Key result
Switching to thermostable Flolan did not significantly change health-related quality of life (SF-36 physical health score 37.9 vs 38.0), though 88% of patients preferred the new formulation.
Why the study?
Does thermostable reformulated epoprostenol sodium improve health-related quality of life and ease of administration compared to currently marketed epoprostenol sodium in patients with severe pulmonary arterial hypertension?
Does thermostable reformulated epoprostenol sodium improve health-related quality of life and ease of administration compared to currently marketed epoprostenol sodium in patients with severe pulmonary arterial hypertension?
Switching to a thermostable formulation of epoprostenol did not significantly improve SF-36 quality of life scores but was preferred by most patients and maintained similar safety and efficacy profiles over 4 weeks.
BACKGROUND: Flolan (epoprostenol sodium) is most commonly prescribed to patients with severe pulmonary arterial hypertension (PAH) owing to the requirement that the drug be delivered by continuous intravenous infusion and the reconstituted solution may only be administered up to 24 hours when it is maintained between a temperature of 2°C and 8°C. The aim of this single-arm, open label study was to describe the effects of the new thermostable formulation of Flolan on health-related quality of life (HRQoL) and ease of administration in subjects switching from the currently marketed Flolan to the reformulated product. METHODS: Following a 4-week run-in period and after 4 weeks of treatment with the reformulated product, patients completed the SF-36 HRQoL questionnaire and a study-specific questionnaire evaluating ease of administration, along with World Health Organization (WHO) functional class, six-minute walked distance (6MWD) and N-terminal-pro B-type natriuretic peptide (NT-proBNP) assessment. RESULTS: 16 participants completed the study. The SF-36 scores remained unchanged from baseline to Week 4. Conversely, there were small improvements for the majority of the study-specific questionnaire items and 14 (88%) subjects preferred the reformulated product to the currently marketed Flolan. There was no significant change in the dose of reformulated product, 6MWD, Borg dyspnoea index, WHO functional class and mean NT-proBNP levels. No significant changes in haemodynamic parameters were seen from baseline to 2 hours post transition in a subset of patients undergoing catheterization. CONCLUSION: The reformulated product was not associated with significant improvement in HRQoL compared with the currently marketed Flolan as measured by the SF-36. However, most subjects preferred the reformulated product to the currently marketed Flolan. Moreover, the 2 formulations of Flolan had similar safety and efficacy profiles. TRIAL REGISTRATION: ClinicalTrials.gov NCT01462565.
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Provencher et al. (2015) studied Pulmonary Arterial Hypertension (n=16). Thermostable Flolan vs. Currently marketed Flolan (baseline) was evaluated on SF-36 physical health component score. Switching to thermostable Flolan did not significantly change health-related quality of life (SF-36 physical health score 37.9 vs 38.0), though 88% of patients preferred the new formulation.
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