title: Irsogladine improves small-intestinal injuries in regular users of nonsteroidal anti-inflammatory drugs.
abstract: BACKGROUND
  Nonsteroidal anti-inflammatory drugs (NSAIDs) cause a high frequency of mucosal injuries in the small intestine. However, no reliable intervention, other than cessation of NSAIDs, has been established.
  
  
  OBJECTIVE
  To evaluate whether irsogladine maleate reduces these injuries while continuing NSAID therapy.
  
  
  METHODS
  Prospective, interventional, endoscopist-blinded, randomized, controlled trial (RCT).
  
  
  METHODS
  University hospital.
  
  
  METHODS
  Patients regularly taking conventional NSAIDs for more than 4 weeks.
  
  
  METHODS
  We initially examined small-intestinal mucosal injuries by capsule endoscopy (CE) and screened participants for the RCT. In the RCT, patients with any mucosal injury were randomly assigned to the irsogladine group (4 mg/day) or the control group.
  
  
  METHODS
  The primary endpoint was the rate of mucosal injury improvement after 4 weeks of treatment monitored with a second CE.
  
  
  RESULTS
  Sixty-one patients were evaluated with the first CE. Small intestine mucosal injuries were found in 41 patients (67.2%) and erosive or ulcerative lesions in 21 patients (34.4%). The injury prevalence was not different with gastroprotective drug treatment. Of 41 patients enrolled, 39 (19 patients in the irsogladine group and 20 in the control group) completed the study. The improvement rate was significantly higher in the irsogladine group (16/19 patients; 84.2%) than in the control group (9/20 patients; 45.0%; P = .02).
  
  
  CONCLUSIONS
  Asymptomatic lesions, single-institution data, and single-blind setting.
  
  
  CONCLUSIONS
  Irsogladine maleate was effective for reducing NSAID-induced small-intestinal mucosal injury. (University Hospital Medical Information Network Clinical Trials Registry number UMIN000001507.).
authors: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
authors: Yoshihiro
authors: Y
authors: Isomura
authors: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
authors: Yutaka
authors: Y
authors: Yamaji
authors: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
authors: Atsuo
authors: A
authors: Yamada
authors: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
authors: Yoshitaka
authors: Y
authors: Watanabe
authors: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
authors: Hirobumi
authors: H
authors: Suzuki
authors: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
authors: Yuka
authors: Y
authors: Kobayashi
authors: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
authors: Shuntaro
authors: S
authors: Yoshida
authors: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
authors: Hirotsugu
authors: H
authors: Watabe
authors: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
authors: Yoshihiro
authors: Y
authors: Hirata
authors: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
authors: Haruhiko
authors: H
authors: Yoshida
authors: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
authors: Kazuhiko
authors: K
authors: Koike
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D053704:Capsule Endoscopy; D005260:Female; D006801:Humans; D007413:Intestinal Mucosa / Q000187:drug effects / Q000473:pathology*; D007421:Intestine, Small / Q000187:drug effects / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D010437:Peptic Ulcer / Q000139:chemically induced / Q000188:drug therapy*; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome; D014227:Triazines / Q000627:therapeutic use*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D014227:Triazines; C041836:irsogladine