Evaluation of the Efficacy and Safety of a Dual Delayed-Release Formulation of 10-mg Esomeprazole in Patients with Gastric Erosions: A Multicenter, Randomized, Double-Blind, Active-Control, Phase III Study
Hyun Lim,
Ju Yup Lee,
Yong Hwan Kwon,
Hee Seok Moon,
Jong Kyu Park,
Ki Bae Kim,
Sang Wook Kim,
Young Hoon Youn,
Sang Gyun Kim,
Gwang Ha Kim,
Ji Won Kim,
Jae-Young Jang,
Kye Sook Kwon,
Joong Goo Kwon,
Hyun-Soo Kim,
Su Jin Hong,
Kwang Jae Lee,
Suck Chei Choi,
Jeong Seop Moon,
Nayoung Kim,
Jong-Jae Park,
Yirang Lim,
Sung Hee Hong,
Hwoon-Yong Jung
Affiliations
Hyun Lim
Department of Internal Medicine, Hallym University College of Medicine, University of Hallym College of Medicine, Anyang, Korea
Ju Yup Lee
Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea
Yong Hwan Kwon
Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Korea
Hee Seok Moon
Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea
Jong Kyu Park
Department of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Korea
Ki Bae Kim
Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea
Sang Wook Kim
Department of Internal Medicine, Jeonbuk National University Hospital, Jeonju, Korea
Young Hoon Youn
Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
Sang Gyun Kim
Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea
Gwang Ha Kim
Department of Internal Medicine, Pusan National University School of Medicine, and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea
Ji Won Kim
Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea
Jae-Young Jang
Department of Gastroenterology and Hepatology, College of Medicine, Kyung Hee University, Seoul, Korea
Kye Sook Kwon
Division of Gastroenterology, Department of Internal Medicine, Inha University College of Medicine, Incheon, Korea
Joong Goo Kwon
Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, Korea
Hyun-Soo Kim
Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Korea
Su Jin Hong
Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Korea
Kwang Jae Lee
Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea
Suck Chei Choi
Department of Gastroenterology, Digestive Disease Research Institute, Wonkwang University Hospital, Iksan, Korea
Jeong Seop Moon
Department of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, Korea
Nayoung Kim
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
Jong-Jae Park
Division of Gastroenterology, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea
Yirang Lim
Hanmi Pharmaceutical Co., Ltd., Seoul, Korea
Sung Hee Hong
Hanmi Pharmaceutical Co., Ltd., Seoul, Korea
Hwoon-Yong Jung
Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Background/Aims : Clinical data on the efficacy and safety of the dual delayed-release formulation of 10-mg esomeprazole (HIP2101) are currently limited. Therefore, this study compared the efficacy and safety of HIP2101 and 20-mg famotidine (RLD2101) in patients with gastric erosions. Methods : In this multicenter, randomized, double-blind, active-control, phase III study, 326 patients with endoscopically proven gastric mucosal erosion were randomly assigned to receive either HIP2101 or RLD2101 once daily for 2 weeks. The primary endpoint was the rate of improvement of erosion. Secondary endpoints (rate of cure of erosion and edema, and rate of improvement of hematin and gastrointestinal symptoms) and treatment-emergent adverse events were compared between the groups. Results : Based on the per-protocol set (PPS) analysis, the improvement rates for erosion were 64.9% (98/151) and 63.7% (100/157) in the HIP2101 and RLD2101 groups, respectively (95% confidence interval, –9.5 to 11.9). The lower bound of the 95% confidence interval was greater than the noninferiority margin of –14%. These results were similar to those of the full analysis set (FAS) (HIP2101 group, 64.6%; RLD2101 group, 62.7%). Based on the PPS and FAS analyses, the cure rates for erosion and edema and the improvement rates for hematin and gastrointestinal symptoms were comparable between the groups. The number of adverse events did not differ significantly between the groups. Conclusions : The efficacy and safety of HIP2101 were comparable to those of RLD2101 in the treatment of gastric erosions and symptomatic improvement. These findings suggest that HIP2101 may be a novel treatment option for gastritis (ClinicalTrials.gov identifier: NCT05024721).
