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Quality of Life, Safety and Efficacy Profile of Flolan Reconstituted with a Novel pH12 Diluent

Mardi Gomberg-Maitland


Andrea Spezzi

Pratap Paruchuru

Steve Provencher

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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, MScon 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

BACKGROUNDEpoprostenol, (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.

METHODSPAH 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.

RESULTSThe following data will be described when the results are available

  1. Demographics of the study population
  2. Dose titration requirements during the observation period with the ph12 formulation
  3. Change in QOL and the SF-36
  4. Change in haemodynamics pre and post transition.
  5. Adverse events.
  6. Change in 6MWD, BDI, NT Pro-BNP and FC.
  7. Infusion site reactions reported during both the treatment periods will be presented in terms of numbers with event details.

CONCLUSIONSA report on the overall change in quality of life, safety and efficacy of epoprostenol reformulated with ph12 diluent and used without ice packs.