Pediatric Gastroenterology, Hepatology & Nutrition

The Korean Society of Pediatric Gastroenterology, Hepatology and Nutrition (대한소아소화기영양학회)
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Efficacy and Safety of Long-Term Administration of Esomeprazole in Japanese Pediatric Patients Aged 1-14 Years with Chronic Gastric Acid-Related Disease

  • Masaaki Mori (Department of Lifetime Clinical Immunology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University) ;
  • Yoshiko Nakayama (School of Health Science, Shinshu University School of Medicine) ;
  • Shigeo Nishimata (Department of Pediatrics and Adolescent Medicine, Tokyo Medical University) ;
  • Tadafumi Yokoyama (Department of Pediatrics, Kanazawa University) ;
  • Ryo Matsuoka (Department of Pediatrics, Fuji City General Hospital) ;
  • Reiko Hatori (Center of Regional Medical Research and Education, Gunma University Hospital) ;
  • Masaki Shimizu (Department of Pediatrics and Developmental Biology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University) ;
  • Katsuhiro Arai (Division of Gastroenterology, National Center for Child Health and Development) ;
  • Yuri Etani (Department of Pediatric Gastroenterology, Nutrition and Endocrinology, Osaka Women's and Children's Hospital) ;
  • Tsuyoshi Sogo (Department of Pediatric Hepatology and Gastroenterology, Saiseikai Yokohama City Tobu Hospital) ;
  • Tomoko Ishizu (Research and Development, AstraZeneca) ;
  • Masahiro Nii (Research and Development, AstraZeneca) ;
  • Ryosuke Nakashima (Research and Development, AstraZeneca) ;
  • Toshiaki Shimizu (Department of Pediatrics and Adolescent Medicine, Juntendo University Graduate School of Medicine)
  • Received : 2024.03.10
  • Accepted : 2024.06.19
  • Published : 2024.09.15
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Abstract

Purpose: To evaluate prolonged esomeprazole use in Japanese pediatric patients for reflux esophagitis (RE) maintenance therapy and prevention of gastric (GU) and/or duodenal ulcers (DU) while using non-steroidal anti-inflammatory drugs (NSAIDs) or low-dose aspirin (LDA). Methods: This multicenter, open-label, parallel-group, phase III study (NCT03553563) included patients who were administered esomeprazole according to body weight (10 mg/day [Groups 1 and 3] and up to 20 mg/day [Groups 2 and 4] for patients weighing 10-20 kg and ≥20 kg, respectively). Efficacy outcomes for Groups 1 and 2 (maintenance therapy for healed RE) and Groups 3 and 4 (prevention of long-term NSAID/LDA use-associated GU/DU) were the presence/absence of RE relapse and GU/DU recurrence, respectively. Results: Esomeprazole as maintenance therapy was associated with a low RE recurrence rate, independent of body weight or dosage. Recurrence rates of RE were 0.0% and 5.3% for Groups 1 and 2, respectively. In patients previously diagnosed with GU and/or DU due to long-term NSAID/LDA use, the recurrence rates of GU/DU during weeks 0-32 were 11.1% and 0.0% in Groups 3 and 4, respectively. Conclusion: Long-term use of 10- or 20-mg, once-daily esomeprazole demonstrated a favorable benefit-risk balance in preventing RE and suppressing recurrence of GU and/or DU secondary to NSAID or LDA therapy in Japanese pediatric patients. No new safety concerns were identified. Esomeprazole may be a viable option for managing RE and preventing GU and DU in Japanese pediatric patients.

Keywords

Acknowledgement

The authors wish to thank the principal investigators, including Yasuo Nakahara (National Hospital Organization Okayama Medical Center), Takahiro Kudo (Juntendo University Faculty of Medicine), Yuichi Yamasaki (Kagoshima University Hospital), Tomoyuki Imagawa (Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical Center), Yuka Ozeki (Osaka Medical and Pharmaceutical University Hospital), and Takayuki Okamura (Sakai City Medical Center); Akira Horiuchi (Showa Inan General Hospital), who was part of the CEC; and the research staff, health care providers, and patients. The authors also wish to thank Lakshini H. S. Mendis, PhD, of Edanz, Japan, for providing medical writing support, which was funded by AstraZeneca, Japan, through EMC K.K., Japan, in accordance with Good Publication Practice guidelines (https://www.ismpp.org/gpp-2022).

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