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Mortality Reduced With Serelaxin (RLX030) in Patients With Acute Heart Failure

Recombinant human hormone relaxes blood vessels (Sept. 24)

Novartis announced on September 24 that the company’s investigational drug serelaxin (RLX030) reduced all-cause mortality in patients with acute heart failure (AHF) in a phase III trial.

The RELAX-AHF study had two primary endpoints to measure reductions in dyspnea, only one of which reached statistical significance. Dyspnea, or shortness of breath, is the most common symptom of AHF. RLX030 was well tolerated in the study.

RELAX-AHF was a 6-month phase III clinical trial to investigate the efficacy and safety of RLX030 for the treatment of AHF. It was a randomized, double-blind, placebo-controlled study involving 1,161 patients in 11 countries. In the study, RLX030 was administered on admission to the hospital in the form of an intravenous infusion for up to 48 hours in addition to loop diuretics and other medicines. The drug was compared with placebo on top of standard-of-care treatment for AHF.

Results of the study will be presented at the American Heart Association (AHA) congress in Los Angeles in November.

Heart failure is a disease in which the heart is unable to supply enough blood to meet the body's needs. Approximately half of all patients die within 5 years of diagnosis, particularly as a result of acute episodes in which their symptoms suddenly become worse, and urgent hospital treatment is needed. AHF places a significant burden on healthcare systems and accounts for approximately 2 million hospitalizations each year in the U.S. and Europe.

Serelaxin (RLX030) is a recombinant form of the human hormone relaxin-2, which occurs naturally in both men and women. In women, relaxin-2 levels increase to support important physiological changes during pregnancy. Serelaxin acts by relaxing the blood vessels, leading to reduced stress on the heart and kidneys in both men and women.

For more information, visit the Novartis Web site.

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