PMID- 23315395
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20130115
LR  - 20211021
IS  - 1173-2563 (Print)
IS  - 1173-2563 (Linking)
VI  - 22
IP  - 2
DP  - 2002
TI  - Comparison of Three 7-Day Pantoprazole-Based Helicobacter pylori Eradication 
      Regimens in a Mexican Population with High Metronidazole Resistance.
PG  - 75-85
LID - 10.2165/00044011-200222020-00002 [doi]
AB  - OBJECTIVE: To compare the efficacy and tolerability of three 7-day 
      pantoprazole-based regimens to eradicate Helicobacter pylori in Mexican patients 
      with peptic ulcer (PU) or non-ulcer dyspepsia (NUD). BACKGROUND: Short-term 
      therapeutic regimens based on a proton pump inhibitor (PPI) and two antibiotics 
      have been recommended for the eradication of H. pylori. Resistance of H. pylori 
      to metronidazole may adversely affect the efficacy of such regimens. PATIENTS AND 
      METHODS: This was a single-centre, randomised, open-label, parallel-group study 
      in which three groups of H. pylori-positive patients with PU or NUD were compared 
      (n = 159; intention-to-treat population). Patients were randomised to receive a 
      7-day pantoprazole-based triple therapy for eradication of H. pylori. Patients 
      received pantoprazole (P) 40mg twice daily in combination with either i) 
      amoxicillin (A) 1000mg twice daily and clarithromycin (C) 500mg three times daily 
      (PAC regimen, n = 51 patients), or ii) clarithromycin 500mg three times daily and 
      metronidazole (M) 500mg three times daily (PCM regimen, n = 55 patients), or iii) 
      amoxicillin 1000mg twice daily and metronidazole 500mg three times daily (PAM 
      regimen, n = 53 patients). After completing eradication therapy, all PU patients 
      were further treated with once-daily pantoprazole 40mg, either for another 3 
      weeks (patients with duodenal ulcer) or for another 7 weeks (patients with 
      gastric ulcer), to ensure complete ulcer healing. At baseline examination, all 
      patients underwent the (14)C-urea breath test and endoscopy; biopsy specimens 
      were taken for histology, CLO-test, H. pylori culture and antibiotic 
      susceptibility testing (agar dilution E-test). Eradication of H. pylori was 
      assessed after all treatment with pantoprazole had been discontinued for at least 
      4 weeks, using the (14)C-urea breath test. RESULTS: In the per-protocol 
      population (n = 153), eradication was achieved in 81.3% (39/48) of patients 
      receiving PAC, 66.0% (35/53) of PCM recipients, and 48.1 % (25/52) of those 
      receiving PAM (p = 0.13 for PAC vs PCM and 0.001 for PAC vs PAM). In the 
      intention-to-treat population, respective eradication rates were 76.5 (39/51), 
      63.6 (35/55) and 47.2% (25/53) [p = 0.22 for PAC vs PCM and 0.004 for PAC vs 
      PAM]. Patient compliance was very good in all treatment groups. The main adverse 
      event affecting 40% of all patients was a metallic taste, assessed as likely 
      related to the antibiotics. Susceptibility to the three study antibiotics was 
      determined for H. pylori isolates using the pretreatment biopsies from 103 
      patients. Resistance to metronidazole was present in 68.2% of patients and to 
      clarithromycin in 24.3%. In 16.8% of patients, H. pylori isolates were resistant 
      to both metronidazole and clarithromycin. In patient populations with H. pylori 
      strains resistant to one or both of the antibiotics used in the respective 
      treatment regimen, eradication rates were consistently lower than in those with 
      susceptible H. pylori strains. However, these differences were not statistically 
      significant, probably due to the small sample size. CONCLUSIONS: The 7-day H. 
      pylori eradication regimen with PAC was superior to PCM and PAM. This is probably 
      due to the high resistance rate to metronidazole in the Mexican population. Thus, 
      H. pylori eradication regimens that involve metronidazole cannot be recommended 
      for Mexican patients. RESULTS from this study highlight the regional differences 
      in efficacy of some well established H. pylori eradication regimens, and suggest 
      that culture and susceptibility testing to define H. pylori resistance patterns 
      in specific geographical areas may be indicated before recommending any 
      particular eradication schedule.
FAU - Dehesa, M
AU  - Dehesa M
AD  - Hospital Especialidades, Centro Medico Nacional Siglo XXI IMSS, Mexico, 
      mdehesa@prodigy.net.mx.
FAU - Larisch, J
AU  - Larisch J
FAU - Dibildox, M
AU  - Dibildox M
FAU - Di Silvio, M
AU  - Di Silvio M
FAU - Lopez, L H
AU  - Lopez LH
FAU - Ramirez-Barba, E
AU  - Ramirez-Barba E
FAU - Torres, J
AU  - Torres J
LA  - eng
PT  - Journal Article
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
EDAT- 2002/01/01 00:00
MHDA- 2002/01/01 00:01
CRDT- 2013/01/15 06:00
PHST- 2013/01/15 06:00 [entrez]
PHST- 2002/01/01 00:00 [pubmed]
PHST- 2002/01/01 00:01 [medline]
AID - 10.2165/00044011-200222020-00002 [doi]
PST - ppublish
SO  - Clin Drug Investig. 2002;22(2):75-85. doi: 10.2165/00044011-200222020-00002.