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ORIGINAL RESEARCH article

Front. Pediatr.
Sec. Pediatric Nephrology
Volume 12 - 2024 | doi: 10.3389/fped.2024.1487441

The Safety of Cyclosporine and Tacrolimus in Pediatric Nephrotic Syndrome Patients: A Real-World Pharmacovigilance Study

Provisionally accepted
Yu Liu Yu Liu 1,2Chong Yan Chong Yan 1,2*Yaowang Zhao Zhao Yaowang Zhao Zhao 1,2Sui Deng Sui Deng 2,3*Jiancheng Zu Jiancheng Zu 1,2*
  • 1 Hunan Children's Hospital, Changsha, China
  • 2 Xiangya School of Medicine, Central South University, Changsha, Hunan Province, China
  • 3 The First People's Hospital of Changde City, Changde, Hunan Province, China

The final, formatted version of the article will be published soon.

    Objective This study aimed to systematically evaluate the safety of cyclosporine (CsA) and tacrolimus (TAC) in pediatric nephrotic syndrome (NS) patients using real-world data from the FDA Adverse Event Reporting System (FAERS). Methods We analyzed adverse event (AE) reports from the FAERS database between Q4 2003 and Q2 2024, focusing on AEs associated with CsA and TAC in NS patients aged 18 years and younger. We employed three signal detection methods—Proportional Reporting Ratio (PRR), Relative Reporting Ratio (RRR), and Reporting Odds Ratio (ROR)—to assess the risk of drug-related AEs. Sensitivity analyses were conducted to explore the influence of gender on AE occurrence. Results A total of 207 CsA-related and 145 TAC-related AE reports were included. CsA was significantly associated with nephropathy toxic (ROR=8.26, 95% CI: 4.21-16.20), urine output decreased (ROR=29.93, 95% CI: 3.66-244.61), and posterior reversible encephalopathy syndrome (ROR=6.70, 95% CI: 3.17-14.14). TAC was associated with an increased risk of dystonia (ROR=67.93, 95% CI: 8.63-534.86), kidney fibrosis (ROR=22.65, 95% CI: 8.16-62.87), and diabetic ketoacidosis (ROR=46.51, 95% CI: 5.68-380.97). Sensitivity analysis indicated that gender influenced the occurrence of AEs, with CsA showing higher nephrotoxicity in male patients, while TAC was more strongly associated with metabolic disorders and neurological AEs in female patients. Conclusion In pediatric NS patients, CsA primarily induces nephrotoxicity and neurological complications, whereas TAC is more likely to cause kidney fibrosis and metabolic disorders. Enhanced monitoring of these AEs and individualized drug adjustments based on patient characteristics are recommended to optimize treatment outcomes and reduce AE incidence.

    Keywords: Tacrolimus, Nephrotic Syndrome, Pediatrics, FAERS, Real-world data, Cyclosporine

    Received: 10 Sep 2024; Accepted: 11 Dec 2024.

    Copyright: © 2024 Liu, Yan, Zhao, Deng and Zu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Chong Yan, Hunan Children's Hospital, Changsha, China
    Sui Deng, Xiangya School of Medicine, Central South University, Changsha, 410008, Hunan Province, China
    Jiancheng Zu, Hunan Children's Hospital, Changsha, China

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