title: Safety and efficacy of long-term esomeprazole 20 mg in Japanese patients with a history of peptic ulcer receiving daily non-steroidal anti-inflammatory drugs.
abstract: BACKGROUND
  Non-steroidal anti-inflammatory drugs (NSAIDs) are an effective and common treatment for chronic pain disorders, but long-term use is associated with risk of potentially life-threatening gastrointestinal adverse events (AEs). The proton pump inhibitor esomeprazole has been found to be effective for gastroprotection in NSAID users, but few long-term studies have been conducted in Japan.
  
  
  METHODS
  This was an open-label, multicentre, single-arm, prospective 1-year study of treatment with esomeprazole (20 mg once daily) in Japanese patients (aged ≥20 years) with endoscopic evidence of previous peptic ulcer and receiving daily oral NSAID therapy (at a stable dose) for a chronic condition. Eligibility was not dictated by type of oral NSAID. The primary objective was to determine long-term safety and tolerability of esomeprazole. Efficacy for prevention of peptic ulcers was also determined (Kaplan-Meier method). All statistical analyses were descriptive.
  
  
  RESULTS
  A total of 130 patients (73.1% women, mean age 62.1 years, 43.8% Helicobacter pylori-positive) received treatment with esomeprazole in addition to long-term NSAID therapy (most commonly for rheumatoid arthritis [n=42] and osteoarthritis [n=34]). Loxoprofen, meloxicam and diclofenac were the most commonly used NSAIDs; cyclo-oxygenase (COX)-2 selective agents were used by 16.2% of patients (n=21). Long-term compliance with esomeprazole (capsule counts) was >75% for the majority of patients. Although 16.9% of patients (n=22) experienced AEs judged to be possibly related to treatment with esomeprazole, they were mostly mild and transient. The most commonly reported possibly treatment-related AEs were abnormal hepatic function, headache, increased γ-glutamyltransferase levels and muscle spasms (2 patients each). Overall, 95.9% (95% confidence interval: 92.3, 99.4) of patients remained ulcer free at 1 year.
  
  
  CONCLUSIONS
  Long-term treatment with esomeprazole (20 mg once daily) is well tolerated and efficacious for preventing ulcer recurrence in Japanese NSAID users with a history of peptic ulcer.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier NCT00595517.
authors.affiliation: Department of Medicine, Jichi Medical University, Shimotsuke, Tochigi, Japan. sugano@jichi.ac.jp
authors.forename: Kentaro
authors.initials: K
authors.lastname: Sugano
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Kinoshita
authors.forename: Hiroto
authors.initials: H
authors.lastname: Miwa
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takeuchi
mesh_terms: D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy; D004008:Diclofenac / Q000627:therapeutic use; D064098:Esomeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007564:Japan; D008111:Liver Function Tests; D008297:Male; D000077239:Meloxicam; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy; D010437:Peptic Ulcer / Q000517:prevention & control*; D010666:Phenylpropionates / Q000627:therapeutic use; D054328:Proton Pump Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D055502:Secondary Prevention; D013035:Spasm / Q000139:chemically induced; D013843:Thiazines / Q000627:therapeutic use; D013844:Thiazoles / Q000627:therapeutic use; D013997:Time Factors; D005723:gamma-Glutamyltransferase / Q000097:blood
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010666:Phenylpropionates; D054328:Proton Pump Inhibitors; D013843:Thiazines; D013844:Thiazoles; D004008:Diclofenac; C040656:loxoprofen; D005723:gamma-Glutamyltransferase; D064098:Esomeprazole; D000077239:Meloxicam