title: Hospitalization and survival in patients using epoprostenol for injection in the PROSPECT observational study.
abstract: BACKGROUND
  Few studies have prospectively reported outcomes in patients with pulmonary arterial hypertension (PAH) treated with epoprostenol in the modern-day era of oral therapy and combination treatments. The Registry to Prospectively Describe Use of Epoprostenol for Injection (Veletri, prolonged room temperature stable-epoprostenol [RTS-Epo]) in Patients with Pulmonary Arterial Hypertension (PROSPECT) was established to prospectively describe the course of PAH in patients prescribed RTS-Epo.
  
  
  METHODS
  PROSPECT is a multicenter, US-based drug registry of primarily group 1 patients with PAH treated with RTS-Epo who were parenteral-naive or parenteral-transitioned at enrollment. Patients were followed until discontinuation of RTS-Epo, withdrawal, loss to follow-up, death, or end of study (maximum 1 year). One-year freedom from hospitalization (FH) and survival estimates were summarized by prostacyclin history (parenteral-naive or parenteral-transitioned), sex, and chronic renal insufficiency (CRI).
  
  
  RESULTS
  A total of 336 patients were included. The overall 1-year FH estimate was 51.0% ± 2.8% and was lower in parenteral-naive patients than parenteral-transitioned patients (42.8% ± 4.3% vs 57.1% ± 3.7%, respectively; P = .002). FH estimates were lower in male patients than female patients (38.3% ± 5.9% vs 54.6% ± 3.2%, respectively; P < .015) and in patients with CRI than patients without CRI (17.0% ± 8.4% vs 53.7% ± 2.9%, respectively; P < .001). The overall 1-year survival estimate was 84.0% ± 2.1%. Survival was poorer in parenteral-naive patients, male patients, and patients with CRI.
  
  
  CONCLUSIONS
  Risk of hospitalization and mortality remain high in patients with PAH. In particular, patients who are parenteral-naive at initiation of RTS-Epo therapy, male patients, and patients with CRI require close monitoring and aggressive clinical management.
authors.affiliation: Mayo Clinic, Mayo Foundation for Medical Education and Research, Rochester, MN.
authors.forename: Robert P
authors.initials: RP
authors.lastname: Frantz
authors.affiliation: University Hospitals, Cleveland, OH.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Schilz
authors.affiliation: Washington University School of Medicine in St. Louis, St. Louis, MO.
authors.forename: Murali M
authors.initials: MM
authors.lastname: Chakinala
authors.affiliation: University of Colorado Hospital, UCHealth University of Colorado Health, Aurora, CO.
authors.forename: David B
authors.initials: DB
authors.lastname: Badesch
authors.affiliation: Baylor College of Medicine, Houston, TX.
authors.forename: Adaani E
authors.initials: AE
authors.lastname: Frost
authors.affiliation: University of Michigan Health System, Regents of the University of Michigan, Ann Arbor, MI.
authors.forename: Vallerie V
authors.initials: VV
authors.lastname: McLaughlin
authors.affiliation: College of Physicians and Surgeons, Columbia University, New York, NY.
authors.forename: Robyn J
authors.initials: RJ
authors.lastname: Barst
authors.affiliation: Actelion Pharmaceuticals Switzerland, Ltd, Allschwil, Switzerland.
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Rosenberg
authors.affiliation: ICON Clinical Research, San Francisco, CA.
authors.forename: Dave P
authors.initials: DP
authors.lastname: Miller
authors.affiliation: Actelion Pharmaceuticals US, Inc, South San Francisco, CA.
authors.forename: Brian K
authors.initials: BK
authors.lastname: Hartline
authors.affiliation: Actelion Pharmaceuticals US, Inc, South San Francisco, CA.
authors.forename: Wade W
authors.initials: WW
authors.lastname: Benton
authors.affiliation: Boston University School of Medicine, Boston, MA. Electronic address: hfarber@bu.edu.
authors.forename: Harrison W
authors.initials: HW
authors.lastname: Farber
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy* / Q000401:mortality* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011446:Prospective Studies; D011725:Pyridines / Q000627:therapeutic use*; D013777:Tetrazoles / Q000627:therapeutic use*; D014665:Vasodilator Agents / Q000627:therapeutic use*
chemical_list: D000959:Antihypertensive Agents; D011725:Pyridines; D013777:Tetrazoles; D014665:Vasodilator Agents; C120582:tezosentan