Pantoprazole fails to reduce upper-GI events among rivaroxaban users

  • Gastroenterology

  • International Clinical Digest
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Takeaway

  • Routine pantoprazole (Protonix; Pfizer) appears not to reduce upper gastrointestinal (GI) events (UGEs) in patients taking low-dose rivaroxaban (Xarelto).
  • These patients had stable coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD).
  • Pantoprazole may reduce bleeding gastroduodenal lesions.
  • Authors urge development of peptic ulcer risk calculator.

Why this matters

  • Antiplatelet, anticoagulant treatment commonly results in GI bleeding. 
  • Few data address proton-pump inhibitors (PPIs) for UGE prevention amid anticoagulation or aspirin.

Key results

  • Mean follow-up, 3 years.
  • Pantoprazole vs placebo:
    • Primary outcome: 1.2% vs 1.3%;
      • HR, 0.88 (95% CI, 0.67-1.15).
    • Bleeding of gastroduodenal lesions (component of primary outcome):
      • HR, 0.52 (95% CI, 0.28-0.94; P=.03);
      • Number needed to treat (NNT), 1770.
  • Post hoc analysis with broader definitions found fewer gastroduodenal ulcer complications with pantoprazole:
    • HR, 0.44 (95% CI, 0.31-0.63);
    • NNT, 498.

Study design

  • Analysis of randomized multinational placebo-controlled double-blind COMPASS (n=17,598).
  • Participants with stable CAD or PAD without clinical PPI need randomly assigned to:
    • Pantoprazole 40 mg daily vs placebo, and to
    • Rivaroxaban 2.5 mg twice daily+aspirin vs rivaroxaban 5 mg twice daily vs aspirin alone.
  • Outcome, pantoprazole vs placebo: clinical UGE.
  • Funding: Bayer AG.

Limitations

  • Trial population at relatively low risk for UGEs.
  • Few bleeding events.
  • Underpowered to assess subgroups.

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