Rabeprazole versus ranitidine for the treatment of erosive gastroesophageal reflux disease: A double-blind, randomized clinical trial

OBJECTIVE: The objective of this study was to compare the efficacy and safe ty of the proton pump inhibitor rabeprazole to that of the histamine-2 (H2) -receptor antagonist ranitidine in the treatment of erosive gastroesophagea l reflux disease. The primary indicator of efficacy was the absence of esop hageal erosions or ulcerations as determined by posttreatment endoscopy. Se condary indicators of efficacy included improvement in frequency and severi ty of daytime and nighttime heartburn. METHODS: A total of 338 patients were enrolled and randomly assigned to the rapy with rabeprazole 20 mg once daily in the morning or to ranitidine 150 mg four times daily. At baseline and at 4 wk, patients underwent endoscopy for evaluation of esophageal lesions. Patients whose lesions healed by wk 4 had therapy discontinued; others remained on therapy and had repeat endosc opy at 8 wk. Also recorded at study visits were patients' ratings of heartb urn symptoms and overall sense of well being, patients' reports of time los t from daily activities, antacid use, and adverse events. Serum gastrin lev els were measured and argyrophil enterochromaffin-like cell histology evalu ated at baseline and when the patient ended therapy. RESULTS: At wk 4, healing was observed in 59% (98/167) of patients assigned to rabeprazole therapy, compared with 36% (60/169) of those receiving rani tidine (p < 0.001). By 8 wk, healing was seen in 87% (146/167) and 66% (112 /169) of patients in the rabeprazole and ranitidine groups, respectively (p < 0.001). There were also significant differences between the two groups f avoring rabeprazole with respect to resolution or improvement of heartburn symptoms and improvement in sense of well-being. No drug-related serious ad verse events were seen with either therapy; fewer patients assigned to rabe prazole had treatment-emergent signs and symptoms. Serum gastrin levels inc reased over baseline in the rabeprazole group, but the mean value remained within normal limits. CONCLUSIONS: Rabeprazole was superior to ranitidine in esophageal healing a nd symptom relief in patients with erosive gastroesophageal reflux disease, and was equally well tolerated. (C) 2000 by Am. Coll. of Gastroenterology.