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

Clinical outcomes from standard sucralfate do not justify a role in the management of erosive and non-erosive gastroesophageal reflux disease. Pre-polymerized sucralfate, sometimes called high potency sucralfate or polymerized cross-linked sucralfate is a new sucralfate formulation recognized by the US FDA in 2005. Positive clinical data from three randomized controlled trials using pre-polymerized sucralfate for GERD and NERD was first reported in 2014 AGA’s Digestive Disease Week (DDW). Gastric refluxate contains protonic acid, dissolved bile acids and proteases each of which cause classic mucosal reactions in the esophageal epithelium. These reactions are symptomatic but may or may not involve erosions. Pre-polymerized sucralfate utilizes biophysical means to exclude all three irritants from epithelial mucosa.

Being non-systemic, the entire clinical effect of any sucralfate rests in the surface concentration of sucralfate achieved. Pre-polymerized sucralfate, presented in 2014 DDW, and discussed here, achieves a surface concentration that is 800% greater than standard sucralfate on normal mucosal lining and 2,400% greater on inflamed or acid-injured mucosa, making it most certainly, a high potency sucralfate. To understand the biomolecular basis of its clinical effect, this review re-introduces the reader to mucosal barrier, discloses the exact site of engagement of sucralfate (mucin within the mucous gel), and how transient sucralfate-mediated biostructural changes in extra-cellular mucin is translated into intra-cellular signaling that modules the mucosal reaction to refluxate. This represents significant enteric cytoprotection.. A broad-based literature review will not only aid understanding of the molecular basis of sucralfate’s clinical effects but will also provide context for an informed impression of whether pre-polymerized sucralfate has a role in the management of GERD and NERD.

Keywords: Polymerized sucralfate; NERD; GERD; Regulatory dichotomy