title: Ten days of levofloxacin-containing concomitant therapy can achieve effective Helicobacter pylori eradication in patients with type 2 diabetes.
abstract: This study investigated whether levofloxacin-containing concomitant therapy can effectively eradicate Helicobacter pylori infection in patients with type 2 diabetes mellitus (T2DM).
  
  
  
  A total of 797 T2DM patients were screened for anti-H. pylori IgG antibodies, and the presence of H. pylori infection was confirmed by13C-urea breath test. We prospectively randomized 114 of these patients to receive either 10 d of levofloxacin-concomitant therapy (n = 55) or sequential therapy (n = 59). Antimicrobial resistance of H. pylori isolates collected from the patients with T2DM (n = 109) and dyspeptic controls without DM (n = 110) was determined using the E-test. This study was approved by our Institutional Review Board (A-BR-103-021).
  
  
  
  The H. pylori eradication rates with concomitant therapy were higher than sequential therapy in both intention-to-treat (96.4% versus 81.4%, p = 0.012) and per-protocol (100% versus 85.4%, p = 0.006) analysis. The adverse effects in both groups were similarly mild. In the patients who received sequential therapy, clarithromycin resistance was significantly associated with eradication failure (p = 0.02). There were no significant differences in the antibiotic-resistant rates to amoxicillin, clarithromycin, metronidazole, tetracycline, and levofloxacin between the patients with and without T2DM.
  
  
  
  Ten days of levofloxacin-containing concomitant therapy is an effective and well-tolerated treatment to eradicate H. pylori infection for T2DM patients. Key messages Ten days of levofloxacin-containing concomitant therapy is well tolerated and superior to clarithromycin-containing sequential therapy for first-line H. pylori eradication in patients with type 2 diabetes. Clarithromycin resistance to H. pylori is the main factor associated with eradication failure in clarithromycin-containing sequential therapy in diabetic patients.
authors.affiliation: a Departments of Pediatrics , National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University , Tainan , Taiwan.|b Institutes of Clinical Medicine, College of Medicine, National Cheng Kung University , Tainan , Taiwan.
authors.forename: Yao-Jong
authors.initials: YJ
authors.lastname: Yang
authors.affiliation: b Institutes of Clinical Medicine, College of Medicine, National Cheng Kung University , Tainan , Taiwan.|c Departments of Internal Medicine , National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University , Tainan , Taiwan.
authors.forename: Chung-Tai
authors.initials: CT
authors.lastname: Wu
authors.affiliation: b Institutes of Clinical Medicine, College of Medicine, National Cheng Kung University , Tainan , Taiwan.|c Departments of Internal Medicine , National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University , Tainan , Taiwan.
authors.forename: Horng-Yih
authors.initials: HY
authors.lastname: Ou
authors.affiliation: b Institutes of Clinical Medicine, College of Medicine, National Cheng Kung University , Tainan , Taiwan.|c Departments of Internal Medicine , National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University , Tainan , Taiwan.
authors.forename: Chin-Han
authors.initials: CH
authors.lastname: Lin
authors.affiliation: b Institutes of Clinical Medicine, College of Medicine, National Cheng Kung University , Tainan , Taiwan.|c Departments of Internal Medicine , National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University , Tainan , Taiwan.
authors.forename: Hsiu-Chi
authors.initials: HC
authors.lastname: Cheng
authors.affiliation: b Institutes of Clinical Medicine, College of Medicine, National Cheng Kung University , Tainan , Taiwan.|c Departments of Internal Medicine , National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University , Tainan , Taiwan.
authors.forename: Wei-Lun
authors.initials: WL
authors.lastname: Chang
authors.affiliation: b Institutes of Clinical Medicine, College of Medicine, National Cheng Kung University , Tainan , Taiwan.|c Departments of Internal Medicine , National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University , Tainan , Taiwan.
authors.forename: Wei-Ying
authors.initials: WY
authors.lastname: Chen
authors.affiliation: d Departments of Pathology , National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University , Tainan , Taiwan.|e Department of Pathology , Ton-Yen General Hospital , Hsin-Chu County , Taiwan.
authors.forename: Hsiao-Bai
authors.initials: HB
authors.lastname: Yang
authors.affiliation: d Departments of Pathology , National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University , Tainan , Taiwan.
authors.forename: Cheng-Chan
authors.initials: CC
authors.lastname: Lu
authors.affiliation: b Institutes of Clinical Medicine, College of Medicine, National Cheng Kung University , Tainan , Taiwan.|c Departments of Internal Medicine , National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University , Tainan , Taiwan.|f Department of Internal Medicine , Tainan Hospital, Ministry of Health and Welfare , Tainan , Taiwan.
authors.forename: Bor-Shyang
authors.initials: BS
authors.lastname: Sheu
mesh_terms: D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D017291:Clarithromycin / Q000008:administration & dosage; D003924:Diabetes Mellitus, Type 2 / Q000382:microbiology*; D024881:Drug Resistance, Bacterial / Q000187:drug effects; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D064704:Levofloxacin / Q000008:administration & dosage*; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D011446:Prospective Studies; D013752:Tetracycline / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D008795:Metronidazole; D064704:Levofloxacin; D000658:Amoxicillin; D013752:Tetracycline; D017291:Clarithromycin
keywords: Antibiotic resistance; H. pylori; diabetes; eradication therapy; levofloxacin