Risk of glaucoma among patients using tadalafil for lower urinary tract symptoms: a multinational cohort study
Abstract
AIM
To evaluate the association between tadalafil use for lower urinary tract symptoms (LUTS) and the risk of developing glaucoma.
METHODS
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.
RESULTS
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%; p50 years, white population and across comorbidities, remaining robust to 1-, 3- and 6-month lag times.
CONCLUSIONS
Tadalafil was…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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