- 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.
- 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.
- 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.
- Low numbers for some events.