Symptom relief in gastroesophageal reflux disease: A randomized, controlled comparison of pantoprazole and nizatidine in a mixed patient population with erosive esophagitis or endoscopy-negative reflux disease

OBJECTIVES: Gastroesophageal reflux disease (GERD) in primary care practice presents symptomatically, and resources to distinguish promptly between er osive esophagitis arid endoscopy-negative reflux disease (ENRD) are limited . It is therefore important to determine the roles of proton pump inhibitor s and histamine-2-receptor antagonists for first-line symptom-based therapy in patients with erosive esophagitis and ENRD. The aim of this study was t o compare pantoprazole 40 mg once daily versus nizatidine 150 mg b.i.d. in a mixed GERD patient population with ENRD or erosive esophagitis (Savary-Mi ller grades 1-3). METHODS: A 4-wk randomized, double-blind, parallel-group, multicenter study conducted in Canada. Eligible patients had experienced GERD symptoms great er than or equal to4 times weekly for >6 months. Patients were randomized t o pantoprazole 40 mg once daily or nizatidine 150 mg b.i.d.. Endoscopy was performed before randomization and after 4 wk of therapy. RESULTS: Of 220 patients randomized to therapy, 208 were available for a mo dified intent-to-treat analysis. Erosive esophagitis was present in 125 pat ients; 35 patients were Helicobacter pylori positive. There was complete sy mptom relief after 7 days of therapy in 14% of patients on nizatidine and i n 40% of those on pantoprazole (p < 0.0001), and after 28 days of treatment in 36% and 63% of patients, respectively (p < 0.0001). After 28 days of tr eatment, adequate heartburn control was reported by 58% of the nizatidine g roup and in 88% of the pantoprazole (p < 0.0001); erosive esophagitis heali ng rates were 44% for nizatidine and 79% for pantoprazole (p < 0.001). Resc ue antacid was needed by a greater number of patients using nizatidine than of those using pantoprazole (p < 0.001). H. pylori infection was associate d with an increased probability of erosive esophagitis healing. CONCLUSIONS: Pantoprazole once daily was superior to nizatidine b.i.d. in p roducing complete heartburn relief in a mixed population of GERD patients a nd in achieving erosion healing. The proportions of patients with complete symptom relief were greater with pantoprazole after 7 days of therapy than with nizatidine after 28 days. The present study data suggest that pantopra zole is a highly effective first-line therapy for the management of gastroe sophageal reflux disease in a primary care practice setting. (Am J Gastroen terol 2001;96:2849-2857. (C) 2001 by Am. Coll. of Gastroenterology).