gms | German Medical Science

Introduction: Vardenafil represents a potent and highly selective phosphodiesterase type 5 (PDE5) inhibitor, which is established for treatment of various diseases. There are several unpublished reports from patients stating that vardenafil has a considerable therapeutic effect on their concomitant tinnitus. This pilot study was conducted to specifically assess the effect of vardenafil in patients with chronic tinnitus.

Methods: In a prospective, randomized, double-blind, placebo-controlled clinical investigation, 42 consecutive subjects with mon- or binaural chronic tinnitus received 10 mg vardenafil (N=21) or matching placebo tablets (N=21) administered orally twice a day over a period of 12 weeks. Clinical examination and data acquisition took place pre-, intra- and post-therapeutically, using a standardized tinnitus questionnaire (TQ), the Short Form 36 health survey (SF-36), audiometric measurements and biomarkers of oxidative stress in patients’ blood. Therapeutic efficacy was evaluated by comparison of subjective and objective parameters with baseline data between both treatment groups (ANCOVA).

Results: Vardenafil had no superior efficacy over placebo in the treatment of chronic tinnitus during this study. Subjective reports of TQ scores and general quality of life areas (SF-36), objective audiometric examinations as well as investigated biomarkers for oxidative stress did not reveal any significant treatment effects or trends.

Conclusions: Although hypoxia and ischemia play a special role in the pathogenesis of tinnitus, the PDE5-inhibitor-induced increase of nitric oxide-mediated vasodilatation exerted no specific influence on tinnitus symptomatology. Considering the unclear risk of rarely associated hearing impairment, systemic application of vardenafil proves to be not appropriate for therapy of chronic tinnitus.