Triple therapy: Amoxicillin 1 gram twice daily/ clarithromycin 500 mg twice daily/ lansoprazole 30 mg twice daily. Dual therapy: Amoxicillin 1 gram 3 times daily/ lansoprazole 30 mg 3 times daily. All treatments were for 14 days. H. pylori eradication was defined as 2 negative tests (culture and histology) at 4 to 6 weeks following the end of treatment. Triple therapy was shown to be more effective than all possible dual therapy combinations. Dual therapy was shown to be more effective than both monotherapies. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. H. pylori Eradication Rates ? Triple Therapy (amoxicillin/ clarithromycin/ lansoprazole) Percent of Patients Cured [95% Confidence Interval] (Number of Patients) Triple Therapy Triple Therapy Study Evaluable Analysis * Intent-to-Treat Analysis * Study 1 92 * [80.0? 97.7] (n = 48) 86 * [73.3? 93.5] (n = 55) Study 2 86 § [75.7? 93.6] (n = 66) 83 § [72.0? 90.8] (n = 70) * This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest ® , (Delta West Ltd., Bentley, Australia), histology, and/ or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. * Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy. * (p< 0.05) versus lansoprazole/ amoxicillin and lansoprazole/ clarithromycin dual therapy. § (p< 0.05) versus clarithromycin/ amoxicillin dual therapy. H. pylori Eradication Rates ? Dual Therapy (amoxicillin/ lansoprazole) Percent of Patients Cured [95% Confidence Interval] (Number of Patients) Dual Therapy Dual Therapy Study Evaluable Analysis * Intent-to-Treat Analysis * Study 1 77 ** [62.5? 87.2] (n = 51) 70 ** [56.8? 81.2] (n = 60) Study 2 66 §§ [51.9? 77.5] (n = 58) 61 §§ [48.5? 72.9] (n = 67) * This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest ® , histology, and/ or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. * Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy. ** (p< 0.05) versus lansoprazole alone. §§ (p< 0.05) versus lansoprazole alone or amoxicillin alone. REFERENCES 1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically -Fourth Edition; Approved Standard. NCCLS Document M7-A4, Vol. 17, No. 2. NCCLS, Wayne, PA, January 1997. 2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests -Sixth Edition; Approved Standard. NCCLS Document M2-A6, Vol. 17, No. 1. NCCLS, Wayne, PA, January 1997. 3. Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol 1988; 30: 66-67. DATE OF ISSUANCE MAY 2003 ©2003, GlaxoSmithKline All rights reserved. GlaxoSmithKline Research Triangle Park, NC 27709 AM: L23 | ||||
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