High Dose (240 mg) Dexlansoprazole Plus Amoxicillin for H. pylori Infection
Abstract
Purpose: To examine whether amoxicillin and high dose dexlansoprazole would reliably achieve H. pylori infections eradication >90%. Methods: An open-label prospective pilot study of H. pylori eradication in treatment-naïve subjects with active H. pylori infection (positive by two tests). Each received amoxicillin 1 g and dexlansoprazole 120 mg each twice a day at approximately 12 hour intervals for 14 days. Success was accessed by urea breath test 4-6 weeks after the end of therapy. An effective therapy was defined as a per-protocol treatment success of 90% or greater; treatment success of 80% or less was prespecified as an unacceptable result. Results: After 13 subjects were entered (12 men, one woman; average age of 54 years) the prespecified stopping rule of 6 treatment failures was achieved (i.e. the 95% confidence interval excluded achieving the required 90% success rate even if 50 patients were entered) and enrollment was stopped. Perprotocol and intention-to-treat treatment success were both 53.8%; (7/13); 95% CI = 25 to 80%. Compliance was 100%. Three patients (23%) reported side effects, all of which were mild and none interrupted therapy. Conclusion: Theoretically, and from experience in Japan, dual PPI plus amoxicillin should successfully eradicate H. pylori provided the intragastric pH can be maintained as near neutral. Clearly, dexlansoprazole, despite being administered at high dose and twice a day (i.e., total daily dose 240 mg), failed to achieve an…
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