%0 Journal Article %A Olivier Sitbon %A Marion Delcroix %A Emmanuel Bergot %A Anco Boonstra %A Pilar Escribano Subias %A Nazzareno Galiè %A John Granton %A David Langleben %A Thomas Pfister %A Jean-Christophe Lemarié %A Gérald Simonneau %T EPITOME-2: Evaluation of a new formulation of epoprostenol sodium in pulmonary arterial hypertension patients switched from an originally approved formulation %D 2012 %J European Respiratory Journal %P P947 %V 40 %N Suppl 56 %X IntroductionEpoprostenol sodium originally approved with glycine-mannitol excipients (epoprostenol GM; Flolan®) is an i.v. pulmonary arterial hypertension (PAH) treatment. Epoprostenol sodium with undisclosed excipients (epoprostenol XX) is a new formulation with improved room temperature stability and simplified storage requirements. EPITOME-2 is an ongoing PAH study evaluating switch from epoprostenol GM to epoprostenol XX.MethodsAdult PAH patients treated with epoprostenol GM for ≥12 months and on a stable dose for the last 3 months were switched to epoprostenol XX. Changes from baseline to 3 months were evaluated for cardiac haemodynamic and clinical parameters, including pulmonary vascular resistance (PVR) and WHO functional class (FC). Safety and tolerability were also evaluated.ResultsOf the 42 patients enrolled, data are available for the first 10 completers. Mean (range) age was 45 (25–78) years and 5 were female. Mean (range) time from diagnosis was 10.57 (1.6–37.1) years. Following switch, patients remained on a stable epoprostenol XX dose at 3 months. There was no change from baseline to Month 3 in haemodynamics or WHO FC (table). Most AEs were typical of epoprostenol therapy.View this table:Epoprostenol XX dose, haemodynamics and WHO FCConclusionsThere are no indications thus far of unexpected safety, tolerability, efficacy or dosing issues arising from switching patients to epoprostenol XX. %U https://erj.ersjournals.com/content/erj/40/Suppl_56/P947.full.pdf