Objective: To evaluate the safety and tolerability of long term treatment w
ith esomeprazole in patients with healed erosive oesophagitis, and to descr
ibe its efficacy in the maintenance of healing.
Design and setting: US multicentre, noncomparative, nonblind study.
Patients and participants: 807 patients with endoscopically confirmed heale
d erosive oesophagitis.
Methods: Patients received esomeprazole 40mg once daily for up to 12 months
. Adverse events and clinical laboratory tests were assessed over the study
period. Endoscopy was performed at the final visit of the antecedent heali
ng trials and at months 6 and 12 of the current safety trial; gastric biops
ies were obtained at the initial visit of the healing trials and at the end
of the safety trial.
Results: 80.9% of patients completed 6 months of treatment; 76.6% completed
12 months of treatment. There were no serious drug-related adverse events.
Diarrhoea, abdominal pain, flatulence, and headache were the only treatmen
t-related adverse events reported by >3% of patients. Mean changes in labor
atory measures were generally small and not clinically meaningful. Plasma g
astrin levels increased, as expected, and reached a plateau after 3 months.
No changes in gastric histological scores were noted in the majority of pa
tients. Evaluation of gastric biopsies revealed an overall decline in chron
ic inflammation and atrophy. Intestinal metaplasia findings remained essent
ially unchanged. Life table estimates of maintenance of healing were 93.7%
[95% confidence interval (CI) 92.0 to 95.5%] at 6 months and 89.4% (95% Cl
87.0 to 91.7%) at 12 months.
Conclusions: Daily treatment with esomeprazole 40mg for up to I year in pat
ients with healed erosive oesophagitis was generally well tolerated and eff
ective. No safety concerns arose.