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薬理と治療
Abstract
Objective To investigate the safety and efficacy of esomeprazole(Nexium® capsules)for preventing the recurrence of gastric╱duodenal ulcers in patients receiving continuous low-dose aspirin to prevent thrombosis or embolism in the real world. Methods This post marketing surveillance study(observation period of 2 years)was conducted using a central registration method. The main safety outcomes were rates of adverse drug reactions(ADRs), infections, and serious adverse events(SAEs). Efficacy was assessed in terms of the recurrence of gastric╱duodenal ulcers and disappearance of subjective symptoms. We also analyzed whether patient background characteristics or treatment regimens were associated with safety or efficacy outcomes. Results Overall, 2295 patients were included in the safety analysis. ADRs occurred in 63 (2.7%)patients. ADRs in three or more patients were constipation(8 patients, 0.3%), diarrhea (5 patients, 0.2%), death(4 patients, 0.2%), and anemia, abdominal distension, dyspepsia and pruritus(3 patients each, 0.1%). Seventeen SAEs occurred in 14 patients. This included seven ADRs in five patients who died and a causal relationship with esomeprazole was not ruled out. The rates of ADRs and SAEs did not increase with long-term administration of esomeprazole. The non-recurrence rates of gastric╱duodenal ulcers were 98.5%, 97.8%, 97.4%, 96.4%, and 92.7% at 12, 24, 36, 52, and 104 weeks, respectively. The disappearance rates of subjective symptoms at the final evaluation were 83.9%, 76.7%, 80.2%, 86.1%, 88.6%, 88.7%, and 79.7% for epigastric pain, anorexia, abdominal distension, heartburn, nausea, vomiting, and belching, respectively. Conclusion This post marketing surveillance of long-term use of esomeprazole found no new safety problems and confirmed its long-term efficacy.
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