Abstract
Purpose :
Late-onset hypogonadism is characterized by a deficiency in serum testosterone levels, adversely affecting multiple organ systems. Testosterone replacement therapy is the mainstay of treatment, but concerns over its safety persist, including possible effects in the eye. The purpose of this study is to determine if testosterone replacement is associated with central serous chorioretinopathy (CSCR).
Methods :
This is a retrospective matched-cohort study using medical claims data from a large, national U.S. insurer. The testosterone cohort was created using all male patients who filled a prescription for testosterone during their time in the plan from 2000-2013. Index date was considered the date of first prescription. Exclusion criteria included less then 2 years of time in the plan prior to the index date, any systemic disease associated with increased testosterone, and any medication use known to have androgen or anti-androgen effects. Ocular exclusion criteria consisted of history of CSCR or other eye disease that could be confused with CSCR. 5 matched controls were chosen for every eligible case, which were matched on age (±3 years), sex, race and similar time in plan (±3 months). Controls were assigned the same index date as their matched case. All eligible patients had to have at least one visit with an eye care provider prior to the index date. The outcome of interest was a new diagnosis of CSCR. Cox proportional regression was used to assess the hazard of CSCR while censoring for end of eligibility or if any of the above exclusion criteria occurred. Other covariates of interest were diabetes mellitus (DM) and hypertension (HTN).
Results :
The testosterone cohort consisted of 9238 incident users compared with 46190 matched controls. Cohorts were similar in age (54.6/54.4 years old in the testosterone and control cohorts, respectively), but the testosterone group had more DM (24.4% vs. 11.4%) and HTN (51.4% vs. 37.9%). Nine (0.10%) cases of CSCR occurred in the testosterone cohort and 22 (0.05%) in the control. After controlling for all covariates of interest, multivariate analysis revealed that testosterone replacement significantly increased the hazard for CSCR (HR: 2.97; 95% CI: 1.32, 6.71; p=0.009).
Conclusions :
Although the incidence of CSCR is low (0.10%) in users of testosterone, replacement therapy increases the hazard of CSCR by 2.97.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.