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Transition from IV epoprostenol to subcutaneous treprostinil in pulmonary arterial hypertension: a controlled trial.
Chest. 2007 Sep; 132(3):757-63.Chest

Abstract

BACKGROUND

We determined the relative efficacy of subcutaneous (SC) treprostinil in stable World Health Organization class II and III patients transitioned from IV epoprostenol.

METHODS

This was an 8-week, multicenter, randomized study in which patients were transitioned from IV epoprostenol to SC treprostinil or placebo over a period of up to 14 days and monitored carefully during and after the transition period for signs of deterioration. Patients with clinical deterioration were returned promptly to epoprostenol. Placebo or SC treprostinil doses were titrated in response to symptoms. Time to adjudicated clinical deterioration was compared between treatment groups, and exercise capacity, symptoms of disease, and safety were assessed throughout the study.

RESULTS

Twenty-two patients were enrolled and completed the study. Seven of 8 patients (88%) [corrected] withdrawn to placebo had clinical deterioration, while only 1 of 14 patients (7%) [corrected] withdrawn to SC treprostinil had clinical deterioration (p = 0.00023 based on a treatment comparison of time to deterioration). Analyses of exercise capacity and symptoms strongly supported the efficacy of SC treprostinil in epoprostenol-treated patients. Adverse events consisted of painful infusion site reactions and anticipated prostacyclin side effects.

CONCLUSIONS

SC treprostinil is effective in pulmonary arterial hypertension and prevents clinical deterioration and maintains functional status in patients transitioned from epoprostenol.

Authors+Show Affiliations

University of Michigan, 24 Frank Lloyd Wright Dr, Ann Arbor, MI 48106-0363, USA. mrubenfi@umich.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

17400684

Citation

Rubenfire, Melvyn, et al. "Transition From IV Epoprostenol to Subcutaneous Treprostinil in Pulmonary Arterial Hypertension: a Controlled Trial." Chest, vol. 132, no. 3, 2007, pp. 757-63.
Rubenfire M, McLaughlin VV, Allen RP, et al. Transition from IV epoprostenol to subcutaneous treprostinil in pulmonary arterial hypertension: a controlled trial. Chest. 2007;132(3):757-63.
Rubenfire, M., McLaughlin, V. V., Allen, R. P., Elliott, G., Park, M. H., Wade, M., & Schilz, R. (2007). Transition from IV epoprostenol to subcutaneous treprostinil in pulmonary arterial hypertension: a controlled trial. Chest, 132(3), 757-63.
Rubenfire M, et al. Transition From IV Epoprostenol to Subcutaneous Treprostinil in Pulmonary Arterial Hypertension: a Controlled Trial. Chest. 2007;132(3):757-63. PubMed PMID: 17400684.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Transition from IV epoprostenol to subcutaneous treprostinil in pulmonary arterial hypertension: a controlled trial. AU - Rubenfire,Melvyn, AU - McLaughlin,Vallerie V, AU - Allen,Roblee P, AU - Elliott,Greg, AU - Park,Myung H, AU - Wade,Michael, AU - Schilz,Robert, Y1 - 2007/03/30/ PY - 2007/4/3/pubmed PY - 2007/10/30/medline PY - 2007/4/3/entrez SP - 757 EP - 63 JF - Chest JO - Chest VL - 132 IS - 3 N2 - BACKGROUND: We determined the relative efficacy of subcutaneous (SC) treprostinil in stable World Health Organization class II and III patients transitioned from IV epoprostenol. METHODS: This was an 8-week, multicenter, randomized study in which patients were transitioned from IV epoprostenol to SC treprostinil or placebo over a period of up to 14 days and monitored carefully during and after the transition period for signs of deterioration. Patients with clinical deterioration were returned promptly to epoprostenol. Placebo or SC treprostinil doses were titrated in response to symptoms. Time to adjudicated clinical deterioration was compared between treatment groups, and exercise capacity, symptoms of disease, and safety were assessed throughout the study. RESULTS: Twenty-two patients were enrolled and completed the study. Seven of 8 patients (88%) [corrected] withdrawn to placebo had clinical deterioration, while only 1 of 14 patients (7%) [corrected] withdrawn to SC treprostinil had clinical deterioration (p = 0.00023 based on a treatment comparison of time to deterioration). Analyses of exercise capacity and symptoms strongly supported the efficacy of SC treprostinil in epoprostenol-treated patients. Adverse events consisted of painful infusion site reactions and anticipated prostacyclin side effects. CONCLUSIONS: SC treprostinil is effective in pulmonary arterial hypertension and prevents clinical deterioration and maintains functional status in patients transitioned from epoprostenol. SN - 0012-3692 UR - https://www.unboundmedicine.com/medline/citation/17400684/Transition_from_IV_epoprostenol_to_subcutaneous_treprostinil_in_pulmonary_arterial_hypertension:_a_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0012-3692(15)36637-X DB - PRIME DP - Unbound Medicine ER -