Safety Of Rebamipide Research Articles

Effectiveness of Rebamipide as a part of the <i>Helicobacter pylori</i> eradication therapy in Russia: a meta-analysis of controlled trials

Aim. To perform a meta-analysis of the data on Rebamipide efficacy and safety as a part of Helicobacter pylori eradication therapy in Russian patients.
 Materials and methods. A search for original studies was conducted in the electronic database of the Russian Science Citation Index (RSCI) on the Scientific Electronic Library (SEL Elibrary.ru). Google (Google.com) was used for the "grey" search. All Russian controlled studies comparing the efficacy and/or safety of Rebamipide as a part of the regimen of H. pylori eradication therapy were included in the final analysis.
 Results. In 6 included controlled trials with a cumulative population (considering double comparisons between multiple groups) of 531 patients (273 in Rebamipide groups and 258 in groups without Rebamipide), the pooled eradication effectiveness was 90.376% (95% confidence interval CI 86.31193.560) in patients receiving Rebamipide and 81.681% (95% CI 76.49986.141) in patients receiving eradication regimens without Rebamipide. The meta-analysis showed that the Rebamipide addition to eradication regimens significantly improved efficacy (odds ratio 2.162, 95% CI 1.2683.685; p=0.005). No significant heterogeneity was found between study results (p=0.863; I2=0.00%); therefore, a fixed effects model was used in the resulting analysis. In addition, the meta-analysis of included studies showed a reduction of adverse events (odds ratio 0.569, 95% CI 0.3330.970) in the groups receiving Rebamipide; p=0.038). This effect of Rebamipide deserves special attention and requires additional study, as the result was at the border of statistical significance in the subanalysis of three studies with a large margin of risk reduction in one of them (with the largest sample of patients).
 Conclusion. The present meta-analysis demonstrated that the Rebamipide addition to H. pylori eradication regimens significantly improves the treatment effectiveness in the Russian patient population.

Evaluation of efficacy and safety of rebamipide use in the triple therapy for Helicobacter pylori eradication: a pilot study

The article presents the results of a pilot prospective randomized study aimed at evaluating the efficacy and safety of rebamipide (Rebagit, PRO.MED.CS Praha a.s., Czech Republic) as part of the triple therapy for helicobacter pylori (H. Pylori) eradication. 54 patients with H. pylori-associated gastric ulcer/duodenal ulcer were enrolled to the study. All patients were randomized to two therapeutic groups depending on the eradication therapy to be received. Group 1 received the standard triple therapy, Group 2 received the standard triple therapy plus rebamipide. The efficacy of H. pylori eradication in Group 1 amounted to 78,2% (ITT), 81,8% (PP), and in Group 2 to 83,8% (ITT), 86,6% (PP). Odd ratio of efficient eradication with the use of rebamipide as part of standard triple therapy for helicobacter pylori eradication was 1,44 (95 CI: 0,36–5,72). The side effect rates between the groups were comparable

Efficacy and Safety of Rebamipide in Prevention of NSAID-Gastropathy

Efficacy and Safety of Rebamipide in Prevention of NSAID-Gastropathy

Preventive Effect of Rebamipide Gargle on Chemoradiotherpy-Induced Oral Mucositis in Patients with Oral Cancer: a Pilot Study

ABSTRACTObjectivesTo assess the efficacy and safety of rebamipide in preventing chemoradiotherapy-induced oral mucositis in patients with oral cancer.Material and MethodsPatients with oral cancer treated with chemoradiotherapy (daily radiotherapy plus docetaxel hydrate once a week) were enrolled for this study. They were assigned in a double-blind fashion to receive either rebamipide gargle or placebo on the days of chemoradiotherapy. Oral mucositis was assessed using the WHO grading system. The primary endpoint of this study was the incidence of grade 3 - 4 mucositis after exposure to 40 Gy radiation (4 weeks). The secondary endpoint was the effect of rebamipide gargle on tumour response to chemoradiotherapy.ResultsTwenty-four patients were randomly assigned to receive rebamipide gargle (n = 12) or placebo-gargle (n = 12) during chemoradiotherapy. The number of patients with severe mucositis (WHO ≥ 3) was higher in the placebo group than in the rebamipide group (83.3% vs. 33.3%, P = 0.036). In addition, no effect of rebamipide gargle on tumour response to chemoradiotherapy was recognized compared with the placebo group.ConclusionsFor patients with oral cancer undergoing chemoradiotherapy, rebamipide gargle may contribute to decrease the severity of oral mucositis.

A Randomized Double-Dummy, Double Blind, Misoprostol Comparative Clinical Trial to Evaluate and Safety of Rebamipide in the Prevention of NSAID-Induced Gastrointestinal Complication

A Randomized Double-Dummy, Double Blind, Misoprostol Comparative Clinical Trial to Evaluate and Safety of Rebamipide in the Prevention of NSAID-Induced Gastrointestinal Complication

Efficacy and safety of rebamipide for the treatment of dry mouth symptoms in patients with Sjögren’s syndrome: a double-blind placebo-controlled multicenter trial

The effects of rebamipide on dry mouth and salivary secretion in Sjögren’s syndrome patients were investigated in a double-blind placebo-controlled study. Rebamipide (100 mg TID) or placebo was administered for eight weeks and patient-assessed improvement of dry mouth and increase in salivary secretion measured by the Saxon test were evaluated. At two, four, and eight weeks, dry mouth improvement rates were, respectively, 26.0, 44.0, and 46.9% for rebamipide and 20.0, 27.1, and 39.1% for placebo, and mean increases in salivary secretion were, respectively, 0.14, 0.24, and 0.35 g for rebamipide and 0.03, 0.09, and 0.17 g for placebo, indicating higher values in the rebamipide group for both parameters at all timepoints but no significant differences between the two groups. Analysis by baseline characteristics suggested a statistically significant salivary secretion increasing effect of rebamipide in cases of primary Sjögren’s syndrome. No difference in the incidence of adverse events was seen between the two groups, confirming the safety of rebamipide. As a salivary secretion increasing effect was strongly suggested in cases of primary Sjögren’s syndrome, further study on the administration of rebamipide for the treatment of dry mouth in patients with Sjögren’s syndrome is required.