0
Original Research: Pulmonary Vascular Disease |

Bosentan for Sarcoidosis-Associated Pulmonary HypertensionBosentan for Sarcoiodosis Pulmonary Hypertension: A Double-Blind Placebo Controlled Randomized Trial

Robert P. Baughman, MD, FCCP; Daniel A. Culver, DO, FCCP; Francis C. Cordova, MD; Maria Padilla, MD; Kevin F. Gibson, MD; Elyse E. Lower, MD; Peter J. Engel, MD
Author and Funding Information

From the Department of Internal Medicine (Drs Baughman and Lower), University of Cincinnati Medical Center, Cincinnati, OH; Cleveland Clinic Foundation (Dr Culver), Cleveland, OH; Department of Internal Medicine (Dr Cordova), Temple University, Philadelphia, PA; Department of Medicine (Dr Padilla), Icahn School of Medicine at Mount Sinai, New York, NY; Division of Pulmonary, Allergy, and Critical Care Medicine (Dr Gibson), University of Pittsburgh, Pittsburgh, PA; and The Christ Hospital (Dr Engel), Cincinnati, OH.

Correspondence to: Robert P. Baughman, MD, FCCP, Department of Medicine, University of Cincinnati Medical Center, 1001 Holmes, Eden Ave, Cincinnati, OH 45267-0565; e-mail: bob.baughman@uc.edu


Funding/Support: This study was supported by Actelion Pharmaceuticals US, Inc.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2014;145(4):810-817. doi:10.1378/chest.13-1766
Text Size: A A A
Published online

Background:  Sarcoidosis-associated pulmonary hypertension (SAPH) is a common problem in patients with persistent dyspneic sarcoidosis. The objective of this study was to determine the effect of bosentan therapy on pulmonary arterial hemodynamics in patients with SAPH.

Methods:  This 16-week study was a double-blind, placebo-controlled trial of either bosentan or placebo in patients with SAPH confirmed by right-sided heart catheterization. Patients were enrolled from multiple academic centers specializing in sarcoidosis care. They were stable on sarcoidosis therapy and were receiving no therapy for pulmonary hypertension. The cohort was randomized two to one to receive bosentan at a maximal dose of 125 mg or placebo bid for 16 weeks. Pulmonary function studies, 6-min walk test, and right-sided heart hemodynamics, including pulmonary artery mean pressure and pulmonary vascular resistance (PVR), were performed before and after 16 weeks of therapy.

Results:  Thirty-five patients completed 16 weeks of therapy (23 treated with bosentan, 12 with placebo). For those treated with bosentan, repeat hemodynamic studies at 16 weeks demonstrated a significant mean ± SD fall in PA mean pressure (−4 ± 6.6 mm Hg, P = .0105) and PVR (−1.7 ± 2.75 Wood units, P = .0104). For the patients treated with placebo, there was no significant change in either PA mean pressure (1 ± 3.7 mm Hg, P > .05) or PVR (0.1 ± 1.42 Wood units, P > .05). There was no significant change in 6-min walk distance for either group. Two patients treated with bosentan required an increase of supplemental oxygen by > 2 L after 16 weeks of therapy.

Conclusions:  This study demonstrated that bosentan significantly improved pulmonary hemodynamics in patients with SAPH.

Trial registry:  ClinicalTrials.gov; No: NCT00581607; URL: www.clinicaltrials.gov

Figures in this Article

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Figures

Tables

References

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Find Similar Articles
CHEST Journal Articles
PubMed Articles
  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543