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Pharmaceutics
Volume 17
Issue 9
10.3390/pharmaceutics17091128
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This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

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

by
Sadia Rehman
1,
Muhammad Farhan
2,
Muhammad Raza Sarfraz
3,
Asma Naveed
4,
Fahad Usman
5,
Anila Bibi
6,
Raheel Ahmed
7,*,
Hiya Huq
8,
Ali Hasan
7,
Jarin Anzoom
9 and
Pobitro Kumar
10
1
Department of Biochemistry, Bahria University of Health Sciences Campus Karachi, Karachi 74400, Pakistan
2
Department of Biochemistry, University of Karachi, Karachi 75270, Pakistan
3
Allied Hospital, Faisalabad Medical University, Faisalabad 38000, Pakistan
4
Department of Nephrology, PNS Shifa Hospital, Karachi 75530, Pakistan
5
Department of Community Medicine and Public Health, Sialkot Medical College, Sialkot 51310, Pakistan
6
Department of Biochemistry, Jinnah Sindh Medical University, Karachi 75510, Pakistan
7
Department of Medicine, National Heart and Lung Institute, Imperial College London, London SW7 2AZ, UK
8
Department of Psychology, Health and Professional Development, Oxford Brookes University, Oxford OX3 0BP, UK
9
School of Allied and Public Health, University of Chester, Chester CH1 4BJ, UK
10
Department of Medicine, Rangpur Medical College, Rangpur 5400, Bangladesh
*
Author to whom correspondence should be addressed.
Pharmaceutics 2025, 17(9), 1128; https://doi.org/10.3390/pharmaceutics17091128 (registering DOI)
Submission received: 22 June 2025 / Revised: 15 August 2025 / Accepted: 26 August 2025 / Published: 28 August 2025
(This article belongs to the Special Issue Optimizing Drug Therapy in Kidney Diseases: Effectiveness and Safety)
Versions Notes

Abstract

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.
Keywords: hemodialysis; renal replacement therapy; carnitine; acetylcarnitine; hyperlipidemias hemodialysis; renal replacement therapy; carnitine; acetylcarnitine; hyperlipidemias

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MDPI and ACS Style

Rehman, S.; Farhan, M.; Sarfraz, M.R.; Naveed, A.; Usman, F.; Bibi, A.; Ahmed, R.; Huq, H.; Hasan, A.; Anzoom, J.; et al. Randomized Clinical Trial for the Optimization of Dyslipidemia Management in Patients with End-Stage Renal Disease Undergoing In-Hospital Maintenance Hemodialysis Therapy. Pharmaceutics 2025, 17, 1128. https://doi.org/10.3390/pharmaceutics17091128

AMA Style

Rehman S, Farhan M, Sarfraz MR, Naveed A, Usman F, Bibi A, Ahmed R, Huq H, Hasan A, Anzoom J, et al. Randomized Clinical Trial for the Optimization of Dyslipidemia Management in Patients with End-Stage Renal Disease Undergoing In-Hospital Maintenance Hemodialysis Therapy. Pharmaceutics. 2025; 17(9):1128. https://doi.org/10.3390/pharmaceutics17091128

Chicago/Turabian Style

Rehman, Sadia, Muhammad Farhan, Muhammad Raza Sarfraz, Asma Naveed, Fahad Usman, Anila Bibi, Raheel Ahmed, Hiya Huq, Ali Hasan, Jarin Anzoom, and et al. 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, no. 9: 1128. https://doi.org/10.3390/pharmaceutics17091128

APA Style

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), 1128. https://doi.org/10.3390/pharmaceutics17091128

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