Effect of a novel kappa-receptor agonist, nalfurafine hydrochloride, on severe itch in 337 haemodialysis patients: a Phase III, randomized, double-blind, placebo-controlled study

Kumagai, Hiroo; Ebata, Toshiya; Takamori, Kenji; Muramatsu, Taro; Nakamoto, Hidetomo; Suzuki, Hiromichi

doi:10.1093/ndt/gfp588

Cited by 300 publications

(239 citation statements)

References 24 publications

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“…It may have a direct effect on the brain and/or provide positive feedback from the skin at the level of the spinal cord. Its effect on itching in randomized trials was less than gabapentin, and its most common side effect is insomnia (14). There remains a need for a more robust evidence base for these and other agents, such as turmeric, montelukast, zinc sulfate, and nalbuphine (15)(16)(17)36).…”

Section: Discussionmentioning

confidence: 99%

“…Nalfurafine, a k-opioid receptor agonist, reduced the severity of itch by 0.95 cm more than placebo on a 10-cm visual analog scale score in one randomized, controlled trial (13) and by 0.9 and 1.0 cm more than placebo in a second using two doses (14). Single randomized, controlled trials of turmeric, montelukast, and zinc sulfate have shown a significant reduction in itch compared with placebo and warrant further study (15)(16)(17).…”

Section: Introductionmentioning

confidence: 98%

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International Comparisons of Prevalence, Awareness, and Treatment of Pruritus in People on Hemodialysis

Rayner¹,

Larkina²,

Mia³

et al. 2017

CJASN

175

238

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Background and objectives Uremic pruritus in patients on hemodialysis is associated with depression, lower quality of life, and mortality. We studied the prevalence, awareness, and treatment of pruritus to assess how well this important condition is currently managed internationally.Design, setting, participants, & measurements Data from 35,452 patients on hemodialysis in up to 17 countries from the Dialysis Outcomes and Practice Patterns Study were analyzed to describe pruritus prevalence from 1996 to 2015. Data from 6256 patients and 268 medical directors in 17 countries in 2012-2015 were analyzed to describe predictors, effects, medical directors' awareness, and treatment of pruritus.Results Patients very much or extremely bothered by itching declined from 28% in 1996 to 18% in 2015. In 2012-2015, among patients nearly always or always bothered by itching, pruritus had a major effect on work and social life; 18% used no treatment for pruritus, and 17% did not report itching to health care staff. In total, 69% of medical directors underestimated the prevalence of pruritus in their unit. Managing high serum phosphorus and low Kt/V was ranked as the most important intervention, but no relationship was found between these factors and pruritus; 57% of medical directors used oral antihistamines for first-line chronic treatment of pruritus. Gabapentin was used by 45% as first-, second-, or third-line treatment. Nalfurafine was only used in Japan.Conclusions The prevalence of pruritus in people on hemodialysis is decreasing but remains underestimated. Large numbers of patients on hemodialysis with severe pruritus do not receive treatment. There is wide variation in the use of unlicensed medications for the treatment of pruritus. These data provide a benchmark for initiatives to improve the management of uremic pruritus.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 98%

International Comparisons of Prevalence, Awareness, and Treatment of Pruritus in People on Hemodialysis

Rayner¹,

Larkina²,

Mia³

et al. 2017

CJASN

175

238

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“…Currently, the mechanism underlying morphine-related pruritus remains uncertain, but morphine-induced pruritus is considered mediated by the l-opioid receptors 31 and the j-opioid receptors. 32,33 Accordingly, administration of butorphanol (a partial l-opioid receptor antagonist and j-opioid receptor agonist) with morphine (l-and j-receptor agonist) would be expected to maintain analgesia (l-and j-receptors) while reducing pruritus. 21 Butorphanol has been used to treat intractable pruritus based on its potential anti-pruritus effect, 5 but debate on the efficacy of prophylactic butorphanol on morphine-induced pruritus still exists.…”

Section: Discussionmentioning

confidence: 99%

Butorphanol prevents morphine-induced pruritus without increasing pain and other side effects: a systematic review of randomized controlled trials

Song

Wang

et al. 2013

Can J Anesth/J Can Anesth

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Purpose Pruritus is a frequent adverse event after administration of morphine. Butorphanol has been used to prevent morphine-induced pruritus, but its efficacy is still controversial. The aim of this systematic review was to evaluate the efficacy of using butorphanol to prevent morphine-induced pruritus. Source We searched PubMed, Cochrane Library, EMBASE, and China's BioMedical Disc for full reports of randomized controlled trials that compared the use of butorphanol with either placebo or no treatment for preventing morphineinduced pruritus. The number of patients experiencing pruritus or other side effects was analyzed using relative risk (RR) with 95% confidence intervals (CI). Principal findings Sixteen trials (795 patients) were analyzed. Continuous intravenous and epidural butorphanol reduced pruritus with RR 0.22 (95% CI 0.10 to 0.45) and RR 0.24 (95% CI 0.16 to 0.36), respectively. Use of epidural butorphanol decreased the number of patients requesting rescue treatment for pruritus (RR 0.57; 95% CI 0.41 to 0.81). Butorphanol decreased postoperative pain intensity at four, eight, and 12 hr with standardized mean differences of -0.29 (95% CI -0.52 to -0.05), -0.30 (95% CI -0.56 to -0.04), and -0.23 (95% CI -0.46 to -0.01), respectively. Epidural but not intravenous butorphanol reduced postoperative nausea and vomiting (PONV) (RR 0.35; 95% CI 0.19 to 0.66). Butorphanol did not increase respiratory depression (RR 0.71; 95% CI 0.31 to 1.63), somnolence (RR 0.71; 95% CI 0.22 to 2.37), or dizziness (RR 2.45; 95% CI 0.35 to 17.14). Conclusion Butorphanol administered with morphine may be an effective strategy for preventing morphineinduced pruritus as it decreases pain intensity and PONV without increasing other side effects. Thus, it can be recommended for preventing morphine-induced pruritus during the perioperative period. RésuméObjectif Le prurit est un effet secondaire néfaste fréquent après l'administration de morphine. Le butorphanol a été utilisé pour prévenir le prurit induit par la morphine, mais son efficacité est encore controversée. L'objectif de cette revue méthodique était d'évaluer l'efficacité du butorphanol pour prévenir le prurit induit par la morphine.

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“…Wikström et al (2005) and Kumagai et al (2010) reported the results of randomized, doubleblind, placebo-controlled clinical studies in which TRK-820 was administered to patients undergoing hemodialysis intravenously or orally (Fig. 5).…”

Section: Clinical Studiesmentioning

confidence: 99%

Opioid Kappa Receptor Selective Agonist TRK-820 (Nalfurafine Hydrochloride)

Fujii¹,

Hirayama²,

Nagase³

2012

Pharmacology

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Effect of a novel kappa-receptor agonist, nalfurafine hydrochloride, on severe itch in 337 haemodialysis patients: a Phase III, randomized, double-blind, placebo-controlled study

Cited by 300 publications

References 24 publications

International Comparisons of Prevalence, Awareness, and Treatment of Pruritus in People on Hemodialysis

International Comparisons of Prevalence, Awareness, and Treatment of Pruritus in People on Hemodialysis

Butorphanol prevents morphine-induced pruritus without increasing pain and other side effects: a systematic review of randomized controlled trials

Opioid Kappa Receptor Selective Agonist TRK-820 (Nalfurafine Hydrochloride)

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