Identifying Crude Drugs in Kampo Medicines Associated with Drug-Induced Liver Injury Using the Japanese Adverse Drug Event Report Database: A Comprehensive Survey

Kimura, Kyosuke; Kikegawa, Mami; Kan, Yusuke; Uesawa, Yoshihiro

doi:10.3390/ph16050678

Cited by 4 publications

(2 citation statements)

References 61 publications

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“…The DEMO Disproportionality analysis. The association between the administration of antifungal triazoles and TdP/QTP was estimated using the reporting odds ratio (ROR) (19)(20)(21). Signal scores were calculated using a case/non-case method (22,23).…”

Section: Methodsmentioning

confidence: 99%

Association of Torsade de Pointes and QT Prolongation With Antifungal Triazoles: Analysis Using a Pharmacovigilance Database

OHYAMA,

AKIYAMA,

IIDA

et al. 2023

In Vivo

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Background/Aim: Torsade de pointes (TdP)/QT prolongation (QTP) is one of the most life-threatening adverse effects of antifungal triazoles. The aim of the present study was to evaluate the association of antifungal triazoles with TdP/QTP by age group and the profile of the time of TdP/QTP onset by analyzing the spontaneous adverse event database for Japan. Patients and Methods: Data registered in the Japanese Adverse Drug Event Report database (JADER) from April 2004 to March 2022 were analyzed. The association between the administration of antifungal triazoles and TdP/QTP according to age was evaluated using an adjusted reporting odds ratio (aROR). In addition, the time-to-onset of TdP/QTP after antifungal triazole treatment was analyzed using the Weibull distribution according to the route of administration. Results: Antifungal triazole treatment was associated with TdP/QTP (aROR=1.77, 95% confidence interval=1.52-2.07). In the subgroup analyses by age group, antifungal triazole treatments in patients ≤29 years old and ≥50 (except ≥90) years old were associated with TdP/QTP. The medians (quartiles) of time-to-onset for intravenous and oral antifungal triazole treatment were 8 (6-12) and 23 (8-86) days, respectively. In addition, the shape parameter in the Weibull distribution analysis of oral triazole treatment revealed that the hazard exhibited an early failure profile. Conclusion: TdP/QTP is associated with antifungal triazoles even in young patients, and patients should be monitored for the development of TdP/QTP, especially early after the initiation of treatment.

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Section: Methodsmentioning

confidence: 99%

Association of Torsade de Pointes and QT Prolongation With Antifungal Triazoles: Analysis Using a Pharmacovigilance Database

OHYAMA,

AKIYAMA,

IIDA

et al. 2023

In Vivo

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“…The association between PPIs and RM was evaluated using the reporting odds ratio (ROR) (16)(17)(18). Signal scores were determined through the case/non-case method (19,20).…”

Section: Disproportionality Analysismentioning

confidence: 99%

Time-to-onset Analysis of Rhabdomyolysis due to Different Proton Pump Inhibitors Using a Pharmacovigilance Database

OHYAMA,

IIDA,

AKIYAMA

et al. 2024

In Vivo

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Background/Aim: Recent research has increasingly demonstrated an association between proton pump inhibitors (PPIs) and serious adverse events. This study aimed to evaluate the association between PPI and rhabdomyolysis (RM), examining its time-to-onset profiles using the Japanese Adverse Drug Event Report (JADER) database. Patients and Methods: Data spanning from April 2004 to March 2022 were used. The association between PPIs and RM was evaluated using the reporting odds ratio (ROR), adjusted for sex and age. Subsequent analyses were conducted after excluding cases involving concomitant use of statins or fibrates. Furthermore, the onset time of RM and Weibull distribution parameters were calculated to evaluate the expression profile of RM, and the outcomes were examined. Results: RM was associated with the use of esomeprazole, omeprazole, and rabeprazole, even in the absence of concomitant statin or fibrate use. The median time to RM onset varied among PPIs, ranging from 6.5 to 127 d. The Weibull distribution parameters indicated that the hazard types of nearly all orally administered PPIs were classified as early failure or close to random failure. Regarding outcomes, cases of death were reported for all PPIs except vonoprazan. Conclusion: The findings suggest the need for vigilant monitoring of RM during PPI administration, particularly in the early stages, considering the varying onset times.Drug-induced myopathies can arise through various mechanisms, including direct myotoxicity associated with substances like corticosteroids, alcohol, cocaine, colchicine, statins, and antimalarials. Additionally, immunologically induced inflammatory myopathy can occur with statins, penicillamine, interferon-alfa/interferon-beta, TNF-alpha blockers, immune checkpoint inhibitors, and monoclonal antibodies. Another mechanism involves indirect skeletal muscle tissue injury resulting from multifactorial etiologies, such as drug-induced comas leading to ischemic muscle compression or drug-induced hypokalemia (1, 2). The clinical manifestations of drug-induced myopathies can vary widely, ranging from asymptomatic or mild myalgias with or without muscle weakness to chronic myopathy with severe weakness and in rare cases, it may progress to more severe conditions like rhabdomyolysis (RM) (1, 3). RM is characterized by muscle necrosis and the release of cell degradation products and intracellular elements into the bloodstream and extracellular space (3, 4). The incidence of acute kidney injury, the most significant consequence of RM, varies from 13% to over 50%, depending on the cause, clinical context, and histological findings at the time of diagnosis (4).Proton pump inhibitors (PPIs) are frequently prescribed medications for the management of gastric acid-related conditions, such as gastroesophageal reflux disease, Helicobacter pylori-induced gastric ulcers, duodenal ulcers, erosive esophagitis, and Zollinger-Ellison syndrome (5, 6). In addition to the common adverse events (AEs) listed in package inserts, recent studies have pro...

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Role of sodium taurocholate cotransporting polypeptide (NTCP) in HBV-induced hepatitis: Opportunities for developing novel therapeutics

Zhang,

Zhang

et al. 2024

Biochemical Pharmacology

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Identifying Crude Drugs in Kampo Medicines Associated with Drug-Induced Liver Injury Using the Japanese Adverse Drug Event Report Database: A Comprehensive Survey

Cited by 4 publications

References 61 publications

Association of Torsade de Pointes and QT Prolongation With Antifungal Triazoles: Analysis Using a Pharmacovigilance Database

Association of Torsade de Pointes and QT Prolongation With Antifungal Triazoles: Analysis Using a Pharmacovigilance Database

Time-to-onset Analysis of Rhabdomyolysis due to Different Proton Pump Inhibitors Using a Pharmacovigilance Database

Role of sodium taurocholate cotransporting polypeptide (NTCP) in HBV-induced hepatitis: Opportunities for developing novel therapeutics

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