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 Oct 01
TA  - The Journal of Rheumatology
PG  - 2264--2268
VI  - 36
IP  - 10
4099  - http://www.jrheum.org/content/36/10/2264.short
4100  - http://www.jrheum.org/content/36/10/2264.full
SO  - J Rheumatol2009 Oct 01; 36
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.