Randomized Clinical Trial for the Optimization of Dyslipidemia Management in Patients with End-Stage Renal Disease Undergoing In-Hospital Maintenance Hemodialysis Therapy

Background/Objectives: End-stage renal disease (ESRD) patients on maintenance hemodialysis (MHD) frequently develop L-carnitine (LC) deficiency, leading to dyslipidemia and increased cardiovascular risk. While LC supplementation may improve dyslipidemia, the optimal route of administration remains unclear. This study evaluates the effects of LC on dyslipidemia in MHD patients and compares oral versus intravenous (IV) administration. Methods: In this dual-center randomized controlled trial (NCT05817799), 102 MHD patients aged 18–50 years were randomized to receive either oral (500 mg thrice daily) or IV LC (20 mg/kg post-dialysis thrice weekly for 23 weeks followed by 500 mg oral daily for 1 week) for 24 weeks, and blood samples were obtained to evaluate lipid profile parameters. Results: Eighty-three patients completed the study (oral n = 49, IV n = 34). Both groups demonstrated significant improvements in all lipid parameters (p < 0.0001). In the oral group, total cholesterol (TC) demonstrated a mean reduction of 15.04 ± 8.52, triglycerides (TG) decreased by 14.84 ± 13.20, and low-density lipoprotein cholesterol (LDL-C) declined by 9.87 ± 8.74, with a rise in high-density lipoprotein (HDL) of 5.34 ± 4.33. In contrast, the IV group showed greater improvement, with TC being reduced by 17.62 ± 8.98, TG reduced by 19.21 ± 11.33, and HDL-C elevated by 7.26 ± 4.35. Group comparison revealed significantly greater LDL reduction in the IV group (71.91 ± 14.37 mg/dL) versus oral group (79.04 ± 14.92 mg/dL, p = 0.03), whereas TC, TG, and HDL changes showed no significant differences (p > 0.05). Conclusions: Both oral and IV interventions effectively improved lipid profiles, and IV administration showed a more pronounced effect on LDL reduction, suggesting potentially greater efficacy of IV administration for LDL reduction.

Citation

Rehman, S., Farhan, M., Sarfraz, M. R., Naveed, A., Usman, F., Bibi, A., Ahmed, R., Huq, H., Hasan, A., Anzoom, J., & Kumar, P. (2025). Randomized Clinical Trial for the Optimization of Dyslipidemia Management in Patients with End-Stage Renal Disease Undergoing In-Hospital Maintenance Hemodialysis Therapy. Pharmaceutics. 17(9), 1-14. https://doi.org/10.3390/pharmaceutics17091128

Publisher

MDPI

Journal

Pharmaceutics

URI

http://hdl.handle.net/10034/629622

DOI

10.3390/pharmaceutics17091128

Type

Article

ISSN

1999-4923

Additional Links

https://www.mdpi.com/1999-4923/17/9/1128