PMID- 30060902
OWN - NLM
STAT- MEDLINE
DCOM- 20200127
LR  - 20210525
IS  - 2255-534X (Electronic)
IS  - 2255-534X (Linking)
VI  - 84
IP  - 3
DP  - 2019 Jul-Sep
TI  - Helicobacter pylori eradication in Mexico with a levofloxacin-based scheme versus 
      standard triple therapy: Results from an open-label, randomized, noninferiority 
      phase iiib trial.
PG  - 274-283
LID - S0375-0906(18)30132-0 [pii]
LID - 10.1016/j.rgmx.2018.04.005 [doi]
AB  - INTRODUCTION AND AIMS: Helicobacter pylori (H. pylori) infection remains the 
      leading cause of several gastroduodenal diseases. Despite the fact that multiple 
      antibiotic regimens have been used to change its associated morbidity and 
      mortality, the prevalence of this bacterial infection continues to be 
      disproportionately high worldwide, mainly due to antibiotic resistance. To assess 
      the noninferiority efficacy and safety of 210-day triple regimens on H. pylori 
      eradication, we evaluated clarithromycin 500mg, lansoprazole 30mg, and 
      amoxicillin 1g, all bid (standard triple therapy or CLA, Group 1) vs. 
      pantoprazole 80mg, levofloxacin 500mg and azithromycin 500mg, all od (PLA, Group 
      2). Both regimens were compared in treatment-naive patients. MATERIALS AND 
      METHODS: An open label phase IIIb randomized and noninferiority trial comparing 
      CLA vs. PLA was carried out for a 10-day period, within the time frame of June 
      2012 and March 2014. Eradication was verified with (13)C-urea breath testing. 
      Gastric biopsies were tested for fluorescence in situ hybridization 
      (FISH)-clarithromycin resistance prior to any antibiotic administration. Efficacy 
      and safety results were analyzed according to the noninferiority methodological 
      approach. RESULTS: From the 227 H. pylori positive subjects that were randomized, 
      194 were finally analyzed as per-protocol. The group 2 eradication rate was 63% 
      and was noninferior to the group 1 eradication rate of 58.5% (upper limit 95% CI: 
      0.11608; below the noninferiority margin: 0.1200). FISH clarithromycin-resistance 
      was found in 28.2% of the cases. Adverse events, all minor and self-limited, were 
      significantly higher in group 1 than in group 2 (86 vs. 65.4%; p=0.001). 
      CONCLUSIONS: First-line H. pylori eradication with 
      pantoprazole/levofloxacin/azithromycin combination therapy is as effective as the 
      standard triple therapy, with better tolerability and easier dosing. 
      Clarithromycin resistance should be considered when selecting antibiotics in 
      Helicobacter pylori eradication treatments. ClinicalTrials.gov identifier 
      NCT02726269.
CI  - Copyright (c) 2018 Asociacion Mexicana de Gastroenterologia. Publicado por Masson 
      Doyma Mexico S.A. All rights reserved.
FAU - Ladron-de-Guevara, L
AU  - Ladron-de-Guevara L
AD  - Servicio de Gastroenterologia, Hospital Angeles Clinica Londres, Ciudad de 
      Mexico, Mexico.
FAU - Bornstein-Quevedo, L
AU  - Bornstein-Quevedo L
AD  - Laboratorio de Inmunohistoquimica y Patologia Molecular, InmunoQ, Ciudad de 
      Mexico, Mexico.
FAU - Gonzalez-Huezo, S
AU  - Gonzalez-Huezo S
AD  - Servicio de Gastroenterologia, Torre Mayo, Metepec, Estado de Mexico, Mexico.
FAU - Castaneda-Romero, B
AU  - Castaneda-Romero B
AD  - Servicio de Gastroenterologia, Hospital Angeles Metropolitano, Ciudad de Mexico, 
      Mexico.
FAU - Costa, F G
AU  - Costa FG
AD  - Laboratorio Asofarma S.A.I. y C. Argentina. Electronic address: 
      fcosta@asofarma.com.
FAU - di Silvio-Lopez, M
AU  - di Silvio-Lopez M
AD  - Servicio de Gastroenterologia, Centro Medico ABC Observatorio, Ciudad de Mexico, 
      Mexico.
LA  - eng
LA  - spa
SI  - ClinicalTrials.gov/NCT02726269
PT  - Comparative Study
PT  - Equivalence Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
TT  - Erradicacion de Helicobacter pylori en Mexico con un esquema basado en 
      levofloxacina versus la triple terapia estandar: resultados de un estudio clinico 
      de fase iiib, abierto, aleatorizado, de no inferioridad.
DEP - 20180727
PL  - Mexico
TA  - Rev Gastroenterol Mex (Engl Ed)
JT  - Revista de gastroenterologia de Mexico (English)
JID - 101778603
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Proton Pump Inhibitors)
RN  - 6GNT3Y5LMF (Levofloxacin)
RN  - H1250JIK0A (Clarithromycin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anti-Bacterial Agents/*therapeutic use
MH  - Breath Tests
MH  - Clarithromycin/pharmacology
MH  - Drug Combinations
MH  - Drug Resistance, Bacterial
MH  - Drug Therapy, Combination
MH  - Female
MH  - Helicobacter Infections/*drug therapy/microbiology/pathology
MH  - *Helicobacter pylori/drug effects
MH  - Humans
MH  - Levofloxacin/*therapeutic use
MH  - Male
MH  - Mexico
MH  - Middle Aged
MH  - Proton Pump Inhibitors/therapeutic use
MH  - Stomach/microbiology/pathology
OTO - NOTNLM
OT  - Clarithromycin
OT  - Claritromicina
OT  - Helicobacter pylori
OT  - Inhibidores de bombas de protones
OT  - Levofloxacin
OT  - Levofloxacina
OT  - Proton pump inhibitors
EDAT- 2018/08/01 06:00
MHDA- 2020/01/28 06:00
CRDT- 2018/08/01 06:00
PHST- 2018/01/16 00:00 [received]
PHST- 2018/03/26 00:00 [revised]
PHST- 2018/04/19 00:00 [accepted]
PHST- 2018/08/01 06:00 [pubmed]
PHST- 2020/01/28 06:00 [medline]
PHST- 2018/08/01 06:00 [entrez]
AID - S0375-0906(18)30132-0 [pii]
AID - 10.1016/j.rgmx.2018.04.005 [doi]
PST - ppublish
SO  - Rev Gastroenterol Mex (Engl Ed). 2019 Jul-Sep;84(3):274-283. doi: 
      10.1016/j.rgmx.2018.04.005. Epub 2018 Jul 27.