Key result
Haemodialysis did not clinically significantly affect the pharmacokinetics of evogliptin, with an AUC last geometric mean ratio of 0.9480 (90% CI 0.8162-1.1010) before versus after haemodialysis.
Why the study?
To investigate the possible effect of haemodialysis on the pharmacokinetic and pharmacodynamic characteristics of evogliptin, a DPP-4 inhibitor.
Does haemodialysis affect the pharmacokinetics and pharmacodynamics of evogliptin in patients with end-stage renal disease?
Does haemodialysis affect the pharmacokinetics and pharmacodynamics of evogliptin in patients with end-stage renal disease?
Effect estimate: GMR 0.9480 (95% CI 0.8162-1.1010)
Haemodialysis does not have a clinically significant effect on the pharmacokinetics and pharmacodynamics of evogliptin, indicating no dose adjustment is necessary based on HD status.
HD timing leaves evogliptin PK/PD unchanged in ESRD; supports no dose adjustment but leaves clinical outcomes open.
Aim To investigate the possible effect of haemodialysis (HD) on the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of evogliptin, a dipeptidyl peptidase‐4 (DPP‐4) inhibitor. Methods A single‐dose, open‐label, parallel‐group study of eight end‐stage renal disease (ESRD) patients and eight matched healthy subjects was conducted. ESRD patients received a single oral dose of evogliptin 5 mg after and before HD with a 2‐week washout between each dose, and healthy subjects received a single oral dose of evogliptin 5 mg. Serial blood, dialysate, and urine samples were collected to assess the PK and PD profiles of evogliptin. To compare PK parameters before and after HD, geometric mean ratios (GMRs) and 90% confidence intervals (CIs) were calculated. Results The GMRs for the maximum concentration and area under the concentration‐time curve from time 0 to the last measurable timepoint (AUC last ) of evogliptin when administered before HD compared with after HD were 0.7293 (90% CI 0.6171‐0.8620) and 0.9480 (90% CI 0.8162‐1.1010), respectively. The maximum DPP‐4 inhibitory effect, area under the DPP‐4 inhibitory effect‐time curve, and time duration of more than 80% DPP‐4 inhibition were comparable when evogliptin was administered before and after HD. Compared with healthy subjects, the mean AUC last of evogliptin was approximately 1.4‐fold greater in ESRD patients, but the difference is unlikely to affect the safety and efficacy of evogliptin. Conclusion The effect of HD on the PK and PD characteristics of evogliptin was not clinically significant; therefore, dose adjustment according to HD status is not necessary.
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Kim et al. (2023) studied end-stage renal disease (ESRD) (n=16). Evogliptin vs. After haemodialysis and healthy subjects was evaluated on Area under the concentration-time curve from time 0 to the last measurable timepoint (AUC last) before vs after haemodialysis (GMR 0.9480, 95% CI 0.8162-1.1010). Haemodialysis did not clinically significantly affect the pharmacokinetics of evogliptin, with an AUC last geometric mean ratio of 0.9480 (90% CI 0.8162-1.1010) before versus after haemodialysis.
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