Quality of life, safety and efficacy profile of thermostable flolan in pulmonary arterial hypertension

PloS One
Steeve ProvencherpH12 Flolan reformulation study group

Abstract

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. 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. 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 t...Continue Reading

References

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May 14, 2016·American Journal of Respiratory and Critical Care Medicine

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Citations

Jan 18, 2017·European Respiratory Review : an Official Journal of the European Respiratory Society·Olivier Sitbon, Anton Vonk Noordegraaf
Mar 2, 2016·European Respiratory Review : an Official Journal of the European Respiratory Society·Anton Vonk NoordegraafHarm Jan Bogaard

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Methods Mentioned

BETA
Assay

Software Mentioned

Flolan

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