Preventive effect of irsogladine or omeprazole on non-steroidal anti-inflammatory drug-induced esophagitis, peptic ulcers, and small intestinal lesions in humans, a prospective randomized controlled study

• Published in: BMC gastroenterology 2013-05, Vol.13 (1), p.85-85, Article 85
• Main Authors: Kuramoto, Takanori, Umegaki, Eiji, Nouda, Sadaharu, Narabayashi, Ken, Kojima, Yuichi, Yoda, Yukiko, Ishida, Kumi, Kawakami, Ken, Abe, Yosuke, Takeuchi, Toshihisa, Inoue, Takuya, Murano, Mitsuyuki, Tokioka, Satoshi, Higuchi, Kazuhide
• Format: Article
• Language: English
• Subjects: Adult; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Anti-Ulcer Agents - therapeutic use; Comparative analysis; Consent; Diclofenac - adverse effects; Drug dosages; Endoscopy, Gastrointestinal; Esophagitis - chemically induced; Esophagitis - prevention & control; Feces - chemistry; Female; Gastroenterology; Gastrointestinal diseases; Humans; Injuries; Intestinal Mucosa - pathology; Intestine, Small - pathology; Leukocyte L1 Antigen Complex - analysis; Male; Occult Blood; Omeprazole - therapeutic use; Peptic Ulcer - chemically induced; Peptic Ulcer - prevention & control; Prevention; Proton pump inhibitors; Recruitment; Small intestine; Studies; Triazines - therapeutic use; Ulcers; Young Adult
• ISSN: 1471-230X; 1471-230X
• DOI: 10.1186/1471-230x-13-85

Proton-pump inhibitors such as omeprazole are a standard treatment to prevent non-steroidal anti-inflammatory drug-induced upper gastrointestinal mucosal injuries. However, it is unclear which drugs may protect against all NSAID-induced digestive-tract injuries. Here, we compare the efficacy of the gastromucoprotective drug irsogladine with omeprazole in preventing NSAID-induced esophagitis, peptic ulcers, and small-intestinal mucosal injury in healthy subjects. Thirty-two healthy volunteers were assigned to an irsogladine group (Group I; n = 16) receiving diclofenac sodium 75 mg and irsogladine 4 mg daily for 14 days, or an omeprazole group (Group O; n = 16) receiving diclofenac sodium 75 mg and omeprazole 10 mg daily for 14 days. Esophagitis and peptic ulcers were evaluated by esophagogastroduodenoscopy and small-intestinal injuries by capsule endoscopy, fecal calprotectin, and fecal occult blood before and after treatment. There was no significant difference between Group I and Group O with respect to the change in lesion score in the esophagus, stomach, and duodenum before and after treatment.NSAID treatment significantly increased the number of small intestinal mucosal breaks per subject by capsule endoscopic evaluation, from a basal level of 0.1 ± 0.3 up to 1.9 ± 2.0 lesions in Group O (p = 0.0002). In contrast, there were no significant changes in the mean number of mucosal breaks before and after co-treatment in Group I (0.3 ± 0.8 to 0.5 ± 0.7, p = 0.62), and the between-group difference was significant (p = 0.0040). Fecal calprotectin concentration, when the concentration before treatment was defined as 1, was significantly increased both in Group O (from 1.0 ± 0.0 to 18.1 ± 37.1, p = 0.0002) and Group I (from 1.0 ± 0.0 to 6.0 ± 11.1, p = 0.0280); the degree of increase in Group O was significantly higher compared with that in Group I (p