Avaliação da eficácia, segurança e tolerabilidade de rabeprazol no tratamento de doenças ácido-pépticas / Evaluation of efficacy, safety and tolerability rabeprazole in treatment of acid-peptic

ABSTRACT

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