Randomised crossover trial of naltrexone in uraemic pruritus

Peer, G; Kivity, Shmuel; Agami, O.; Fireman, Elizabeth; Silverberg, Donald S.; Blum, Miriam; Iaina, Adrian

doi:10.1016/s0140-6736(96)04176-1

Cited by 274 publications

(164 citation statements)

References 23 publications

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“…[89][90][91] In a randomized, controlled, crossover study of 15 HD patients, 1 week of naltrexone treatment significantly improved pruritus severity compared to placebo. 49 Two subsequent trials, however, failed to confirm this effect. In a randomized, double-blind, controlled, crossover study of 23 HD patients by Pauli-Magnus et al, naltrexone did not significantly improve pruritus intensity compared to placebo over a 4-week treatment period.…”

Section: Opioid Imbalance Treatmentmentioning

confidence: 98%

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Chronic kidney disease-associated pruritus: impact on quality of life and current management challenges

Shirazian¹,

Aina²,

Park³

et al. 2017

IJNRD

103

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Chronic kidney disease-associated pruritus (CKD-aP) is a distressing, often overlooked condition in patients with CKD and end-stage renal disease. It affects ~40% of patients with end-stage renal disease and has been associated with poor quality of life, poor sleep, depression, and mortality. Prevalence estimates vary based on the instruments used to diagnose CKD-aP, and standardized diagnostic instruments are sorely needed. Treatment studies have often yielded conflicting results. This is likely related to studies that are limited by small sample size, flawed designs, and nonstandardized diagnostic instruments. Several large well-designed treatment trials have recently been completed and may soon influence CKD-aP management.

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Section: Opioid Imbalance Treatmentmentioning

confidence: 98%

“…48 Similarly, it has been hypothesized that over-stimulation of endogenous opioid receptors causes CKD-aP. 49 Another similar hypothesis suggests that CKD-aP results from an imbalance of mu and kappa-opioid receptor activity with mu-receptor overactivation increasing itch and kappa receptor blockade also increasing itch. 50 …”

Section: Opioid Imbalance Hypothesismentioning

confidence: 99%

Chronic kidney disease-associated pruritus: impact on quality of life and current management challenges

Shirazian¹,

Aina²,

Park³

et al. 2017

IJNRD

103

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“…[14][15][16][17][18][19] Nalfurafine hydrochloride (Remitch capsules 2.5 μg; Toray Industries, Inc., Tokyo, Japan) is a selective κ-receptor agonist that was developed in 1992. In nonclinical studies, nalfurafine suppressed scratching behavior, 20,21 showed no drug dependence (unlike morphine, which agonizes the μ-receptor), [21][22][23][24] and, unlike the existing κ-receptor agonists, caused no aversion.…”

mentioning

confidence: 99%

Post-marketing surveillance study of the safety and efficacy of nalfurafine hydrochloride (Remitch<sup>® </sup>capsules 2.5 μg) in 3,762 hemodialysis patients with intractable pruritus

Kozono

Yoshitani

Nakano

2018

IJNRD

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Background Intractable pruritus in hemodialysis patients can significantly decrease their quality of life and is also associated with poor vital prognosis. Although combined multiple causes of intractable pruritus in these patients have been identified, no existing treatments are proven to be sufficiently effective. We conducted a post-marketing surveillance to follow-up and assess the safety and efficacy of nalfurafine, a selective κ-opioid receptor agonist, for the treatment of intractable pruritus in patients undergoing hemodialysis. Patients and methods Hemodialysis patients with intractable pruritus from institutions in Japan who received oral nalfurafine hydrochloride between January 2010 and December 2013 were enrolled in the surveillance. Surveillance was completed in July 2015. Safety data during 1 year after nalfurafine treatment onset, and efficacy data of nalfurafine evaluating the first 12-week treatment period and the following period until 1 year after the initial dose of nalfurafine (using global assessment of the itch improvement by the physician, Visual Analog Scale, and the Shiratori’s severity scores) were collected and analyzed. Results In total, 3,762 patients were analyzed for safety. Adverse drug reactions were experienced by 402/3,762 (10.69%) patients. The most frequent adverse drug reactions were insomnia (127/3,762 [3.38%] patients), constipation (34 [0.90%]), somnolence (32 [0.85%]), dizziness (23 [0.61%]), nausea (13 [0.35%]), and malaise (9 [0.24%]). No patients developed dependence on nalfurafine. Nalfurafine was effective in 82.50% (2,880/3,491) of patients during the first 12 weeks and in 84.95% (2,167/2,551) on treatment during the subsequent period until 1 year after nalfurafine treatment initiation. Statistically significant decreases were reported in the Visual Analog Scale and the Shiratori’s severity scores ( p <0.001). Conclusion Oral nalfurafine hydrochloride (from 2.5 μg/day to a maximum of 5.0 μg/day) continues to be safe and effective for the treatment of intractable pruritus in hemodialysis patients in real-world clinical settings.

