Randomized placebo-controlled crossover trial of tadalafil in Raynaud's phenomenon secondary to systemic sclerosis.
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.


CONCLUSIONS
Tadalafil appears to be safe and well tolerated but lacks efficacy in comparison to placebo as a treatment for RP secondary to SSc.
Schiopu
Elena
E
University of Michigan Scleroderma Program, 24 Frank Lloyd Wright Drive, P. O. Box 481, Ann Arbor, MI 48106-5753, USA.
Hsu
Vivien M
VM
Impens
Ann J
AJ
Rothman
Jennifer A
JA
McCloskey
Deborah A
DA
Wilson
Julianne E
JE
Phillips
Kristine
K
Seibold
James R
JR
D000328:Adult; D002243:Carbolines / Q000009:adverse effects / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D010865:Pilot Projects; D011446:Prospective Studies; D011928:Raynaud Disease / Q000188:drug therapy* / Q000209:etiology*; D012595:Scleroderma, Systemic / Q000150:complications*; D000068581:Tadalafil; D016896:Treatment Outcome
D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D000068581:Tadalafil