Real-world-evidence,prospective-observational study to evaluate safety and effectiveness of rabeprazole dual-delayed-release capsules in patients with gastroesophageal reflux disease  

作　　者：Parimal Lawate Virender Chauhan Lingampalli Rajendra Prasad Abhimanrao Pawar Atul G Puranik Alok Bansal Abhiram Koganti Ashok Jaiswal Pranali Puradkar Kunal Jhaveri 

机构地区：[1]Department of Gastroenterology and Liver Disease,Jehangir Hospital,Pune 411001,Mahārāshtra,India [2]Department of Gastroenterology,Kainos Superspeciality Hospital,Rohtak 124001,Haryāna,India [3]Department of Gastroenterology,Vrinda Gastro Liver and Endoscopy Clinic,Kurnool 518002,Andhra Pradesh,India [4]Department of Gastroenterology,Bharati Vidyapeeth(Deemed To Be)University Medical College and Hospital,Sangli 416410,Mahārāshtra,India [5]Department of Surgery,Puranik Hospital,Mumbai 400064,Mahārāshtra,India [6]Department of Gastroenterology,Gastro Neuro Clinic,Jabalpur 482002,Madhya Pradesh,India [7]Department of Gastroenterology,KIMS Hospitals,Hyderabad 500032,Telangāna,India [8]Department of Medical Affairs,Zydus Healthcare Limited,Mumbai 400063,Mahārāshtra,India

出　　处：《World Journal of Gastrointestinal Pharmacology and Therapeutics》2025年第1期37-45,共9页世界胃肠药理与治疗学杂志(英文)

摘　　要：BACKGROUND Abnormal gastric acid reflux into the esophagus causes symptoms of gastroeso-phageal reflux disease(GERD)such as heartburn and regurgitation and also leads to mucosal damage.This damage can further lead to complications such as Bar-rett’s esophagus and esophagitis.Conventional proton pump inhibitors(PPIs)often fail to reduce nocturnal acid production,leaving patients with unresolved symptoms that worsen at night and decreased satisfaction.Happi ER,a novel dual delayed-release(DDR)formulation of rabeprazole,aims to address these limitations by providing both immediate and prolonged acid suppression.AIM To evaluate the safety and effectiveness of rabeprazole DDR 20 mg capsule in patients with GERD.METHODS This study involved a multicenter,real-world,prospective,observational design over an eight-week period.A total of 1022 GERD patients were treated with rabeprazole DDR 20 mg capsules(Happi ER),as prescribed by their physicians.We included adult patients with confirmed GERD and persistent heartburn symptoms despite prior PPI use.Outcome measures included heartburn severity,frequency of night-time awakenings,use of rescue medications,and overall patient satisfaction.RESULTS Rabeprazole DDR 20 mg capsules(Happi ER)were shown to be highly effective in treating GERD symptoms.At the end of the study,the mean heartburn score improved significantly from 2.46±0.67 at baseline to 0.16±0.39(P<0.0001).The median number of night-time awakenings decreased to 0(P<0.0001).More than 93%of patients rated the therapy as“excellent”or“very good”,reflecting high satisfaction.No significant adverse effects were reported,and the safety profile was comparable to that of traditional PPIs.CONCLUSION By providing both rapid and sustained acid suppression,Happi ER effectively treats GERD,particularly with respect to night-time symptoms.Its safety and efficacy profile make it a viable option for individuals with mild-to-moderate GERD,significantly improving the quality of life and symptom management.

关 键 词：Gastroesophageal reflux disease HEARTBURN Acid reflux RABEPRAZOLE Dual delayed-release 

分 类 号：R57[医药卫生—消化系统]