Sucralfate effervescent tablet: treatment of peptic ulcer disease and change in serum aluminium concentration

Abstract

In a single-centre randomised clinical trial, a new effervescent formulation of sucralfate was compared with the granular formulation of the drug in the treatment of peptic ulcer. The effervescent tablet had not been previously administered to human subjects. Fifty patients with endoscopically verified duodenal (40) and gastric (10) ulcers were treated with 2.0 g sucralfate twice daily, given either as a granular formulation or effervescent tablet. Control endoscopies were performed at weeks 4 and 8 and again at week 12 if gastric ulcers had not healed earlier. The healing rates in the effervescent tablet group were 71% (15/21) and 86% (18/21) after 4 and 8 weeks. In this group one gastric ulcer had to be treated for a further 4 weeks and had not healed at week 12. The corresponding rates in the sucralfate granulate group were 95% (18/19) after 4 and 8 weeks. Serum aluminium concentrations were measured simultaneously before and after treatment. The aluminium concentration almost doubled in both treatment groups during dosing with sucralfate. This effect has not been described previously in the course of therapy with sucralfate in patients with peptic ulcer disease and should be borne in mind when considering treatment with this drug.