PT - JOURNAL ARTICLE AU - Elena Schiopu AU - Vivien M. Hsu AU - Ann J. Impens AU - Jennifer A. Rothman AU - Deborah A. McCloskey AU - Julianne E. Wilson AU - Kristine Phillips AU - James R. Seibold TI - Randomized Placebo-Controlled Crossover Trial of Tadalafil in Raynaud's Phenomenon Secondary to Systemic Sclerosis AID - 10.3899/jrheum.090270 DP - 2009 Sep 15 TA - The Journal of Rheumatology PG - jrheum.090270 4099 - http://www.jrheum.org/content/early/2009/09/11/jrheum.090270.short 4100 - http://www.jrheum.org/content/early/2009/09/11/jrheum.090270.full AB - Objective Raynaud’s phenomenon (RP) is an important clinical feature of systemic sclerosis (SSc) for which consistently effective therapies are lacking. The study was designed to assess the safety, tolerability, and efficacy of tadalafil, a selective, long acting type V cyclic GMP phosphodiesterase (PDE-5) inhibitor, in this clinical syndrome. Methods We performed a prospective, randomized, double-blind, placebo-controlled, crossover study comparing oral tadalafil at a fixed dose of 20 mg daily for a period of 4 weeks versus placebo in women with RP secondary to SSc. Results Thirty-nine subjects completed the study and were evaluable. There were no statistically significant differences in Raynaud Condition Score (RCS), frequency of RP episodes, or duration of RP episodes between treatment groups. Placebo response was a confounding factor. Tadalafil was well tolerated. Conclusion Tadalafil appears to be safe and well tolerated but lacks efficacy in comparison to placebo as a treatment for RP secondary to SSc.