A Real-World Data Derived Pharmacovigilance Assessment on Drug-Induced Nephropathy: Implication on Gaps in Patient Care

This retrospective cross-sectional study aims to investigate the prevalence and seriousness of drug-induced nephrotoxicity and to identify clinical predictors intensifying the seriousness of nephrotoxicity. Adverse drug events (ADEs) reported to the Korean Adverse Event Reporting System Database (KA...

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Bibliographic Details
Published in:Healthcare (Basel) 2023-12, Vol.12 (1), p.95
Main Authors: Kim, Yujin, Choi, Chang-Young, Sunwoo, Yongjun, Go, Chaerin, Kim, Semi, Eom, Sae Hyun, Shin, Sooyoung, Choi, Yeo Jin
Format: Article
Language:English
Subjects:
Age
Aged patients
Antibiotics
Care and treatment
Causality
Clinical medicine
Clinical significance
Comorbidity
Complications and side effects
Diagnosis
Drug interactions
Drug therapy
Immunosuppressive agents
Kidney diseases
Kidneys
Medical personnel
Nonsteroidal anti-inflammatory drugs
Patient safety
Patients
Pharmacovigilance
Polypharmacy
Product safety
Regression analysis
Risk factors
Terminology
Toxicity
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Summary:This retrospective cross-sectional study aims to investigate the prevalence and seriousness of drug-induced nephrotoxicity and to identify clinical predictors intensifying the seriousness of nephrotoxicity. Adverse drug events (ADEs) reported to the Korean Adverse Event Reporting System Database (KAERS DB) from January 2012 to December 2021 were investigated. The association between the seriousness and the etiologic drug was estimated in reporting odds ratio (ROR) based on disproportionality analysis. Logistic regression was utilized to recognize predictors associated with serious nephrotoxicity. The majority of ADEs were reported in ages 30 to 59, and immunosuppressants were the most etiologic medications. ADEs involving antibiotics, including vancomycin (ROR 0.268; 95% CI 0.129-0.557), were less likely to be serious. More than 93% of cyclosporine-related ADEs were serious nephrotoxicity, whereas tacrolimus was less likely to report serious nephrotoxicity (ROR 0.356; 95% CI 0.187-0.680). The risk of serious nephrotoxicity was decreased with aging (ROR 0.955; 95% CI 0.940-0.972) while increased in women (OR 2.700; 95% CI 1.450-5.008). Polypharmacy was associated with increased risk of interstitial nephritis (OR 1.019; 95% CI 1.001-1.038). However, further studies investigating the impact of clinical practice on ADE incidences as well as clinical prognosis related to nephrotoxicity are obligated.
ISSN:2227-9032
2227-9032
DOI:10.3390/healthcare12010095