Use of phosphodiesterase 5 inhibitors is not associated with ocular adverse events. The journal of sexual medicine Belladelli, F., Li, S., Zhang, C. A., Muncey, W., Del Giudice, F., Glover, F., Seranio, N., Basran, S., Fallara, G., Montorsi, F., Salonia, A., Eisenberg, M. L. 2023

Abstract

Phosphodiesterase 5 inhibitor (PDE5i) use has been linked to a number of ocular side effects, such as serous retinal detachment (SRD), retinal vascular occlusion (RVO), and ischemic optic neuropathy (ION).We investigated the risk for SRD, RVO, and ION in patients using PDE5is.We utilized the IBM MarketScan (2007-2021) Commercial and Medicare Supplemental Databases (version 2.0) for this analysis. To estimate overall events risk, Cox proportional hazard models were applied to calculate the hazard ratios (HRs) for erectile dysfunction (ED) diagnosis and the different treatments, adjusting for region, median age, obesity, diabetes mellitus, hyperlipidemia, smoking, hypertension, coronary artery disease, and sleep apnea. Additionally, the same analyses were performed to calculate the HRs for benign prostatic hyperplasia (BPH) diagnosis and the different treatments.HRs for SRD, RVO, and ION.In total, 1?938?262 men with an ED diagnosis were observed during the study period. Among them, 615?838 (31.8%) were treated with PDE5is. In total, 2?175?439 men with a BPH diagnosis were observed during the study period. Among them, 175?725 (8.1%) were treated with PDE5is. On adjusted Cox regression analysis, PDE5i use was not associated with SRD, RVO, ION, and any ocular event when compared with ED diagnosis and other ED treatments. Importantly, as the intensity of ED treatment increased, so did the risk of ocular events. In addition, PDE5i use was not associated with SRD and ION when compared with BPH diagnosis and other BPH treatments. In contrast, in patients with BPH, PDE5i use was associated with RVO (HR, 1.14; 95% CI, 1.06-1.23). Importantly, patients with BPH receiving other medical treatment (ie, 5a reductase/alpha blocker; HR, 1.11; 95% CI, 1.06-1.16) or surgical treatment (HR, 1.10; 95% CI, 1.02-1.19) had a higher risk of RVO.We did not observe any consistent association between PDE5i use and any ocular adverse events (SRD, RVO, and ION).Because we did not have access to the patients' medical records, we recorded outcome definitions using ICD-9 and ICD-10 coding.Patients using PDE5is for ED or BPH indications did not have an increased risk of ocular events, even when compared with other treatments for ED or BPH.

View details for DOI 10.1093/jsxmed/qdad137

View details for PubMedID 37861186