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

<b>Background/Objectives</b>: 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. <b>Methods</b>: 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. <b>Results</b>: Eighty-three patients completed the study (oral <i>n</i> = 49, IV <i>n</i> = 34). Both groups demonstrated significant improvements in all lipid parameters (<i>p</i> < 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, <i>p</i> = 0.03), whereas TC, TG, and HDL changes showed no significant differences (<i>p</i> > 0.05). <b>Conclusions</b>: 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.

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Journal
Pharmaceutics
Published
2025-08-28
DOI
https://doi.org/10.3390/pharmaceutics17091128
Primary Topic
Lipoproteins and Cardiovascular Health
Type
article
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article

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

Ali Hasan, Asma Naveed, Fahad Usman, Muhammad Farhan et al.
Pharmaceutics
Lipoproteins and Cardiovascular Health
article

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

Ali Hasan, Asma Naveed, Fahad Usman, Muhammad Farhan, Sadia Rehman, Muhammad Raza Sarfraz, Anila Bibi, P. Ravi Kumar, Raheel Ahmed, Hiya Huq, Jarin Anzoom
article en

Abstract

<b>Background/Objectives</b>: 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. <b>Methods</b>: 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. <b>Results</b>: Eighty-three patients completed the study (oral <i>n</i> = 49, IV <i>n</i> = 34). Both groups demonstrated significant improvements in all lipid parameters (<i>p</i> < 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, <i>p</i> = 0.03), whereas TC, TG, and HDL changes showed no significant differences (<i>p</i> > 0.05). <b>Conclusions</b>: 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.

PharmaceuticsVol. 17(9)
Oxford Brookes University (GB), University of Chester (GB), Begum Rokeya University (BD), University of Karachi (PK), Punjab Medical College (PK), Dar Al-Shifa Hospital (PS), Civil Hospital Karachi (PK), Dinajpur Medical College (BD), Allied Hospital (PK), Jinnah Sindh Medical University (PK), University of Management and Technology (PK), Lung Institute (US), Bahria University (PK)
Openalex Percentile: Top 63%
Lipoproteins and Cardiovascular Health
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