Delirium risk of histamine-2 receptor antagonists and proton pump inhibitors: A study based on the adverse drug event reporting database in Japan

Kikkawa, Nao; Sogawa, Rintaro; Monji, Akira; Sumi, Shintaro; Murakawa-Hirachi, Toru; Kubo, Toshiki; Eguchi, Yuko; Miyamoto, Yuki; Kamo, Masahiro; Tobita, Shuko; Yukawa, Misako; Uchida, Rina; Egoshi, Masayoshi; Shimanoe, Chisato

doi:10.1016/j.genhosppsych.2021.07.010

Cited by 11 publications

(6 citation statements)

References 25 publications

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“…A positive family history of affective disorders and/or the frequent comorbidity of bipolar disorder in PMS 3 could also represent independent risk factors. If replicated, this observation may support adopting H 2 -receptor antagonists as first-line treatment for gastritis and/or esophagitis in PMS, although this drug class should also be monitored for neuropsychiatric and cognitive adverse effects 19,20 …”

Section: Discussionmentioning

confidence: 92%

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Depression and Catatonia Associated With Lansoprazole in an Adolescent With Phelan-McDermid Syndrome

Persico

Ricciardello

Alessandrini

et al. 2022

J Clin Psychopharmacol

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Section: Discussionmentioning

confidence: 92%

“…If replicated, this observation may support adopting H 2 -receptor antagonists as first-line treatment for gastritis and/or esophagitis in PMS, although this drug class should also be monitored for neuropsychiatric and cognitive adverse effects. 19,20 Transfer of Ethyl Loflazepate Into Cord Blood, Breast Milk, and Infant's Serum…”

Section: Discussionmentioning

confidence: 99%

Depression and Catatonia Associated With Lansoprazole in an Adolescent With Phelan-McDermid Syndrome

Persico

Ricciardello

Alessandrini

et al. 2022

J Clin Psychopharmacol

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“…The Pharmaceutical and Medical Device Agency (PMDA) in Japan has been managing adverse event reports of drugs from medical users, and these adverse event reports are utilized by various studies as the JADER database (16). The details of the JADER database have been described elsewhere (17). As shown in Figure 1, the extracted data were 654,795 reports and 544,864 reports were analysed in the current study.…”

Section: Methodsmentioning

confidence: 99%

Antihypertensive Drug Combinations Modify Cisplatin-induced Acute Kidney Injury

Takeuchi¹,

Sogawa²,

Tsuruhashi³

et al. 2022

In Vivo

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Background/Aim: There is limited evidence about the nephrotoxicity of calcium channel blockers (CCBs) and renin-angiotensin system (RAS) inhibitors with concomitant cisplatin (CDDP). We investigated whether combinations of antihypertensive drugs are associated with CDDP-related acute kidney injury (AKI) using the Japanese Adverse Drug Event Report database. Patients and Methods: We analysed 544,864 reports in the database from 2004 to 2020. A reporting odds ratio (ROR) and confidence interval (CI) with adjustment for potential confounding factors was calculated for AKI for each drug and the combined use of the drugs and CDDP. Results: CDDP, CCBs, and RAS inhibitors were all detected signals for AKI. The ROR in cases with concomitant use of CCBs, RAS inhibitors, and CDDP (adjusted ROR 7.28;) was higher than that in cases with use of each drug. Conclusion: AKI may require more attention when patients receiving CDDP take CCBs and RAS inhibitors together.Cisplatin (CDDP) is a platinum-based anticancer drug with many indications, and is positioned as a key drug for a wide range of cancer types including head and neck (1), lung (2, 3), oesophageal (4), and gastric (5) cancers. However, CDDPbased therapies can cause severe and life-threatening adverse events, typically mucosal injury in the gastrointestinal tract and myelosuppression. Acute kidney injury (AKI) is another adverse event of CDDP administration, with a reported incidence of 30-40% (6). Because CDDP-induced AKI is dosedependent, large fluid volumes, diuretics, and magnesium are often administered to prevent its development. Despite these measures, it is difficult to completely prevent AKI in patients receiving CDDP, and it often becomes a problem with advancing treatment. Identified risk factors for CDDP-induced AKI include older age, total CDDP dose, hypoalbuminaemia, hypokalaemia, diabetes, and cardiovascular disease (7-9). Hypertension (HT) was also identified as a risk factor for CDDP-induced AKI (10, 11), but studies have evaluated the presence or absence of a diagnosis of HT and did not clarify whether there were differences in AKI development depending on the antihypertensive drugs taken.Antihypertensive drugs are classified into several types, including calcium channel blockers (CCBs), renin-angiotensin system (RAS) inhibitors, and beta blockers. The prescription ratios of CCBs and RAS inhibitors were reported to be high among antihypertensive drugs in Japan (12). In animal studies, combined use of CCBs and CDDP was shown to increase the risk of nephrotoxicity development in rats (13,14). Use of RAS inhibitors was further identified as an independent risk factor for CDDP-induced AKI in elderly patients (15). However, the relationship between these combinations and the expression of AKI have not been clarified.Adverse event reports compiled during the post-marketing stages of drugs are provided by the Japanese regulatory authorities in a database and act as valuable tools for postmarketing surveillance to reflect the realities of clinical practice. T...

