Observational Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Pharmacol Ther. Mar 5, 2025; 16(1): 103898
Published online Mar 5, 2025. doi: 10.4292/wjgpt.v16.i1.103898
Real-world-evidence, prospective-observational study to evaluate safety and effectiveness of rabeprazole dual-delayed-release capsules in patients with gastroesophageal reflux disease
Parimal Lawate, Virender Chauhan, Lingampalli Rajendra Prasad, Abhimanrao Pawar, Atul G Puranik, Alok Bansal, Abhiram Koganti, Ashok Jaiswal, Pranali Puradkar, Kunal Jhaveri
Parimal Lawate, Department of Gastroenterology and Liver Disease, Jehangir Hospital, Pune 411001, Mahārāshtra, India
Virender Chauhan, Department of Gastroenterology, Kainos Superspeciality Hospital, Rohtak 124001, Haryāna, India
Lingampalli Rajendra Prasad, Department of Gastroenterology, Vrinda Gastro Liver and Endoscopy Clinic, Kurnool 518002, Andhra Pradesh, India
Abhimanrao Pawar, Department of Gastroenterology, Bharati Vidyapeeth (Deemed To Be) University Medical College and Hospital, Sangli 416410, Mahārāshtra, India
Atul G Puranik, Department of Surgery, Puranik Hospital, Mumbai 400064, Mahārāshtra, India
Alok Bansal, Department of Gastroenterology, Gastro Neuro Clinic, Jabalpur 482002, Madhya Pradesh, India
Abhiram Koganti, Department of Gastroenterology, KIMS Hospitals, Hyderabad 500032, Telangāna, India
Ashok Jaiswal, Pranali Puradkar, Kunal Jhaveri, Department of Medical Affairs, Zydus Healthcare Limited, Mumbai 400063, Mahārāshtra, India
Author contributions: Lawate P and Chauhan V conducted patient enrollment and data collection; Prasad LR and Pawar A wrote and edited the manuscript; Puranik AG, Bansal A, Koganti A, Jaiswal A, Puradkar P, and Jhaveri K supervised the study; Prasad LR and Pawar A assisted with data analysis and manuscript revisions; Koganti A created the images and graphics; all of the authors read and approved the final version of the manuscript to be published.
Informed consent statement: Informed consent was obtained from all participants involved in the study.
Conflict-of-interest statement: The authors declare no conflicts of interest.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Data sharing statement: No additional data are available for this study. The dataset analyzed was fully anonymized, and no further information can be provided beyond the results presented in this manuscript.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Kunal Jhaveri, MD, Department of Medical Affairs, Zydus Healthcare Limited, Zydus Tower, CTS 460/6, Village Pahadi Off IB Patel Road, Goregaon East, Mumbai 400063, Mahārāshtra, India. kunal.jhaveri@zyduslife.com
Received: December 13, 2024
Revised: January 24, 2025
Accepted: February 10, 2025
Published online: March 5, 2025
Processing time: 81 Days and 18.7 Hours
Abstract
BACKGROUND

Abnormal gastric acid reflux into the esophagus causes symptoms of gastroesophageal reflux disease (GERD) such as heartburn and regurgitation and also leads to mucosal damage. This damage can further lead to complications such as Barrett’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.

Keywords: Gastroesophageal reflux disease; Heartburn; Acid reflux; Rabeprazole; Dual delayed-release

Core Tip: The novel dual delayed-release formulation of rabeprazole, Happi ER, addresses the unmet needs of gastroesophageal reflux disease (GERD) management by offering both immediate and sustained acid suppression. This real-world evidence study demonstrated significant improvements in heartburn severity, reduced night-time awakenings, and enhanced patient satisfaction, particularly in patients with mild-to-moderate GERD. With a safety profile comparable to that of traditional proton pump inhibitors and superior efficacy in managing nocturnal symptoms, Happi ER provides a comprehensive and reliable solution for long-term GERD management.