Clinical Study on the Combined Use of Tadalafil and Epalrestat in the Treatment of Diabetic Neurovascular Erectile Dysfunction
Abstract
This study aims to evaluate the clinical efficacy of tadalafil combined with epalrestat in the treatment of diabetic neurovascular erectile dysfunction (ED). Eighty patients diagnosed with diabetic neurovascular ED admitted to between January 2022 and October 2024 were randomly allocated into two groups (n = 40 each). The control group received tadalafil monotherapy, while the observation group was additionally treated with epalrestat. Both regimens lasted 12 weeks. Outcomes assessed pre- and post-treatment included International Index of Erectile Function-5 (IIEF-5), Erection Hardness Score (EHS), modified Sexual Life Quality Questionnaire (mSLQQ-QoL), penile hemodynamic parameters [peak systolic velocity (PSV), end-diastolic velocity (EDV), resistance index (RI)], and serum markers of endothelial function [endothelin-1 (ET-1), von Willebrand factor (vWF), and asymmetric dimethylarginine (ADMA)]. Treatment safety was also evaluated. Post-treatment, both groups showed significant improvements in IIEF-5 scores, proportion of EHS grade III-IV, and mSLQQ-QoL scores, with greater changes observed in the combination group (P 0.05). Tadalafil combined with epalrestat therapy for diabetic neurovascular ED can synergistically improve erectile function, erection hardness, sexual life quality, penile hemodynamics, and vascular endothelial function, with good safety and no increased risk of drug-related adverse events.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 40 participants or records.
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