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Safety and efficacy of IV treprostinil for pulmonary arterial hypertension: a prospective, multicenter, open-label, 12-week trial.
Chest. 2006 Mar; 129(3):683-8.Chest

Abstract

BACKGROUND

Pulmonary arterial hypertension (PAH) is a life-threatening disease for which both continuous IV epoprostenol and continuous subcutaneous treprostinil have proven effective. With continuous IV treprostinil having potential advantages over both of the above therapies, we investigated the safety and efficacy of this regimen in patients with PAH.

METHODS

We conducted a 12-week, prospective, open-label, uncontrolled, multicenter study of continuous IV treprostinil in 16 patients with PAH that was idiopathic (n = 8), related to connective tissue disease (n = 6), or related to congenital heart disease (n = 2). The primary end point was change from baseline to week 12 in exercise capacity assessed by the 6-min walk (6MW) test.

RESULTS

Continuous IV treprostinil increased 6MW distance (mean +/- SE) by 82 m from baseline (319 +/- 22 m) to week 12 (400 +/- 26 m) [n = 14; p = 0.001]. There were also significant improvements in the secondary end points of Naughton-Balke treadmill time (p = 0.007), Borg dyspnea score (p = 0.008), and hemodynamics (mean pulmonary artery pressure, p = 0.03; cardiac index, p = 0.002; pulmonary vascular resistance, p = 0.001) at week 12 compared with baseline. Side effects were mild and consistent with those reported with prostacyclin treatment. One death, unrelated to study drug, occurred during the 12-week study in a patient who received 3 days of treprostinil and died 2 weeks later.

CONCLUSIONS

Long-term IV infusion of treprostinil is safe and appears to be effective for the treatment of patients with PAH.

Authors+Show Affiliations

Division of Pulmonary and Critical Care Medicine, Room 351 Bell Building, Duke University Medical Center, Durham, NC 27710, USA. tapso001@mc.duke.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16537868

Citation

Tapson, Victor F., et al. "Safety and Efficacy of IV Treprostinil for Pulmonary Arterial Hypertension: a Prospective, Multicenter, Open-label, 12-week Trial." Chest, vol. 129, no. 3, 2006, pp. 683-8.
Tapson VF, Gomberg-Maitland M, McLaughlin VV, et al. Safety and efficacy of IV treprostinil for pulmonary arterial hypertension: a prospective, multicenter, open-label, 12-week trial. Chest. 2006;129(3):683-8.
Tapson, V. F., Gomberg-Maitland, M., McLaughlin, V. V., Benza, R. L., Widlitz, A. C., Krichman, A., & Barst, R. J. (2006). Safety and efficacy of IV treprostinil for pulmonary arterial hypertension: a prospective, multicenter, open-label, 12-week trial. Chest, 129(3), 683-8.
Tapson VF, et al. Safety and Efficacy of IV Treprostinil for Pulmonary Arterial Hypertension: a Prospective, Multicenter, Open-label, 12-week Trial. Chest. 2006;129(3):683-8. PubMed PMID: 16537868.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of IV treprostinil for pulmonary arterial hypertension: a prospective, multicenter, open-label, 12-week trial. AU - Tapson,Victor F, AU - Gomberg-Maitland,Mardi, AU - McLaughlin,Vallerie V, AU - Benza,Raymond L, AU - Widlitz,Allison C, AU - Krichman,Abigail, AU - Barst,Robyn J, PY - 2006/3/16/pubmed PY - 2006/4/28/medline PY - 2006/3/16/entrez SP - 683 EP - 8 JF - Chest JO - Chest VL - 129 IS - 3 N2 - BACKGROUND: Pulmonary arterial hypertension (PAH) is a life-threatening disease for which both continuous IV epoprostenol and continuous subcutaneous treprostinil have proven effective. With continuous IV treprostinil having potential advantages over both of the above therapies, we investigated the safety and efficacy of this regimen in patients with PAH. METHODS: We conducted a 12-week, prospective, open-label, uncontrolled, multicenter study of continuous IV treprostinil in 16 patients with PAH that was idiopathic (n = 8), related to connective tissue disease (n = 6), or related to congenital heart disease (n = 2). The primary end point was change from baseline to week 12 in exercise capacity assessed by the 6-min walk (6MW) test. RESULTS: Continuous IV treprostinil increased 6MW distance (mean +/- SE) by 82 m from baseline (319 +/- 22 m) to week 12 (400 +/- 26 m) [n = 14; p = 0.001]. There were also significant improvements in the secondary end points of Naughton-Balke treadmill time (p = 0.007), Borg dyspnea score (p = 0.008), and hemodynamics (mean pulmonary artery pressure, p = 0.03; cardiac index, p = 0.002; pulmonary vascular resistance, p = 0.001) at week 12 compared with baseline. Side effects were mild and consistent with those reported with prostacyclin treatment. One death, unrelated to study drug, occurred during the 12-week study in a patient who received 3 days of treprostinil and died 2 weeks later. CONCLUSIONS: Long-term IV infusion of treprostinil is safe and appears to be effective for the treatment of patients with PAH. SN - 0012-3692 UR - https://www.unboundmedicine.com/medline/citation/16537868/Safety_and_efficacy_of_IV_treprostinil_for_pulmonary_arterial_hypertension:_a_prospective_multicenter_open_label_12_week_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0012-3692(15)52271-X DB - PRIME DP - Unbound Medicine ER -