Efficacy of S-Pantoprazole 20 mg Compared with Pantoprazole 40 mg in the Treatment of Reflux Esophagitis: A Randomized, Double-Blind Comparative Trial

Abstract

S-isomer (S) pantoprazole is known to be more effective and less dependent on cytochrome 2C19 than R-isomer (R)-pantoprazole. The purpose of this study was to compare the efficacy and safety of S-pantoprazole 20 mg versus pantoprazole 40 mg for treatment of reflux esophagitis. This multi-center, double-blind, randomized trial enrolled patients with endoscopically documented reflux esophagitis. Patients were assigned to receive either 20 mg S-pantoprazole or 40 mg pantoprazole once daily for 4 weeks. Endoscopy and symptoms were assessed after 4 weeks of treatment. In patients whose reflux esophagitis was not resolved at 4 weeks, treatment was extended to 8 weeks and symptoms were reassessed. Heartburn, chest pain, acid regurgitation, globus, and overall symptoms were rated. The primary efficacy endpoint was healing of esophagitis, and secondary endpoints were symptomatic and endoscopic improvement. Sixty-seven patients in the S-pantoprazole group (52 male, mean age 51 years) and 62 in the pantoprazole group (61 male, mean age 50 years) were analyzed per protocol. The healing rate of reflux esophagitis was 85 % at 4 weeks and 94 % at 8 weeks in the S-pantoprazole group, which did not differ from those in the pantoprazole group (84 and 97 %, respectively). After treatment, individual and overall gastroesophageal reflux disease (GERD) symptoms and esophagitis improved compared with baseline inflammation in both groups. Intergroup differences in symptoms and endoscopic healing were not significant. The efficacy and safety of 20 mg S-pantoprazole were comparable to those of 40 mg pantoprazole for treatment of reflux esophagitis and symptomatic improvement of GERD.