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Safety and efficacy of inhaled treprostinil as add-on therapy to bosentan in pulmonary arterial hypertension.
J Am Coll Cardiol. 2006 Oct 03; 48(7):1433-7.JACC

Abstract

OBJECTIVES

This study evaluated the safety and efficacy of inhaled treprostinil as add-on therapy to oral bosentan in patients with pulmonary arterial hypertension (PAH).

BACKGROUND

The addition of a long-acting prostacyclin analogue via the inhaled route might be a safe and effective strategy to optimize therapy in PAH patients on bosentan.

METHODS

Twelve patients with symptomatic PAH despite bosentan received either 30 microg of inhaled treprostinil 4 times daily (n = 6) or 45 microg 4 times daily (n = 6), via an ultrasonic nebulizer. Six-min walk distance (6MWD), functional class, and hemodynamics were assessed at baseline and 12 weeks.

RESULTS

One patient was excluded from analysis due to the subsequent finding of pulmonary capillary hemangiomatosis. In the remaining 11 patients, inhaled treprostinil was safe and well tolerated. Inhaled treprostinil was associated with an increase in 6MWD at 12 weeks (baseline 339 +/- 86, 12 week, 1 h post-inhalation 406 +/- 121 m, 67-m change, p = 0.01). An improvement in 6MWD of 49 m from baseline was noted during the trough period, just before inhalation of treprostinil (p = 0.009). The 6MWD improvement of at least 10% was noted in 1 of 6 patients receiving 30 microg versus 5 of 6 receiving 45 microg. Over 12 weeks, significant decreases were noted in mean pulmonary arterial pressure (-10%) and in pulmonary vascular resistance (-26%). Functional class improved from III to II in 9 of 11 patients.

CONCLUSIONS

This trial suggests that inhaled treprostinil is safe, well tolerated, and associated with significant improvements in exercise capacity, functional class, and pulmonary hemodynamics in symptomatic patients with PAH on bosentan.

Authors+Show Affiliations

UCSD Medical Center, La Jolla, California 92037, USA. rchannick@ucsd.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

17010807

Citation

Channick, Richard N., et al. "Safety and Efficacy of Inhaled Treprostinil as Add-on Therapy to Bosentan in Pulmonary Arterial Hypertension." Journal of the American College of Cardiology, vol. 48, no. 7, 2006, pp. 1433-7.
Channick RN, Olschewski H, Seeger W, et al. Safety and efficacy of inhaled treprostinil as add-on therapy to bosentan in pulmonary arterial hypertension. J Am Coll Cardiol. 2006;48(7):1433-7.
Channick, R. N., Olschewski, H., Seeger, W., Staub, T., Voswinckel, R., & Rubin, L. J. (2006). Safety and efficacy of inhaled treprostinil as add-on therapy to bosentan in pulmonary arterial hypertension. Journal of the American College of Cardiology, 48(7), 1433-7.
Channick RN, et al. Safety and Efficacy of Inhaled Treprostinil as Add-on Therapy to Bosentan in Pulmonary Arterial Hypertension. J Am Coll Cardiol. 2006 Oct 3;48(7):1433-7. PubMed PMID: 17010807.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of inhaled treprostinil as add-on therapy to bosentan in pulmonary arterial hypertension. AU - Channick,Richard N, AU - Olschewski,Horst, AU - Seeger,Werner, AU - Staub,Ted, AU - Voswinckel,Robert, AU - Rubin,Lewis J, Y1 - 2006/09/14/ PY - 2006/03/29/received PY - 2006/05/19/revised PY - 2006/05/26/accepted PY - 2006/10/3/pubmed PY - 2006/10/13/medline PY - 2006/10/3/entrez SP - 1433 EP - 7 JF - Journal of the American College of Cardiology JO - J. Am. Coll. Cardiol. VL - 48 IS - 7 N2 - OBJECTIVES: This study evaluated the safety and efficacy of inhaled treprostinil as add-on therapy to oral bosentan in patients with pulmonary arterial hypertension (PAH). BACKGROUND: The addition of a long-acting prostacyclin analogue via the inhaled route might be a safe and effective strategy to optimize therapy in PAH patients on bosentan. METHODS: Twelve patients with symptomatic PAH despite bosentan received either 30 microg of inhaled treprostinil 4 times daily (n = 6) or 45 microg 4 times daily (n = 6), via an ultrasonic nebulizer. Six-min walk distance (6MWD), functional class, and hemodynamics were assessed at baseline and 12 weeks. RESULTS: One patient was excluded from analysis due to the subsequent finding of pulmonary capillary hemangiomatosis. In the remaining 11 patients, inhaled treprostinil was safe and well tolerated. Inhaled treprostinil was associated with an increase in 6MWD at 12 weeks (baseline 339 +/- 86, 12 week, 1 h post-inhalation 406 +/- 121 m, 67-m change, p = 0.01). An improvement in 6MWD of 49 m from baseline was noted during the trough period, just before inhalation of treprostinil (p = 0.009). The 6MWD improvement of at least 10% was noted in 1 of 6 patients receiving 30 microg versus 5 of 6 receiving 45 microg. Over 12 weeks, significant decreases were noted in mean pulmonary arterial pressure (-10%) and in pulmonary vascular resistance (-26%). Functional class improved from III to II in 9 of 11 patients. CONCLUSIONS: This trial suggests that inhaled treprostinil is safe, well tolerated, and associated with significant improvements in exercise capacity, functional class, and pulmonary hemodynamics in symptomatic patients with PAH on bosentan. SN - 1558-3597 UR - https://www.unboundmedicine.com/medline/citation/17010807/Safety_and_efficacy_of_inhaled_treprostinil_as_add_on_therapy_to_bosentan_in_pulmonary_arterial_hypertension_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0735-1097(06)01835-3 DB - PRIME DP - Unbound Medicine ER -