Crises in Antimicrobial Stewardship: Misuse of Clarithromycin for Helicobacter pylori Therapy

Authors

David Y Graham

Publication Date

3-1-2024

Journal

Pharmacoepidemiology

DOI

10.3390/pharma3010006

PMID

39777230

PMCID

PMC11706568

PubMedCentral® Posted Date

1-7-2025

PubMedCentral® Full Text Version

Author MSS

Published Open-Access

yes

Keywords

clarithromycin, antimicrobial stewardship, Helicobacter pylori, therapy, vonoprazan, antibiotic misuse, concomitant therapy, Food and Drug Administration, Centers for Medicare and Medicaid Services, Executive Order on Combating Antibiotic-Resistant Bacteria

Abstract

Helicobacter pylori is a class I carcinogen that infects more than 100 million individuals in the United States. Antimicrobial therapy for H. pylori has typically been prescribed empirically rather than based on susceptibility testing. Until recently, therapeutic recommendations have generally ignored the principles of antibiotic stewardship. A combination of a proton pump inhibitor (PPI), amoxicillin, and clarithromycin (triple therapy) remains popular despite increasing clarithromycin resistance and poor cure rates. Concomitant therapy (a PPI, amoxicillin, clarithromycin, and metronidazole) is recommended and widely used despite all patients receiving at least one unneeded antibiotic. In 2020, the Food and Drug Administration approved vonoprazan, amoxicillin, and clarithromycin triple therapy, which administers unneeded clarithromycin to >90% of patients (i.e., ~6 tons of unneeded clarithromycin/million treatments). In the late 1980s, the infectious disease community functionally transferred responsibility for the management of H. pylori to gastroenterology, which has managed the infection as another common gastrointestinal disease such as constipation. In 2022, both traditional and noninvasive molecular-based susceptibility testing for H. pylori became available in the United States. In order to reduce and prevent antibiotic misuse, the infectious disease community should reclaim responsibility for the management of this important infectious disease.