Signals of gastroesophageal reflux disease caused by incretin-based drugs: a disproportionality analysis using the Japanese adverse drug event report database

Abstract Background Incretin-based drugs are important in the treatment of type 2 diabetes. However, among the incretin-based drugs, glucagon-like peptide-1 receptor agonists (GLP-1-RAs) have been reported to cause gastroesophageal reflux disease (GERD)-like symptoms making it difficult to continue...

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Main Authors: Yoshihiro Noguchi, Hayato Katsuno, Anri Ueno, Manami Otsubo, Aki Yoshida, Yuta Kanematsu, Ikuto Sugita, Hiroki Esaki, Tomoya Tachi, Teruo Tsuchiya, Hitomi Teramachi
Format: Article
Language:English
Published: BMC 2018-06-01
Series:Journal of Pharmaceutical Health Care and Sciences
Subjects:
Online Access:http://link.springer.com/article/10.1186/s40780-018-0109-z
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author Yoshihiro Noguchi
Hayato Katsuno
Anri Ueno
Manami Otsubo
Aki Yoshida
Yuta Kanematsu
Ikuto Sugita
Hiroki Esaki
Tomoya Tachi
Teruo Tsuchiya
Hitomi Teramachi
author_facet Yoshihiro Noguchi
Hayato Katsuno
Anri Ueno
Manami Otsubo
Aki Yoshida
Yuta Kanematsu
Ikuto Sugita
Hiroki Esaki
Tomoya Tachi
Teruo Tsuchiya
Hitomi Teramachi
author_sort Yoshihiro Noguchi
collection DOAJ
description Abstract Background Incretin-based drugs are important in the treatment of type 2 diabetes. However, among the incretin-based drugs, glucagon-like peptide-1 receptor agonists (GLP-1-RAs) have been reported to cause gastroesophageal reflux disease (GERD)-like symptoms making it difficult to continue treatment. Therefore, with the aim of clarifying the relationship between incretin-based drugs and GERD-like symptoms, we conducted a pharmacoepidemiological study using the Japanese adverse drug event report database (JADER). Methods Dipeptidyl peptidase-4 inhibitors (DPP-4-Is) and GLP-1-RAs were set as the incretin-based target drugs. The reporting odds ratio (ROR) and the information component (IC) was used for the detection of quantitative signals. Furthermore, we also compared the time to onset of GERD-like symptoms by log-rank test. Results GERD-like symptoms were reported in 36 GLP-1-RAs cases (ROR: 5.61, 95% confidence interval (95% CI): 3.95–7.96 and IC: 2.17, 95% CI: 1.66–2.67) and GLP-1-RAs were detected in the signal. In contrast, DPP-4-Is were not detected in the signal. There was no sex difference with regard to the expression time of GERD-like symptoms by GLP-1-RAs (log-rank test, p = 0.5381). However, the expression time of GERD-like symptoms from GLP-1-RAs was shorter in patients older than 70 years of age than that in those younger than 70 years of age (log-rank test, p < 0.0001). Conclusions The administration of GLP-1-RA had a higher incidence of GERD-like symptoms earlier than the administration of DPP-4-Is. In this study, although we think that further investigation is necessary, and suggest that patients older than 70 years of age who have been administered GLP-1-RAs need earlier attention to address GERD-like symptoms than younger patients.
