COMPARATIVE ROLE OF OMEPRAZOLE IN THE TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE

OBJECTIVE: TO review gastroesophageal reflux disease (GERD) and its tr eatment, with emphasis on the use and place of omeprazole, a proton pu mp inhibitor. DATA SOURCES: A compilation prepared by the National Lib rary of Medicine's Interactive Retrieval Services (Medlars II) for the period 1987 to 1994 was used as the data source. STUDY SELECTION: Foc us was placed on human comparative clinical studies with well-accepted measures of esophageal healing (endoscopy) and symptom resolution. Sa fety data were compiled from the clinical trials literature and large postmarketing data studies. Pharmacoeconomic studies selected were jud ged to meet the criteria of good design, presence of sensitivity testi ng, and statement of perspective. DATA EXTRACTION: Data were obtained from double-blind, controlled clinical studies. Other data were extrac ted from pertinent literature of good design and significant results. DATA SYNTHESIS: Overall, the clinical trials of omeprazole for the tre atment of patients with erosive GERD demonstrate that omeprazole provi des superior therapy in terms of esophageal healing symptom resolution and patient compliance when compared with histamine(2)-receptor antag onists (H(2)RAs) 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 nec essary in patients with impaired renal or hepatic function or in the e lderly, Finally, although the acquisition drug cost for daily treatmen t of patients with GERD is highest with the use of omeprazole, pharmac oeconomic studies indicate that treatment is more cost-effective with the use of omeprazole than with H(2)RA or antacid treatment alone or c ombined with nonpharmacologic approaches. CONCLUSIONS: Based on effica cy, safety, and cost-effectiveness, omeprazole is the drug of choice f or the treatment of patients with endoscopically confirmed erosive GER D.