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Addition of inhaled treprostinil to oral therapy for pulmonary arterial hypertension: a randomized controlled clinical trial.
J Am Coll Cardiol. 2010 May 04; 55(18):1915-22.JACC

Abstract

OBJECTIVES

This study assessed the efficacy and safety of inhaled treprostinil in pulmonary arterial hypertension (PAH) patients receiving therapy with either bosentan or sildenafil.

BACKGROUND

There is no cure for PAH, despite effective treatments, and outcomes remain suboptimal. The addition of inhaled treprostinil, a long-acting prostacyclin analog, might be a safe and effective treatment addition to other PAH-specific oral therapies.

METHODS

Two hundred thirty-five PAH patients with New York Heart Association (NYHA) functional class III (98%) or IV symptoms and a 6-min walk distance (6MWD) of 200 to 450 m while treated with bosentan (70%) or sildenafil were randomized to inhaled treprostinil (up to 54 mug) or inhaled placebo 4 times daily. The primary end point was peak 6MWD at 12 weeks. Secondary end points included time to clinical worsening, Borg Dyspnea Score, NYHA functional class, 12-week trough 6MWD, 6-week peak 6MWD, quality of life, and PAH signs and symptoms. The biomarker N-terminal pro-brain natriuretic peptide (NT-proBNP) was assessed.

RESULTS

Twenty-three patients withdrew from the study prematurely (13 treprostinil, 10 placebo). The Hodges-Lehmann between-treatment median difference in change from baseline in peak 6MWD was 19 m at week 6 (p = 0.0001) and 20 m at week 12 (p = 0.0004). Hodges-Lehmann between-treatment median difference in change from baseline in trough 6MWD at week 12 was 14 m (p = 0.0066). Quality of life measures and NT-proBNP improved on active therapy. There were no improvements in other secondary end points, including time to clinical worsening, Borg Dyspnea Score, NYHA functional class, and PAH signs and symptoms. Inhaled treprostinil was safe and well-tolerated.

CONCLUSIONS

This trial demonstrates that, among PAH patients who remain symptomatic on bosentan or sildenafil, inhaled treprostinil improves exercise capacity and quality of life and is safe and well-tolerated. (TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension; NCT00147199).

Authors+Show Affiliations

University of Michigan Health System, CVC Cardiovascular Medicine, Ann Arbor, Michigan 48109-5853, USA. vmclaugh@umich.eduNo 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)

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

Language

eng

PubMed ID

20430262

Citation

McLaughlin, Vallerie V., et al. "Addition of Inhaled Treprostinil to Oral Therapy for Pulmonary Arterial Hypertension: a Randomized Controlled Clinical Trial." Journal of the American College of Cardiology, vol. 55, no. 18, 2010, pp. 1915-22.
McLaughlin VV, Benza RL, Rubin LJ, et al. Addition of inhaled treprostinil to oral therapy for pulmonary arterial hypertension: a randomized controlled clinical trial. J Am Coll Cardiol. 2010;55(18):1915-22.
McLaughlin, V. V., Benza, R. L., Rubin, L. J., Channick, R. N., Voswinckel, R., Tapson, V. F., Robbins, I. M., Olschewski, H., Rubenfire, M., & Seeger, W. (2010). Addition of inhaled treprostinil to oral therapy for pulmonary arterial hypertension: a randomized controlled clinical trial. Journal of the American College of Cardiology, 55(18), 1915-22. https://doi.org/10.1016/j.jacc.2010.01.027
McLaughlin VV, et al. Addition of Inhaled Treprostinil to Oral Therapy for Pulmonary Arterial Hypertension: a Randomized Controlled Clinical Trial. J Am Coll Cardiol. 2010 May 4;55(18):1915-22. PubMed PMID: 20430262.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Addition of inhaled treprostinil to oral therapy for pulmonary arterial hypertension: a randomized controlled clinical trial. AU - McLaughlin,Vallerie V, AU - Benza,Raymond L, AU - Rubin,Lewis J, AU - Channick,Richard N, AU - Voswinckel,Robert, AU - Tapson,Victor F, AU - Robbins,Ivan M, AU - Olschewski,Horst, AU - Rubenfire,Melvyn, AU - Seeger,Werner, PY - 2009/07/21/received PY - 2009/12/17/revised PY - 2010/01/04/accepted PY - 2010/5/1/entrez PY - 2010/5/1/pubmed PY - 2010/5/14/medline SP - 1915 EP - 22 JF - Journal of the American College of Cardiology JO - J. Am. Coll. Cardiol. VL - 55 IS - 18 N2 - OBJECTIVES: This study assessed the efficacy and safety of inhaled treprostinil in pulmonary arterial hypertension (PAH) patients receiving therapy with either bosentan or sildenafil. BACKGROUND: There is no cure for PAH, despite effective treatments, and outcomes remain suboptimal. The addition of inhaled treprostinil, a long-acting prostacyclin analog, might be a safe and effective treatment addition to other PAH-specific oral therapies. METHODS: Two hundred thirty-five PAH patients with New York Heart Association (NYHA) functional class III (98%) or IV symptoms and a 6-min walk distance (6MWD) of 200 to 450 m while treated with bosentan (70%) or sildenafil were randomized to inhaled treprostinil (up to 54 mug) or inhaled placebo 4 times daily. The primary end point was peak 6MWD at 12 weeks. Secondary end points included time to clinical worsening, Borg Dyspnea Score, NYHA functional class, 12-week trough 6MWD, 6-week peak 6MWD, quality of life, and PAH signs and symptoms. The biomarker N-terminal pro-brain natriuretic peptide (NT-proBNP) was assessed. RESULTS: Twenty-three patients withdrew from the study prematurely (13 treprostinil, 10 placebo). The Hodges-Lehmann between-treatment median difference in change from baseline in peak 6MWD was 19 m at week 6 (p = 0.0001) and 20 m at week 12 (p = 0.0004). Hodges-Lehmann between-treatment median difference in change from baseline in trough 6MWD at week 12 was 14 m (p = 0.0066). Quality of life measures and NT-proBNP improved on active therapy. There were no improvements in other secondary end points, including time to clinical worsening, Borg Dyspnea Score, NYHA functional class, and PAH signs and symptoms. Inhaled treprostinil was safe and well-tolerated. CONCLUSIONS: This trial demonstrates that, among PAH patients who remain symptomatic on bosentan or sildenafil, inhaled treprostinil improves exercise capacity and quality of life and is safe and well-tolerated. (TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension; NCT00147199). SN - 1558-3597 UR - https://www.unboundmedicine.com/medline/citation/20430262/Addition_of_inhaled_treprostinil_to_oral_therapy_for_pulmonary_arterial_hypertension:_a_randomized_controlled_clinical_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0735-1097(10)00779-5 DB - PRIME DP - Unbound Medicine ER -