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RELAX-AHF: Serelaxin improved symptoms, CV mortality in hospitalized HF patients
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LOS ANGELES — New results from the RELAX-AHF trial indicate that the investigational drug serelaxin improved signs and symptoms of HF, markedly reduced worsening of HF in the hospital and decreased CV and all-cause mortality in patients with acute HF.
John R. Teerlink
Compared with placebo, patients with acute HF assigned to receive serelaxin (RLX030, Novartis) experienced significant relief of dyspnea — the first primary endpoint — with a 19% increase from baseline in area under the curve (AUC) through day 5 (P=.0075), John R. Teerlink, MD, professor of medicine at the University of California, San Francisco, said during a press conference at the American Heart Association Scientific Sessions 2012. However, the second primary endpoint, which required patients to have moderate to marked improvement in dyspnea relief at all three time points of 6, 12 and 24 hours, was not achieved.
Researchers also found a 37% reduction in CV death through 180 days (P=.028), with a number needed to treat of 29, according to Teerlink, who is also director of HF at the San Francisco VA Medical Center. There were no differences in the two secondary endpoints, CV death or HF/renal failure reshosptialization through day 60 and the days alive out of hospital through day 60. A slight increase in HF or renal failure rehospitalizations through day 60, however, offset the decrease in CV death.
Further, data associated serelaxin with early and persistent reductions in worsening of HF. By 14 days, there was a significant 30% reduction in the risk for worsening HF in serelaxin-treated patients, Teerlink said. Duration of ICU care was also reduced by about one-third of a day and initial hospitalization length of stay by almost a full day with serelaxin, he said.
“What the RELAX-AHF trial shows is that serelaxin clearly improves signs and symptoms of HF and markedly reduces worsening of HF in the hospital and provides a longer term CV and all-cause mortality benefit,” Teerlink told Cardiology Today.
“What we need to do now is get a sense of the future of the drug, in terms of its approval from the investigative and regulatory community. That’s going to be first,” he said. “The other point that I will reinforce is, if these findings are supported by the community, it will result in a mandate to use this agent in the appropriate patients and will dramatically change the landscape of treatment for acute HF.”
RELAX-AHF is a phase 3 trial of 1,161 patients at 96 sites in 11 countries. The researchers randomly assigned patients to serelaxin 30 mcg/kg per day or placebo through a 48-hour IV infusion. Patients received medication within 16 hours of hospitalization for HF-related symptoms of dyspnea with evidence of decline in renal function. They also received standard therapy with diuretics. – by Melissa Foster
For more information:
Teerlink JR. Late-breaking clinical trials: Management of LV dysfunction: Devices and drugs. Presented at: the American Heart Association Scientific Sessions 2012; Nov. 3-7, 2012; Los Angeles.
Disclosure: Teerlink is a consultant for and has received research grants from Corthera and Novartis.
Perspective
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Gregg C. Fonarow , MD
For HF, this is the most exciting trial presented here at AHA. For more than 20 years, there has been a search to find one or more medications that would help patients presenting with acute decompensated HF. There are over 1 million patients per year hospitalized with acute HF, and this is a patient population that is highly symptomatic and at high risk for adverse outcomes. Although diuretics can help decongest those patients, we have not had a therapy that has improved clinical outcomes and symptoms up and above loop diuretics.
What’s exciting here is after the initial pilot study there is a prospective, randomized trial with approximately 1,000 patients and one of the two primary endpoints is a significant reduction in objectively measured shortness of breath using a well-validated visual analog scale. More importantly, if we’re going to relieve symptoms, we want to make sure this is a safe drug with clear evidence of safety. This trial showed a 37% reduction in all-cause mortality. If this finding can be replicated, it’s a phenomenal breakthrough of reduction in all-cause mortality or CV mortality in this patient population. There is such tremendous excitement and enthusiasm about the results of RELAX-AHF because there are few areas in CV medicine where we’ve had absolutely no therapies improve outcome.
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