Introduction: Phosphodiesterase-5 inhibitors (PDE5i) are the first-line line treatment for men with ED. The use of PDE5I has recenty been linked to several ocular side effects, such as serous retinal detachment (SRD), retinal vascular occlusion (RVO), and ischemic optic neuropathy (ION). However, the risk factors for major ocular events and ED overlap suggesting that the association may not be causative. The current study investigated the risk for SRD, RVO, and ION in patients using PDE5Is. Methods: We utilized the IBM® MarketScan® (2007 to 2016) Commercial and Medicare Supplemental Databases (v 2.0, DOI: 10.57761/ray7-1g16). Cox proportional hazard models were applied to calculate the risk of ocular events after the diagnosis and or treatment of ED (i.e. PDE5i, penile injection/urethral suppositories, penile prosthesis placement) while adjusing for relevant comorbidities. As a further analysis, the use of PDE5i in men with BPH was also examined. Results: In total, 1,565,006 men with an ED diagnosis were identified. Among them, 525,624 (33.6%) were treated with a PDE5i. In total, 1,806,803 men with a BPH diagnosis were observed during the study period with 141,607 (7.8%) treated with a PDE5i. On adjusted analysis, PDE5i use was not consistently associated with SRD, ION, and any ocular event when compared to ED diagnosis and other ED treatments. However, men who received a penile prosthesis had a higher risk of ocular events RVO (HR: 2.36; 95% CI: 1.81–3.09). In addition, PDE5i use was associated with SRD, RVO, and ION in the BPH cohort. In fact, BPH patients using 5a reductase/alpha blocker or prostatectomy had the highest risk of ocular events. Conclusions: In the current report, no consistent association with PDE5i use and adverse ocular events (i.e. SRD, RVO, and ION) was identified. For erectile dysfunction, men requiring more invasive treatment of ED (i.e. men with more severe ED who required more invasive treatments) carried the highest risk of adverse ocular events. The link between PDE5i use and ocular events is consistent with biases related to common risk factors suggesting patient counseling about this association is unnecessary. SOURCE OF Funding: Data for this project were accessed using the Stanford Center for Population Health Sciences Data Core. The PHS Data Core is supported by a National Institutes of Health National Center for Advancing Translational Science Clinical and Translational Science Award (UL1TR003142) and from Internal Stanford funding. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
