Two formulations of epoprostenol sodium in the treatment of pulmonary arterial hypertension: EPITOME-1 (epoprostenol for injection in pulmonary arterial hypertension), a phase IV, open-label, randomized study - 20/01/14
, David B. Badesch, MD b, Ivan M. Robbins, MD c, Victor F. Tapson, MD d, Harold I. Palevsky, MD e, Nick H. Kim, MD f, Steven M. Kawut, MD e, Adaani Frost, MD g, Wade W. Benton, PharmD h, Jean-Christophe Lemarie, MSc i, Frederic Bodin, MD j, Lewis J. Rubin, MD f, Vallerie McLaughlin, MD kRésumé |
Background |
Epoprostenol sodium with arginine-mannitol excipients (epoprostenol AM; Veletri [Actelion Pharmaceuticals Ltd, Allschwil, Switzerland]) and epoprostenol sodium with glycine-mannitol excipients (epoprostenol GM; Flolan [GlaxoSmithKline, Triangle Park, NC]) are intravenous treatments for pulmonary arterial hypertension (PAH). Epoprostenol AM contains different inactive excipients, resulting in greater stability at room temperature compared with epoprostenol GM.
Methods |
In this prospective, multicenter, open-label, randomized, phase IV exploratory study, epoprostenol-naïve patients in need of injectable prostanoid therapy were randomized 2:1 to open-label epoprostenol AM or epoprostenol GM. The study period was 28 days, followed by a 30-day safety follow-up. Study aims were to descriptively compare the safety, tolerability, drug metabolite levels, and treatment effects of epoprostenol AM and epoprostenol GM in PAH. Statistical analysis was descriptive only because of the exploratory nature of the study.
Results |
Thirty patients with PAH (18-70 years, 24 women, 20 idiopathic PAH) were randomized to epoprostenol AM (n = 20) or epoprostenol GM (n = 10). Most frequently reported adverse events included jaw pain, headache, nausea, and flushing. Two deaths occurred during the study period, and 1 death occurred during the 30-day safety follow-up period, all in patients receiving epoprostenol AM. All deaths were classified by the treating physician as unrelated to epoprostenol AM. The median (range) change from baseline to day 28 in 6-minute walk distance was 36 m (−127 to 210 m) and 49 m (−44 to 110 m) for the epoprostenol AM and epoprostenol GM groups, respectively.
Conclusions |
In this randomized clinical study of epoprostenol AM in PAH, use of this novel preparation with greater room temperature stability was well tolerated.
Le texte complet de cet article est disponible en PDF.Plan
| ☆ | This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-No Derivative Works License, which permits non-commercial use, distribution, and reproduction in any medium, provided the original author and source are credited. |
| Randomized controlled registration no. NCT01105091. |
Vol 167 - N° 2
P. 218 - février 2014 Retour au numéro
Article précédent
- EPITOME-2: An open-label study assessing the transition to a new formulation of intravenous epoprostenol in patients with pulmonary arterial hypertension
- Olivier Sitbon, Marion Delcroix, Emmanuel Bergot, Anco B. Boonstra, John Granton, David Langleben, Pilar Escribano Subías, Nazzareno Galiè, Thomas Pfister, Jean-Christophe Lemarié, Gérald Simonneau
- Short-term hemodynamic effect of angiotensin-converting enzyme inhibition in patients with severe aortic stenosis : A placebo-controlled, randomized study
- Morten Dalsgaard, Kasper Iversen, Jesper Kjaergaard, Peer Grande, Jens Peter Goetze, Peter Clemmensen, Christian Hassager
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?