Original Article—Alimentary Tract

Journal of Gastroenterology

, Volume 45, Issue 8, pp 816-820

First online:

Dual proton pump inhibitor plus amoxicillin as an empiric anti-H. pylori therapy: studies from the United States

  • David Y. GrahamAffiliated withDepartment of Medicine, Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine Email author 
  • , Syed Ussama JavedAffiliated withDepartment of Medicine, Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine
  • , Sara KeihanianAffiliated withDepartment of Medicine, Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine
  • , Suhaib AbudayyehAffiliated withDepartment of Medicine, Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine
  • , Antone R. OpekunAffiliated withDepartment of Medicine, Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine

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Abstract

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.

Aim

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.

Keywords

Proton pump inhibitors Helicobacter pylori Amoxicillin Clinical trial H. pylori eradication