Abstract
BACKGROUND/AIMS: Gastroesophageal reflux disease (GERD) is a chronic and recurrent condition requiring constant dietary management and medication. This study evaluated the efficacy and safety of HIP1601, a dual delayed-release formulation of esomeprazole, in patients with GERD in a clinical setting. METHODS: This prospective, multicenter, observational study was conducted at 309 medical institutions in Korea between June 2021 and March 2023. HIP1601 was administered at daily doses of 40 mg or 20 mg to 5,407 patients requiring treatment or prevention of erosive esophagitis. The primary outcome was the improvement rate of GERD symptoms at four weeks. GERD-related symptoms and treatment-emergent adverse events were also analyzed. RESULTS: This study included 5,282 patients in the safety analysis set and 5,232 in the full analysis set. At four weeks, the improvement rate of GERD symptoms was 92.1% (95% confidence interval [CI]: 91.3-92.8%). By eight weeks, the improvement rate increased to 94.6% (95% CI: 94.0-95.3%). After HIP1601 administration, the severity scores for all four GERD symptoms decreased to less than 1, with statistically significant changes in the scores (p<0.001). HIP1601 was well-tolerated, with minimal adverse events reported (0.17%), and the treatment-emergent adverse events were mild to moderate in severity. CONCLUSIONS: HIP1601 showed strong efficacy and safety in managing GERD symptoms, with high rates of symptom relief at four and eight weeks. Its extended action and improved symptom control make it a promising therapeutic option for GERD patients.