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ARTICLE

Risk Factors for Helicobacter pylori Resistance in the United States: The Surveillance of H. pylori Antimicrobial Resistance Partnership (SHARP) Study, 1993–1999

Joette M. Meyer, PharmD; Nancy P. Silliman, PhD; Wenjin Wang, PhD; Nancy Y. Siepman, PhD; Jennifer E. Sugg, MS; David Morris, PhD; Jie Zhang, PhD; Helen Bhattacharyya, PhD; Eileen C. King, PhD; and Robert J. Hopkins, MD, MPH + TM

1 January 2002 | Volume 136 Issue 1 | Pages 13-24

Background: Pretreatment antimicrobial resistance has an important impact on the efficacy of many Helicobacter pylori treatment regimens.

Objective: To estimate the prevalence of H. pylori resistance to antimicrobials in the United States, to characterize risk factors associated with H. pylori antimicrobial resistance, and to explore the association between drug utilization and antimicrobial resistance patterns over time.

Design: Meta-analysis using patient-level data.

Setting: 20 nationwide trials of H. pylori eradication.

Patients: 3624 men and women, each of whom contributed one isolate.

Measurements: Rates of H. pylori resistance to clarithromycin, metronidazole, and amoxicillin, according to geographic region, age, sex, study year, ethnicity, ulcer status, test method, and study.

Results: Overall resistance to clarithromycin, metronidazole, and amoxicillin was 10.1% (95% CI, 9.1% to 11.1% [360 of 3571 patients]), 36.9% (CI, 35.1% to 38.7% [1063 of 2883 patients]), and 1.4% (CI, 1.0% to 1.8% [48 of 3486 patients]), respectively. In multivariable analyses, multiple risk factors were associated with resistance to individual agents. Clarithromycin resistance was significantly associated with geographic region (P = 0.050), older age (P < 0.001), female sex (P < 0.001), inactive ulcer disease (P < 0.001), and study (P = 0.010). Metronidazole resistance was significantly associated with female sex (P < 0.001), earlier year of study enrollment (P = 0.036), Asian ethnicity (P < 0.001), use of an epsilometer test (P = 0.002), and study (P < 0.001). Amoxicillin resistance was low and was not significantly associated with any risk factor. In the 1990s, when rates for use of oral macrolides and metronidazole were relatively stable, clarithromycin resistance rates were stable and metronidazole resistance rates varied.

Conclusions: Clinicians should consider risk factors for antimicrobial resistance when deciding which patients should have susceptibility testing and when choosing appropriate H. pylori treatments in the empirical setting.

Author and Article Information

From U.S. Food and Drug Administration, Rockville, Maryland; Wyeth-Ayerst Research, Philadelphia, and AstraZeneca L.P., Wayne, Pennsylvania; TAP Pharmaceutical Products, Inc., Deerfield, and Abbott Laboratories, Abbott Park, Illinois; Pfizer Central Research, New York, New York; and Procter & Gamble, Mason, Ohio.

Disclaimer: This article contains the professional views of the authors and does not necessarily represent the official position of the U.S. Food and Drug Administration.

Requests for Single Reprints: Joette M. Meyer, PharmD, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Division of Pharmaceutical Evaluation III (HFD-880), 9201 Corporate Boulevard, Room S-402, Rockville, MD 20850.

Current Author Addresses: Dr. Meyer: Division of Drug Evaluation III (HFD-880), 9201 Corporate Boulevard, Room S-402, Rockville, MD 20850.

Dr. Silliman: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Division of Biostatistics III (HFD-725), 9201 Corporate Boulevard, Rockville, MD 20850.

Dr. Wang: Wyeth-Ayerst Research, Box 8299, Philadelphia, PA 19101.

Dr. Siepman: TAP Pharmaceutical Products, Inc., 675 North Field Drive, Lake Forest, IL 60045.

Ms. Sugg: AstraZeneca L.P., 725 Chesterbrook Boulevard, D-3W, Wayne, PA 19087-5677.

Drs. Morris and Zhang: Abbott Laboratories, 100 Abbott Park Road, D-491, AP6B-1SW, Abbott Park, IL 60064-6124.

Dr. Bhattacharyya: Pfizer Central Research, 235 East 42nd Street, New York, NY 10017-5755.

Dr. King: Procter & Gamble Pharmaceuticals, Inc., Box 8006, Mason, OH 45040.

Dr. Hopkins: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Division of Special Pathogen and Immunologic Drug Products (HFD-590), 9201 Corporate Boulevard, Rockville, MD 20850.

Author Contributions: Conception and design: J.M. Meyer, R.J. Hopkins.

Analysis and interpretation of the data: J.M. Meyer, N.P. Silliman.

Drafting of the article: J.M. Meyer, R.J. Hopkins.

Critical revision of the article for important intellectual content: J.M. Meyer, N.P. Silliman, N.Y. Siepman, J.E. Sugg, D. Morris, J. Zhang, R.J. Hopkins.

Final approval of the article: J.M. Meyer, N.P. Silliman, N.Y. Siepman, E.C. King, H. Bhattacharyya, R.J. Hopkins.

Statistical expertise: N.P. Silliman, W. Wang, N.Y. Siepman, D. Morris, J. Zhang, E.C. King.

Collection and assembly of data: J.M. Meyer, W. Wang, N.Y. Siepman, J.E. Sugg, D. Morris, J. Zhang, H. Bhattacharyya, E.C. King.

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