Ketotifen for Moderate-to-Severe Uremic Pruritus in Chronic Dialysis Patients: A Prospective Observational Study

Background: Uremic pruritus affects up to 90% of individuals and substantially impairs quality of life, in the group of patients undergoing chronic dialysis. Despite multiple therapeutic options, an optimal and well tolerated treatment remains elusive. Ketotifen, a mast cell stabilizer with antihistaminic properties prevent itch by inhibition of mast cell derived tryptase, which modulates protease-activated receptor-2 (PAR-2) in the cowhage itch pathway. Materials and Methods: In this prospective observational study, 230 chronic dialysis patients were screened, of whom 48 (20.9%) had clinically significant pruritus identified using a structured questionnaire. Twenty-four patients with moderate-to-severe symptoms who were prescribed ketotifen as part of routine clinical care consented to prospective follow-up. Ketotifen was initiated at 1 mg twice daily, with dose escalation to 2 mg twice daily in patients with persistent symptoms according to routine clinical practice. Pruritus severity was assessed using visual (VAS), verbal (VRS), and numerical (NRS) rating scales before and after treatment. Results: After two weeks of initial 1mg therapy, 19 showed significant clinical improvement. Mean scores reduced 77.5 [-&gt;] 27.1 (VAS), 87.5 [-&gt;] 20.8 (VRS), and 74.2 [-&gt;] 25 (NRS) (around 65% reduction with p < 0.001 across all scales). Clinical relief was achieved in 83.3% overall and mild tolerable drowsiness occurred only at the 2mg dose. Conclusion: Ketotifen is a safe, effective and well tolerated option for moderate to severe uremic pruritus in dialysis patients. Larger multicenter studies are warranted to confirm efficacy and optimize dosing.