Efficacy and safety of ralinepag, a novel oral IP agonist, in PAH patients on mono or dual background therapy: results from a phase 2 randomised, parallel group, placebo-controlled trial

The European Respiratory Journal
Fernando TorresLewis J Rubin

Abstract

This phase 2 study was designed to assess the efficacy, safety and tolerability of immediate-release orally administered ralinepag, a selective, non-prostanoid prostacyclin receptor agonist with a 24-h terminal half-life, compared to placebo in adult patients with symptomatic pulmonary arterial hypertension (PAH). 61 PAH patients who were receiving standard care, including mono or dual PAH-targeted background therapy were randomised 2:1 to ralinepag (n=40) or placebo (n=21). The starting dose of ralinepag was 10 μg twice daily. Dosage was then up-titrated as tolerated over the course of the 9-week dose-titration period, to a maximum total daily dose of 600 μg (300 μg twice daily). The primary efficacy end-point was the absolute change in pulmonary vascular resistance (PVR) from baseline to week 22. Additional end-points included percentage change in PVR from baseline, other haemodynamic parameters, 6-min walk distance (6MWD) and safety and tolerability. Ralinepag significantly decreased PVR by 163.9 dyn·s·cm-5 compared to an increase of 0.7 dyn·s·cm-5 with placebo (p=0.02); the least-squares mean change from baseline PVR was -29.8% compared with placebo (p=0.03). 6MWD increased from baseline by 36.2 m with ralinepag and 29.4 m ...Continue Reading

References

Sep 18, 2002·Circulation·Vallerie V McLaughlinStuart Rich
Jan 22, 2004·Circulation·Rohit BudhirajaPaul M Hassoun
Jun 15, 2004·Journal of the American College of Cardiology·Marc HumbertMarlene Rabinovitch
May 28, 2009·Circulation·Nazzareno GalièUNKNOWN Pulmonary Arterial Hypertension and Response to Tadalafil (PHIRST) Study Group
Jun 29, 2010·American Journal of Respiratory and Critical Care Medicine·Hossein A GhofraniSteve Pascoe
Jun 21, 2011·Frontiers in Pharmacology·Jeremiah StithamJohn Hwa
Jun 29, 2011·Current Molecular Medicine·C MidgettJ Hwa
Mar 1, 2012·The European Respiratory Journal·Gérald SimonneauIrene M Lang
May 9, 2015·Journal of the American College of Cardiology·Vallerie V McLaughlinMarc Humbert

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Citations

Sep 2, 2020·Expert Opinion on Pharmacotherapy·Evangelia PanagiotidouGeorgia Pitsiou
Apr 17, 2020·Frontiers in Medicine·Irene Z PanJohn J Ryan
Jan 22, 2021·Expert Review of Respiratory Medicine·Pilar Escribano SubíasMaria Francesca Perelló
Nov 24, 2020·Current Cardiovascular Risk Reports·Jennalyn D MayeuxJohn J Ryan
Dec 1, 2021·Expert Review of Respiratory Medicine·Ralf EwertChristian F Opitz

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