Alimentary TractLong-term omeprazole treatment in resistant gastroesophageal reflux disease: Efficacy, safety, and influence on gastric mucosa☆,☆☆
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.
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Supported by Astra Hässle AB, Mölndal, Sweden.