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“…Our analyses were performed according to previously described methods [13]. The extracted reports were divided into the following groups according to the reported odds ratio (ROR) and 95% con dence interval For multivariate logistic regression analysis, the calculated RORs (crude RORs) for antiepileptic drugs were adjusted for age, sex, reporting year, use of BZAs and opioids, dementia, and each antiepileptic drug as the explanatory variables.…”

Section: Statistical Analysesmentioning

confidence: 99%

Risk of delirium with antiepileptic drug use: a study based on the Japanese Adverse Drug Event Report database

et al. 2023

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BackgroundAntiepileptic drugs may cause delirium, and the risk may vary with each drug. However, related studies have provided inconsistent results. AimTo investigate whether antiepileptic drugs cause delirium by analysing adverse drug event reports compiled in the post-marketing stages of drugs and recorded in a database established by Japanese regulatory authorities. MethodA total of 573,316 reports registered between 2004 and 2020 were used to create a dataset. The search terms for delirium as the item of interest were selected from the Standardized Medical Dictionary for Regulatory Activities Queries. Reporting odds ratios and 95% con dence intervals of adverse events associated with use of antiepileptic drugs were calculated after adjusting for potential confounders. ResultsThere were 27,194 reports of antiepileptic drug-related adverse events. Of these, 189 reports were associated with antiepileptic drugs and delirium (crude reporting odds ratio, 1.66; 95% con dence interval, 1.43-1.92). The use of lacosamide (adjusted reporting odds ratio, 2.51; 95% con dence interval, 1.28-4.94), lamotrigine (adjusted reporting odds ratio, 1.71; 95% con dence interval, 1.16-2.52), levetiracetam (adjusted reporting odds ratio, 1.82; 95% con dence interval, 1.28-2.59), and valproic acid (adjusted reporting odds ratio, 1.53; 95% con dence interval, 1.19-1.97) was related to a signi cantly higher reporting odds ratio for delirium, even after adjustment for possible confounding factors. However, no signals for delirium were detected with any of these drugs under benzodiazepine receptor agonist usage. ConclusionThe study ndings suggest that antiepileptic drugs may cause delirium. Impact StatementsUse of antiepileptic drugs may be associated with delirium; in particular, lacosamide, lamotrigine, levetiracetam, and valproic acid may increase the delirium risk. Antiepileptic drugs were not associated with delirium when used with benzodiazepine receptor agonists.The results of this study may prove useful for improving the management of delirium.

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Delirium risk of histamine-2 receptor antagonists and proton pump inhibitors: A study based on the adverse drug event reporting database in Japan

Cited by 11 publications

References 25 publications

Depression and Catatonia Associated With Lansoprazole in an Adolescent With Phelan-McDermid Syndrome

Depression and Catatonia Associated With Lansoprazole in an Adolescent With Phelan-McDermid Syndrome

Antihypertensive Drug Combinations Modify Cisplatin-induced Acute Kidney Injury

Risk of delirium with antiepileptic drug use: a study based on the Japanese Adverse Drug Event Report database

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