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

Publication ,  Journal Article
Schiopu, E; Hsu, VM; Impens, AJ; Rothman, JA; McCloskey, DA; Wilson, JE; Phillips, K; Seibold, JR
Published in: J Rheumatol
October 2009

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.

Duke Scholars

Published In

J Rheumatol

DOI

EISSN

1499-2752

Publication Date

October 2009

Volume

36

Issue

10

Start / End Page

2264 / 2268

Location

Canada

Related Subject Headings

  • Treatment Outcome
  • Tadalafil
  • Scleroderma, Systemic
  • Raynaud Disease
  • Prospective Studies
  • Pilot Projects
  • Phosphodiesterase Inhibitors
  • Middle Aged
  • Humans
  • Female
 

Citation

APA
Chicago
ICMJE
MLA
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Schiopu, E., Hsu, V. M., Impens, A. J., Rothman, J. A., McCloskey, D. A., Wilson, J. E., … Seibold, J. R. (2009). Randomized placebo-controlled crossover trial of tadalafil in Raynaud's phenomenon secondary to systemic sclerosis. J Rheumatol, 36(10), 2264–2268. https://doi.org/10.3899/jrheum.090270
Schiopu, Elena, Vivien M. Hsu, Ann J. Impens, Jennifer A. Rothman, Deborah A. McCloskey, Julianne E. Wilson, Kristine Phillips, and James R. Seibold. “Randomized placebo-controlled crossover trial of tadalafil in Raynaud's phenomenon secondary to systemic sclerosis.J Rheumatol 36, no. 10 (October 2009): 2264–68. https://doi.org/10.3899/jrheum.090270.
Schiopu E, Hsu VM, Impens AJ, Rothman JA, McCloskey DA, Wilson JE, et al. Randomized placebo-controlled crossover trial of tadalafil in Raynaud's phenomenon secondary to systemic sclerosis. J Rheumatol. 2009 Oct;36(10):2264–8.
Schiopu, Elena, et al. “Randomized placebo-controlled crossover trial of tadalafil in Raynaud's phenomenon secondary to systemic sclerosis.J Rheumatol, vol. 36, no. 10, Oct. 2009, pp. 2264–68. Pubmed, doi:10.3899/jrheum.090270.
Schiopu E, Hsu VM, Impens AJ, Rothman JA, McCloskey DA, Wilson JE, Phillips K, Seibold JR. Randomized placebo-controlled crossover trial of tadalafil in Raynaud's phenomenon secondary to systemic sclerosis. J Rheumatol. 2009 Oct;36(10):2264–2268.

Published In

J Rheumatol

DOI

EISSN

1499-2752

Publication Date

October 2009

Volume

36

Issue

10

Start / End Page

2264 / 2268

Location

Canada

Related Subject Headings

  • Treatment Outcome
  • Tadalafil
  • Scleroderma, Systemic
  • Raynaud Disease
  • Prospective Studies
  • Pilot Projects
  • Phosphodiesterase Inhibitors
  • Middle Aged
  • Humans
  • Female