Vardenafil: a novel type 5 phosphodiesterase inhibitor for the treatment of erectile dysfunction.

Orally administered phosphodiesterase type 5 (PDE5) inhibitors have become the first-line treatment option for erectile dysfunction (ED). Vardenafil is a potent and highly selective PDE5 inhibitor developed as an oral therapy for ED. Two pivotal, randomised, double-blind, multi-centre studies have evaluated the use of vardenafil in men with ED. Vardenafil improved the rate of achieving and maintaining an erection during sexual intercourse. Improvement was also noted in other aspects of sexual function, including confidence, orgasmic function and overall satisfaction. Vardenafil produces clinically and statistically significant improvements in erectile function regardless of age, baseline severity and aetiology and is efficacious for the treatment of ED in diabetic and postradical prostatectomy patients. Vardenafil has a rapid onset of action, in which erections sufficiently rigid for eventual intercourse completion can be achieved as early as 16 min after ingestion. Vardenafil 20 mg has sustained long-term efficacy by providing up to 92% of patients with improved erections during > 2 years of treatment. Vardenafil is well-tolerated, with an adverse event profile typical of this class of PDE5 inhibitors. The most common adverse events were headache, flushing, rhinitis and dyspepsia, which were mild-to-moderate in severity and they generally attenuated with continued use. Vardenafil may be associated with transient reductions in blood pressure and commensurate increases in heart rate, with the overall incidence of cardiovascular-related adverse events similar to that of placebo. Although claims can be made about potential features of benefit for each of the currently marketed PDE5 inhibitors, there are at present, no non-pharmaceutical company sponsored, peer-reviewed, head-to-head trials that have been published.