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The PROSPECT Registry: Study Design, Patient Characteristics, and Treatment Patterns

Harrison Farber

Robert Frantz

Robert Schilz

Murali Chakinala

W. Benton

D. Miller

B. K. Hartline

Robyn Barst


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Conference: 2012 International PHA Conference and Scientific Sessions

Release Date: 06.22.2012

Presentation Type: Abstracts

Farber HW;1 Frantz RP;2 Schilz R;3 Chakinala M;Benton WW;Miller DP;Hartline BK;Barst, RJ7

1. Boston University School of Medicine, Boston, MA, USA
2.Mayo Clinic, Rochester, MN, USA
3. University Hospitals of Cleveland, Cleveland, OH, USA
4. Washington University School of Medicine, St. Louis, MO, USA
5. Actelion Pharmaceuticals US, Inc., South San Francisco, CA, USA 
6. ICON Late Phase & Outcomes Research, San Francisco, CA, USA
7. Columbia University College of Physicians and Surgeons, New York, NY, USA

BACKGROUNDEpoprostenol for injection (Veletri®, EFI) offers an enhanced stability profile and eliminates the need for ice packs in the treatment of pulmonary arterial hypertension (PAH). We assessed baseline parameters and titration patterns of the first 100 patients enrolled in the registry to prospectively evaluate use of epoprostenol for injection (Veletri®, EFI), comparing prostacyclin (PGI2)-naïve with -transitioned patients.

METHODSPROSPECT (ongoing) includes patients currently receiving, being initiated on, or transitioning from other PAH PGI2 analogs (A) to EFI. 17 patients were naïve to PAH-specific drugs; 23 were PGI2-naïve; 50 transitioned from Flolan® or generic equivalent; 2 transitioned from subcutaneous treprostinil; 8 transitioned from inhaled PGI2A.

RESULTSAt EFI start, PGI2-naïve (n=40) and -transitioned patients (n=60), respectively, were: age (mean±SD) 49±17 vs 53±13 years; PAH duration, 2±3 vs 7±6 years; female, 58 vs 88%; Caucasian, 80 vs 85%; idiopathic PAH, 48 vs 55%. At most recent assessment at or prior to enrollment, 6-minute walk distance was 330±84 m (n=26) vs 340±140 m (n=47) and functional class III was 65% vs 38%. Concomitant medications were phosphodiesterase-5 inhibitor alone (30 vs 28%); endothelin receptor antagonist alone (10 vs 15%); both agents (15 vs 18%). Median initial dose and maximal sustained dose with no clinically meaningful titrations (dose change ≥+/-10%) for ≥90 days were 2 vs 29 and 20 vs 33 ng/kg/min. Median time to maximal sustained dose was 100 days in PGI2-naïve patients. To date, 25 PGI2-naïve and 35 PGI2-transitioned patients have completed the 6-month assessment; estimated 6-month survival from enrollment was 91±5% and 93±3%, respectively.

CONCLUSIONPROSPECT will characterize treatment patterns, safety, and 1-year outcomes of EFI.