title: Safety and efficacy of 1-week levofloxacin-based triple therapy in first-line treatment for Helicobacter pylori-related peptic ulcer disease in Kashmir, India.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Gastroenterology, Sher-i-Kashmir Institute of Medical Sciences, Soura, Srinagar, Jammu and Kashmir, India.
authors.forename: Altaf
authors.initials: A
authors.lastname: Shah
authors.forename: Gul
authors.initials: G
authors.lastname: Javid
authors.forename: Showkat Ali
authors.initials: SA
authors.lastname: Zargar
authors.forename: Farooq
authors.initials: F
authors.lastname: Teli
authors.forename: Bashir Ahmad
authors.initials: BA
authors.lastname: Khan
authors.forename: Ghulam Nabi
authors.initials: GN
authors.lastname: Yattoo
authors.forename: Ghulam Mohammad
authors.initials: GM
authors.lastname: Gulzar
authors.forename: Jaswinder Singh
authors.initials: JS
authors.lastname: Sodhi
authors.forename: Mushtaq Ahmad
authors.initials: MA
authors.lastname: Khan
authors.forename: Abid
authors.initials: A
authors.lastname: Shoukat
authors.forename: Reyaz
authors.initials: R
authors.lastname: Saif
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D000897:Anti-Ulcer Agents / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer / Q000188:drug therapy / Q000453:epidemiology / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D015994:Incidence; D007194:India; D064704:Levofloxacin / Q000008:administration & dosage*; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage*; D008875:Middle Aged; D010437:Peptic Ulcer / Q000188:drug therapy* / Q000453:epidemiology / Q000209:etiology; D011446:Prospective Studies; D013276:Stomach Ulcer / Q000188:drug therapy / Q000453:epidemiology / Q000209:etiology; D014011:Tinidazole / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D014011:Tinidazole; D008795:Metronidazole; D064704:Levofloxacin