Efficacy and Safety of Long-Term Administration of Esomeprazole in Japanese Pediatric Patients Aged 1–14 Years with Chronic Gastric Acid-Related Disease
10.5223/pghn.2024.27.5.274
- Author:
Masaaki MORI
1
;
Yoshiko NAKAYAMA
;
Shigeo NISHIMATA
;
Tadafumi YOKOYAMA
;
Ryo MATSUOKA
;
Reiko HATORI
;
Masaki SHIMIZU
;
Katsuhiro ARAI
;
Yuri ETANI
;
Tsuyoshi SOGO
;
Tomoko ISHIZU
;
Masahiro NII
;
Ryosuke NAKASHIMA
;
Toshiaki SHIMIZU
Author Information
1. Department of Lifetime Clinical Immunology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan
- Publication Type:Original Article
- From:Pediatric Gastroenterology, Hepatology & Nutrition
2024;27(5):274-285
- CountryRepublic of Korea
- Language:English
-
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.
