To review gastroesophageal reflux disease (GERD) and its treatment, with emphasis on the use and place of omeprazole, a proton pump inhibitor.
Data Sources:
A compilation prepared by the National Library of Medicine's Interactive Retrieval Services (Medlars II) for the period 1987 to 1994 was used as the data source.
Study Selection:
Focus was placed on human comparative clinical studies with well-accepted measures of esophageal healing (endoscopy) and symptom resolution. Safety data were compiled from the clinical trials literature and large postmarketing data studies. Pharmacoeconomic studies selected were judged to meet the criteria of good design, presence of sensitivity testing, and statement of perspective.
Data Extraction:
Data were obtained from double-blind, controlled clinical studies. Other data were extracted from pertinent literature of good design and significant results.
Data Synthesis:
Overall, the clinical trials of omeprazole for the treatment of patients with erosive GERD demonstrate that omeprazole provides superior therapy in terms of esophageal healing symptom resolution and patient compliance when compared with histamine2-receptor antagonists (H2RAs) and antacids. In addition, studies also indicate that omeprazole is the most effective agent for the treatment of patients with GERD refractory to other treatments. Dosage adjustment is not necessary in patients with impaired renal or hepatic function or in the elderly. Finally, although the acquisition drug cost for daily treatment of patients with GERD is highest with the use of omeprazole, pharmacoeconomic studies indicate that treatment is more cost-effective with the use of omeprazole than with H2RA or antacid treatment alone or combined with nonpharmacologic approaches.
Conclusions:
Based on efficacy, safety, and cost-effectiveness, omeprazole is the drug of choice for the treatment of patients with endoscopically confirmed erosive GERD.
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