TOPLINE

A multinational cohort study found the use of tadalafil, a phosphodiesterase type 5 (PDE5) inhibitor, for lower urinary tract symptoms was associated with a 22% higher risk for glaucoma over 5 years than non-PDE5 inhibitor use. Using tadalafil was also associated with higher risks for ocular hypertension, primary open-angle glaucoma, and initiation of treatment for glaucoma.

METHODOLOGY

• Researchers conducted a multinational, retrospective cohort study using the TriNetX database to evaluate the association between tadalafil use for lower urinary tract symptoms and the risk of developing glaucoma.
• The study analyzed 73,854 men aged 40 years or older with lower urinary tract symptoms between 2012 and 2022, comprising 36,927 tadalafil users and 36,927 matched non-PDE5 inhibitor users.
• Men with a history of glaucoma before cohort entry were excluded, as were those with concurrent use of other PDE5 inhibitors or incomplete lower urinary tract symptom medication history; tadalafil users were also required to have either a refill or an ongoing prescription within 3-12 months after the initial prescription.
• Participants were followed for up to 5 years; the primary outcome was incident glaucoma recorded after the index date (the date of the first tadalafil prescription).
• Secondary outcomes included ocular hypertension, primary open-angle glaucoma, normal-tension glaucoma, primary angle-closure glaucoma, and initiation of glaucoma treatment.

TAKEAWAY

• Over 5 years of follow-up, tadalafil use was associated with a 22% higher risk for glaucoma than non-PDE5 inhibitor use (hazard ratio [HR], 1.22; 95% CI, 1.12-1.33).
• The 5-year cumulative incidence of glaucoma was 3.93% among men who took tadalafil and 3.16% among matched nonusers of the drug.
• Tadalafil use was also associated with more than 30% elevated risks for ocular hypertension (HR, 1.32; 95% CI, 1.06-1.65), primary open-angle glaucoma (HR, 1.33; 95% CI, 1.05-1.67), and initiation of glaucoma treatment (HR, 1.33; 95% CI, 1.20-1.47).
• Subgroup analyses showed a significantly increased risk for glaucoma with tadalafil use in men aged 50 years or older (HR, 1.29) and in White patients (HR, 1.16). Similar associations were observed across comorbidities including hypertension, hyperlipidemia, obesity, and chronic kidney disease.
• The association remained robust after excluding individuals who developed glaucoma within 1, 3, or 6 months after initiation of tadalafil.

IN PRACTICE

“These findings do not contraindicate tadalafil use but highlight the importance of baseline ophthalmic assessment and regular follow-up, particularly in patients with preexisting glaucoma, ocular hypertension, a family history of glaucoma, high myopia, or those requiring long-term therapy,” the researchers reported.

SOURCE

The study was led by Yun Hsia of the National Taiwan University Hospital in Taipei, Taiwan. It was published online on August 4 in the British Journal of Ophthalmology.

LIMITATIONS

Although propensity score matching was used to make the two groups as similar as possible, some unmeasured factors may still have affected the results. Although alpha-blocker monotherapy could have served as a comparison group, it was not used because alpha-blockers can lower blood pressure and may also affect blood flow to the eye, which could introduce additional bias. In addition, because the database was de-identified, individual patient records could not be reviewed to confirm glaucoma diagnoses or examine detailed eye test results.

DISCLOSURES

This study was supported by the Taichung Veterans General Hospital, Taichung, Taiwan. No relevant conflicts of interest were disclosed by the authors.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.