Gastroenterology

Gastroenterology

Volume 118, Issue 4, April 2000, Pages 661-669
Gastroenterology

Alimentary Tract
Long-term omeprazole treatment in resistant gastroesophageal reflux disease: Efficacy, safety, and influence on gastric mucosa,☆☆

https://doi.org/10.1016/S0016-5085(00)70135-1Get rights and content

Abstract

Background & Aims: The efficacy and safety of long-term acid suppression remains a subject for debate. We report data from patients with refractory reflux esophagitis who were undergoing maintenance therapy with ≥20 mg omeprazole daily for a mean period of 6.5 years (range, 1.4–11.2 years). Methods: Patients with severe reflux esophagitis resistant to long-term therapy with H2-receptor antagonists and who were not eligible for surgery were evaluated at least annually for endoscopic relapse and histological changes in the gastric corpus. Results: In 230 patients (mean age, 63 years at entry; 36% were ≥70 years), there were 158 relapses of esophagitis during 1490 treatment years (1 per 9.4 years), with no significant difference in relapse rates between Helicobacter pylori–positive and –negative patients. All patients rehealed during continued therapy with omeprazole at the same or higher dose. The annual incidence of gastric corpus mucosal atrophy was 4.7% and 0.7% in H. pylori–positive and –negative patients, respectively, which was mainly observed in elderly patients who had moderate/severe gastritis at entry. In patients with baseline moderate/severe gastritis, the incidences were similar: 7.9% and 8.4%, respectively. Corpus intestinal metaplasia was rare, and no dysplasia or neoplasms were observed. The adverse event profile was as might be expected from this elderly group of patients. Conclusions: Long-term omeprazole therapy (up to 11 years) is highly effective and safe for control of reflux esophagitis.

GASTROENTEROLOGY 2000;118:661-669

Section snippets

Patients and study design

The study was performed to assess the long-term efficacy and safety of omeprazole, given on a compassionate-use basis to patients with persistent reflux esophagitis who had not responded to treatment with H2-receptor antagonists. The patients were not eligible for surgery because of their age or other medical problems. Before their initial healing treatment with omeprazole, 67 patients had taken H2-receptor antagonists for more than 2 years and 17 patients had taken them for more than 5 years.

Patient population

A total of 230 patients were included between 1985 and 1989 at hospital centers in the Netherlands (118), Australia (69), Canada (38), and Germany (5) and were followed up for a mean of 6.5 years (range, 1.4–11.2 years). Before long-term follow-up, patients were first healed with 40 mg omeprazole daily; 14% of the patients took longer than the stipulated 12 weeks to heal. Most of these patients were healed after another 4 weeks; only 6 patients needed higher doses to heal. These 6 patients were

Discussion

We present efficacy and safety data from the longest follow-up period to date of omeprazole treatment in patients with reflux esophagitis poorly responsive to treatment with H2-receptor antagonists. Omeprazole proved to be very effective and safe in the long-term management of this difficult patient group. No dysplasia or neoplasia was observed in any of the gastric corpus biopsy specimens during treatment for up to 11 years.

The results show that omeprazole is very effective for up to 11 years

Acknowledgements

The authors thank the following investigators who took part in this study: Australia: H. Jackson, M. Mackinnon, D. Williams. Canada: M. R. Belsheim, A. Farley, R. L. Goodacre, J. M. Howard, R. H. Hunt, D. B. Menard, H. Navert, R. P. E. Reynolds, W. E. Waterfall, C. N. Williams. Germany: V. Eckardt. Netherlands: J. W. de Bruijne, C. P. M. Dekkers, H. P. M. Festen, J. B. M. J. Jansen, C. B. H. W. Lamers, A. E. G. Lückers. The authors also thank Dr. E. J. Kuipers for constructive comments.

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    Address requests for reprints to: Elly C. Klinkenberg-Knol, M.D., Ph.D., Department of Gastroenterology, Free University Hospital, De Boelelaan 1117, 1007 MB, Amsterdam, The Netherlands. e-mail: [email protected]; fax: (31) 20-444-0554.

    ☆☆

    Supported by Astra Hässle AB, Mölndal, Sweden.

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