Citation

Kozono H, Yoshitani H, Nakano R. International Journal of Nephrology and Renovascular Disease 2018; 11: 9-24.

Copyright

(Copyright © 2018)

DOI

10.2147/IJNRD.S145720

PMID

unavailable

Abstract

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. © 2018 Kozono et al.

Language: en

Keywords

adolescent; Safety; adult; human; suicide; Japan; child; female; male; injury; multiple organ failure; aged; dementia; head injury; Hemodialysis; insomnia; abdominal pain; subdural hematoma; depression; anger; anxiety; hemodialysis; malnutrition; heart failure; major clinical study; vomiting; mental disease; anticonvulsive agent; anxiolytic agent; neuroleptic agent; prolactin; prolactin blood level; triacylglycerol; brain infarction; cognitive defect; hallucination; headache; somnolence; vertigo; middle aged; anxiety disorder; sleep disorder; constipation; orthostatic hypotension; heart infarction; Alzheimer disease; falling; thyrotropin; thyrotropin blood level; dehydration; drug safety; drug dependence; drug fatality; drug efficacy; diarrhea; nausea; tremor; hyperprolactinemia; Efficacy; restlessness; irritability; asthma; dysphagia; delirium; eosinophilia; erythema; acute heart infarction; congestive heart failure; bronchitis; respiratory tract disease; rash; lung edema; hypertension; neurologic disease; side effect; hypnotic agent; amnesia; diabetes mellitus; infection; metabolic disorder; asthenia; gynecomastia; heart arrhythmia; heart disease; hyperlipidemia; hyperuricemia; hypocalcemia; anemia; arthralgia; hyperthyroidism; pruritus; tinnitus; lung cancer; brain hemorrhage; peripheral neuropathy; hematologic disease; phosphorus; gastrointestinal disease; musculoskeletal disease; vascular disease; hypoglycemic coma; leukocyte count; aspiration pneumonia; postmarketing surveillance; thorax disease; visual analog scale; brain contusion; endocrine disease; liver dysfunction; coughing; Post-marketing surveillance; heart palpitation; thorax pain; abdominal distension; hemoptysis; lactate dehydrogenase; dyspepsia; malaise; pneumonia; iron deficiency anemia; intestine obstruction; lymph node metastasis; irritable colon; diplopia; dizziness; drug eruption; neck pain; polydipsia; eye disease; Graves disease; auditory hallucination; acute pancreatitis; memory disorder; peritonitis; liver disease; papule; dysarthria; thyroid crisis; dyskinesia; gamma glutamyltransferase; Article; consciousness disorder; bone density; hypertriglyceridemia; abdominal discomfort; gastritis; hemoglobin; contact dermatitis; gastroesophageal reflux; hyperkalemia; skin disease; hypesthesia; stomach cancer; Pruritus; gastroenteritis; upper respiratory tract infection; angina pectoris; gait disorder; visual hallucination; restless legs syndrome; stomatitis; hypercalcemia; connective tissue disease; ear disease; genital system disease; infestation; inner ear disease; mediastinum disease; metrorrhagia; nutritional disorder; uterus cancer; logorrhea; hyperphagia; appendicitis; decreased appetite; herpes zoster; interstitial lung disease; psoas abscess; T wave; listlessness; muscle spasm; free thyroxine index; cardiopulmonary insufficiency; colon cancer; skin abscess; hepatobiliary disease; hyperphosphatemia; acute heart failure; heart atrium flutter; hyperammonemia; enterocolitis; dysgeusia; compression fracture; eyelid edema; abnormal sensation; blepharitis; joint swelling; cataract; neuralgia; skin exfoliation; limb pain; faintness; sudden deafness; alkaline phosphatase; musculoskeletal pain; mycosis; allergic conjunctivitis; very elderly; eosinophil count; paralytic ileus; femur fracture; pleurisy; breast disease; occlusive cerebrovascular disease; positional dizziness; chronic bronchitis; hypertransaminasemia; erythroderma; esophagus varices bleeding; lip swelling; peripheral occlusive artery disease; free liothyronine index; ankle fracture; bacterial meningitis; diskitis; acute cholecystitis; melena; chronic gastritis; malignant neoplasm; platelet count; disease severity assessment; stress ulcer; esophagus carcinoma; vertebral canal stenosis; anal inflammation; benign neoplasm; disorders of lipid metabolism; gastric ulcer bleeding; hangnail; inguinal pain; intestine polyp; larynx pain; nalfurafine; Nalfurafine hydrochloride; nephrogenic anemia; parathyroid hormone; pemphigoid; periarthritis; secondary hyperparathyroidism; Shiratori severity score; shunt failure; shunt occlusion; thalamic hemorrhage; thalamus hemorrhage; thymol turbidity test; variant angina pectoris; zinc sulfate