Randomized Placebo-Controlled Crossover Trial of Tadalafil in Raynaud's Phenomenon Secondary to Systemic Sclerosis

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-...

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Bibliographic Details
Published in:Journal of rheumatology 2009-10, Vol.36 (10), p.2264-2268
Main Authors: SCHIOPU, Elena, HSU, Vivien M, IMPENS, Ann J, ROTHMAN, Jennifer A, MCCLOSKEY, Deborah A, WILSON, Julianne E, PHILLIPS, Kristine, SEIBOLD, James R
Format: Article
Language:English
Subjects:
Adult
Biological and medical sciences
Blood and lymphatic vessels
Carbolines - adverse effects
Carbolines - therapeutic use
Cardiology. Vascular system
Cross-Over Studies
Diseases of the osteoarticular system
Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous
Dose-Response Relationship, Drug
Double-Blind Method
Female
Humans
Medical sciences
Middle Aged
Phosphodiesterase Inhibitors - adverse effects
Phosphodiesterase Inhibitors - therapeutic use
Pilot Projects
Prospective Studies
Raynaud Disease - drug therapy
Raynaud Disease - etiology
Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis
Scleroderma, Systemic - complications
Tadalafil
Treatment Outcome
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Summary: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. 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. 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. Tadalafil appears to be safe and well tolerated but lacks efficacy in comparison to placebo as a treatment for RP secondary to SSc.
ISSN:0315-162X
1499-2752
DOI:10.3899/jrheum.090270