Abstract | BACKGROUND: METHODS AND RESULTS: Three hundred forty-nine patients (intent-to-treat population) not receiving endothelin receptor antagonist or phosphodiesterase type-5 inhibitor background therapy were randomized ( treprostinil, n=233; placebo, n=116). The primary analysis population (modified intent-to-treat) included 228 patients ( treprostinil, n=151; placebo, n=77) with access to 0.25-mg treprostinil tablets at randomization. The primary end point was change from baseline in 6-minute walk distance at week 12. Secondary end points included Borg dyspnea index, clinical worsening, and symptoms of PAH. The week 12 treatment effect for 6-minute walk distance (modified intent-to-treat population) was 23.0 m (P=0.0125). For the intent-to-treat population, 6-minute walk distance improvements were observed at peak (26.0 m; P=0.0001) and trough (17.0 m; P=0.0025) plasma study drug concentrations. Other than an improvement in the combined 6-minute walk distance/Borg dyspnea score, there were no significant changes in secondary end points. Oral treprostinil therapy was generally well tolerated; the most common adverse events (intent-to-treat) were headache (69%), nausea (39%), diarrhea (37%), and pain in jaw (25%). CONCLUSIONS: Oral treprostinil improves exercise capacity in PAH patients not receiving other treatment. Oral treprostinil could provide a convenient, first-line prostacyclin treatment option for PAH patients not requiring more intensive therapy. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00325403.
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Authors | Zhi-Cheng Jing, Keyur Parikh, Tomas Pulido, Carlos Jerjes-Sanchez, R James White, Roblee Allen, Adam Torbicki, Kai-Feng Xu, David Yehle, Kevin Laliberte, Carl Arneson, Lewis J Rubin |
Journal | Circulation
(Circulation)
Vol. 127
Issue 5
Pg. 624-33
(Feb 05 2013)
ISSN: 1524-4539 [Electronic] United States |
PMID | 23307827
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antihypertensive Agents
- Epoprostenol
- treprostinil
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Topics |
- Administration, Oral
- Adolescent
- Adult
- Aged
- Antihypertensive Agents
(administration & dosage, adverse effects, therapeutic use)
- Child
- Dyspnea
(epidemiology)
- Epoprostenol
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Exercise Tolerance
(physiology)
- Familial Primary Pulmonary Hypertension
- Female
- Humans
- Hypertension, Pulmonary
(drug therapy, physiopathology)
- Incidence
- International Cooperation
- Longitudinal Studies
- Male
- Middle Aged
- Treatment Outcome
- Walking
(physiology)
- Young Adult
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