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S512 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

2023; Lippincott Williams & Wilkins; Volume: 118; Issue: 10S Linguagem: Inglês

10.14309/01.ajg.0000951688.08131.f2

1572-0241

Vinay Kumar, Pankaj Nemade, Barun Kumar, P. Shravan Kumar, Kartikeya Parmar, Ashok Mohite, Dillip K Mohanty, KS Poornachandra, Manoj Lahoti, Nikhil Jillawar, Ravindra Gaadhe, Mandodari Rajurkar, Piyush M. Patel, Sapan Behera, Pravin Ghadge, Lalit Lakhwani, Suyog Mehta, Sadhna Joglekar,

Helicobacter pylori-related gastroenterology studies

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 (Figure 1). 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< 0.0001) 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. Conclusion: 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.Figure 1.: 95% Confidence Interval Graph for Mean and Median difference (A) Mean difference (B) Median difference ITT = intention to treat, mITT = modified intent to treat, PP = per protocol. Note: The red dotted line represents non-inferiority margin. Values in the Figure represents percentage.