Real-world use of difelikefalin in hemodialysis patients at a large dialysis organization in the United States: a retrospective database study.

IF 2.2 4区 医学 Q2 UROLOGY & NEPHROLOGY
Linda H Ficociello, Rachel Lasky, Hans-Juergen Arens, Despina Ruessmann, Michael S Anger
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引用次数: 0

Abstract

Background: Chronic kidney disease-associated pruritus (CKD-aP) can negatively impact quality of life and survival among patients receiving maintenance hemodialysis. Difelikefalin, a selective κ-opioid receptor agonist, is the first medication approved for treatment of moderate-to-severe CKD-aP among patients on chronic hemodialysis. This retrospective database study assessed the real-world safety and effectiveness of difelikefalin across a large US dialysis organization.

Methods: We analyzed de-identified data from 715 adult hemodialysis patients treated with difelikefalin who had a Worst Itching Intensity Numerical Rating Scale (WI-NRS) score (0 = no itching to 10 = worst itch imaginable) assessed before therapy. Patients were classified as having received at least 30 difelikefalin doses over 12 weeks (complete regimen group; CRG) or fewer doses over that time period (incomplete regimen group; IRG). Mean baseline and follow-up WI-NRS scores were compared and potential adverse events evaluated.

Results: Mean (SD) baseline WI-NRS scores were 8.5 (1.7), indicative of severe pruritic symptomatology. In the 22% of patients with follow-up data, mean WI-NRS scores improved by 2.9 points (8.4 [severe] to 5.4 [moderate]; P < 0.0001). This mean improvement was more pronounced in CRG patients (n = 84; 3.6) compared with IRG patients (n = 84; 2.2). Overall, 46% of patients experienced a 3-point reduction in itch severity. Difelikefalin initiation was not associated with changes in rates of nausea, diarrhea, vomiting, headache, or trouble walking. Dizziness and hyperkalemia were infrequent, but statistically significant with increases in dizziness (0.09% vs. 0.20%) and hyperkalemia (2.0% vs. 2.6%) were observed during treatment with difelikefalin.

Conclusions: In this analysis of real-world difelikefalin use in a US hemodialysis population, patients experienced significant reductions in CKD-aP, based on a validated measure of pruritus. Patients remaining on therapy for 12 weeks demonstrated greater symptom reductions than those patients receiving partial treatment. In combination with controlled trials, these data suggest that difelikefalin is an effective and well-tolerated treatment for the management of CKD-aP in adult patients receiving hemodialysis.

在美国的一个大型透析组织中,在血透患者中实际使用异花铁素:一项回顾性数据库研究。
背景:慢性肾脏疾病相关性瘙痒(CKD-aP)会对维持性血液透析患者的生活质量和生存产生负面影响。Difelikefalin是一种选择性κ-阿片受体激动剂,是首个被批准用于治疗慢性血液透析患者中重度CKD-aP的药物。这一回顾性数据库研究评估了异似泻灵在美国一家大型透析组织中的安全性和有效性。方法:我们分析了715名接受difelikefalin治疗的成人血液透析患者的去识别数据,这些患者在治疗前评估了最严重瘙痒强度数值评定量表(WI-NRS)评分(0 =无瘙痒至10 =可想象的最严重瘙痒)。患者被分类为在12周内接受了至少30次异花素剂量(完整方案组;CRG)或更少的剂量(不完全方案组;伊斯兰革命卫队)。比较基线和随访WI-NRS平均评分,并评估潜在不良事件。结果:平均(SD)基线WI-NRS评分为8.5(1.7),提示严重瘙痒症状。在22%的随访患者中,WI-NRS平均评分提高了2.9分(8.4分[重度]至5.4分[中度];结论:在对美国血液透析人群中实际使用异花镰刀素的分析中,基于有效的瘙痒测量,患者的CKD-aP显着降低。继续治疗12周的患者比接受部分治疗的患者表现出更大的症状减轻。结合对照试验,这些数据表明,difelikefalin是一种有效且耐受性良好的治疗接受血液透析的成人患者CKD-aP的方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BMC Nephrology
BMC Nephrology UROLOGY & NEPHROLOGY-
CiteScore
4.30
自引率
0.00%
发文量
375
审稿时长
3-8 weeks
期刊介绍: BMC Nephrology is an open access journal publishing original peer-reviewed research articles in all aspects of the prevention, diagnosis and management of kidney and associated disorders, as well as related molecular genetics, pathophysiology, and epidemiology.
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