Vardenafil for the Treatment of Raynaud Phenomenon: A Randomized, Double-blind, Placebo-Controlled Crossover Study

Abstract

Raynaud phenomenon (RP) is common and occurs with severe symptoms, particularly in patients with connective tissue disease (CTD), in whom RP may lead to digital ulcerations and amputations.^1,2 Medical therapy in these patients remains unsatisfactory. Administration of phosphodiesterase type 5 (PDE5) inhibitors, which inhibit the degradation of cyclic guanosine monophosphate (cGMP) in vascular smooth muscle cells, promote vasorelaxation and are a promising therapeutic approach. However, randomized controlled trials have yielded conflicting results.³ We previously had conducted an open-label study with vardenafil hydrochloride trihydrate in patients with RP as a proof of concept.⁴ Our objective was to confirm our findings in a double-blind, randomized, placebo-controlled trial.