[Evaluation of efficacy, safety and tolerability rabeprazole in treatment of acid-peptic diseases ].

BACKGROUND

Rabeprazole, a substituted benzimidazole, represents a new generation of proton pump inhibitors that has recently been approved by the FDA and European Union for treatment of acid-related diseases.

OBJECTIVES

To assess the efficacy and tolerability of rabeprazole 20 mg in actual conditions of use in everyday clinical practice on subjects with diagnosis of erosive gastroesophageal reflux disease and/or gastric and/or duodenal ulcer.

PATIENTS/

METHODS

A total of 171 outpatients (55% men, 45% women) with a mean age of 42.5 years were enrolled in this trial. The majority of subjects (81.0%) were Caucasians. Patients with endoscopically confirmed erosive/ulcerative gastroesophageal reflux disease (Savary-Miller classification), duodenal ulcer and/or benign gastric ulcer were eligible to receive rabeprazole 20 mg once daily for 4 to 8 weeks, depending on the diagnosis and at investigators' discretion. Patients were requested to record their symptoms in a diary card in a daily basis.

RESULTS

One hundred and sixty two patients completed the study in accordance with the protocol. Reflux esophagitis was diagnosed in 78 (48.1%) patients, duodenal ulcer in 39 (24.1%) and gastric ulcer in 24 (14.8%). Eleven (6.8%) patients presented reflux esophagitis associated with duodenal ulcer and 7 (4.3%) associated with gastric ulcer. Finally, 3 (1.9%) presented both gastric and duodenal ulcer. Fifty-three percentage of patients were free of symptoms on the first day of treatment and 89.5% after a week. The healing rate was 84.4% for patients with reflux esophagitis, 90.6% for duodenal ulcer and 90.9% for gastric ulcer. The adverse effects were minimal and transitory.

CONCLUSIONS

Rabeprazole is highly effective and well tolerated in acute healing of reflux esophagitis and peptic ulcers. In addition, it provides fast symptoms relief.