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Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial hypertension: a double-blind, randomized, placebo-controlled trial.
Am J Respir Crit Care Med. 2002 Mar 15; 165(6):800-4.AJ

Abstract

Pulmonary arterial hypertension is a life-threatening disease for which continuous intravenous prostacyclin has proven to be effective. However, this treatment requires a permanent central venous catheter with the associated risk of serious complications such as sepsis, thromboembolism, or syncope. Treprostinil, a stable prostacyclin analogue, can be administered by a continuous subcutaneous infusion, avoiding these risks. We conducted a 12-week, double-blind, placebo-controlled multicenter trial in 470 patients with pulmonary arterial hypertension, either primary or associated with connective tissue disease or congenital systemic-to-pulmonary shunts. Exercise capacity improved with treprostinil and was unchanged with placebo; the between treatment group difference in median six-minute walking distance was 16 m (p = 0.006). Improvement in exercise capacity was greater in the sicker patients and was dose-related, but independent of disease etiology. Concomitantly, treprostinil significantly improved indices of dyspnea, signs and symptoms of pulmonary hypertension, and hemodynamics. The most common side effect attributed to treprostinil was infusion site pain (85%) leading to premature discontinuation from the study in 8% of patients. Three patients in the treprostinil treatment group presented with an episode of gastrointestinal hemorrhage. We conclude that chronic subcutaneous infusion of treprostinil is an effective treatment with an acceptable safety profile in patients with pulmonary arterial hypertension.

Authors+Show Affiliations

Division of Pulmonary and Critical Care Medicine, Antoine Béclère Hospital, Clamart, Paris-Sud University, Clamart, France. gerald.simonneau@abc.ap-hop-paris.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo 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
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11897647

Citation

Simonneau, Gerald, et al. "Continuous Subcutaneous Infusion of Treprostinil, a Prostacyclin Analogue, in Patients With Pulmonary Arterial Hypertension: a Double-blind, Randomized, Placebo-controlled Trial." American Journal of Respiratory and Critical Care Medicine, vol. 165, no. 6, 2002, pp. 800-4.
Simonneau G, Barst RJ, Galie N, et al. Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial hypertension: a double-blind, randomized, placebo-controlled trial. Am J Respir Crit Care Med. 2002;165(6):800-4.
Simonneau, G., Barst, R. J., Galie, N., Naeije, R., Rich, S., Bourge, R. C., Keogh, A., Oudiz, R., Frost, A., Blackburn, S. D., Crow, J. W., & Rubin, L. J. (2002). Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial hypertension: a double-blind, randomized, placebo-controlled trial. American Journal of Respiratory and Critical Care Medicine, 165(6), 800-4.
Simonneau G, et al. Continuous Subcutaneous Infusion of Treprostinil, a Prostacyclin Analogue, in Patients With Pulmonary Arterial Hypertension: a Double-blind, Randomized, Placebo-controlled Trial. Am J Respir Crit Care Med. 2002 Mar 15;165(6):800-4. PubMed PMID: 11897647.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial hypertension: a double-blind, randomized, placebo-controlled trial. AU - Simonneau,Gerald, AU - Barst,Robyn J, AU - Galie,Nazzareno, AU - Naeije,Robert, AU - Rich,Stuart, AU - Bourge,Robert C, AU - Keogh,Anne, AU - Oudiz,Ronald, AU - Frost,Adaani, AU - Blackburn,Shelmer D, AU - Crow,James W, AU - Rubin,Lewis J, AU - ,, PY - 2002/3/19/pubmed PY - 2002/4/18/medline PY - 2002/3/19/entrez SP - 800 EP - 4 JF - American journal of respiratory and critical care medicine JO - Am. J. Respir. Crit. Care Med. VL - 165 IS - 6 N2 - Pulmonary arterial hypertension is a life-threatening disease for which continuous intravenous prostacyclin has proven to be effective. However, this treatment requires a permanent central venous catheter with the associated risk of serious complications such as sepsis, thromboembolism, or syncope. Treprostinil, a stable prostacyclin analogue, can be administered by a continuous subcutaneous infusion, avoiding these risks. We conducted a 12-week, double-blind, placebo-controlled multicenter trial in 470 patients with pulmonary arterial hypertension, either primary or associated with connective tissue disease or congenital systemic-to-pulmonary shunts. Exercise capacity improved with treprostinil and was unchanged with placebo; the between treatment group difference in median six-minute walking distance was 16 m (p = 0.006). Improvement in exercise capacity was greater in the sicker patients and was dose-related, but independent of disease etiology. Concomitantly, treprostinil significantly improved indices of dyspnea, signs and symptoms of pulmonary hypertension, and hemodynamics. The most common side effect attributed to treprostinil was infusion site pain (85%) leading to premature discontinuation from the study in 8% of patients. Three patients in the treprostinil treatment group presented with an episode of gastrointestinal hemorrhage. We conclude that chronic subcutaneous infusion of treprostinil is an effective treatment with an acceptable safety profile in patients with pulmonary arterial hypertension. SN - 1073-449X UR - https://www.unboundmedicine.com/medline/citation/11897647/Continuous_subcutaneous_infusion_of_treprostinil_a_prostacyclin_analogue_in_patients_with_pulmonary_arterial_hypertension:_a_double_blind_randomized_placebo_controlled_trial_ L2 - http://www.atsjournals.org/doi/full/10.1164/ajrccm.165.6.2106079?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -