Investigating the impact of tadalafil on progression of age-related macular degeneration: a health insurance claims database analysis

Purpose

To assess the effect of tadalafil use on progression of early/intermediate to advanced exudative or non-exudative age-related macular degeneration (AMD) in a real-world population.

Design

Retrospective cohort study utilizing Optum's de-identified Clinformatics® Data Mart Database (CDM).

Methods

Patients were included from January 2015 to December 2020 aged 55 and older with an index International Classification of Diseases, Tenth Revision (ICD-10) diagnosis of early or intermediate AMD who had a 2-year period of continuous enrollment prior to the index diagnosis date (lookback period), 5 years of continuous follow-up, and who did not meet any exclusion criteria (claims for a phosphodiesterase-5 (PDE-5) inhibitor other than tadalafil during the study, diagnosis of advanced non-exudative or exudative AMD, or claims for exudative AMD treatment during the lookback period). Treated patients with claims for tadalafil during the study period were matched 1:1 to untreated controls by age, sex, race, and smoking status. We assessed the effect of any tadalafil use, high (≥2700 mg) cumulative dose tadalafil vs. matched untreated controls, high (>2700 mg) vs. low (≤2700 mg) cumulative dose tadalafil, and the 2-year cumulative dose of tadalafil (per 100 mg) as a continuous variable on incidence of progression to exudative or advanced non-exudative AMD during the 2-year follow-up.

Results

There was no significant difference in odds of progression to exudative AMD or advanced non-exudative AMD in the control vs treated groups (OR = 0.802, 95% CI (0.558–1.152), p = 0.233; OR = 1.326, 95% CI (0.757–2.323), p = 0.323). High (≥2700 mg) cumulative dose tadalafil was not associated with a significant difference in odds of progression to exudative AMD or advanced non-exudative AMD when compared to the matched controls (OR = 0.455, 95% CI (0.202–1.025), p = 0.057; OR = 1.000, 95% CI (0.318–3.142), p = 1.000). There was no significant difference in odds of progression to exudative AMD or advanced non-exudative AMD in the high (>2700 mg) vs. low (≤2700 mg) cumulative dose tadalafil (OR = 0.590, 95% CI (0.296–1.177), p = 0.134; OR = 1.039, 95% CI (0.440–2.460), p = 0.931). Lastly, there was no significant difference in odds of progression to exudative AMD or advanced non-exudative AMD when assessing the 2-year cumulative tadalafil dose (per 100 mg) as a continuous variable (OR = 1.000, 95% CI (1.000–1.000), p = 0.305; OR = 1.000, 95% CI (1.000–1.000), p = 0.878).

Conclusion

In a retrospective cohort study of a large nationwide health insurance claims database, tadalafil use was not associated with progression of AMD.