Conference: 2012 International PHA Conference and Scientific Sessions
Release Date: 06.22.2012
Presentation Type: Abstracts
Studer SM1; Kawut SM2; Benton WW3; McConnell JW4; Hobbs K4; Villanueva D3; Talwar A5; Palevsky HI2
1. Newark Beth Israel Medical Center, Newark, NJ, USA
2. Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA
3. Actelion Pharmaceuticals US, Inc., South San Francisco, CA, USA
4. Kentuckiana Pulmonary Associates, Louisville, KY, USA
5. North Shore University Hospital, Manahasset, NY, USA
BACKGROUND: Inhaled 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 as well as subcutaneous administration. Patients on inhaled iloprost 10 μg/mL with extended treatment times are at risk for incomplete dosing. We hypothesized that iloprost 20 μg/mL would shorten treatment times and increase the percentage of completed treatments. In vitro studies have demonstrated a 50% reduction in inhalation times with iloprost 20 μg/mL.
METHODS: This was a multicenter, Phase 4 clinical study. Inhalation times and percent incomplete doses were downloaded from the I-neb® device during the in-clinic visit. Patients served as their own control for historical comparison of inhalation time for their last 28 days on 10 μg/mL (Period 1); and the last 28 days on 20 μg/mL prior to entry into the study (Period 2). Patients completed two Global Assessment and Patient Perception Questionnaires regarding 20 μg/mL concentration. The primary endpoint was the difference in inhalation times between 10 μg/mL and 20 μg/mL concentrations as measured by the treatment delivery time using the I-neb® via the INSIGHT software.
RESULTS: Nineteen patients on iloprost 10 μg/mL were enrolled with the following characteristics at in-clinic visit: median age of 62 yrs (min, max: 24, 86); 79% female; BMI of 26.3 (18, 38); idiopathic or familial PAH (68.4%). At in-clinic visit, the time since initiation of iloprost was 11.3 months (3, 61); patients were exposed to the 20 μg/mL concentration for 7.9 months (1, 16). The 20 μg/mL concentration reduced the inhalation times from median of 10.8 min (4.9, 20.6) to 4.4 min (2.2, 12.7; P <0.001) while maintaining similar numbers of inhalations per day. Incomplete doses decreased from 4.3% in Period 1 to 0.7% in Period 2 (P = 0.2). All patients reported an improvement or no change in Patient Assessment Questionnaires. No serious adverse events were reported, and all adverse events were mild or moderate in severity.
CONCLUSION: In this study, the 20 μg/mL iloprost concentration was associated with shortened treatment times and a decrease in percent incomplete doses compared with the 10 μg/mL iloprost concentration. The observed safety profile was similar to other studies of inhaled iloprost.