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spelling doaj.art-5d608066a8ab424f94ea2ae4f18df0c12022-12-21T18:59:13ZengBMCJournal of Pharmaceutical Health Care and Sciences2055-02942018-06-01411810.1186/s40780-018-0109-zSignals of gastroesophageal reflux disease caused by incretin-based drugs: a disproportionality analysis using the Japanese adverse drug event report databaseYoshihiro Noguchi0Hayato Katsuno1Anri Ueno2Manami Otsubo3Aki Yoshida4Yuta Kanematsu5Ikuto Sugita6Hiroki Esaki7Tomoya Tachi8Teruo Tsuchiya9Hitomi Teramachi10Laboratory of Clinical Pharmacy, Gifu Pharmaceutical UniversityLaboratory of Clinical Pharmacy, Gifu Pharmaceutical UniversityLaboratory of Clinical Pharmacy, Gifu Pharmaceutical UniversityLaboratory of Clinical Pharmacy, Gifu Pharmaceutical UniversityLaboratory of Clinical Pharmacy, Gifu Pharmaceutical UniversityLaboratory of Clinical Pharmacy, Gifu Pharmaceutical UniversityLaboratory of Clinical Pharmacy, Gifu Pharmaceutical UniversityLaboratory of Clinical Pharmacy, Gifu Pharmaceutical UniversityLaboratory of Clinical Pharmacy, Gifu Pharmaceutical UniversityCommunity Health Support and Research CenterLaboratory of Clinical Pharmacy, Gifu Pharmaceutical UniversityAbstract Background Incretin-based drugs are important in the treatment of type 2 diabetes. However, among the incretin-based drugs, glucagon-like peptide-1 receptor agonists (GLP-1-RAs) have been reported to cause gastroesophageal reflux disease (GERD)-like symptoms making it difficult to continue treatment. Therefore, with the aim of clarifying the relationship between incretin-based drugs and GERD-like symptoms, we conducted a pharmacoepidemiological study using the Japanese adverse drug event report database (JADER). Methods Dipeptidyl peptidase-4 inhibitors (DPP-4-Is) and GLP-1-RAs were set as the incretin-based target drugs. The reporting odds ratio (ROR) and the information component (IC) was used for the detection of quantitative signals. Furthermore, we also compared the time to onset of GERD-like symptoms by log-rank test. Results GERD-like symptoms were reported in 36 GLP-1-RAs cases (ROR: 5.61, 95% confidence interval (95% CI): 3.95–7.96 and IC: 2.17, 95% CI: 1.66–2.67) and GLP-1-RAs were detected in the signal. In contrast, DPP-4-Is were not detected in the signal. There was no sex difference with regard to the expression time of GERD-like symptoms by GLP-1-RAs (log-rank test, p = 0.5381). However, the expression time of GERD-like symptoms from GLP-1-RAs was shorter in patients older than 70 years of age than that in those younger than 70 years of age (log-rank test, p < 0.0001). Conclusions The administration of GLP-1-RA had a higher incidence of GERD-like symptoms earlier than the administration of DPP-4-Is. In this study, although we think that further investigation is necessary, and suggest that patients older than 70 years of age who have been administered GLP-1-RAs need earlier attention to address GERD-like symptoms than younger patients.http://link.springer.com/article/10.1186/s40780-018-0109-zDisproportionality analysisIncretin-based drugsGlucagon-like peptide-1 receptor agonistsDPP-4 inhibitorsGastroesophageal reflux diseaseJapanese adverse drug event report database
spellingShingle Yoshihiro Noguchi
Hayato Katsuno
Anri Ueno
Manami Otsubo
Aki Yoshida
Yuta Kanematsu
Ikuto Sugita
Hiroki Esaki
Tomoya Tachi
Teruo Tsuchiya
Hitomi Teramachi
Signals of gastroesophageal reflux disease caused by incretin-based drugs: a disproportionality analysis using the Japanese adverse drug event report database
Journal of Pharmaceutical Health Care and Sciences
Disproportionality analysis
Incretin-based drugs
Glucagon-like peptide-1 receptor agonists
DPP-4 inhibitors
Gastroesophageal reflux disease
Japanese adverse drug event report database
title Signals of gastroesophageal reflux disease caused by incretin-based drugs: a disproportionality analysis using the Japanese adverse drug event report database
title_full Signals of gastroesophageal reflux disease caused by incretin-based drugs: a disproportionality analysis using the Japanese adverse drug event report database
title_fullStr Signals of gastroesophageal reflux disease caused by incretin-based drugs: a disproportionality analysis using the Japanese adverse drug event report database
title_full_unstemmed Signals of gastroesophageal reflux disease caused by incretin-based drugs: a disproportionality analysis using the Japanese adverse drug event report database
title_short Signals of gastroesophageal reflux disease caused by incretin-based drugs: a disproportionality analysis using the Japanese adverse drug event report database
title_sort signals of gastroesophageal reflux disease caused by incretin based drugs a disproportionality analysis using the japanese adverse drug event report database
topic Disproportionality analysis
Incretin-based drugs
Glucagon-like peptide-1 receptor agonists
DPP-4 inhibitors
Gastroesophageal reflux disease
Japanese adverse drug event report database
url http://link.springer.com/article/10.1186/s40780-018-0109-z
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