- High-dose esomeprazole proton-pump inhibitor (PPI) was more effective for Barrett’s esophagus than low-dose PPI, especially when combined with aspirin without NSAIDs use.
Why this matters
- Current guidelines for Barrett’s esophagus, the biggest risk factor for esophageal adenocarcinoma, recommend low-dose PPI.
- Randomized, prospective, multicenter, phase 3 AspECT trial.
- 2557 patients with Barrett’s esophagus received 20 mg esomeprazole/day (low dose) and no aspirin (n=705), 80 mg esomeprazole/day (high dose) and no aspirin (n=704), low-dose PPI+aspirin (n=571), or high-dose PPI+aspirin (n=577).
- Primary endpoint: time to all-cause mortality, esophageal adenocarcinoma, or high-grade dysplasia.
- Median 8.9-year follow-up.
- Funding: Cancer Research UK, AstraZeneca, and others.
- Primary endpoint reached in 313 patients.
- High-dose PPI significantly more effective than low-dose (time ratio [TR], 1.27; 95% CI, 1.01-1.58).
- Aspirin and no aspirin groups were similar (TR, 1.24; 95% CI, 0.98-1.57) except when patients who received NSAIDs were excluded (TR, 1.29; 95% CI, 1.01-1.66).
- High-dose PPI+aspirin was more effective than low-dose PPI+aspirin (TR, 1.59; 95% CI, 1.14-2.23).
- High-dose PPI+aspirin was more effective than high-dose PPI alone (TR, 1.38; 95% CI, 0.98-1.94).
- Just 1% of patients overall had treatment-related adverse events of grade 3-5.
- Ideal length of treatment was not studied.