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RESPIRE Registry: Inhalation Times and Treatment Adherence of Iloprost Delivered at 10 µg/mL and 20 µg/mL Concentrations in Patients with Pulmonary Arterial Hypertension

J. W. McConnell

K. Hobbs

Jean Elwing

R. Pushkin

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Conference: 2010 International PHA Conference and Scientific Sessions

Release Date: 06.24.2010

Presentation Type: Abstracts

McConnell J1, Hobbs K1, Elwing J2, Pushkin R3.
1. Kentuckiana Pulmonary Associates, Louisville, KY, USA
2. University of Cincinnati, Cincinnati, OH, USA
3. Actelion Pharmaceuticals US, San Francisco, CA, USA

BACKGROUND: Inhalational delivery of prostacyclin analogues for the treatment of pulmonary arterial hypertension (PAH) is non-invasive and avoids the complications associated with permanent indwelling intravenous catheters. One potential caveat of inhalation therapy is the length of time required for inhalation of a full dose. The RESPIRE Registry (NCT00902603) is an ongoing multicenter, observational, US-based registry that follows patients with PAH who have been receiving inhaled iloprost therapy for at least 3 months. Here we report a comparison of inhalation times and treatment adherence of iloprost delivered at 10 μg/mL and 20 μg/mL concentrations.

METHODS: Inhalation times and percent incomplete doses were downloaded from the I-neb® Adaptive Aerosol Delivery® inhalation device. RESPIRE patients were included in this analysis if inhalation data at the 10 μg/mL concentration (5 μg/dose) were available for at least 2 weeks followed by at least 2 weeks of inhalation data at the 20 μg/mL concentration (5 μg/dose). Patients were excluded if they had >50% incomplete doses.

RESULTS: Eleven patients met the inclusion criteria of exposure to both 10 μg/mL and 20 μg/mL inhaled iloprost formulations of whom 9 had less than 50% incomplete doses and were included in the data analysis (interim data-cut as of January 2010). Mean (SD) age was 69.3 (8.8) years, 67% were female, 7 patients were diagnosed with idiopathic PAH, 1 was diagnosed with CTD-APAH and 1 was diagnosed with PoPH-APAH. Patients were exposed to the 10 μg/mL and 20 μg/mLconcentration for 559.9 (526.7) and 52 (23.8) days and inhaled 2199 (1920) and 248.1 (156.6) doses, respectively. Using the 20 μg/mL concentration patients reduced their mean inhalation times (full dose records) from 12.3 (3.2) min to 5.4 (1.4) min (<0.01) while maintaining similar numbers of inhalations per day. Percent incomplete doses decreased from 12 (11.5) to 2.9 (2.5) (=0.03).

CONCLUSIONS: In this interim analysis, the 20 μg/mL iloprost concentration shortened treatment times by 56% and was associated with a decrease in percent incomplete doses compared to the 10 μg/mL iloprost concentration. Future studies are needed to investigate whether increased compliance is related to improved outcomes in patients with PAH.