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Randomized Placebo-Controlled Crossover Trial of Tadalafil in Raynaud’s Phenomenon Secondary to Systemic Sclerosis
- Source :
- The Journal of Rheumatology. 36:2264-2268
- Publication Year :
- 2009
- Publisher :
- The Journal of Rheumatology, 2009.
-
Abstract
- 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.
- Subjects :
- Adult
medicine.medical_specialty
medicine.drug_mechanism_of_action
Phosphodiesterase Inhibitors
Immunology
Pilot Projects
Placebo
Scleroderma
Tadalafil
law.invention
Double-Blind Method
Rheumatology
Randomized controlled trial
law
Internal medicine
medicine
Humans
Immunology and Allergy
Prospective Studies
Prospective cohort study
Cross-Over Studies
Scleroderma, Systemic
Dose-Response Relationship, Drug
business.industry
Raynaud Disease
Middle Aged
medicine.disease
Crossover study
Surgery
Treatment Outcome
Tolerability
Female
business
Phosphodiesterase 5 inhibitor
Carbolines
medicine.drug
Subjects
Details
- ISSN :
- 14992752 and 0315162X
- Volume :
- 36
- Database :
- OpenAIRE
- Journal :
- The Journal of Rheumatology
- Accession number :
- edsair.doi.dedup.....a71e289f61dca17efca260a765f6d500