Journal article

Publication year: 2011

Pages: 1274-1283

Journal: Chest Journal

Volume number: 140

Issue number: 5

ISSN: 0012-3692

eISSN: 1931-3543

DOI Link: https://doi.org/10.1378/chest.10-0969

Publisher: Elsevier

Abstract: 
Background: The long-term safety and tolerability of sildenafil treatment of pulmonary arterial hypertension (PAH) were assessed. Methods: Two hundred fifty-nine of 277 randomized and treated patients completed a 12-week, double-blind, placebo-controlled trial (SUPER-1 [Sildenafil Use in Pulmonary Arterial Hypertension]) of oral sildenafil in treatment-naive patients with PAH (96% functional class HMI) and entered an open-label uncontrolled extension study (SUPER-2) that continued until the last patient completed 3 years of sildenafil treatment. Patients titrated to sildenafil 80 mg tid; one dose reduction for tolerability was allowed during the titration phase. Results: The median duration of sildenafil treatment across SUPER-1 and SUPER-2 was 1,242 days (range, 1-1,523 days); 170 patients (61%) completed both studies, and 89 patients discontinued from SUPER-2. After 3 years, 87% of 183 patients on treatment were receiving sildenafil 80 mg tid. Of patients remaining under follow-up, 3%, 10%, and 18% were receiving a second approved PAH therapy at 1, 2, and 3 years, respectively. At 3 years post-SUPER-1 baseline, 127 patients had an increased 6-min walk distance (6MWD); 81 improved and 86 maintained functional class. Most adverse events were of mild or moderate severity. At 3 years, 53 patients had died (censored, n = 37). Three-year estimated survival rate was 79%; if all censored patients were assumed to have died, 3-year survival rate was 68%. No deaths were considered to be treatment related. Conclusions: Long-term treatment of PAH initiated as sildenafil monotherapy was generally Well tolerated. After 3 years, the majority of patients (60%) who entered the SUPER-1 trial improved or maintained their functional status, and 46% maintained or improved 6MWD.

Harvard Citation style: Rubin, L., Badesch, D., Fleming, T., Galie, N., Simonneau, G., Ghofrani, H., et al. (2011) Long-term Treatment With Sildenafil Citrate in Pulmonary Arterial Hypertension The SUPER-2 Study, Chest Journal, 140(5), pp. 1274-1283. https://doi.org/10.1378/chest.10-0969

APA Citation style: Rubin, L., Badesch, D., Fleming, T., Galie, N., Simonneau, G., Ghofrani, H., Oakes, M., Layton, G., Serdarevic-Pehar, M., McLaughlin, V., & Barst, R. (2011). Long-term Treatment With Sildenafil Citrate in Pulmonary Arterial Hypertension The SUPER-2 Study. Chest Journal. 140(5), 1274-1283. https://doi.org/10.1378/chest.10-0969