title: Efficacy and safety of treprostinil: an epoprostenol analog for primary pulmonary hypertension.
abstract: Intravenous epoprostenol is currently FDA approved for management of primary pulmonary hypertension, but it requires intravenous infusion and is associated with adverse effects. The objective of this study was to evaluate the effects of an epoprostenol analog, treprostinil, for management of pulmonary hypertension. Ten tertiary care academic institutions with pulmonary hypertension programs participated in these pilot trials. In the first trial, intravenous epoprostenol and intravenous treprostinil were compared. In the second trial, intravenous treprostinil and subcutaneous treprostinil were compared. In the third trial, subcutaneous treprostinil was compared with placebo infusion during an 8-week period. Intravenous epoprostenol and intravenous treprostinil resulted in a similar reduction in pulmonary vascular resistance acutely (22% and 20%, respectively). Intravenous treprostinil and subcutaneous treprostinil also demonstrated comparable short-term decrease in pulmonary vascular resistance (23% and 28%, respectively). The placebo-controlled 8-week trial demonstrated a mean improvement of 37 +/- 17 m as measured by the 6-minute walk distance in patients receiving treprostinil compared with a 6 +/- 28 m reduction in those receiving placebo. There were trends toward an improvement in cardiac index and pulmonary vascular resistance index in the treprostinil group. Subcutaneous treprostinil has favorable hemodynamic effects when given acutely and in the short term. Treprostinil can be given safely to an ambulatory patient with a novel subcutaneous delivery pump system.
authors.affiliation: Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois 60612, USA. vmclaugh@rush.edu
authors.forename: Vallerie V
authors.initials: VV
authors.lastname: McLaughlin
authors.forename: Sean P
authors.initials: SP
authors.lastname: Gaine
authors.forename: Robyn J
authors.initials: RJ
authors.lastname: Barst
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Oudiz
authors.forename: Robert C
authors.initials: RC
authors.lastname: Bourge
authors.forename: Adaani
authors.initials: A
authors.lastname: Frost
authors.forename: Ivan M
authors.initials: IM
authors.lastname: Robbins
authors.forename: Victor F
authors.initials: VF
authors.lastname: Tapson
authors.forename: Michael D
authors.initials: MD
authors.lastname: McGoon
authors.forename: David B
authors.initials: DB
authors.lastname: Badesch
authors.forename: Jeff
authors.initials: J
authors.lastname: Sigman
authors.forename: Robert
authors.initials: R
authors.lastname: Roscigno
authors.forename: Shelmer D
authors.initials: SD
authors.lastname: Blackburn
authors.forename: Carl
authors.initials: C
authors.lastname: Arneson
authors.forename: Lewis J
authors.initials: LJ
authors.lastname: Rubin
authors.forename: Stuart
authors.initials: S
authors.lastname: Rich
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D002648:Child; D011464:Epoprostenol / Q000008:administration & dosage* / Q000009:adverse effects* / Q000031:analogs & derivatives* / Q000737:chemistry; D005260:Female; D006439:Hemodynamics / Q000187:drug effects / Q000502:physiology; D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D018709:Statistics, Nonparametric
chemical_list: D011464:Epoprostenol; C427248:treprostinil