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Dyspnea and congestion are the cardinal presenting features of AHF. The rapid onset or
change in signs and symptoms of HF – breathlessness, orthopnea, hepatojugular reflux,
paroxysmal nocturnal dyspnea, and fatigue – require urgent care. Hospitalization and WHF
with accompanying end organ damage, namely, WRF and myocardial wall stress and injury,
are both associated with increased mortality. Although therapies are available to relieve
dyspnea and congestion in AHF, the disease burden remains high as no therapy has shown a
mortality benefit.
Serelaxin infused for 48 hours in patients with AHF resulted in significant improvement in
dyspnea and signs and symptoms of congestion and was associated with significant reductions
in early WHF events and LOS during the index hospitalization including duration in intensive
care. A 37% reduction in the risk of CV and all-cause mortality was demonstrated in the
serelaxin-treated patients in RELAX-AHF. Biomarker changes suggest serelaxin therapy has
a protective effect on end organs, heart and kidney, which may explain the benefit in mortality.
These findings were consistent with Pre-RELAX-AHF both with respect to relief of dyspnea
and signs and symptoms of congestion and the magnitude of effect on mortality reduction at
the recommended dose.
Serelaxin, as a 48-hour continuous infusion was well-tolerated with an overall AE profile very
similar to placebo in most areas except in hypotension-related AEs. BP decrease events can
occur in a proportion of patients due to the vascular mechanism of action of the drug, but this
safety concern is manageable with routine BP monitoring, and dose reduction or
discontinuation measures if considered necessary.
Together, the results of the Pre-RELAX-AHF and RELAX-AHF studies provide compelling
support for a well-tolerated agent, which favorably affects both signs and symptoms of AHF
and has a positive effect on CV mortality and overall mortality.
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