P1807 - Effect of Esomeprazole Dual Release Gastro-Resistant Tablets in Patients With Refractory Gastroesophageal Reflux Disease in Comparison to Esomeprazole Tablets: A Double-Blind Randomized, Phase 3 Active-Controlled Trial

Vinay Kumar, MD, DM¹, Pankaj Nemade, DNB², B. Ramesh Kumar, MD, DM, FACG,³, P Shravan Kumar, MD, DM, FACG⁴, Kartikeya Parmar, MD⁵, Ashok Mohite, MD, DM, DNB⁶, Dillip Mohanty, MD, DNB⁷, Poornachandra KS, MD, DM⁸, Manoj Lahoti, MD, DM, FACG⁹, Nikhil Jillawar, ¹⁰, Ravindra Gaadhe, MD¹¹, Mandodari Rajurkar, MPH¹², Piyush Patel, MD¹², Sapan Behera, MD, DM¹³, Pravin Ghadge, MD¹², Lalit Lakhwani, MD¹², Suyog Mehta, MD¹², Sadhna Joglekar, MD^14
1GSVM Medical College, Kanpur Nagar, Uttar Pradesh, India; ²Medipoint Hospital Pvt. Ltd., Pune, Maharashtra, India; ³Osmania General Hospital and Medical College, Hyderabad, Telangana, India; ⁴Gandhi Hospital, Secunderabad, Telangana, India; ⁵B.J. Medical College and Civil Hospital, Ahmedabad, Gujarat, India; ⁶GI-One Hospital, Aurangabad, Maharashtra, India; ⁷Sparsh Hospital, Bhubaneshwar, Orissa, India; ⁸Sparsh Super Specialty Hospital, Bangalore, Karnataka, India; ⁹Suyash Institute of Medical Science, Chhattisgarh, Maharashtra, India; ¹⁰Lifepoint Multispecialty Hospital, Pune, Maharashtra, India; ¹¹Shivam Hospital, Ahmedabad, Gujarat, India; ¹²Sun Pharma Laboratories Limited, Mumbai, Maharashtra, India; ¹³Sun Pharma Laboratories Limited, Goregaon, Maharashtra, India; ¹⁴Sun Pharmaceutical Industries Limited, Mumbai, Maharashtra, India

Introduction: Esomeprazole, the S-isomer of omeprazole is considered efficacious in gastroesophageal reflux disease (GERD), the efficacy of esomeprazole is suggested to be further improved by novel drug delivery technology with decreased dose-frequency and greater treatment compliance. The study aimed to assess effect of esomeprazole dual release gastro resistant (DRGR) 80 mg once-daily (OD) in comparison to esomeprazole 40 mg twice-daily (BID) in refractory GERD.

Methods: This Phase 3, randomized, double-blind, double dummy trial included patients with refractory GERD who had experienced heartburn symptom on at least 2 of 7 days, regurgitation symptom on at least 1 of 7 days, and did not fully respond to proton-pump inhibitors (PPIs) OD, for at least 8 weeks prior to randomization. Eligible patients were randomized (1:1) to 4-week treatment with esomeprazole DRGR 80 mg tablets OD [Test arm] OR esomeprazole tablets 40 mg BID [Comparator arm] along with matching placebos.

Results: Of total 296 screened patients; 278 patients were randomized (139 patients [Test arm] and 139 [Comparator arm]). At Week 4, mean difference in percentage of 24-hour heartburn (with neither day-time nor night-time) free days from Baseline between Test and Comparator arms (primary endpoint) was 1.23% (95% confidence interval [CI]: − 4.79%, 7.26%) and median difference from baseline was 0.55% (95% CI: − 3.33%, 3.42%) with no statistical difference (p=0.8655) between the arms. Similar results were observed at Week 2, no statistical difference (p=0.8931) between the arms with respect to mean and median differences. Percentage of days without rescue medicines, without night-time and day-time heartburn were comparable between the arms. Significant improvement in GERD-quality-of-life score and significant reduction in frequency scale for the symptoms of GERD at Weeks 2 and 4 was observed within each arm (p< .0001) with no statistical difference between the arms. No statistical difference was observed in patients who achieved sustained resolution of heartburn, percentage of 24-hour regurgitation-free days, and proportion of responder as per clinical global impression improvement scale at Weeks 2 and 4. No severe/serious adverse events were observed.

Discussion: Overall, esomeprazole DRGR tablets 80 mg OD was non inferior to esomeprazole tablets 40 mg BID in providing 24-hour heartburn (with neither day-time nor night-time) free days in patients with refractory GERD at Weeks 2 and 4. Both the study products were safe and well tolerated.



Disclosures:


Vinay Kumar, MD, DM¹, Pankaj Nemade, DNB², B. Ramesh Kumar, MD, DM, FACG,³, P Shravan Kumar, MD, DM, FACG⁴, Kartikeya Parmar, MD⁵, Ashok Mohite, MD, DM, DNB⁶, Dillip Mohanty, MD, DNB⁷, Poornachandra KS, MD, DM⁸, Manoj Lahoti, MD, DM, FACG⁹, Nikhil Jillawar, ¹⁰, Ravindra Gaadhe, MD¹¹, Mandodari Rajurkar, MPH¹², Piyush Patel, MD¹², Sapan Behera, MD, DM¹³, Pravin Ghadge, MD¹², Lalit Lakhwani, MD¹², Suyog Mehta, MD¹², Sadhna Joglekar, MD¹⁴. P1807 - Effect of Esomeprazole Dual Release Gastro-Resistant Tablets in Patients With Refractory Gastroesophageal Reflux Disease in Comparison to Esomeprazole Tablets: A Double-Blind Randomized, Phase 3 Active-Controlled Trial, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.