The Role for Pre-Polymerized Sucralfate in Management of Erosive and Non-Erosive Gastroesophageal Reflux Disease – High Potency Sucralfate-Mucin Barrier for Enteric Cytoprotection

Abstract

The superior performance of acid-controlling therapies, namely proton pump inhibitors (PPI) and histamine-2 receptor antagonists (H2RA), eroded the early but tenuous role of sucralfate in the treatment of gastroesophageal reflux disease (GERD), which role had resulted from clinical off-labeled use of sucralfate’s original regulatory indication, wihch was the management of duodenal ulcers. The clinical performance of standard sucralfate dosed at 14mg per kg (1 gram) four times daily was clinically inconsistent, substantially unimpressive and led to its exclusion from most clinical guidelines for GERD [1-4]. Clinical efficacy for standard sucralfate, whether tablet or suspension, had been largely mediocre for both erosive GERD and for NERD, non-erosive gastroesophageal reflux disease. There were two notable exceptions a trial conducted by Simon, et al. [5] in NERD patients using a mucoadherent gel formulation of sucralfate (twice as potent as sucralfate suspension in terms of retention on the mucosal lining of the gastrointestinal (GI) tract [6,7]) and a trial conducted by Vermieidien, et al. [8] using sucralfate suspension for eGERD. In the former study [5], a 14mg/ Abstract