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Safety and efficacy of 1-week levofloxacin-based triple therapy in first-line treatment for Helicobacter pylori-related peptic ulcer disease in Kashmir, India

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Abstract

Background and Objectives

There is no ideal therapy for eradication of Helicobacter pylori infection. We evaluated the efficacy and safety of 1-week triple therapy with rabeprazole, levofloxacin, and tinidazole in a metronidazole resistance prevalent region for eradicating H. pylori infection in patients with gastroduodenal ulcers.

Methods

This was an open-label, prospective study. Consecutive patients with endoscopy-proven duodenal or gastric ulcer and who were H. pylori-positive were treated with levofloxacin 500 mg once a day, rabeprazole 20 mg twice a day, and tinidazole 500 mg twice daily for 7 days followed by rabeprazole 20 mg OD for 8 weeks. Endoscopy was repeated 8 weeks after the end of therapy to check for ulcer healing and H. pylori status.

Results

One hundred and thirty-one patients with gastroduodenal ulcers (duodenal 118, and gastric 13) were included. Drug compliance was 97.7 %. The eradication rate of H. pylori by intention-to-treat analysis was 85.5 % (95 % confidence interval 79.5–91.5) (112 of 131 patients) and by per-protocol analysis was 91.8 % (95 % confidence interval 86.9–96.7) (112 of 122 patients). Adverse effects were reported in 17 %: abdominal pain in 3.05 %, metallic taste in 6.87 %, and nausea and vomiting in 4.58 %.

Conclusions

Levofloxacin–tinidazole-based triple therapy was highly effective and safe as a first-line regimen in Indian patients with gastroduodenal ulcer disease associated with H. pylori infection. The regimen was well tolerated.

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Authors and Affiliations

  1. Department of Gastroenterology, Sher-i-Kashmir Institute of Medical Sciences, Soura, Srinagar, Jammu and Kashmir, 190 011, India

    Altaf Shah, Gul Javid, Showkat Ali Zargar, Farooq Teli, Bashir Ahmad Khan, Ghulam Nabi Yattoo, Ghulam Mohammad Gulzar, Jaswinder Singh Sodhi, Mushtaq Ahmad Khan, Abid Shoukat & Reyaz Saif

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  1. Altaf Shah
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  2. Gul Javid
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  3. Showkat Ali Zargar
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  4. Farooq Teli
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  7. Ghulam Mohammad Gulzar
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  8. Jaswinder Singh Sodhi
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Correspondence to Showkat Ali Zargar.

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Shah, A., Javid, G., Zargar, S.A. et al. Safety and efficacy of 1-week levofloxacin-based triple therapy in first-line treatment for Helicobacter pylori-related peptic ulcer disease in Kashmir, India. Indian J Gastroenterol 32, 32–36 (2013). https://doi.org/10.1007/s12664-012-0285-y

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  • DOI: https://doi.org/10.1007/s12664-012-0285-y

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