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Proton Pump Inhibitors: Effective First-Line Treatment for Management of Dyspepsia

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Abstract

The aim of this study was to evaluate the reasons for trial exclusion among dyspeptic patients and estimate the proportion that may have benefited from proton pump inhibitor (PPI) therapy. Stringent inclusion criteria for enrollment in two multicenter functional dyspepsia trials included dyspepsia (predominant persistent/recurrent upper abdominal discomfort [UAD] during the prior 3 months) of at least moderate intensity during ≥30% of days during the prior 2 to 3 weeks. Exclusion criteria were mild/infrequent UAD; heartburn and UAD of equal frequency; predominant heartburn with UAD; endoscopic evidence of erosive esophagitis or Barrett’s or gastric and/or duodenal erosions (>5) or ulcers; irritable bowel syndrome (IBS); other gastrointestinal diagnoses; or other “non-categorized” disorders. Of 2,588 screened patients, 1,667 were excluded. Excluded patients by category had mild/infrequent UAD (12.5%, n=324), heartburn and UAD of equal frequency (1.1%, n=29), predominant heartburn with UAD (11.6%, n=300), endoscopic evidence of erosive esophagitis or Barrett's (6.2%, n=160), gastric and/or duodenal erosions (1.4%, n=36), gastric and/or duodenal ulcers (2.0%, n=53), IBS (7%, n=180), “other” gastrointestinal diagnoses (2.8%, n=73), or other “non-categorized” disorders (19.8%, n=512). Fifty-four percent of patients (902/1,667) had symptoms/diagnoses that would be expected to improve with PPI therapy. Individuals with IBS, “other,” or “non-categorized” disorders were considered to have symptoms unlikely to respond to PPI treatment. Empiric PPI treatment would be expected to provide symptom relief to the majority of dyspepsia sufferer who present in clinical practice. PPIs represent the best currently available therapy for acid-related disorders and should be considered the first-line management approach in patients with uninvestigated dyspepsia.

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Abbreviations

FD:

functional dyspepsia

FDA:

Food and Drug Administration

GERD:

gastroesophageal reflux disease

H2RAs:

histamine-2 receptor antagonists

IBS:

irritable bowel syndrome

OTC:

over the counter

PPI:

proton pump inhibitor

UAD:

upper abdominal discomfort

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Acknowledgment

Research was funded by TAP Pharmaceutical Products Inc., Lake Forest, IL.

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Authors and Affiliations

  1. University of Virginia Health Sciences Center, Charlottesville, VA, 22908-0708, USA

    David A. Peura

  2. TAP Pharmaceutical Products Inc., Lake Forest, IL, USA

    Jeff Gudmundson, Nancy Siepman & Betsy L. Pilmer

  3. University of Connecticut Health Center, Farmington, CT, USA

    James Freston

Authors
  1. David A. Peura
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  2. Jeff Gudmundson
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  3. Nancy Siepman
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  4. Betsy L. Pilmer
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  5. James Freston
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Correspondence to David A. Peura.

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Peura, D.A., Gudmundson, J., Siepman, N. et al. Proton Pump Inhibitors: Effective First-Line Treatment for Management of Dyspepsia. Dig Dis Sci 52, 983–987 (2007). https://doi.org/10.1007/s10620-006-9156-7

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  • DOI: https://doi.org/10.1007/s10620-006-9156-7

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