Clinical Endoscopy

Original Article

Efficacy of Albis for the Prevention of Gastric Mucosal Injury Concomitant with the Use of Low-Dose Aspirin: A Prospective, Randomized, Placebo-Controlled Study: Sang Gyun Kim, Nayoung Kim, Sung Kwan Shin, In Kyung Sung, Su Jin Hong, Hyo-Jin Park; Clin Endosc 2017;50(2):179-184. Published online May 19, 2016; DOI: https://doi.org/10.5946/ce.2016.031

Background
/Aims: Long-term use of aspirin can be a risk factor of peptic ulcer diseases. The aim of this study was to evaluate the efficacy of Albis (Daewoong Pharmaceutical Co., Ltd.) for the prevention of gastric mucosal injury caused by aspirin.
Methods
Aspirin users were enrolled and randomized into the Albis or placebo group. Screening and follow-up endoscopy were performed for modified Lanza scores (MLSs). Primary outcome was measured by the incidence rate of peptic ulcer, and secondary outcomes were measured by the incidence rate of gastritis, improvement in MLS and subjective symptoms.
Results
In total, 81 aspirin users were randomized, 43 in the Albis group and 38 in the placebo group. There was no incidence of peptic ulcer in both groups. The incidence of gastritis was significantly higher in the placebo group (44.4% vs. 10.0%, p=0.003); however, the scores of mucosal edema, hyperemia and hemorrhage were not statistically different between the two groups (p>0.05). The frequency of subjective symptoms were more improved in the Albis group than in the placebo group (p=0.023).
Conclusions
The incidence of gastritis was lower in the group that received low-dose aspirin and Albis. The development of peptic ulcer due to long-term use of aspirin might be prevented with concomitant use of Albis.

Citations

Citations to this article as recorded by

Xiaojianzhong decoction attenuates gastric mucosal injury by activating the p62/Keap1/Nrf2 signaling pathway to inhibit ferroptosis
Juan Chen, Jiaxiang Zhang, Ting Chen, Shengchuan Bao, Jingtao Li, Hailiang Wei, Xin Hu, Yan Liang, Fanrong Liu, Shuguang Yan
Biomedicine & Pharmacotherapy.2022; 155: 113631. CrossRef
A measure of asymmetry for ordinal square contingency tables with an application to modified LANZA score data
Satoru Shinoda, Kouji Yamamoto, Kouji Tahata, Sadao Tomizawa
Journal of Applied Statistics.2020; 47(7): 1251. CrossRef

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Efficacy and Safety of Albis^Ⓡ in Acute and Chronic Patients with Gastritis: A Double-blind, Placebo-controlled, Randomized Multi-center Study: Hae Won Han, M.D., Myung-Gyu Choi, M.D., Sang Young Seol, M.D.*, Dong Ho Lee, M.D.^†, Hwoon-Yong Jung, M.D.^‡, Tae Nyeun Kim, M.D.^§, Suck Chei Choi, M.D.^∥ and Hyen Soo Kim, M.D.^¶; Korean J Gastrointest Endosc 2011;42(4):215-221. Published online April 28, 2011

Abstract PDF: Background
/Aims: Albis^Ⱂ is a newly developed drug comprised of ranitidine, bismuth and sucralfate. The aim of the study was to prove non-inferiority of Albis^Ⱂ compared to Stillen^Ⱂ 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 Albis^Ⱂ, and 96 from the Stillen^Ⱂ group were included in the per protocol (PP) analysis. The endoscopic improvement rate was not different between the Albis^Ⱂ 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 Albis^Ⱂ 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 Albis^Ⱂ for peptic ulcers has non-inferiority compared to Stillen^Ⱂ for treating erosive gastritis. A low dosage of Albis^Ⱂ is cost efficient and safe. (Korean J Gastrointest Endosc 2011;42:215-221)

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