Document Detail

Long-term treatment with omeprazole for refractory reflux esophagitis: efficacy and safety.
MedLine Citation:
PMID:  8017742     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: 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. DESIGN: Cohort analytic study with a mean follow-up of 48 months (range, 36 to 64 months). SETTING: Patients receiving ambulatory care from referral centers. PATIENTS: 91 patients with gastroesophageal reflux disease resistant to treatment with an H2-receptor antagonist but subsequently responsive to 40 mg of omeprazole daily. INTERVENTION: Open maintenance therapy consisting of 20 mg of omeprazole daily in 86 patients and 40 mg daily in 5 patients. OUTCOME MEASURES: Endoscopy to assess healing; side effects, laboratory values, fasting serum gastrin level, and gastric corpus biopsies to assess safety. RESULTS: 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. CONCLUSIONS: 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.
E C Klinkenberg-Knol; H P Festen; J B Jansen; C B Lamers; F Nelis; P Snel; A Lückers; C P Dekkers; N Havu; S G Meuwissen
Publication Detail:
Type:  Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Annals of internal medicine     Volume:  121     ISSN:  0003-4819     ISO Abbreviation:  Ann. Intern. Med.     Publication Date:  1994 Aug 
Date Detail:
Created Date:  1994-07-26     Completed Date:  1994-07-26     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0372351     Medline TA:  Ann Intern Med     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  161-7     Citation Subset:  AIM; IM    
Free University Hospital, Department of Gastroenterology, Amsterdam, the Netherlands.
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MeSH Terms
Barrett Esophagus / drug therapy
Drug Resistance
Esophagitis, Peptic / blood,  drug therapy*,  pathology
Gastrins / blood
Life Tables
Omeprazole / administration & dosage,  adverse effects,  therapeutic use*
Time Factors
Treatment Outcome
Reg. No./Substance:
0/Gastrins; 73590-58-6/Omeprazole
Comment In:
Ann Intern Med. 1994 Aug 1;121(3):232-3   [PMID:  8017751 ]
Ann Intern Med. 1995 Feb 1;122(3):236; author reply 236-7   [PMID:  7888009 ]
Ann Intern Med. 1995 Feb 1;122(3):236; author reply 236-7   [PMID:  7810947 ]

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