Conference: 2012 International PHA Conference and Scientific Sessions
Release Date: 06.22.2012
Presentation Type: Abstracts
Mardi Gomberg-Maitland MD, MSc1; Andrea Spezzi MBBS, MFPM2; Pratap Paruchuru MFPM, FRCS2; Steve Provencher MD, MSc3 on behalf of the pH12 Flolan reformulation study group
1. University of Chicago Medical Center, Chicago, IL
2. GlaxoSmithKline R&D, London, UK
3.Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec, Canada
BACKGROUND: Epoprostenol, (Flolan) treatment is considered gold standard therapy for pulmonary arterial hypertension patients with World Health Organization functional class (FC) III /IV symptoms. Reconstituted Flolan solution is thermo labile and requires use of icepacks to maintain the temperature below 8c when the solution is used for more than 8 hours, which is associated with potential under dosing and resultant acute worsening and inconvenience to patients. This study examined the impact on quality of life (QOL), safety and efficacy of Flolan when reconstituted with a new pH12 diluent that renders stability at room temperatures up to 35o C, obviating the need for ice pack usage.
METHODS: PAH patients on stable dose Flolan enrolled in this open label study. After completing a 4-week run in period receiving the existing formulation, patients were treated for 4 weeks with the pH12 formulation. Observation on the day of switch for at least 6 and up to 48 hours occurred for clinical monitoring. Hemodynamic assessments were made prior to and after the switch to the pH12 formulation dependent on the individual patients’ clinical needs at the discretion of the investigator. Measures pre- switch and at 4 weeks included: a QOL study specific questionnaire and SF-36, 6-minute walk distance (6MWD), Borg Dyspnoea index (BDI), N-terminal pro- Brain Natriuretic Peptide (NT-Pro BNP) and FC. Adverse and serious adverse events were collected and included an assessment of infusion site reactions.
RESULTS: The following data will be described when the results are available
CONCLUSIONS: A report on the overall change in quality of life, safety and efficacy of epoprostenol reformulated with ph12 diluent and used without ice packs.