Background: Uremic pruritus (UP) is a highly prevalent and disturbing problem in patients with advanced chronic kidney disease (CKD); however, treatment of UP is largely unsatisfactory. The present study was designed to investigate the effectiveness of mirtazapine, an atypical antidepressant agent with potent antagonistic activity against serotonin (5HT2, 5HT3) and histamine (H1) receptors, in the treatment of pruritus in hemodialysis (HD) patients.
Methods: An 8-week long, prospective, open-label, and cross-over randomized clinical trial study was conducted on 77 HD patients with chronic pruritus. After a 2-week washout period, eligible patients were randomly assigned either to the mirtazapine (15 mg per day) or gabapentin (100 per day) for 2 weeks. Following 2 weeks washout period, subjects crossed over to the other treatment arm for 2 more weeks. The severity of pruritus was measured seven times during each treatment period using the visual analogue scale (VAS). Furthermore, at the end of the study, patients also were blindly asked which treatment (first or last in the sequential course of the study) they preferred.
Results: Sixty-one patients completed two treatment periods of the study. Although, compared to baseline, both gabapentin and mirtazapine treatment resulting in significant improvement in VAS scores, decreasing in pruritus severity was significantly greater in the mirtazapine treatment period compared with the gabapentin treatment period (P < 0.001). Furthermore, although side effects such as drowsiness and dry mouth more reported in the mirtazapine treatment period, overall higher percentage of the study patients preferred mirtazapine over gabapentin for the treatment of their pruritus symptoms.
Conclusions: Although preliminary, our study provides evidence that mirtazapine can be an effective therapy for UP in patients who are on maintenance HD. However, further studies would be necessary to confirm effectiveness as well as the safety of mirtazapine in the long-term management of chronic pruritus.
Keywords: Chronic kidney disease; Gabapentin; Mirtazapine; Uremic pruritus.