A Randomized, Double-Blind, Active-Control, Noninferiority, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of Esomeprazole/Sodium Bicarbonate 20/800 mg in Patients with Nonerosive Gastroesophageal Reflux Disease.

Su Hyun Park, Kang Nyeong Lee, Oh Young Lee, Myung Gyu Choi, Jie-Hyun Kim, In-Kyung Sung, Jae Young Jang, Kyung Sik Park, Hoon Jai Chun, Eun Young Kim, Jun Kyu Lee, Jin Seok Jang, Gwang Ha Kim, Su Jin Hong, Yong Chan Lee, Suck-Chei Choi, Hyun Soo Kim, Tae Oh Kim, Gwang Ho Baik, Yong Cheol Jeon

Journal: Gut and liver 2023;17(2):226-233

PMID: 35730245

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Abstract

BACKGROUND/AIMS

Efficacy of proton pump inhibitors is limited in patients with nonerosive reflux disease (NERD). The aim of this study was to comparatively evaluate the efficacy and safety of esomeprazole with sodium bicarbonate and esomeprazole alone.

METHODS

This was a multicenter, randomized, double-blind, active-controlled, noninferiority comparative study. A total of 379 patients with NERD were randomly allocated to receive either Esoduo (esomeprazole 20 mg with sodium bicarbonate 800 mg) or Nexium (esomeprazole 20 mg) once daily for 4 weeks from January 2019 to December 2019. The patients had a history of heartburn for at least 2 days in the week before randomization as well as in the last 3 months and no esophageal mucosal breaks on endoscopy. The primary endpoint was a complete cure of heartburn at week 4. The secondary and exploratory endpoints as well as the safety profiles were compared in the groups at weeks 2 and 4.

RESULTS

A total of 355 patients completed the study (180 in the Esoduo group and 175 in the Nexium group). The proportions of patients without heartburn in the entire 4th week of treatment were not different between the two groups (33.33% in the Esoduo group and 35% in the Nexium group, p=0.737). There were no significant differences in most of the secondary and exploratory endpoints as well as the safety profiles.

CONCLUSIONS

Esoduo is as effective and safe as Nexium for managing typical symptoms in patients with NERD (ClinicalTrial.gov identifier: NCT03928470).

Address: Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.; Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.; Department of Internal Medicine, Gangnam Severance Hospital, Seoul, Korea.; Department of Internal Medicine, Konkuk University College of Medicine, Seoul, Korea.; Department of Internal Medicine, College of Medicine, Kyung Hee University, Seoul, Korea.; Department of Internal Medicine, Keimyung University College of Medicine, Daegu, Korea.; Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea.; Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, Korea.; Department of Internal Medicine, Dongguk University Ilsan Hospital, Dongguk University College of Medicine, Goyang, Korea.; Department of Internal Medicine, Dong-A University Hospital, Dong-A University College of Medicine, Busan, Korea.; Department of Internal Medicine, Pusan National University School of Medicine, Busan, Korea.; Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Korea.; Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.; Department of Internal Medicine, Wonkwang University College of Medicine, Iksan, Korea.; Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, Korea.; Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, Korea.; Department of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Korea.; Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea.

DOI: 10.5009/gnl220023

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MeSH Terms: Humans, Esomeprazole, Heartburn, Sodium Bicarbonate, Treatment Outcome, Gastroesophageal Reflux, Proton Pump Inhibitors, Double-Blind Method