart rate.
The study was funded by Servier, which makes Procoralan.
In a commentary in the Lancet, John R. Teerlink, MD, of the University of California San Francisco, writes that much more work is needed before any firm conclusions can be drawn.
Less than 25% of patients were getting the recommended dose of standard beta-blocker therapy, he says. And although all patients in the trial potentially qualified for implantable medical devices like defibrillators to shock a stopped heart back into rhythm, less than 3% percent had them, Teerlink writes.
Procoralan "might reduce heart failure hospitalizations when added to contemporary heart failure therapies. However, whether [it] can improve outcomes in addition to optimally managed heart failure therapies or its benefits relative to other therapies, especially beta blockers, remains unknown," he writes.
Jessup agrees further work is needed. "But if a patient can't tolerate beta-blockers or beta-blockers fail to get the heart rate down, this might prove to be an important addition to their treatment," she says.