ATS 2021 will feature presentations of original research from accepted abstracts. Mini Symposia and Thematic Poster Sessions are abstract based sessions.
Please use the form below to browse scientific abstracts and case reports accepted for ATS 2021. Abstracts presented at the ATS 2021 will be published in the Online Abstract Issue of the American Journal of Respiratory and Critical Care Medicine, Volume 203, May 3, 2021.
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Riociguat Was Effective in Increasing Time until Clinical Worsening in Sarcoidosis Associated Pulmonary Hypertension: Results of a One Year Double Blind, Placebo Controlled Trial
Session Title
TP25 - TP025 SARCOIDOSIS: DIAGNOSIS, PROGNOSIS, AND TREATMENT
Abstract
A1828 - Riociguat Was Effective in Increasing Time until Clinical Worsening in Sarcoidosis Associated Pulmonary Hypertension: Results of a One Year Double Blind, Placebo Controlled Trial
Author Block: R. P. Baughman1, O. A. Shlobin2, R. Gupta3, P. Engel4, J. I. Stewart5, E. E. Lower1, F. Rohaghi6, S. D. Nathan7; 1University of Cincinnati, Cincinnati, OH, United States, 2Inova Fairfax Heart and Lung Instit, Falls Church, VA, United States, 3Thoracic Medicine and Surgery, Temple University, Philadelphia, PA, United States, 4cardiology, the christ hospital, cincinnati, OH, United States, 5Temple Lung Center, Philadelphia, PA, United States, 6Cleveland Clinic Florida, Westin, FL, United States, 7Inova Fairfax Hosp, Falls Church, VA, United States.
Introduction: Riociguat is effective in delaying the time to clinical worsening (TCW) in patients with groups 1 and 4 pulmonary hypertension. We performed a double blind, placebo controlled trial of riociguat versus placebo for sarcoidosis-associated pulmonary hypertension (SAPH). Methods: Patients with SAPH confirmed by right heart catherization were randomized 1:1 to riociguat (RIO) or placebo (PLAC). Study medication was titrated every two weeks for 12 weeks, with a follow up for 48 weeks. Patients underwent six minute walk distance (6MWD) and spirometry every 8 weeks. Predefined TCW events were one or more of the following: 1) all-cause mortality; 2) need for hospitalization due to worsening cardiopulmonary status attributable to progression of disease; 3) >15% decrease in the 6MWD test; 4) worsening of WHO functional class was a primary study endpoint. Changes in 6MWD and FVC were calculated from baseline to TCW or end of study visit. Results: A total of 16 patients (8 in each arm) were randomized (see table). There was no difference in pulmonary artery mean (PA mean), pulmonary vascular resistance (PVR), initial 6MWD, or forced vital capacity (FVC) between the two groups. One RIO patient was withdrawn due to noncompliance, but end of study spirometry and 6MWD were available for analysis. Five of 8 PLAC patients met TCW criteria while none of the RIO patients experienced a qualifying event (Fisher’s exact test p=0.0256). By Log-rank analysis, RIO patients were in the study for a significantly longer period (Chi square=6.259, p=0.0124). The 6MWD decreased in the PLAC group (-55.9m (-176.8 to 60) (median (range)) but rose in the RIO group (+42.7m (-7.5 to +91.4), p=0.0149). Four of eight RIO patients but only 1 of 8 PLAC patients had a >30m improvement in 6MWD (p>0.05). There were no significant adverse events associated with riociguat. Conclusion: Over the one year of the study, riociguat was effective in preventing clinical worsening and improving exercise capacity in patients with SAPH.
Author Block: R. P. Baughman1, O. A. Shlobin2, R. Gupta3, P. Engel4, J. I. Stewart5, E. E. Lower1, F. Rohaghi6, S. D. Nathan7; 1University of Cincinnati, Cincinnati, OH, United States, 2Inova Fairfax Heart and Lung Instit, Falls Church, VA, United States, 3Thoracic Medicine and Surgery, Temple University, Philadelphia, PA, United States, 4cardiology, the christ hospital, cincinnati, OH, United States, 5Temple Lung Center, Philadelphia, PA, United States, 6Cleveland Clinic Florida, Westin, FL, United States, 7Inova Fairfax Hosp, Falls Church, VA, United States.
Introduction: Riociguat is effective in delaying the time to clinical worsening (TCW) in patients with groups 1 and 4 pulmonary hypertension. We performed a double blind, placebo controlled trial of riociguat versus placebo for sarcoidosis-associated pulmonary hypertension (SAPH). Methods: Patients with SAPH confirmed by right heart catherization were randomized 1:1 to riociguat (RIO) or placebo (PLAC). Study medication was titrated every two weeks for 12 weeks, with a follow up for 48 weeks. Patients underwent six minute walk distance (6MWD) and spirometry every 8 weeks. Predefined TCW events were one or more of the following: 1) all-cause mortality; 2) need for hospitalization due to worsening cardiopulmonary status attributable to progression of disease; 3) >15% decrease in the 6MWD test; 4) worsening of WHO functional class was a primary study endpoint. Changes in 6MWD and FVC were calculated from baseline to TCW or end of study visit. Results: A total of 16 patients (8 in each arm) were randomized (see table). There was no difference in pulmonary artery mean (PA mean), pulmonary vascular resistance (PVR), initial 6MWD, or forced vital capacity (FVC) between the two groups. One RIO patient was withdrawn due to noncompliance, but end of study spirometry and 6MWD were available for analysis. Five of 8 PLAC patients met TCW criteria while none of the RIO patients experienced a qualifying event (Fisher’s exact test p=0.0256). By Log-rank analysis, RIO patients were in the study for a significantly longer period (Chi square=6.259, p=0.0124). The 6MWD decreased in the PLAC group (-55.9m (-176.8 to 60) (median (range)) but rose in the RIO group (+42.7m (-7.5 to +91.4), p=0.0149). Four of eight RIO patients but only 1 of 8 PLAC patients had a >30m improvement in 6MWD (p>0.05). There were no significant adverse events associated with riociguat. Conclusion: Over the one year of the study, riociguat was effective in preventing clinical worsening and improving exercise capacity in patients with SAPH.
