Regular use of phosphodiesterase type 5 inhibitors (PDE-5 inhibitors) may increase risk for serous retinal detachment (SRD), retinal vascular occlusion (RVO), and ischemic optic neuropathy (ION), according to a study published in JAMA Ophthalmology

Researchers conducted a cohort study with a nested case-control analysis using data obtained from the PharMetrics Plus database (IQVIA) between January 1, 2006, and December 31, 2020. Members of the cohort were followed up until the first diagnosis of SRD, RVO, or ION or termination of insurance coverage. For each patient, 4 controls were matched based on age and time of study entry using density-based sampling. The research team compared risk for regular users of PDE-5 inhibitors with that for nonusers, adjusting for potential confounding variables. They excluded cases with diagnoses of SRD, RVO, and ION in the year prior to the cohort. 

First diagnosis of SRD, RVO, or ION were identified via ICD-9 and ICD-10 codes. The team calculated adjusted incidence rate ratios (IRRs) with 95% confidence intervals (CIs) using conditional logistic regression, while controlling for hypertension, coronary artery disease, smoking, and diabetes (for all 3 outcomes) as well as sleep apnea for the ION outcome.


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The cohort consisted of 213,033 men receiving PDE-5 inhibitors, including 123,347 sildenafil users, 78,609 tadalafil users, 6604 vardenafil users, and 4473 avanafil users. The case-control analysis comprised a total of 1146 cases of SRD (278), RVO (628), and ION (240) and 4584 corresponding controls, and their mean ages were 64.6±13.3 years. 

Compared with the control group, patients with SRD, RVO, and ION were more likely to have hypertension, diabetes, coronary artery disease, and sleep apnea

Researchers found that the adjusted IRR for the composite end points of any of the 3 outcomes were 1.85 (95% CI, 1.41-2.42; incidence, 15.5 cases per 10,000 person-years). They also found that the adjusted IRR for SRD, RVO, and ION as individual outcomes were 2.58 (95% CI, 1.55-4.30; incidence, 3.8 cases per 10,000 person-years), 1.44 (95% CI, 0.98-2.12; incidence, 8.5 cases per 10,000 person-years), and 2.02 (95% CI, 1.14-3.58; incidence, 3.2 cases per 10,000 person-years), respectively.  

“The results of this cohort study confirm the findings from other studies regarding the risk of ION associated with PDE-5 inhibitors use but also quantifies the risk of SRD and RVO associated with use of these drugs, which has not been previously assessed,” report the researchers. “The findings suggest individuals who regularly use PDE-5 inhibitors need to be cognizant of ocular adverse events associated with these drugs and alert their physicians if they experience any visual deficits.”

Study limitations include the inability to verify actual drug intake, lack of access to patients’ medical records, and the risk for the study outcomes associated with each individual PDE-5 inhibitor separately could not be evaluated.  

Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures. 

Reference

Etminan M, Sodhi M, Mikelberg FS, Maberley D. Risk of ocular adverse events associated with use of phosphodiesterase 5 inhibitors in men in the US. JAMA Ophthalmol. Published online April 7, 2022. doi:10.1001/jamaophthalmol.2022.0663