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“…Opioid antagonists were reported to inhibit experimentally induced itching in healthy individuals 18) and pruritus and scratching in patients with dermatoses and systemic disorders. [19][20][21] In contrast, epidural and intrathecal opioids were known to induce pruritus at analgesic doses. 22) We found that opioid antagonists suppressed hind-paw scratching induced by pruritogens 17,23) and associated with allergy 24) and chronic dermatitis 25) in mice.…”

Section: Scratching Behaviors and Opioid Receptorsmentioning

confidence: 99%

Methods for Preclinical Assessment of Antipruritic Agents and Itch Mechanisms Independent of Mast-Cell Histamine

Kuraishi

2015

Biological & Pharmaceutical Bulletin

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Itch is a sensation that provokes a desire to scratch. Mast-cell histamine was thought to be a key itch mediator. However, histamine and mast-cell degranulation were reported not to elicit scratching in animals. It was difficult to investigate the pathophysiology of itching and to evaluate the antipruritic efficacy of chemical agents in the early 1990 s. We showed that hind-paw scratching and biting were elicited by stimulation with pruritogenic agents in mice. Those results demonstrated for the first time that cutaneous itching could be evaluated behaviorally in animals. We established various animal models of pathological itch of the skin (dry skin, mosquito allergy, surfactant-induced pruritus, and herpes zoster) and mucus membranes (pollen allergy). Mast-cell histamine did not play a key role in itching in any animal model examined except for the pollen allergy model. Histamine is not an exclusive itch mediator of mast cells; tryptase and leukotriene B 4 released from mast cells also act as itch mediators. Epidermal keratinocytes release several itch mediators, such as leukotriene B 4 , sphingosylphosphorylcholine, thromboxane A 2 , nociceptin, nitric oxide, and histamine, which may play important roles in pathological itching. Appropriate animal models of pathological itching are needed for pharmacological evaluation of the antipruritic efficacy of chemical agents.

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Randomised crossover trial of naltrexone in uraemic pruritus

Cited by 274 publications

References 23 publications

Chronic kidney disease-associated pruritus: impact on quality of life and current management challenges

Chronic kidney disease-associated pruritus: impact on quality of life and current management challenges

Post-marketing surveillance study of the safety and efficacy of nalfurafine hydrochloride (Remitch<sup>® </sup>capsules 2.5 μg) in 3,762 hemodialysis patients with intractable pruritus

Methods for Preclinical Assessment of Antipruritic Agents and Itch Mechanisms Independent of Mast-Cell Histamine

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Randomised crossover trial of naltrexone in uraemic pruritus

Cited by 274 publications

References 23 publications

Chronic kidney disease-associated pruritus: impact on quality of life and current management challenges

Chronic kidney disease-associated pruritus: impact on quality of life and current management challenges

Post-marketing surveillance study of the safety and efficacy of nalfurafine hydrochloride (Remitch<sup>&reg; </sup>capsules 2.5 &mu;g) in 3,762 hemodialysis patients with intractable pruritus

Methods for Preclinical Assessment of Antipruritic Agents and Itch Mechanisms Independent of Mast-Cell Histamine

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Product

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Post-marketing surveillance study of the safety and efficacy of nalfurafine hydrochloride (Remitch<sup>® </sup>capsules 2.5 μg) in 3,762 hemodialysis patients with intractable pruritus