PPIs: little harm seen in 3 years of use

  • Gastroenterology

  • International Clinical Digest
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Takeaway

  • Among patients with cardiovascular or peripheral artery disease, proton pump inhibitors (PPIs) are not associated with higher rates of adverse events, except enteric infection, vs placebo.
  • Authors: “This trial suggests that limiting prescription of PPI therapy because of concerns of long-term harm is not appropriate.”

Why this matters

  • Previous observational data suggested harms from long-term PPI use, including pneumonia, fracture, cerebrovascular events, but the results may be attributable to confounding.

Key results

  • Median follow-up, 3.01 years.
  • Pantoprazole (Protonix; Pfizer) vs placebo: 
    • Enteric infections: OR, 1.33 (95% CI, 1.01-1.75); number needed to harm, 301.
    • Clostridium difficile infection: 
    • Similar between-group rates of a long list of complications, including myocardial infarction, stroke, or cardiovascular death; hospitalization; all-cause mortality; cancers; pneumonia; fracture; incident diabetes; gastric atrophy.

Study design

  • Analysis of randomized multinational placebo-controlled double-blind COMPASS (n=17,598).
  • Participants with stable coronary artery or peripheral arterial disease without clinical PPI need randomly assigned to:
    • Pantoprazole 40 mg daily vs placebo, and to
    • Rivaroxaban (Xarelto; Janssen)+aspirin vs rivaroxaban vs aspirin alone. 
  • Outcome: multiple safety events.
  • Funding: Bayer AG.

Limitations

  • Low numbers for some events.

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