Clinical Question

Does aspirin plus a proton pump inhibitor (PPI) prevent death, malignant transformation, or histologic progression in patients with Barrett esophagus?

Bottom Line

In this study, patients with Barrett esophagus were less likely to die or develop esophageal cancer or high-grade dysplasia if they took high-dose esomeprazole (Nexium) alone or in combination with aspirin. (Level of Evidence = 1b)

Synopsis

These authors recruited 2,557 patients with at least 1 cm of Barrett esophagus to participate in a study with a randomized factorial design that included low- or high-dose esomeprazole (20 mg daily or 40 mg twice daily, respectively) with or without aspirin (300 mg in the United Kingdom or 325 mg in Canada). The researchers followed the patients for up to 10 years in person or by telephone. In the even years during follow-up, endoscopy was also performed. Although the patients knew what treatment they received, the pathologists who reviewed the biopsy material were unaware of the patients' treatment allocation. The authors used a composite outcome of all-cause mortality, esophageal adenocarcinoma, or high-grade dysplasia. After a median of 8.9 years, 313 total patients experienced the composite outcome. Patients who took high-dose esomeprazole had fewer events (11%) than those who took the low dose (14%; number needed to treat [NNT] = 36; 95% CI, 19 to 406). The combination of aspirin plus esomeprazole was more effective: 9% of patients taking aspirin plus high-dose esomeprazole compared with 14% of those taking aspirin plus low-dose esomeprazole (NNT = 20; CI, 12 to 67) experienced the primary outcome. Aspirin alone was ineffective in preventing the primary outcome. A total of 718 patients experienced at least one adverse event (28%), 61 of whom experienced a serious event (2% of the total pool, 8% of adverse events), but the differences among the treatment groups were similar.

Study design: Randomized controlled trial (single-blinded)

Funding source: Industry and government

Allocation: Concealed

Setting: Outpatient (specialty)

Reference: Jankowski JA, de Caestecker J, Love SB, et al. Esomeprazole and aspirin in Barrett's oesophagus (AspECT): a randomised factorial trial. Lancet. 2018;392(10145):400–408.