Document Detail

Omeprazole versus ranitidine or ranitidine/metoclopramide in poorly responsive symptomatic gastroesophageal reflux disease.
MedLine Citation:
PMID:  8792695     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: To evaluate complete symptom resolution, mucosal healing, and tolerability of omeprazole, ranitidine, or ranitidine/metoclopramide in patients with poorly responsive, symptomatic gastroesophageal reflux disease (GERD). METHODS: Adults with persistent symptomatic GERD after ranitidine treatment were stratified by esophagitis grade and randomized to omeprazole 20 mg once daily, ranitidine HCI 150 mg twice daily, or ranitidine HCI 150 mg twice daily plus metoclopramide HCI 10 mg four times daily. Endoscopies were conducted at baseline and at wk 4 and 8. Patients assessed overall symptom improvement at wk 4 and 8 and evaluated daytime and nighttime heartburn, dysphagia, and acid regurgitation daily. RESULTS: After 1 wk, 13% of patients receiving omeprazole (N = 100) had complete resolution of all GERD symptoms versus 1% and 3% of patients receiving ranitidine (N = 97) or ranitidine/metoclopramide (N = 93), respectively (p < 0.001). More patients receiving omeprazole had complete symptom resolution at wk 4 (33%) and at the end of the study (64%; both p < 0.001) than patients receiving ranitidine (8% and 28%, respectively) or ranitidine/metoclopramide (7% and 29%, respectively). Regardless of baseline esophagitis grade, more patients receiving omeprazole had complete symptom resolution. At wk 8, more than 91% of patients with grade 0 or 1 esophagitis at baseline were still healed irrespective of treatment. At wk 8, 80% of patients with esophagitis grade 2 or higher at entry were healed with omeprazole (p < 0.001 vs ranitidine [40%] and ranitidine/metoclopramide [46%]). Thirty-four percent of patients reported an adverse event. Significantly more patients receiving combination treatment reported an adverse event than patients treated with single agents. CONCLUSIONS: In patients with persistent GERD symptoms after ranitidine, omeprazole (20 mg daily for up to 8 wk) provides faster and more complete resolution of common GERD symptoms than continued ranitidine (300 mg daily) alone or in combination with metoclopramide (40 mg daily). Omeprazole provides significantly higher rates of endoscopic healing than ranitidine alone or with metoclopramide. Omeprazole and ranitidine are generally well tolerated. The addition of metoclopramide to ranitidine significantly increases adverse events.
J E Richter; S M Sabesin; D G Kogut; R M Kerr; L D Wruble; M J Collen
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The American journal of gastroenterology     Volume:  91     ISSN:  0002-9270     ISO Abbreviation:  Am. J. Gastroenterol.     Publication Date:  1996 Sep 
Date Detail:
Created Date:  1996-10-17     Completed Date:  1996-10-17     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0421030     Medline TA:  Am J Gastroenterol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1766-72     Citation Subset:  IM    
Department of Gastroenterology, Cleveland Clinic Foundation, Ohio, USA.
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MeSH Terms
Dopamine Antagonists / administration & dosage,  adverse effects,  therapeutic use*
Drug Administration Schedule
Drug Therapy, Combination
Enzyme Inhibitors / administration & dosage,  therapeutic use*
Esophagitis, Peptic / drug therapy*
Histamine H2 Antagonists / administration & dosage,  therapeutic use*
Metoclopramide / administration & dosage,  adverse effects,  therapeutic use*
Middle Aged
Omeprazole / administration & dosage,  therapeutic use*
Ranitidine / therapeutic use*
Time Factors
Reg. No./Substance:
0/Dopamine Antagonists; 0/Enzyme Inhibitors; 0/Histamine H2 Antagonists; 364-62-5/Metoclopramide; 66357-35-5/Ranitidine; 73590-58-6/Omeprazole

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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