Akina Takami,1 Gen Terashima,2 Yuichi Shiotsuki,2 Koki Yamashita,3 Ataru Igarashi1 1Department of Health Policy and Public Health, Graduate School of Pharmaceutical Sciences, the University of Tokyo, Tokyo, Japan; 2Real World Evidence Division, JMDC, Inc., Tokyo, Japan; 3Maxwell International, Inc., Chiba, JapanCorrespondence: Akina Takami, Department of Health Policy and Public Health, Graduate School of Pharmaceutical Sciences, the University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan, Tel +81 3 5841 4828, Fax +81 3 5841 4829, Email mariechanmail@g.ecc.u-tokyo.ac.jpIntroduction: Long-term use of proton pump inhibitors (PPIs) requires careful observation with endoscopy in Japan. However, there are no studies examining whether monitoring is being properly carried out in clinical practice. Thus, we investigate the usage of PPIs by the presence or absence of endoscopic monitoring using a claims database.Methods: This study was a retrospective observational cohort study using the nationwide claims database. We obtained data of patients diagnosed with GERD (excluding suspected cases) between April 2014 and March 2024. Inclusion criteria were patients aged 18 years or older, continuously prescribed drugs of interest (omeprazole, lansoprazole, rabeprazole, esomeprazole, and vonoprazan) for 8 weeks or more. To assess the duration of prescriptions over a one-year period, the medication possession ratio (MPR) showing the prescription days per year ratio was examined. MPR was compared between patients who underwent endoscopy endoscopy(+) group and those who did not endoscopy(-) group during the follow-up period of 12 months.Results: A total of 398,253 patients endoscopy(+) group: 142,653; endoscopy(-) group: 255,600 were included in the analysis. The median MPR was 0.534 in the endoscopy(+) group and 0.805 in the endoscopy(-) group; MPR was significantly higher in the endoscopy(-) group (p < 0.0001).Conclusion: These findings revealed that the long-term administration of PPIs without monitoring esophageal mucosa by endoscopy in patients with GERD is a common practice in Japan. However, compliance with the package inserts suggesting adequate observation, including periodic endoscopic examinations, should be highlighted to ensure safety.Keywords: proton pump inhibitor, gastroesophageal reflux disease, safety, post-marketing, real-world data
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