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Safely Transitioning from Inhaled Iloprost to Inhaled Treprostinil Sodium -Results from a Multicenter Open-Label Study in Patients with Pulmonary Arterial Hypertension

Robert Bourge

Victor Tapson

Zeenat Safdar

Raymond Benza

Richard Channick

Erika Berman Rosenzweig

Shelley Shapiro

C.S. McSwain

S. K. Gotzkowsky

A. C. Nelsen


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Conference: 2011 PH Professional Network Symposium

Release Date: 09.22.2011

Presentation Type: Abstracts

RC Bourge, MD; VF Tapson, MD; Z Safdar, MD; RL Benza, MD; RN Channick, MD; EB Rosenzweig, MD; SM Shapiro, MD, PhD; CS McSwain, MSc; SK Gotzkowsky, PharmD; AC Nelsen, PharmD; LJ Rubin, MD
1. University of Alabama at Birmingham, Birmingham, AL
2. Duke University Medical Center, Durham, NC
3. Baylor College of Medicine, Houston, TX
4. Allegheny General Hospital, Pittsburgh, PA
5. UCSD Medical Center, La Jolla, CA
6. Columbia Presbyterian Medical Center, New York, NY
7. West Los Angeles VA, Los Angeles, CA
8. United Therapeutics Corp., Research Triangle Park, NC
9. UCSD Medical Center, San Diego, CA

PURPOSE: The delivery of inhaled iloprost (ILO) requires inhalation 6 to 9 times per day. Another inhaled therapy, treprostinil sodium (iTRE) may offer a safe and more convenient administration option (four times daily [qid]), while maintaining the clinical benefit of prostacyclins.

METHODS AND MATERIALS: Patients initiated iTRE at 3 breaths (6 mcg/breath) qid after immediate termination of ILO in an open-label, prospective, multicenter study to assess the safety of transition, dosing, exercise capacity and quality of life (QoL). Dosing of iTRE was escalated as tolerated to a target dose of 9 breaths qid.

The six minute walk (6MW) test was used to measure exercise capacity, Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) to measure overall QoL, symptoms and functioning, and an activities diary to measure daily inhalation time. Measures were compared at baseline while on ILO and at 12 weeks on iTRE (Wilcoxon signed-rank test).

RESULTS: Twelve week results are described on the total cohort of 73 patients (57F: 16M, mean age 49 years). Forty-eight percent had idiopathic or familial pulmonary arterial hypertension (PAH); 42% were WHO Functional Class III; and median 6MW at Baseline was 378m. At entry, 59% were taking 5mcg ILO at least 6 times daily (ILO labeled dose is 2.5-5.0 mcg 6-9 times per day). Seventy-four percent of subjects were dosing at least 9 breaths qid of iTRE and reached 9 breaths in a mean of 18 days (SD:±17). 6MW improved by a median of 16 meters (p<0.001; mean±SD: 16±36). All domains of the CAMPHOR improved and were statistically significant at week 12 (p<0.001). Total daily inhalation time decreased from 66 min to 13 min while on iTRE (p<0.001). Common adverse events included cough (74%), headache (44%), and nausea (30%). No subject acutely deteriorated after transitioning.

CONCLUSIONS: This study demonstrated that the rapid transition from inhaled ILO to iTRE in PAH patients is well tolerated and associated with maintenance of exercise capacity and improved QoL.