engleski

Efficacy of pantoprazole compared with ranitidine in the treatment of reflux-oesophagitis: a double-blind parallel and longitudinal comparative study

INTRODUCTION Gastrooesophageal reflux disease (GORD) is caused by abnormal reflux of gastric contents into the oesophagus, which produces symptomatic clinical condition or histopathologc alteration of the oesophageal mucosa. The condition is best controlled with acid supressive drugs, and proton pump inhibitors have proven to be the most potent of these. AIM The aim of this study was to evaluate the efficacy of a proton pump inhibitor pantoprazole in the short-term management of patients with GORD in comparison to H2 receptor antagonist ranitidine. METHODS Clinical study consisting of two phases was performed. The first phase was a double-blind trial where 184 outpatients with endoscopically verified GORD and Savary-Miller grade II or III were randomized into two parallel groups. Group A (94 subjects) received 40 mg of pantoprazole daily ; group B (90 subjects) 300 mg of ranitidine daily, for 4 to 8 weeks. Patients from group B who were not responding to ranitidine therapy after 8 weeks (36 subjects) were enrolled into the second phase, where they were treated with 40 mg of pantoprazole for 4 to 8 weeks. Clinical assessments were conducted at 0, 2, 4 and 8 weeks, while endoscopies were carried out at the beginning and the end of the treatment phases. Complete healing was defined as loss of symptoms and normal finding upon endoscopy. RESULTS Following 4 weeks of therapy, complete healing of GORD was seen in 77/94 (81.9%) of patients treated with pantoprazole, vs. 39/90 (43.3%) on ranitidine therapy (P < 0.001). After 8 weeks of therapy, healing rates were 86/94 (91.5%) for pantoprazole and 54/90 (60.0%) for ranitidine group (P < 0.001). In the second phase, complete healing was achieved in 28/36 patients resistant to ranitidine therapy after 4 weeks, and 32/36 patients after 8 weeks of treatment with pantoprazole, with healing rates of 77.8% and 88.9%, respectively (P < 0.05). CONCLUSION Our clinical trial demonstrates that 40 mg pantoprazole is highly effective and significantly superior to 300 mg ranitidine in acute treatment of patients with GORD.

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