Elly C. Klinkenberg-Knol, MD, PhD; Henk P. M. Festen, MD, PhD; Jan B. M. J. Jansen, MD, PhD; Cornelis B. H. W. Lamers, MD, PhD; Frits Nelis, MD, PhD; Pleun Snel, MD, PhD; Anton Luckers, MD; Cornelius P. M. Dekkers, MD; Niilo Havu, MD, PhD; Stephan G. M. Meuwissen, MD, PhD
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.
Cohort analytic study with a mean follow-up of 48 months (range, 36 to 64 months).
Patients receiving ambulatory care from referral centers.
91 patients with gastroesophageal reflux disease resistant to treatment with an H2-receptor antagonist but subsequently responsive to 40 mg of omeprazole daily.
Open maintenance therapy consisting of 20 mg of omeprazole daily in 86 patients and 40 mg daily in 5 patients.
Endoscopy to assess healing; side effects, laboratory values, fasting serum gastrin level, and gastric corpus biopsies to assess safety.
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.
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.
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Klinkenberg-Knol EC, Festen HPM, Jansen JBMJ, Lamers CBHW, Nelis F, Snel P, et al. Long-Term Treatment with Omeprazole for Refractory Reflux Esophagitis: Efficacy and Safety. Ann Intern Med. 1994;121:161-167. doi: 10.7326/0003-4819-121-3-199408010-00001
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Published: Ann Intern Med. 1994;121(3):161-167.
Esophageal Disorders, Gastroenterology/Hepatology, Gastroesophageal Reflux Disease, Geriatric Medicine, Peptic Disease.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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