A randomized controlled study of 6% gabapentin topical formulation for chronic kidney disease-associated pruritus

Background Novel agents with good safety profiles are needed in the management of chronic kidney disease-associated pruritus (CKD-AP). This study aims to assess the efficacy and safety of topical gabapentin in the treatment of CKD-AP. Methods The authors conducted a randomized, double-blind, vehicle-controlled study. The key inclusion criteria were: (i) patients on hemodialysis for at least 8 weeks, and (ii) a baseline visual analog scale (VAS) pruritus score >= 5. Patients were randomized into two groups. Topical 6% gabapentin was used in the experimental group while plain permeation cream was used for the control group. The primary endpoint was the mean change in pruritus scores using the VAS (MCPS-VAS) from baseline after 1 and 2 weeks of once daily application. Results Thirty patients (15 per group) were included in the analysis. Treatment with 6% topical gabapentin resulted in significantly decreased mean pruritus scores at 1 week (mean score 2.7; range 0-5; P < 0.001) and 2 weeks (mean score 1.3, range 0-5; P < 0.001) from baseline (mean score 5.9; range 5-8). The MCPS-VAS of the two groups were not significantly different (P = 0.8) after 1 week. However, the MCPS-VAS of the experimental group (mean change -4.6; range 0-7) was significantly greater (P = 0.01) compared to control (mean change -2.6; range -1 to 5) after 2 weeks. There were no drug-related adverse events reported. Conclusion Our results suggest that short-term use of topical gabapentin may significantly decrease CKD-AP severity after 2 weeks with no reported acute adverse events.