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- Title
Long-term treatment with omeprazole for refractory reflux esophagitis: efficacy and safety.
- Authors
Klinkenberg-Knol, Elly C.; Festen, Henk P. M.; Jansen, Jan B. M. J.; Lamers, Cornells B. H. W.; Nelis, Frits; Snel, Pleun; Liickers, Anton; Dekkers, Cornelius P. M.; Havu, Niilo; Meuwissen, Stephan G. M.; Klinkenberg-Knol, E C; Festen, H P; Jansen, J B; Lamers, C B; Nelis, F; Snel, P; Lückers, A; Dekkers, C P; Havu, N; Meuwissen, S G
- Abstract
<bold>Objective: </bold>To evaluate the long-term efficacy and safety of omeprazole in patients with gastroesophageal reflux disease resistant to treatment with histamine-2 (H2)-receptor antagonists.<bold>Design: </bold>Cohort analytic study with a mean follow-up of 48 months (range, 36 to 64 months).<bold>Setting: </bold>Patients receiving ambulatory care from referral centers.<bold>Patients: </bold>91 patients with gastroesophageal reflux disease resistant to treatment with an H2-receptor antagonist but subsequently responsive to 40 mg of omeprazole daily.<bold>Intervention: </bold>Open maintenance therapy consisting of 20 mg of omeprazole daily in 86 patients and 40 mg daily in 5 patients.<bold>Outcome Measures: </bold>Endoscopy to assess healing; side effects, laboratory values, fasting serum gastrin level, and gastric corpus biopsies to assess safety.<bold>Results: </bold>Esophagitis recurred in 47% of the patients receiving 20 mg of omeprazole daily, but all rehealed after the dose was doubled. Seven of 40 patients (18%) had a second relapse after a mean follow-up time of 24 months (range, 9 to 36 months) that was successfully treated with a further 20-mg dose increment for a mean period of 36 months (range, 6 to 39 months). Median gastrin levels increased initially from 60 ng/L before study entry to 162 ng/L (P < 0.01) with treatment and reached a plateau during maintenance treatment. Very high gastrin levels (> 500 ng/L) were observed in a subgroup (11%) of patients. The incidence of micronodular hyperplasia increased from 2.5% of the patients at first biopsy to 20% at the last biopsy (P = 0.001), with a corresponding progression of gastritis to subatrophic or atrophic gastritis from less than 1% to 25% (P < 0.001), which was more pronounced in patients with very high serum gastrin levels.<bold>Conclusions: </bold>Maintenance therapy with omeprazole was effective for at least 5 years in patients with gastroesophageal reflux disease resistant to treatment with H2-receptor antagonists. Treatment was accompanied by a persistent increase in serum gastrin levels and an increase of micronodular argyrophil cell hyperplasia and subatrophic or atrophic gastritis.
- Subjects
OMEPRAZOLE; GASTROESOPHAGEAL reflux; HISTAMINE receptors
- Publication
Annals of Internal Medicine, 1994, Vol 121, Issue 3, p161
- ISSN
0003-4819
- Publication type
journal article
- DOI
10.7326/0003-4819-121-3-199408010-00001