ORLANDO – The phosphodiesterase type 5 inhibitor vardenafil significantly improved clinical symptoms and digital blood flow in patients with primary or secondary Raynaud syndrome in a randomized, placebo-controlled, double-blind crossover trial.
Thus, vardenafil (Levitra) appears to provide a novel, albeit off-label, therapeutic option in patients with this common, often disabling disorder for which treatment options have been limited, Dr. Evren Caglayan declared at the annual Scientific Sessions of the American Heart Association.
The study involved 53 patients with primary or secondary Raynaud syndrome who in double-blind fashion received vardenafil at 10 mg twice daily or placebo for 6 weeks. A subsequent weeklong washout period was followed crossover to 6 weeks in the other study arm.
Digital blood flow measured by laser Doppler flowmetry at room temperature after 6 weeks of continuous vardenafil therapy improved by a mean of 18.7%, compared to baseline but was unchanged during the control period, according to Dr. Caglayan of the University of Cologne (Germany).
A standardized patient questionnaire administered daily was used to assess clinical symptoms. The results were summarized as the Raynaud Condition Score. During vardenafil therapy the score declined from a baseline mean of 4.3 to 3.0 (P less than .01), mainly reflecting fewer Raynaud attacks and shorter cumulative duration of attacks.
No treatment-related adverse events occurred.
These randomized trial results confirm the favorable findings of an earlier open-label 40-patient study conducted by Dr. Caglayan and coworkers (Arch. Intern. Med. 2006;166:231-3).
The therapeutic rationale for using vardenafil in patients with Raynaud syndrome lies in the broad observation that PDE5 inhibitors exert vasodilatory properties, particularly in diseased tissue.
Dr. Caglayan declared having no financial conflicts with regard to this study, which was funded by Bayer.