Effects of 6-12 months of esomeprazole treatment on the gastric mucosa.
OBJECTIVE
The aim of this study was to determine the effect of 6-12 months of treatment with esomeprazole on the histopathology of the gastric mucosa.


METHODS
Two identically designed, randomized, placebo-controlled trials of esomeprazole 40, 20, or 10 mg daily for up to 6 months, as well as a noncomparative, multicenter trial of esomeprazole 40 mg daily for up to 12 months, were conducted in 1326 patients with healed erosive esophagitis (1294 negative for Helicobacter pylori [H. pylori]). Gastric biopsy samples were obtained before treatment and on completion of (or discontinuation from) the trials. Samples were evaluated for the presence of H. pylori, characteristics of acute gastritis or atrophic gastritis, and enterochromaffin-like cell pathology.


RESULTS
During treatment with esomeprazole, the number of patients with an improvement in gastric histological scores was typically greater than or equal to the number who worsened. Gastric histological scores worsened for each corporal or antral characteristic of gastritis in <6.2% of patients. Histological scores with esomeprazole and placebo were similar throughout the 6-month trials. Only one among 1326 patients treated with esomeprazole (H. pylori negative) had evidence of treatment-emergent atrophic gastritis. On final biopsy, 5-12% of patients had abnormal enterochromaffin-like cell scores (simple, linear, or micronodular hyperplasia). There were no instances of enterochromaffin-like cell dysplasia, carcinoids, or neoplasia.


CONCLUSIONS
Patients with healed erosive esophagitis receiving esomeprazole for up to 12 months had minor fluctuations in gastric histological scores, similar to those experienced in untreated populations. Use of esomeprazole did not raise any safety concerns with respect to the development of atrophic gastritis, or cause clinically significant changes in enterochromaffin-like cells.
Genta
Robert M
RM
Department of Pathology, Geneva University Hospitals, Geneva, Switzerland.
Rindi
Guido
G
Fiocca
Roberto
R
Magner
David J
DJ
D'Amico
Donald
D
Levine
Douglas S
DS
D000328:Adult; D000897:Anti-Ulcer Agents / Q000494:pharmacology* / Q000627:therapeutic use; D019861:Enterochromaffin-like Cells / Q000473:pathology; D064098:Esomeprazole / Q000494:pharmacology* / Q000627:therapeutic use; D004941:Esophagitis / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology*; D005753:Gastric Mucosa / Q000187:drug effects* / Q000473:pathology*; D005755:Gastrins / Q000097:blood; D005757:Gastritis, Atrophic / Q000473:pathology; D016481:Helicobacter Infections; D016480:Helicobacter pylori; D006801:Humans; D008679:Metaplasia
D000897:Anti-Ulcer Agents; D005755:Gastrins; D064098:Esomeprazole