Disproportionality Analysis of Safety Signals for a Wide Variety of Opioid-Related Adverse Events in Elderly Patients Using the Japanese Adverse Drug Event Report (JADER) Database

Omoto, Takashi; Asaka, Jun-ichi; Sakai, Takamasa; Satô, Fumihiko; Goto, Nobuyuki; Kudo, Kazuhiko

doi:10.1248/bpb.b20-00904

Cited by 8 publications

(3 citation statements)

References 34 publications

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“…22 A signal was considered detected if the lower limit of the 95%CI for the ROR was greater than 1. 23 ROR = (a / b) / (c / d) 95% CI = exp log (ROR)…”

Section: Discussionmentioning

confidence: 99%

“…The table contained 4 categories: (1) the number of patients who experienced the specific AE after taking a target drug, (2) the number of patients who experienced all other AEs after taking the target drug, (3) the number of patients who experienced the specific adverse event after taking nontarget drugs, and (4) the number of patients who experienced all other AEs after taking the nontarget drugs 22 . A signal was considered detected if the lower limit of the 95%CI for the ROR was greater than 1 23

$$\begin{equation*}{\mathrm{\ ROR\ }} = \left( {\mathrm{a}} \right.\ / \left.

…”

Section: Methodsmentioning

confidence: 99%

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Disproportionality Analysis on Hypothyroidism With Roxadustat Using the Japanese Adverse Drug Event Database

Kouki

Okada

Ozaki

et al. 2023

The Journal of Clinical Pharma

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Hypoxia‐inducible factor prolyl‐hydroxylase inhibitor (HIF‐PHI) is a novel agent for the treatment of renal anemia. HIF‐PHI increases endogenous erythropoietin production by inhibiting the degradation of an erythropoietin transcription factor. Although beneficial effects are expected from HIF‐PHI, its novel mechanism raises concerns regarding the risk of potential adverse events. The cases of hypothyroidism, which had not been reported in clinical trials, were reported after the administration of roxadustat in a real‐world setting. However, the effects of HIF‐PHIs on thyroid function have not yet been fully evaluated. This study aimed to assess the clinical impact of HIF‐PHIs on thyroid function using the Japanese Adverse Drug Event Report database, a spontaneous reporting system in Japan, because HIF‐PHIs were made available in Japan before they were available in other countries. Although a disproportionality signal for hypothyroidism was detected with roxadustat (reporting odds ratio [ROR]:22.1, 95% confidence interval [CI]:18.3‐26.7, no signals were detected with another HIF‐PHI, daprodustat (ROR:1.3, 95%CI:0.3‐5.4), and epoetin beta pegol (ROR:1.2, 95%CI:0.5‐2.7). Signals of hypothyroidism due to roxadustat were also detected regardless of age or sex. Approximately 50% of hypothyroidism cases were reported within 50 days of starting roxadustat use. These results indicate that roxadustat use may be related to the development of hypothyroidism. The need for monitoring of thyroid function should be alerted during roxadustat administration regardless of age or sex.

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“…22 A signal was considered detected if the lower limit of the 95%CI for the ROR was greater than 1. 23 ROR = (a / b) / (c / d) 95% CI = exp log (ROR)…”

Section: Discussionmentioning

confidence: 99%

$$\begin{equation*}{\mathrm{\ ROR\ }} = \left( {\mathrm{a}} \right.\ / \left.

…”

Section: Methodsmentioning

confidence: 99%

Disproportionality Analysis on Hypothyroidism With Roxadustat Using the Japanese Adverse Drug Event Database

Kouki

Okada

Ozaki

et al. 2023

The Journal of Clinical Pharma

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“…We analyzed 44 years of data from 1978 to 2021 for the drugs listed in the FAERS database (https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fdaadverse-event-reporting-system-faers-public-dashboard) and the Japanese Pharmacopoeia 18th Edition (https://www.pmda.go.jp/english/rs-sb-std/standards-development/jp/0029.html?print). For CDDPinduced ototoxicity, 12 preferred terms (PTs) related to hearing impairment were established according to the ICH International Medical Dictionary for Regulatory Activities/Japanese version 25.0 (Neurosensory hypoacusis, Deafness neurosensory, Mixed deafness, Hypoacusis, Sudden hearing loss, Conductive deafness, Deafness unilateral, Deafness bilateral, and Tinnitus), and Reporting Odds Ratios (RORs) were calculated based on a previous article [11].…”

Section: Methodsmentioning

confidence: 99%

Dexamethasone reduces cisplatin-induced ototoxicity by inducing cisplatin resistance through metallothionein-2

Ujiie,

Nishiya,

Yamamoto

et al. 2024

Preprint

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Purpose Ototoxicity is a common side effect caused by the anticancer drug cisplatin (CDDP), which reduces patient quality of life. One CDDP-resistance mechanism that occurs in recurrent cancers is heavy metal detoxification by metallothionein-2 (mt2). Here, we show that in zebrafish larvae, dexamethasone (DEX) reduces CDDP-induced ototoxicity. Methods Transgenic zebrafish (cldn: gfp; atoh1: rfp) that express green and red fluorescent protein neuromasts and hair cells were used. The zebrafish were pretreated with mt2 inducers at 52 h post-fertilization (hpf) for 8 h, followed by CDDP treatment for 12 h. The lateral line hair cells of CDDP-treated zebrafish at 72 hpf were observed by fluorescence microscopy. Results The Reporting Odds ratio (ROR) decreased after the American Society of Clinical Oncology (ASCO) first guideline recommended DEX as an antiemetic treatment for cancer chemotherapy in 1999. Pretreatment with DEX protected 72 hpf zebrafish hair cells from CDDP-induced toxicity. The expression of mt2 mRNA was significantly increased by the combination of 10 µM DEX with CDDP. mt2 gene editing reversed the protective effect of DEX against CDDP-induced damage in hair cells. Conclusion DEX prevents hair cells from CDDP-induced ototoxicity mediated by increased mt2 expression, which is a resistance mechanism for platinum-based anticancer drugs.

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Medikamentenkomplikationen – Dosisfindung und Interaktionen

Keller

Schulte-Kemna

2023

Geriatrische Nephrologie

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Disproportionality Analysis of Safety Signals for a Wide Variety of Opioid-Related Adverse Events in Elderly Patients Using the Japanese Adverse Drug Event Report (JADER) Database

Cited by 8 publications

References 34 publications

Disproportionality Analysis on Hypothyroidism With Roxadustat Using the Japanese Adverse Drug Event Database

Disproportionality Analysis on Hypothyroidism With Roxadustat Using the Japanese Adverse Drug Event Database

Dexamethasone reduces cisplatin-induced ototoxicity by inducing cisplatin resistance through metallothionein-2

Medikamentenkomplikationen – Dosisfindung und Interaktionen

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