PMID- 23530709
OWN - NLM
STAT- MEDLINE
DCOM- 20131204
LR  - 20211021
IS  - 1471-230X (Electronic)
IS  - 1471-230X (Linking)
VI  - 13
DP  - 2013 Mar 26
TI  - 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.
PG  - 54
LID - 10.1186/1471-230X-13-54 [doi]
AB  - 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 gamma-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. CONCLUSION: 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. TRIAL REGISTRATION: 
      ClinicalTrials.gov identifier NCT00595517.
FAU - Sugano, Kentaro
AU  - Sugano K
AD  - Department of Medicine, Jichi Medical University, Shimotsuke, Tochigi, Japan. 
      sugano@jichi.ac.jp
FAU - Kinoshita, Yoshikazu
AU  - Kinoshita Y
FAU - Miwa, Hiroto
AU  - Miwa H
FAU - Takeuchi, Tsutomu
AU  - Takeuchi T
CN  - Esomeprazole NSAID Preventive Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT00595517
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20130326
PL  - England
TA  - BMC Gastroenterol
JT  - BMC gastroenterology
JID - 100968547
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Phenylpropionates)
RN  - 0 (Proton Pump Inhibitors)
RN  - 0 (Thiazines)
RN  - 0 (Thiazoles)
RN  - 144O8QL0L1 (Diclofenac)
RN  - 3583H0GZAP (loxoprofen)
RN  - EC 2.3.2.2 (gamma-Glutamyltransferase)
RN  - N3PA6559FT (Esomeprazole)
RN  - VG2QF83CGL (Meloxicam)
SB  - IM
MH  - Aged
MH  - Anti-Inflammatory Agents, Non-Steroidal/*therapeutic use
MH  - Arthritis, Rheumatoid/drug therapy
MH  - Diclofenac/therapeutic use
MH  - Esomeprazole/adverse effects/*therapeutic use
MH  - Female
MH  - Headache/chemically induced
MH  - Humans
MH  - Japan
MH  - Liver Function Tests
MH  - Male
MH  - Meloxicam
MH  - Middle Aged
MH  - Osteoarthritis/drug therapy
MH  - Peptic Ulcer/*prevention & control
MH  - Phenylpropionates/therapeutic use
MH  - Proton Pump Inhibitors/adverse effects/*therapeutic use
MH  - Secondary Prevention
MH  - Spasm/chemically induced
MH  - Thiazines/therapeutic use
MH  - Thiazoles/therapeutic use
MH  - Time Factors
MH  - gamma-Glutamyltransferase/blood
PMC - PMC3623652
EDAT- 2013/03/28 06:00
MHDA- 2013/12/16 06:00
PMCR- 2013/03/26
CRDT- 2013/03/28 06:00
PHST- 2012/07/10 00:00 [received]
PHST- 2013/03/18 00:00 [accepted]
PHST- 2013/03/28 06:00 [entrez]
PHST- 2013/03/28 06:00 [pubmed]
PHST- 2013/12/16 06:00 [medline]
PHST- 2013/03/26 00:00 [pmc-release]
AID - 1471-230X-13-54 [pii]
AID - 10.1186/1471-230X-13-54 [doi]
PST - epublish
SO  - BMC Gastroenterol. 2013 Mar 26;13:54. doi: 10.1186/1471-230X-13-54.