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, 25 (3), 403-412

Efficacy and Safety of AlbisD Compared With Omeprazole 20 Mg in Patients With Non-erosive Reflux Disease: A Randomized, Open-label, Active-controlled, Pilot Study

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Efficacy and Safety of AlbisD Compared With Omeprazole 20 Mg in Patients With Non-erosive Reflux Disease: A Randomized, Open-label, Active-controlled, Pilot Study

Eun Jin Kim et al. J Neurogastroenterol Motil.

Abstract

Background/aims: Proton pump inhibitors (PPIs) are frequently used to treat non-erosive reflux disease (NERD), but their effect is limited. It is not known whether a potential alternative, AlbisD, containing ranitidine hydrochloride, sucralfate hydrate, and tripotassium dicitrato bismuthate, is effective and safe in treating NERD. The aim of the study is to evaluate the efficacy and safety of AlbisD compared with omperazole in patients with NERD.

Methods: This was a multicenter, randomized, open-label, parallel-group, non-inferiority comparative study. A total of 126 patients with NERD were randomly allocated to either AlbisD twice daily or omeprazole 20 mg once daily for 4 weeks from February 2016 to August 2016. The study patients had histories of heartburn or regurgitation of moderate severity (> score 2) and a frequency of at least 2 episodes per week, and had no mucosal breaks of the esophagus on endoscopy. The primary efficacy variable was complete cure of heartburn at week 4. Secondary efficacy variables evaluating symptoms of heartburn and acid reflux as well as safety profiles were compared in the 2 groups at week 2 and 4 after treatment.

Results: A total of 113 patients completed the study (57 and 56 in AlbisD and omeprazole groups, respectively). The proportion of patients with complete cure of heartburn at week 4 was not significantly different between the AlbisD and omeprazole groups (35.1% vs 32.1% respectively, P = 0.740). There were no significant differences between the 2 groups in the any secondary variables including proportions of days without heartburn or acid reflux over 4 weeks (including daytime and nighttime). Adverse events were similarly reported in the 2 groups (7 [12.3%] vs 6 [10.7%]), and there were no serious adverse events.

Conclusions: The efficacy and safety of AlibsD in treating NERD patients are not inferior to those of omeprazole. Therefore, AlbisD can be an alternative to PPIs for NERD.

Keywords: Bismuth; Gastroesophageal reflux; Omeprazole; Ranitidine; Sucralfate.

Conflict of interest statement

Conflicts of interest: This study was sponsored by Daewoong, Seoul, Korea. The authors are solely responsible for the contents, and the content does not necessarily represent the official views of the Daewoong.

Figures

Figure 1
Figure 1
Enrolment, randomization, and follow-up in the study. FAS, full analysis set; PPS, per-protocol set.
Figure 2
Figure 2
The primary outcome results of the study: Complete resolution, no heartburn on each day (both daytime and nighttime) for the 7 days at week 4. The one-sided confidence interval, 97.5% of the difference between the 2 groups, was −0.1480 (−14.8%), which was within the non-inferiority tolerance limit of −15.0%.

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