CLINICAL RESEARCH: PULMONARY VASCULAR DISEASE
Safety and Efficacy of Inhaled Treprostinil as Add-On Therapy to Bosentan in Pulmonary Arterial Hypertension
Richard N. Channick, MD*,*,
Horst Olschewski, MD ,
Werner Seeger, MD ,
Ted Staub, MS ,
Robert Voswinckel, MD and
Lewis J. Rubin, MD*
* UCSD Medical Center, La Jolla, California
Medizinischen Universitaet Graz, Graz, Austria
University of Giessen, Giessen, Germany
LungRx, Satellite Beach, Florida
Manuscript received March 29, 2006;
revised manuscript received May 19, 2006,
accepted May 26, 2006.
* Reprint requests and correspondence: Dr. Richard N. Channick, UCSD Medical Center, 9300 Campus Point Drive, La Jolla, California 92037 (Email: rchannick{at}ucsd.edu).
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 µg of inhaled treprostinil 4 times daily (n = 6) or 45 µg 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 µg versus 5 of 6 receiving 45 µg. 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.
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Abbreviations and Acronyms
| | ERA = endothelin receptor antagonist | | PAH = pulmonary arterial hypertension | | PAPmean = mean pulmonary arterial pressure | | PCH = pulmonary capillary hemangiomatosis | | PVR = pulmonary vascular resistance | | 6MWD = 6-min walk distance |
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