Background
/Aims: AlbisⰒ is a newly developed drug comprised of ranitidine, bismuth and sucralfate. The aim of the study was to prove non-inferiority of AlbisⰒ compared to StillenⰒ for treating erosive gastritis.
Methods
This study was a randomized, double-blind, multi-center trial. The primary endpoint was 2 weeks of treatment.
Results
Of the 229 patients in the intention-to-treat (ITT) population, 87 from the AlbisⰒ, and 96 from the StillenⰒ group were included in the per protocol (PP) analysis. The endoscopic improvement rate was not different between the AlbisⰒ group and the control in both the PP (42.5%, 39.6%) and ITT (35.3%, 34.5%) populations. The endoscopic cure of erosion was also not different in the AlbisⰒ group than that in the control group in both the PP (32.3%, 31.3%) and ITT (27.6%, 27.4%) populations. The endoscopic improvement rate for hemorrhage, edema, and erythema were also not different between the two groups in both the PP and ITT populations. No statistically significant differences were observed for adverse events between the two groups.
Conclusions
Half of the approved dose of AlbisⰒ for peptic ulcers has non-inferiority compared to StillenⰒ for treating erosive gastritis. A low dosage of AlbisⰒ is cost efficient and safe. (Korean J Gastrointest Endosc 2011;42:215-221)