Results from a new analysis of the phase III RELAX-AHF study published in the European Heart Journal and presented at the European Society of Cardiology ( ESC ) Congress in Amsterdam, has indicated that the investigational medicine RLX030 ( Serelaxin ) consistently improved symptoms and mortality across multiple subgroups of patients with acute heart failure ( AHF ) assessed in the trial.

The addition of RLX030 to conventional treatment led to improvements in breathlessness ( dyspnea ) and mortality at 6 months across all pre-specified subgroups including those with renal impairment ( eGFR less than 50ml/min ), the elderly ( greater than or equal to 75 years ) and patients with atrial fibrillation, although the small numbers of patients in each group limit the statistical conclusions that can be drawn.

Results from RELAX-AHF previously presented in 2012 demonstrated that RLX030 reduced the risk of death by more than one-third ( 37% ) compared with conventional treatment at six months.
RLX030 is currently the only drug for which a reduction in all-cause mortality has been observed in patients with acute heart failure in a major study.

RELAX-AHF was an international randomized, double-blind study involving 1,161 patients and was designed to compare the efficacy and safety profile of RLX030 to placebo in addition to standard therapy for the treatment of acute heart failure.
RLX030 was given within 16 hours of hospitalization ( mean 7.8 hours ) in the form of an intravenous infusion ( 30 mcg per kg per day ) for 48 hours in addition to conventional therapy for acute heart failure.
The study had two primary endpoints using different scales to measure reduction in breathlessness.
The visual analog scale ( VAS ) showed a significant benefit up to day five ( p=0.0075 ), whereas the Likert scale ( a baseline-related short-term assessment of dyspnea relief ) did not reach significance at 6, 12 and 24 hours ( p=0.702 ).
As one of the primary endpoints was met the study was positive according to protocol criteria.

Analysis of additional endpoints showed that patients who received RLX030 had a 37% reduction in the risk of mortality at 6 months after an acute heart failure episode compared with those who received conventional treatment.
RLX030 also significantly reduced heart failure worsening up to day 14 ( p=0.026 ) thereby decreasing the need for intensified treatment, as well as reducing the mean length of stay in hospital by 0.9 days ( p=0.039 ) and in the intensive/cardiac care unit by 0.4 days ( p=0.029 ).
The study did not meet secondary endpoints including days alive and out of hospital up to day 60 ( p=0.438 ), and cardiovascular death or re-hospitalization due to heart or kidney failure up to day 60 ( p=0.862 ).
RELAX-AHF showed that the side effects of RLX030 were comparable to conventional therapy and the drug was generally well tolerated.

RLX030 is a form of a naturally occurring hormone ( human relaxin-2 ), present in both men and women, although its levels rise in pregnant women to help the body cope with the additional cardiovascular demands during pregnancy. ( Xagena )

Source: Novartis, 2013

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