SUCRALFATE EFFERVESCENT TABLET - TREATMENT OF PEPTIC-ULCER DISEASE AND CHANGE IN SERUM ALUMINUM CONCENTRATION

In a single-centre randomised clinical trial, a new effervescent formu lation of sucralfate was compared with the granular formulation of the drug in the treatment of peptic ulcer. The effervescent tablet had no t been previously administered to human subjects. Fifty patients with endoscopically verified duodenal (40) and gastric (10) ulcers were tre ated with 2.0 g sucralfate twice daily, given either as a granular for mulation or effervescent tablet. Control endoscopies were performed at weeks 4 and 8 and again at week 12 if gastric ulcers had not healed e arlier. The healing rates in the effervescent tablet group were 71% (1 5/21) and 86% (18/21) after 4 and 8 weeks. In this group one gastric u lcer had to be treated for a further 4 weeks and had not healed at wee k 12. The corresponding rates in the sucralfate granulate group were 9 5% (18/19) after 4 and 8 weeks. Serum aluminium concentrations were me asured simultaneously before and after treatment. The aluminium concen tration almost doubled in both treatment groups during dosing with suc ralfate, This effect has not been described previously in the course o f therapy with sucralfate in patients with peptic ulcer disease and sh ould be borne in mind when considering treatment with this drug.