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薬理と治療
Abstract
Objective Esomeprazole, the S-isomer of omeprazole, was approved in 2011 in Japan and has since been widely used in clinical practice. Non-steroidal anti-inflammatory drugs(NSAIDs) are also widely used for chronic pain control; however, long-term use of NSAIDs is an established risk factor for peptic ulcer. This specific clinical experience investigation was conducted to confirm the long-term safety and efficacy of esomeprazole for the prevention of NSAID-related peptic ulcer in actual clinical practice. Design Safety and efficacy of esomeprazole were evaluated in the prospective case series setting. Methods Patients receiving long-term NSAIDs therapy for chronic pain control and treated with esomeprazole for the first time for prevention of recurrence of peptic ulcer were enrolled in this survey. Twenty mg of esomeprazole was administrated once a day, and the observation period was set at 1 year. Patients were enrolled via a central registration system. Adverse drug reactions, severe adverse events, ulcer -free rates, subjective symptoms, and factors that may affect safety and efficacy of esomeprazole were investigated from April 2012 to September 2014. Results In the safety analysis set of 1521 patients, 38 events of adverse drug reactions were reported in 26 patients(1.7%). No time-related trend was observed in the adverse drug reaction rate. In the efficacy analysis, ulcer-free rates were 92.7%, 90.7%, and 89.9% at 12 weeks, 24 weeks, and 52 weeks, respectively. Rates of disappearance of subjective symptoms were 90.1% for epigastric pain, 80.6% for anorexia, 80.7% for abdominal bloating, 89.7% for heartburn, 90.0% for nausea, 95.5% for vomiting, and 82.2% for burping. No new issues regarding the safety and efficacy profile of esomeprazole were found in this survey. Conclusion The present survey demonstrated that esomeprazole provides good tolerability and long-term protection against the recurrence of NSAID-related peptic ulcer in actual clinical practice in Japan.
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