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Low-Dose Tadalafil and Cabergoline versus Cabergoline alone in Management of Erectile Dysfunction in Patients with End-Stage Renal Disease and Hyperprolactinemia Undergoing Hemodialysis

Ali Sobhi Ali Abd ElMaqsood, Elsayed M. Salih, Mohammed Abd Elrahim Elsalhy, Hazem Sayed Ahmed Ayoub

Al-Azhar International Medical Journal /Al-Azhar International Medical Journal, 2025

120 participants

Abstract

Background: Hyperprolactinemia in chronic kidney disease (CKD) is associated with high rates of hypogonadism and erectile dysfunction (ED). This study compares the efficacy, safety, and side effects of cabergoline monotherapy versus low-dose tadalafil combined with cabergoline in treating ED in end-stage renal disease (ESRD) patients undergoing hemodialysis with hyperprolactinemia. Patients and Methods: A total of 120 male ESRD patients on hemodialysis with ED and hyperprolactinemia were enrolled from November 2023 to December 2024 at Al-Azhar Hemodialysis Units, Cairo, Egypt. Patients were randomly assigned to two groups: Group 1 received 0.5 mg of cabergoline weekly, while Group 2 received 5 mg of tadalafil daily along with 0.5 mg of cabergoline. Efficacy was assessed using the International Index of Erectile Function-5 (IIEF-5) and hormonal assays for prolactin and testosterone after 6 weeks of treatment. Results: The combined Cabergoline/Tadalafil group showed a significant improvement in IIEF-5 scores (from 14.79 to 22.8, P<0.001), whereas the Cabergoline-only group showed no significant change. Prolactin levels decreased significantly in both groups (P<0.05), with no significant change in testosterone levels. Side effects were more common in the combined Cabergoline/Tadalafil group: 35% had back pain, 8.3% dizziness, and 48.3% headaches, compared to 11.6%, 1.7%, and 11.7%, respectively, in the Cabergoline-only group (P<0.05). Conclusion: Low-dose tadalafil combined…

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: 120 participants or records.

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