Publications by authors named "F Menzaghi"
Article Synopsis
- Pruritus, a common issue for chronic kidney disease (CKD) patients on haemodialysis, can significantly decrease quality of life (QoL).
- A study analyzing data from three phase 3 trials demonstrated that the novel drug difelikefalin significantly reduces pruritus intensity, leading to improved QoL as measured by the Skindex-10 questionnaire.
- Greater reductions in pruritus intensity were linked to better scores in QoL domains related to disease, mood, and social functioning, emphasizing the importance of managing itch for overall well-being in CKD patients.
Background: Difelikefalin is a selective kappa opioid receptor agonist that is approved for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis (HD). In this study, we assessed the pharmacokinetics (PK) of intravenous (IV) difelikefalin in healthy subjects, in non-dialysis-dependent (NDD) subjects with varying stages of kidney disease, and in subjects with end-stage renal disease (ESRD) undergoing HD.
Methods: The PK and safety of single IV doses of difelikefalin (3.
Key Points: No correlation was observed between pruritus severity and serum phosphate or response to placebo or difelikefalin in patients with CKD-associated pruritus undergoing hemodialysis. Difelikefalin improved itch versus placebo irrespective of baseline serum phosphate.
Background: CKD-associated pruritus (CKD-aP) has historically been associated with elevated serum phosphate (sP).
Introduction: Black and African American (AA) people are over-represented in the kidney failure population; therefore, the safety and efficacy of difelikefalin in Black/AA patients was evaluated.
Methods: This was a post hoc, pooled exploratory subgroup analysis of the Phase 3 KALM-1 and -2 studies. Patients undergoing hemodialysis (HD) who had moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) at enrollment were stratified into self-reported Black/AA or White subgroups.
Rationale & Objective: Itching is a frequent symptom experienced by people with chronic kidney disease (CKD). We investigated the associations of CKD-associated pruritus (CKD-aP) with clinical outcomes.
Study Design: This was a longitudinal cohort study.