Abstract
BackgroundRebamipide is a gastroprotective agent with promising results against gastric damage induced by non-steroidal anti-inflammatory drugs. The present study evaluated if rebamipide protects against naproxen-induced gastric damage in healthy volunteers. Changes in gastric PGE2 tissue concentration were also evaluated.MethodsAfter a preliminary endoscopy to rule out previous gastric macroscopic damage, twenty-four healthy volunteers of both sexes were divided into 2 groups. One group received sodium naproxen 550 mg b.i.d. plus placebo for 7 days, while the other group received sodium naproxen 550 mg b.i.d. plus rebamipide 100 mg b.i.d. At the end of treatment, a new endoscopy was performed. Gastric macroscopic damage was evaluated by the Cryer score and by the modified Lanza score. The primary outcome measure of the trial was the macroscopic damage observed in each treatment group at the end of treatment. Biopsies were collected at both endoscopies for PGE2 quantification and histopathological analysis (secondary outcomes). Tissue PGE2 was quantified by ELISA. The randomization sequence was generated using 3 blocks of 8 subjects each. Volunteers and endoscopists were blind to whether they were receiving rebamipide or placebo.ResultsAll recruited volunteers completed the trial. Sodium naproxen induced gastric damage in both groups. At the end of the study, median Cryer score was 4 in both groups (Difference = 0; 95%CI = −1 to 0; p = 0.728). In the placebo group, the mean tissue PGE2 concentration was 1005 ± 129 pg/mL before treatment and 241 ± 41 pg/mL after treatment (p < 0.001). In the rebamipide group, the mean tissue PGE2 concentration was 999 ± 109 pg/mL before treatment, and 168 ± 13 pg/mL after treatment (p < 0.001). There was no difference in mean tissue PGE2 between the two groups (difference = 5; 95%CI from −334.870 to 345.650; p = 0.975). No significant change was observed at the histopathological evaluation, despite the evident macroscopic damage induced by naproxen.ConclusionRebamipide does not protect against naproxen-induced gastric damage in healthy volunteers.Trial registrationClinicalTrials.gov, NCT02632812. Registered 14 December 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s12876-016-0472-x) contains supplementary material, which is available to authorized users.
Highlights
Rebamipide is a gastroprotective agent with promising results against gastric damage induced by non-steroidal anti-inflammatory drugs
Rebamipide has been described as a GI mucosal protector agent with promising results in prophylaxis and treatment of GI ulcers caused by non-steroidal antiinflammatory drugs (NSAIDs), H. pylori or endoscopic submucosal dissection [9,10,11,12,13,14,15]
The present study evaluated whether rebamipide could provide a protective effect against naproxen-induced gastric damage in healthy volunteers
Summary
Rebamipide is a gastroprotective agent with promising results against gastric damage induced by non-steroidal anti-inflammatory drugs. The present study evaluated if rebamipide protects against naproxen-induced gastric damage in healthy volunteers. Naproxen 660 – 1000 mg per day administered for 2 to 14 days is used as a model for NSAID-induced gastroduodenal damage in healthy volunteers [4,5,6,7,8]. Concomitant administration of rebamipide 100 mg with ibuprofen 600 mg t.i.d. for 7 consecutive days resulted in a mean gastric damage score of 1.3 ± 1.0, which was significantly lower than that of the control group (mean score of 2.9 ± 1.7), as assessed by the modified Lanza score (p = 0.032) [10]. In patients with rheumatic disease rebamipide 100 mg b.i.d. showed a protective effect against NSAID-induced gastric damage [18]
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
