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Vardenafil (Levitra, Bayer Healthcare/GlaxoSmithKline, USA) is a phosphodiesterase 5 inhibitor developed specifically for use as an oral therapy for erectile dysfunction (ED). This review provides an overview of recent clinical trial results that support the use of this compound as first-line therapy in patients with ED. Specifically, data from clinical trials performed in multiple countries have shown strong efficacy and good safety in the general population as well as in difficult-to-treat subpopulations, such as patients post bilateral nerve sparing radical prostatectomy and patients with diabetes mellitus. Furthermore, the features of a rapid onset of action, good reliability and increased patient satisfaction, while elements such as erection hardness and overall sexual experience may provide additional benefits to this particular patient group. Together with a good safety profile and minimal interactions with food and alcohol, it is clear that vardenafil offers a viable first-line treatment choice for men with ED.