Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial

Sugano, Kentaro; Kontani, Teiji; Katsuo, Shinichi; Takei, Yoshinori; Sakaki, Nobuhiro; Ashida, Kiyoshi; Mizokami, Yuji; Asaka, Masahiro; Matsui, Shigeyuki; Kanto, Tatsuya; Soen, Satoshi; Takeuchi, Tsutomu; Hiraishi, Hideyuki; Hiramatsu, Naoki

doi:10.1007/s00535-012-0541-z

Cited by 30 publications

(36 citation statements)

References 25 publications

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“…Such findings are consistent with another recent study of treatment with lansoprazole (15 mg od) in long-term NSAID users in Japan [18]. Notably, the nature and frequency of AEs with esomeprazole in the present study was generally consistent throughout the 1-year treatment duration, and only a small proportion of patients experienced AEs that were assessed as possibly drug-related by the investigator.…”

Section: Discussionsupporting

confidence: 93%

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

et al. 2013

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BackgroundNon-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.MethodsThis 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.ResultsA 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.ConclusionLong-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 registrationClinicalTrials.gov identifier NCT00595517.

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Section: Discussionsupporting

confidence: 93%

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

et al. 2013

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“…However, both lansoprazole and esomeprazole significantly reduce the recurrence of peptic ulcers in Japanese patients using NANSAIDs. Furthermore, at present, the use of PPIs to prevent peptic ulcer recurrence in patients using NSAIDs is approved by the Japanese health insurance system in patients using NSAIDs (7,8). The results of our study indicate that PPIs, but not H2RAs, prevent the occurrence of peptic ulcers and hemorrhagic lesions in elderly patients receiving NANSAIDs.…”

Section: Discussionsupporting

confidence: 55%

“…Moreover, the effects of PPIs are superior to those of misoprostol in preventing peptic ulcer recurrence in patients taking NSAIDs (6). Although gastric acid secretion is lower in Japanese than in Western populations, both lansoprazole and esomeprazole significantly reduce the recurrence of peptic ulcers compared with mucosal protective agents (MPAs) in NSAID users (7,8). Lansoprazole is also superior to MPAs in reducing the recurrence of peptic ulcers associated with LDA (9).…”

Section: Introductionmentioning

confidence: 99%

Proton Pump Inhibitor Treatment Decreases the Incidence of Upper Gastrointestinal Disorders in Elderly Japanese Patients Treated with NSAIDs

et al. 2014

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Objective The Japanese health insurance system approved the use of proton pump inhibitors (PPIs) for the prevention of peptic ulcers in patients using low-dose aspirin (LDA) and/or non-steroidal anti-inflammatory drugs (NSAIDs). However, many orthopedists and physicians do not prescribe PPIs to elderly patients with atrophic gastritis. The aim of this study was to determine whether PPIs are effective in preventing gastrointestinal mucosal injury in elderly Japanese patients with atrophic gastritis. Methods We examined the associations between the use of antiulcer drugs and endoscopic findings in elderly Japanese patients using LDA or NSAIDs. Patients We evaluated 100 patients using LDA and 58 patients using non-aspirin NSAIDs 65 years of age or older. All patients underwent upper GI endoscopy to detect the presence of open ulcers and hemorrhagic lesions and assess the extent of atrophic gastritis. Results Among the patients using LDA, the prevalence of open ulcers was significantly lower in the patients using PPIs than in those using mucosal protective agent only and those not receiving antiulcer treatment (p<0.001). Among the patients using NSAIDs, the patients treated with PPIs exhibited a significantly lower incidence of open ulcers than the patients not receiving antiulcer treatment (p=0.012). Open-type atrophic gastritis was observed in nearly 70% of the patients. Conclusion The use of PPI treatment is advisable in order to prevent the discontinuation of LDA or NSAIDs due to the development of gastrointestinal disorders in elderly patients with atrophic gastritis.

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“…Moreover, in a Japanese study of 24-week monitoring of patients with a history of ulcers, the usefulness of lansoprazole, as compared to placebo (mucosal protective drugs), was observed [113]. One study showed that when the NSAID-induced ulcer was healed, all patients started a combination of celecoxib plus esomeprazole or placebo.…”

Section: Commentmentioning

confidence: 99%

Evidence-based clinical practice guidelines for peptic ulcer disease 2015

et al. 2016

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The Japanese Society of Gastroenterology (JSGE) revised the evidence-based clinical practice guidelines for peptic ulcer disease in 2014 and has created an English version. The revised guidelines consist of seven items: bleeding gastric and duodenal ulcers, Helicobacter pylori (H. pylori) eradication therapy, non-eradication therapy, drug-induced ulcer, non-H. pylori, non-nonsteroidal anti-inflammatory drug (NSAID) ulcer, surgical treatment, and conservative therapy for perforation and stenosis. Ninety clinical questions (CQs) were developed, and a literature search was performed for the CQs using the Medline, Cochrane, and Igaku Chuo Zasshi databases between 1983 and June 2012. The guideline was developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Therapy is initially provided for ulcer complications. Perforation or stenosis is treated with surgery or conservatively. Ulcer bleeding is first treated by endoscopic hemostasis. If it fails, surgery or interventional radiology is chosen. Second, medical therapy is provided. In cases of NSAID-related ulcers, use of NSAIDs is stopped, and anti-ulcer therapy is provided. If NSAID use must continue, the ulcer is treated with a proton pump inhibitor (PPI) or prostaglandin analog. In cases with no NSAID use, H. pylori-positive patients receive eradication and anti-ulcer therapy. If first-line eradication therapy fails, second-line therapy is given. In cases of non-H. pylori, non-NSAID ulcers or H. pyloripositive patients with no indication for eradication therapy, non-eradication therapy is provided. The first choice is PPI therapy, and the second choice is histamine 2-receptor antagonist therapy. After initial therapy, maintenance therapy is provided to prevent ulcer relapse.

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Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial

Cited by 30 publications

References 25 publications

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

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

Proton Pump Inhibitor Treatment Decreases the Incidence of Upper Gastrointestinal Disorders in Elderly Japanese Patients Treated with NSAIDs

Evidence-based clinical practice guidelines for peptic ulcer disease 2015

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