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Selepressin, a novel selective vasopressin V1A agonist, is an effective substitute for norepinephrine in a phase IIa randomized, placebo-controlled trial in septic shock patients.


ABSTRACT: Vasopressin is widely used for vasopressor support in septic shock patients, but experimental evidence suggests that selective V1A agonists are superior. The initial pharmacodynamic effects, pharmacokinetics, and safety of selepressin, a novel V1A-selective vasopressin analogue, was examined in a phase IIa trial in septic shock patients.This was a randomized, double-blind, placebo-controlled multicenter trial in 53 patients in early septic shock (aged ?18 years, fluid resuscitation, requiring vasopressor support) who received selepressin 1.25 ng/kg/minute (n?=?10), 2.5 ng/kg/minute (n?=?19), 3.75 ng/kg/minute (n?=?2), or placebo (n?=?21) until shock resolution or a maximum of 7 days. If mean arterial pressure (MAP) ?65 mmHg was not maintained, open-label norepinephrine was added. Co-primary endpoints were maintenance of MAP >60 mmHg without norepinephrine, norepinephrine dose, and proportion of patients maintaining MAP >60 mmHg with or without norepinephrine over 7 days. Secondary endpoints included cumulative fluid balance, organ dysfunction, pharmacokinetics, and safety.A higher proportion of the patients receiving 2.5 ng/kg/minute selepressin maintained MAP >60 mmHg without norepinephrine (about 50% and 70% at 12 and 24 h, respectively) vs. 1.25 ng/kg/minute selepressin and placebo (p?

SUBMITTER: Russell JA 

PROVIDER: S-EPMC5557574 | BioStudies | 2017-01-01

REPOSITORIES: biostudies

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