Hearing loss with phosphodiesterase-5 inhibitors: a prospective and objective analysis with tadalafil.

ABSTRACT

OBJECTIVES/HYPOTHESIS: To assess the effect of tadalafil on auditory functions. STUDY DESIGN: Prospective observational study in a tertiary care hospital. METHODS: Twenty-five tadalafil naïve patients with erectile dysfunction or pulmonary artery hypertension were subjected to pure-tone and brainstem-evoked response audiometry before drug therapy, and 3 and 30 days following drug therapy. Results were compared using analysis of variance for repeated measures with Bonferonni correction. RESULTS: Fifteen patients were taking tadalafil 10 mg for erectile dysfunction, and another 10 patients were on tadalafil 20 mg once daily for pulmonary artery hypertension. No statistically significant difference was found in hearing threshold at baseline and at follow-up (P > .05). However, three patients on tadalafil 20 mg showed a significant increase in hearing threshold at higher frequencies. There was no incidence of sudden sensorineural hearing loss in the study group. CONCLUSIONS: This is the first prospective and observational study that evaluated the effect of tadalafil on auditory functions with objective tests. Although there was no statistically significant result to confirm or refute the association between tadalafil and hearing impairment, increased threshold at higher frequencies after taking tadalafil supports the results from previous studies and hints at a possible relationship between the two. Similar large sample studies are warranted to know the exact association of phosphodiesterase-5 inhibitors on auditory functions.