Safety and efficacy of long term esomeprazole therapy in patients with healed erosive oesophagitis

Citation
Pn. Maton et al., Safety and efficacy of long term esomeprazole therapy in patients with healed erosive oesophagitis, DRUG SAFETY, 24(8), 2001, pp. 625-635
Citations number
43
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Pharmacology
Journal title
DRUG SAFETY
ISSN journal
0114-5916 → ACNP
Volume
24
Issue
8
Year of publication
2001
Pages
625 - 635
Database
ISI
SICI code
0114-5916(2001)24:8<625:SAEOLT>2.0.ZU;2-K
Abstract
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.