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Aspirin/esomeprazole therapy reduced PGE2 in patients with Barrett’s esophagus
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Patients with Barrett’s esophagus who were treated with esomeprazole and higher doses of aspirin experienced significant reductions in prostaglandin E2 tissue concentrations compared with patients receiving placebo in a recent study.
After a 28-day run-in phase of 40 mg esomeprazole twice a day, researchers randomly assigned patients with Barrett’s esophagus (BE) to also receive either 81 mg aspirin (n=47), 325 mg aspirin (n=45) or placebo (n=30) once daily for 28 days. Esophageal biopsies were conducted before and after treatment, and degree of change to absolute mean prostaglandin E2 (PGE2) concentrations were established. Other evaluated factors included percentage change in PGE2, treatment adherence and incidence of adverse events.
Upon initial biopsy, differences in PGE2 values were not significant between groups (P=.27). Among 114 evaluable participants following treatment, PGE2 was reduced by 123.9 ± 284.0 pg/mL in the 81-mg group (P<.0001 for change) and 174.9 ± 263.62 pg/mL in the 325-mg group (P<.0001), compared with 67.6 ± 229.68 in the placebo group (P=.27). The difference in mean change was significant between the placebo group and 325-mg group (P=.0204) but not the 81-mg group (P=.0955), or between aspirin groups (P=.26).
Percentage changes to PGE2 values were statistically significant in the treated groups (P=.0004 for 81 mg and P<.0001 for 325 mg), but not the placebo group (P=.68). Differences in percentage change were significant between the placebo and low-dose (P=.0007) and high-dose aspirin groups (P<.0001), but not between treated groups (P=.45).
Adverse events occurred at similar rates between all three groups (P=.36 for difference), and were experienced by 21.7% of participants overall. Reported events included hiatal hernia erosion (one placebo patient and one treated patient), antral erosions (one placebo patient) and gastroesophageal junction erosion (one treated patient). Adherence to treatment was high and not statistically significant between all groups. (P=.57).
“To our knowledge, we report the largest prospective chemoprevention trial in patients with BE conducted in North America,” the researchers wrote. “Given the importance of PGE2 and related molecular pathways in Barrett’s-associated carcinogenesis, this dual regimen of aspirin and esomeprazole warrants further evaluation as a novel chemoprevention strategy for an increasingly common disease with potentially devastating clinical outcomes.”
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