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Efficacy of Metronidazole as Second‐Line Drug for the Treatment of Helicobacter pylori Infection in the Japanese Population: A Multicenter Study in the Tokyo Metropolitan Area

2006; Wiley; Volume: 11; Issue: 3 Linguagem: Inglês

10.1111/j.1523-5378.2006.00394.x

1523-5378

Takeshi Matsuhisa, Takashi Kawai, Tatsuhiro Masaoka, Hidekazu Suzuki, Masayoshi Ito, Yo Kawamura, K. Tokunaga, Masayuki Suzuki, Tetsuya Mine, Shinichi Takahashi, Nobuhiro Sakaki,

Gastric Cancer Management and Outcomes

Abstract Background: With the increase in the frequency of clarithromycin‐resistant Helicobacter pylori ( H. pylori ), there is rising concern about the decline of the eradication rate of this infection following treatment. The Tokyo Hp Study Group examined the eradication rate in response to a second‐line regimen consisting of proton pump inhibitor (PPI), amoxicillin, and metronidazole by conducting a multicenter study in the Tokyo Metropolitan Area. Materials and Methods: Two hundred and twenty‐eight patients with H. pylori infection, in whom the first‐line therapy with a PPI, amoxicillin, and clarithromycin administered for 1 week had failed to eradicate the infection, were enrolled in this study. These cases were randomly assigned to one of the two second‐line regimens containing metronidazole (PPI/AM 500 or PPI/AM 750 ) administered for 1 week. 13 C‐urea breath test was performed as a diagnostic method test for H. pylori infection not earlier than 8 weeks after the second‐line therapy. Results: Intention‐to‐treat (ITT) and per‐protocol (PP) analyses revealed an eradication rate of 87.6 and 90.6%, respectively, following PPI/AM 500 treatment, and 86.9 and 88.6%, respectively, following PPI/AM 750 treatment. Neither analysis revealed any significant difference in the eradication rate between PPI/AM 500 and PPI/AM 750 ( p = .876 and .621, respectively). According to ITT and PP analyses, the eradication rates following treatment with PPI/AM 500 were 85.2 and 88.5% with the use of lansoprazole, 62.5 and 62.5% with the use of omeprazole, and 93.2 and 96.5% with the use of rabeprazole, respectively. There was a significant difference in the eradication rates between PPI (omeprazole)/AM 500 and PPI (rabeprazole)/AM 500 . In the case of PPI/AM 750 , the corresponding eradication rates were 84.8 and 87.0% with the use of lansoprazole, 92.9 and 92.9% with the use of omeprazole, and 92.9 and 92.9% with the use of rabeprazole, respectively. There were no significant differences in the eradication rates obtained with the use of the three PPIs. Conclusions: Both PPI/AM 500 and PPI/AM 750 administered for 1 week appeared to be highly effective second‐line regimens for the treatment of H. pylori infection in Japanese patients. From the viewpoint of adverse events, PPI/AM 500 appeared to be safe compared with PPI/AM 750 .