Abstract 13048: Vardenafil Improves Clinical Symptoms and Digital Blood Flow in Patients With Primary and Secondary Raynaud Syndrome - Results From a Randomized Controlled Trial
Raynaud's syndrome (RS) is a common, often disabling disorder with limited therapeutic options particularly in patients with connective tissue diseases. We have previously demonstrated in an open-label pilot study that the phosphodiesterase type 5 (PDE5) inhibitor vardenafil is effective in these patients. The objective now was to determine whether long-term vardenafil treatment improves clinical symptoms, duration and frequency of attacks, as well as digital blood flow in patients with RS. A mono-centric randomized double-blind cross-over study was conducted with 57 patients from the outpatient clinic of the University Hospital of Cologne. Inclusion criteria were primary or secondary RS, an age between 18 and 80 years and written informed consent. 53 (42 female and 11 male) patients with a mean age of 51.7±12.2 years were randomized to receive either vardenafil or placebo for 6 weeks. A cross-over with an additional treatment period of 6 weeks was conducted after a one week wash out phase. Patients were followed up to 4 weeks after the last drug intake. Digital blood flow was measured by laser-Doppler flowmetry at room temperature and during the cold-exposure test before medical treatment, 1 hour after the initial intake and after 6 weeks of continuous treatment. Clinical symptoms were assessed with a standardized patient questionnaire daily throughout the study and summarized as the Raynaud condition score (RCS). Primary outcomes were changes in the RCS and digital blood flow. Secondary endpoints were safety and tolerability of the drug. Vardenafil improved digital blood flow significantly by a mean±SEM of 18.8%±7.5% at 6 weeks of treatment at room temperature (p<0.01). Consistently, clinical symptoms improved mainly due to fewer Raynaud attacks and a shorter cumulative duration of Raynaud attacks. The Raynaud condition score significantly declined from a mean±SD of 4.3±2.5 to 3.00±1.9 (P <0.01). 3 SAEs occurred throughout the study, but none of it was related to the drug intake. The PDE5-inhibitior vardenafil significantly improves peripheral blood flow and clinical symptoms in patients with primary and secondary RS and, thus, may provide a novel therapeutic option in these patients. Trial Registration: ClinicalTrials.gov Identifier: NCT01291199
- © 2011 by American Heart Association, Inc.