Vardenafil Improves Raynaud Phenomenon in Controlled Study

Steven Fox

June 20, 2012

June 20, 2012 — Use of the erectile dysfunction drug vardenafil appears to improve clinical symptoms and digital blood flow in patients with Raynaud phenomenon (RP), according to findings from the largest randomized controlled study to date on the topic. The study was published online June 18 in the Archives of Internal Medicine.

This is not the first report detailing use of the phosphodiesterase type 5 (PDE5) inhibitors for RP, but the results of previous trials have been mixed.

Evren Caglayan, MD, from the University Hospital in Cologne, Germany, and coauthors note that their group previously saw good results using vardenafil for RP in an open-label study.

To confirm those observations, the investigators launched the double-blind, randomized, placebo-controlled trial. They recruited 53 patients who were seen in dermatology and angiology clinics at the University Hospital, Cologne, from January 2006 through August 2009. The majority of patients (42/53) were women. Nearly 90% had secondary RP, mainly because of systemic sclerosis. The remainder had primary RP.

Patients discontinued any vasoactive drugs at least a week before starting in the current study.

The study design included a 2-period crossover for 6 weeks to gauge the safety and efficacy of vardenafil (10 mg twice a day) for treating RP. A 1-week washout period preceded switching patients between the treatment and placebo groups.

The investigators tracked changes in Raynaud condition scores (RCS) by having patients complete a standardized questionnaire each day. They also periodically measured digital blood flow with a laser Doppler perfusion imager.

"Vardenafil significantly reduced the RCS on average by −0.45 compared with placebo (P = .03) and decreased the number (−0.51 vs placebo; P = .005) and cumulative duration (−11.43 minutes vs placebo; P = .003) of Raynaud attacks per day," the authors write.

Significant improvements in RP clinical symptoms were associated with increased digital blood flow, but the changes in circulation did not reach statistical significance (+0.04 vs placebo; P = .14).

When the investigators compared results in various subgroups, they found that vardenafil appeared to be most effective in patients with primary RP. In patients with secondary RP, those who had limited cutaneous systemic scleroderma fared better than other subsets of patients with secondary RP, the authors note.

One surprising finding from the study was that the clinical efficacy of vardenafil appeared to linger after the drug was discontinued.

"Interestingly, in patients receiving vardenafil first, the RCS remained low during the washout phase and the entire second phase of the study when patients received placebo, suggesting a prolonged drug effect," the authors note. Even so, they say that when they analyzed the data for a carryover effect, no significant relationship was seen.

"This study is, to our knowledge, the largest randomized controlled trial investigating the efficacy and safety of a PDE5 inhibitor in patients with RP. The findings demonstrate that vardenafil is safe and improves clinical symptoms in these patients," the authors conclude.

Raynaud phenomenon is believed to be triggered by hyperactivation of the sympathetic system, which in turn causes extreme vasoconstriction of the peripheral blood vessels. If not adequately managed, it can cause hypoxia. In addition, chronic and/or recurrent cases may produce atrophy of the skin, subcutaneous tissues, and muscle. In some less common cases, it may lead to ulceration and ischemic gangrene.

The authors have disclosed no relevant financial relationships.

Arch Intern Med. Published online June 18, 2012. Full text


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