Dual proton pump inhibitor plus amoxicillin as an empiric anti-H. pylori therapy: studies from the United States.
BACKGROUND
Studies with CYP2C19 slow metabolizers have shown that the combination of a proton pump inhibitor (PPI) plus amoxicillin (dual therapy) can reliably cure more than 90% of Helicobacter pylori infections. Theoretically, the use of a PPI dose that provides equivalent acid suppression with fast metabolizers and slow metabolizers would achieve high cure rates irrespective of the CYP2C19 genotype.


OBJECTIVE
To evaluate high-dose PPI plus amoxicillin dual therapy for H. pylori eradication.


METHODS
H. pylori-infected individuals (positive by 2 tests) received esomeprazole 40 mg plus amoxicillin 750 mg every 8 h for 14 days. The protocol was planned based on the "efficient identification strategy" requiring more than 90% success, with stop criteria of 6 or more failures within 50 patients or a cure rate of less than 80%.


RESULTS
Thirty-six patients (5 women, 31 men), average age 58 years, were enrolled before achieving stop criteria. All were first H. pylori treatments. The intention-to-treat cure was achieved in 26/36 [72.2%; 95% confidence interval (CI) = 56-84%] and in 26/35 per protocol (74.2%; 95% CI = 56-87%). There were no significant side effects. Compliance was 85% or greater in all (100% in 91.6%).


CONCLUSIONS
If the hypothesis that consistently high intragastric pH is required to reliably achieve more than 90% H. pylori eradication, our regimen was not sufficient. Success may require more than every 8 h dosing, the concomitant administration of sodium bicarbonate, or the use of a long-acting PPI. However, the result was positive in that dual therapy with the doses tested here was at least as successful as empiric triple therapy.
Graham
David Y
DY
Department of Medicine, Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, RM 3A-320 (111D), 2002 Holcombe Boulevard, Houston, TX 77030, USA. dgraham@bcm.tmc.edu
Javed
Syed Ussama
SU
Keihanian
Sara
S
Abudayyeh
Suhaib
S
Opekun
Antone R
AR
D000658:Amoxicillin / Q000008:administration & dosage / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001189:Aryl Hydrocarbon Hydroxylases / Q000235:genetics; D065731:Cytochrome P-450 CYP2C19; D004359:Drug Therapy, Combination; D064098:Esomeprazole / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects / Q000302:isolation & purification; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome; D014481:United States
D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D000658:Amoxicillin; D001189:Aryl Hydrocarbon Hydroxylases; C045793:CYP2C19 protein, human; D065731:Cytochrome P-450 CYP2C19; D064098:Esomeprazole