Pharmacovigilance study of the association between dipeptidyl peptidase–4 inhibitors and angioedema using the FDA Adverse Event Reporting System (FAERS)

Ohyama, Katsuhiro; Shindo, Junichiro; Takahashi, Tomohiro; Takeuchi, Hironori; Hori, Yusuke S.

doi:10.1038/s41598-022-17366-x

Cited by 10 publications

(8 citation statements)

References 41 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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“…59,60 Other publications, like a study of Ohyama et al, support the hypothesis, that DPP4-4 inhibitors may induce angioedema in prone patients, even in the absence of a concomitant ACE inhibitor intake. 61 According to the International/Canadian HAE Guideline, HAE patients should discontinue or rather avoid the intake of DPP-4 inhibitors. 56 mTOR inhibitors: mTOR inhibitors (like sirolimus and everolimus) are a class of drugs that inhibit the mechanistic target of rapamycin ( = mTOR).…”

Section: Dpp-4 Inhibitorsmentioning

confidence: 99%

Concomitant medication in patients with bradykinin‐mediated angioedema – there's more than ACE inhibitors

Lochbaum

Hoffmann

Greve

et al. 2023

J Deutsche Derma Gesell

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SummaryBradykinin‐mediated angioedema is a rare, non‐allergic, potentially life‐threatening disease. ACE inhibitor‐induced angioedema and hereditary angioedema (HAE) are the two most common presentations. Therapeutic options, pathophysiology and diagnosis continue to be investigated, with considerable progress in HAE over the last few decades. For all patients with bradykinin‐mediated angioedema, there are several medications that should be avoided or administered with caution. Some of the triggering medications are well known, while others are suspected or of unknown significance. A common denominator is that there is no approved therapy for bradykinin‐mediated angioedema as a drug side effect. Some medications, such as tissue plasminogen activator, have a higher incidence of angioedema with potential airway compromise than ACE inhibitors, although this fact is widely underappreciated. In this review, we aim to summarize what is currently known and recommended about concomitant medication in HAE patients and the interaction of other bradykinin‐influencing drugs.

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Pharmacovigilance study of the association between dipeptidyl peptidase–4 inhibitors and angioedema using the FDA Adverse Event Reporting System (FAERS)

Cited by 10 publications

References 41 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

Concomitant medication in patients with bradykinin‐mediated angioedema – there's more than ACE inhibitors

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