| Title: |
Difelikefalin improves itch-related sleep disruption in patients undergoing haemodialysis. |
| Authors: |
Weiner, Daniel E, Schaufler, Thilo, McCafferty, Kieran, Kalantar-Zadeh, Kamyar, Germain, Michael, Ruessmann, Despina, Morin, Isabelle, Menzaghi, Frédérique, Wen, Warren, Ständer, Sonja |
| Source: |
Nephrology Dialysis Transplantation; Jul2024, Vol. 39 Issue 7, p1125-1137, 13p |
| Subject Terms: |
SLEEP interruptions, SLEEP quality, HEMODIALYSIS patients, RANK correlation (Statistics), QUALITY of life |
| Abstract: |
Background Poor sleep quality is associated with higher mortality and lower quality of life in patients with chronic kidney disease–associated pruritus (CKD-aP). Difelikefalin reduces itch in patients with CKD-aP undergoing haemodialysis (HD). This post hoc analysis of the Phase 3 difelikefalin studies (Study 3105 and the pooled dataset from KALM-1 and KALM-2) evaluated whether itch reduction in individuals with CKD-aP improved sleep quality. Methods Itch intensity was assessed in patients undergoing HD who had moderate-to-severe CKD-aP treated with intravenous difelikefalin (0.5 µg/kg, three times weekly) (N = 222, Study 3105; N = 426, KALM-1 and -2) or placebo (N = 425, KALM-1 and -2) for 12 weeks, using the Worst Itch Intensity Numerical Rating Scale (WI-NRS). Sleep quality was assessed using the sleep disability question of the 5-D Itch Scale (5-D SDQ) in all studies and, in Study 3105, with the Sleep Quality Numeric Rating Scale (SQ-NRS). Results Greater improvements in sleep quality were observed in patients with ≥3-point versus <3-point WI-NRS improvement using SQ-NRS in Study 3105 [mean (95% confidence interval) −5.2 (–5.6, −4.8) vs −1.5 (–2.0, −1.0)] and 5-D SDQ in KALM-1 and -2 [–1.8 (–2.1, −1.6) vs −0.8 (–1.1, −0.4)]. SQ-NRS and WI-NRS scores were highly correlated at both baseline and Week 12 in Study 3105 (Spearman correlation coefficient: 0.77 and 0.84, respectively). Correlations were also observed between 5-D SDQ and WI-NRS scores in Study 3105 and KALM-1 and -2. Conclusions In patients undergoing HD with moderate-to-severe CKD-aP, itch reduction with intravenous difelikefalin was associated with improved sleep quality. As disturbed sleep may contribute to mortality and morbidity in CKD-aP, difelikefalin may help to address a major clinical burden by improving sleep quality, secondary to itch relief. Trial Registration KALM-1 (NCT03422653), KALM-2 (NCT03636269), Study 3105 (NCT03998163). [ABSTRACT FROM AUTHOR] |
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| Database: |
Complementary Index |
