Efficacy and safety of treprostinil: an epoprostenol analog for primary pulmonary
hypertension.
Author(s): McLaughlin VV(1), Gaine SP, Barst RJ, Oudiz RJ, Bourge RC, Frost A, Robbins IM,
Tapson VF, McGoon MD, Badesch DB, Sigman J, Roscigno R, Blackburn SD, Arneson C,
Rubin LJ, Rich S; Treprostinil Study Group.
Affiliation(s): Author information:
(1)Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois 60612, USA.
vmclaugh@rush.edu
Publication date & source: 2003, J Cardiovasc Pharmacol. , 41(2):293-9
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.
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