Abstract 195: The Effect Of Phosphodiesterase-5 Inhibitors On Major Adverse Cardiovascular Events And Mortality In A Large Cohort Of Men With Erectile Dysfunction From A Nationwide Insurance Database: A Retrospective Study

Abstract

Background: Phosphodiesterase type 5 inhibitor (PDE-5i) medications are effective in treating Erectile Dysfunction (ED) for tens of millions of men in the US and worldwide. The objective of this study was to determine the effect of PDE-5is on the incidence of major adverse cardiovascular events (MACE) (composite outcome of cardiovascular (CV) death, hospitalization for myocardial infarction, coronary revascularization, stroke, heart failure, or unstable angina pectoris) and all-cause death. Methods: A retrospective observational cohort study was conducted in a large US commercial and Medicare insurance claims database in men with ≥1 diagnosis of ED without prior MACE hospitalization within 1 year from Jan 2006 to Oct 2020. The exposed group had ≥1 claim for PDE-5i; the unexposed group had no claims for PDE-5i and were matched 2:1 on baseline risk variables. The primary outcome was MACE and secondary outcome was all-cause death, determined by multivariate Cox proportional hazard modeling. Death data were obtained via National Death Index linkage. Results: In this population, MACE was reduced by 13% in men exposed (n=23,816) to PDE-5is (hazard ratio (HR) 0.87; 95% Confidence Interval (CI) 0.79-0.95) vs. non-exposure (n=48,682) over mean follow up of 29 and 37 months, respectively. This was driven by reductions in coronary revascularization (HR 0.85; 0.73-0.98), heart failure (HR 0.83; 0.72-0.97), unstable angina (HR 0.78; 0.64-0.96), and CV death (HR 0.61; 0.41-0.90). PDE-5i-exposed men had a 25% reduction in all-cause death (HR 0.75; 0.65-0.87). Men without coronary artery disease but with CV risk factors at baseline showed a similar pattern. In the main study cohort, men in the highest quartile of PDE-5i exposure had the greatest reductions in MACE (HR 0.45; 0.37-0.54) and all-cause death (HR 0.51; 0.37-0.71) vs. the lowest exposure quartile. In a subgroup with baseline type 2 diabetes (n=6,305), PDE-5i exposure was associated with a lower MACE risk (HR 0.79; 0.64-0.97). All comparisons are significant at p<0.05. Conclusions: In a large population of US men with ED, PDE-5i exposure was associated with reductions in MACE, CV death, and overall death risk compared to non-exposure. Risk reduction was positively correlated with PDE-5i exposure level.