Randomised clinical trial: esomeprazole for the prevention of nonsteroidal anti‐inflammatory drug‐related peptic ulcers in <scp>J</scp>apanese patients

Sugano, Kentaro; Kinoshita, Yoshikazu; Miwa, Hiroto; Takeuchi, Tsutomu

doi:10.1111/j.1365-2036.2012.05133.x

Cited by 25 publications

(19 citation statements)

References 29 publications

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“…Indeed, the ulcer-free rate with esomeprazole 20 mg od in the present 1-year study (95.9%) is better than those seen in the placebo-controlled, 6-month VENUS and PLUTO studies (ulcer-free rates of 94.7% and 94.8%, respectively; life-table estimates) [13]. A double-blind, randomised placebo-controlled trial conducted in Japan also showed superior efficacy of esomeprazole in preventing NSAID-related ulcer recurrence compared with Western studies [14]. …”

Section: Discussionmentioning

confidence: 68%

“…The proton pump inhibitor (PPI) esomeprazole has been shown to be efficacious in the prevention of peptic ulcers and upper GI symptoms related to NSAID use in European, North American and Japanese patients [12-14], but few long-term studies have been conducted in the corresponding Japanese population. The present study therefore investigated the safety and tolerability of long-term treatment with esomeprazole 20 mg in Japanese patients with an endoscopically-confirmed history of peptic ulcer who were also receiving daily NSAID therapy.…”

Section: Introductionmentioning

confidence: 99%

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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: Discussionmentioning

confidence: 68%

Section: Introductionmentioning

confidence: 99%

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: Discussionmentioning

confidence: 59%

“…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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“…The long-term administration of proton pump inhibitors (PPIs) is useful for preventing recurrent reflux esophagitis or recurrent gastroduodenal ulcers induced by nonsteroidal anti-inflammatory drugs or low-dose aspirin [1, 2]. However, several adverse reactions, such as an increase in the blood gastrin level, have been reported.…”

Section: Introductionmentioning

confidence: 99%

Does the Novel Potassium-Competitive Acid Blocker Vonoprazan Cause More Hypergastrinemia than Conventional Proton Pump Inhibitors? A Multicenter Prospective Cross-Sectional Study

Kojima¹,

Takeuchi²,

Sanomura³

et al. 2018

Digestion

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Background/Aim: The long-term administration of proton pump inhibitors (PPIs) is useful for preventing recurrent reflux esophagitis. On the other hand, several adverse reactions, such as an increase in the blood gastrin level, have been reported. The aim of the present study was to examine the increase in the blood gastrin level due to the long-term administration of conventional PPIs compared with vonoprazan. Methods: A prospective cross-sectional study was conducted. We examined the blood gastrin levels of patients taking vonoprazan or conventional PPIs in whom the grade of atrophic gastritis had been endoscopically evaluated in the last year. Results: The blood gastrin level was significantly higher in the vonoprazan group than that in the PPI group in patients with milder or no atrophic gastritis, irrespective of the administration periods. However, no significant difference was observed between the groups in patients with severe atrophic gastritis. Conclusion: Vonoprazan more markedly increased the blood gastrin level compared with conventional PPIs in patients with milder or no atrophic gastritis. This indicates that vonoprazan may have stronger acid-suppressing effects in such patients than conventional PPIs. Key Message: We should be aware of the potential development of hypergastrinemia during the long-term administration of vonoprazan, especially in patients with mild or no atrophic gastritis.

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Randomised clinical trial: esomeprazole for the prevention of nonsteroidal anti‐inflammatory drug‐related peptic ulcers in Japanese patients

Abstract: SUMMARY BackgroundThe use of proton pump inhibitors for prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced gastrointestinal adverse events is well documented. However, data regarding the efficacy and safety of this approach in Japan are scarce.

Cited by 25 publications

References 29 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

Does the Novel Potassium-Competitive Acid Blocker Vonoprazan Cause More Hypergastrinemia than Conventional Proton Pump Inhibitors? A Multicenter Prospective Cross-Sectional Study

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