Risk of glaucoma among patients using tadalafil for lower urinary tract symptoms: a multinational cohort study

To evaluate the association between tadalafil use for lower urinary tract symptoms (LUTS) and the risk of developing glaucoma.

This multinational, retrospective cohort study was conducted using the TriNetX database. Men aged ≥40 years with a history of LUTS were enrolled between 2012 and 2022. Individuals with a history of glaucoma prior to cohort entry were excluded. Participants were categorised into the tadalafil group and the non-phosphodiesterase type 5 inhibitor (non-PDE5i) group. Propensity score matching (1:1) was conducted to balance age, race, comorbidities, renal function and concomitant medications. Hazard ratios (HRs) were estimated for incident glaucoma of different subtypes and initiation of glaucoma treatment.

The cohort included 36 927 tadalafil users and 36 927 matched non-PDE5i users. Up to 5 years, tadalafil use was associated with an increased risk of glaucoma compared with non-PDE5i use (HR 1.22; 95% CI 1.12 to 1.33). Elevated risks were observed for ocular hypertension (HR 1.32; 95% CI 1.06 to 1.65), primary open-angle glaucoma (HR 1.33; 95% CI 1.05 to 1.67) and initiation of glaucoma treatment (HR 1.33; 95% CI 1.20 to 1.47). No significant associations were found for low-tension or primary angle-closure glaucoma. Tadalafil users had a higher 5-year cumulative incidence than non-users (3.93% vs 3.16%; p<0.001), with consistent risk in men >50 years, white population and across comorbidities, remaining robust to 1-, 3- and 6-month lag times.

Tadalafil was associated with increased risk of glaucoma compared with non-PDE5i in males with LUTS. Ophthalmic evaluation and follow-up may be considered, particularly in patients with risk factors for glaucoma.