Dataset Information

The effectiveness of sertraline in alleviating uremic pruritus in hemodialysis patients: a randomized clinical trial.

ABSTRACT:

Introduction

Uremic pruritus (UP) is a common and distressing symptom in end stage renal disease (ESRD) patients. Many approaches have been tested to improve UP without a clear success. We aimed to assess the effect of sertraline on UP in hemodialysis (HD) patients.

Methods

This research is a double-blinded, placebo-controlled, multicentric randomized clinical trial which included sixty patients maintained on regular HD. Patients were allocated to receive sertraline 50 mg twice daily or placebo for 8 weeks. The Visual analogue scale (VAS) and the 5-D itch scale were used to assess pruritus before and after the course of treatment.

Results

At study end in sertraline group, there was a significant decrease from baseline findings in the VAS score (p < 0.001), and the 5-D itch scale (p < 0.001). On the other hand, in placebo group the VAS score showed a slight non-significant decrease (p = 0.469), and the 5-D scale (p = 0.584) increased from baseline measurements. The percentage of patients with severe and very severe pruritus decreased significantly in the sertraline group in both scores [(VAS score: p = 0.004), (5-D itch score: p = 0.002)] with no significant change in the placebo group [(VAS score: p = 0.739), (5-D itch scale: p = 0.763)]. There was a significant positive relation between the VAS and 5-D itch scores and serum urea with p value of 0.002 and 0.001 respectively, and serum ferritin with p value of < 0.001 with both.

Conclusions

Patients treated with sertraline had a significant improvement in pruritus as compared with those who received placebo suggesting a potential role for sertraline to treat uremic pruritus in HD patients. Larger randomized clinical trials are needed to confirm these findings.

Trial registration

ClinicalTrials.gov NCT05341843. First registration date: 22/04/2022.

SUBMITTER: Elsayed MM

PROVIDER: S-EPMC10239082 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Publications

The effectiveness of sertraline in alleviating uremic pruritus in hemodialysis patients: a randomized clinical trial.

Elsayed Mohamed Mamdouh MM Elgohary Iman Ezzat IE Abdelhamid Heidi Hesham Said HHS Zaki Sherif Aziz SA

BMC nephrology 20230603 1

<h4>Introduction</h4>Uremic pruritus (UP) is a common and distressing symptom in end stage renal disease (ESRD) patients. Many approaches have been tested to improve UP without a clear success. We aimed to assess the effect of sertraline on UP in hemodialysis (HD) patients.<h4>Methods</h4>This research is a double-blinded, placebo-controlled, multicentric randomized clinical trial which included sixty patients maintained on regular HD. Patients were allocated to receive sertraline 50 mg twice da ...[more]

PMID: 37270517

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Project description:ImportancePatients with pruritus receiving hemodialysis frequently experience oppressive physical and psychiatric symptoms that directly affect their quality of life and increase mortality. However, treatment options are limited.ObjectiveTo determine the clinically recommended dose of difelikefalin, a κ-opioid receptor agonist, based on the efficacy, dose response, safety, and pharmacokinetics.Design, setting, and participantsThis randomized, double-blind, placebo-controlled, 4-arm phase 2 trial was conducted from February 1, 2019, to October 22, 2019, at 94 sites in Japan. Patients with moderate to severe pruritus receiving hemodialysis were enrolled.InterventionsDifelikefalin (0.25, 0.5, and 1.0 μg/kg) and placebo were intravenously administered 3 times a week at the end of each hemodialysis session for 8 weeks.Main outcome and measuresThe primary end point was the change from baseline in the weekly mean Worst Itching Intensity Numerical Rating Scale (NRS) score at week 8. Secondary outcomes measured changes in itch-related quality-of-life score using the Skindex-16 and 5-D itch scale. Safety was assessed according to adverse events, laboratory tests, vital signs, body weight, and 12-lead electrocardiogram.ResultsA total of 247 Japanese patients (186 male [75%]; mean [SD] age, 64.5 [11.7] years) were randomized to placebo (n = 63), 0.25 μg/kg of difelikefalin (n = 61), 0.5 μg/kg of difelikefalin (n = 61), or 1.0 μg/kg of difelikefalin (n = 62). The changes from baseline in the adjusted mean (SE) of the 24-hour Worst Itching Intensity NRS score at week 8 were -2.86 (0.29) in the placebo group, -2.97 (0.29) in the 0.25 μg/kg of difelikefalin group, -3.65 (0.30) in the 0.5 μg/kg of difelikefalin group, and -3.64 (0.30) in the 1.0 μg/kg of difelikefalin group. Significant differences were found in the 0.5 μg/kg of difelikefalin group (adjusted mean difference, -0.80; 95% CI, -1.55 to -0.04; P = .04) and the 1.0 μg/kg of difelikefalin group (adjusted mean difference, -0.78; 95% CI, -1.54 to -0.03; P = .04) compared with placebo. The Skindex-16 overall score and 5-D itch scale total score indicated an improvement with treatment with 0.5 and 1.0 μg/kg of difelikefalin (adjusted weekly mean [SE] Skindex-16 overall score at week 8, -27.79 [2.05]; 95% CI, -31.83 to -23.74 for 0.5 μg/kg of difelikefalin and -22.69 [2.04]; 95% CI, -26.71 to -18.68 for 1.0 μg/kg of difelikefalin; adjusted weekly mean [SE] 5-D itch scale total score at week 8, -6.5 [0.4]; 95% CI, -7.2 to -5.8 for 0.5 μg/kg of difelikefalin and -6.8 [0.3]; 95% CI, -7.5 to -6.2 for 1.0 μg/kg of difelikefalin). The incidence of adverse events was 67% (42 of 63 patients) in the placebo group, 72% (44 of 61 patients) in the 0.25 μg/kg of difelikefalin group, 77% (47 of 61 patients) in the 0.5 μg/kg of difelikefalin group, and 85% (53 of 62 patients) in the 1.0 μg/kg of difelikefalin group. No dependency was reported.Conclusions and relevanceThe findings of this phase 2 randomized clinical trial of difelikefalin suggest that 0.5 μg/kg of difelikefalin should be the clinically recommended dose as a new option for treating moderate to severe pruritus in patients undergoing hemodialysis because of its efficacy, acceptable tolerability, and manageable safety profile.Trial registrationClinicalTrials.gov Identifier: NCT03802617.

Dataset Information

The effectiveness of sertraline in alleviating uremic pruritus in hemodialysis patients: a randomized clinical trial.

Introduction

Methods

Results

Conclusions

Trial registration

Publications

The effectiveness of sertraline in alleviating uremic pruritus in hemodialysis patients: a randomized clinical trial.

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