Pantoprazole therapy in the long-term management of severe acid peptic disease - Clinical efficacy, safety, serum gastrin, gastric histology, and endocrine cell studies

OBJECTIVE: Pantoprazole is the third proton pump inhibitor to become availa ble. When this study was started, there were few data on its long-term use. Our aim was to investigate this aspect and, because powerful inhibitors of acid secretion can cause hypergastrinemia and, in experimental animals, en terochromaffin-like cell hyperplasia, we also monitored serum gastrin and e ndocrine cell histology. METHODS: One hundred fifty patients refractory to H2-receptor antagonists, running an aggressive course or with complications, were entered into a 5-y r treatment program. We performed serial endoscopy, checked for adverse eve nts, and laboratory values. We also monitored serum gastrin, gastric endocr ine cell histology, and antral and corpus gastritis. RESULTS: This report presents results from up to 3 yr of treatment. Cumulat ive healing on 40-80 mg of pantoprazole was 82% at 4 wk and 92% by 12 wk. M ost patients became asymptomatic within 4 wk. Remission on maintenance trea tment with 40 mg (n = 111) was 85% at 12 months and 78% at 24 months. Treat ment was safe; only four patients had adverse events definitely related to pantoprazole. Elevations in gastrin were modest and there were no significa nt changes in gastric endocrine cells. The number of enterochromaffin-like cells tended to decrease. CONCLUSION: Pantoprazole is effective, safe, and does not seem to be associ ated with large increases in serum gastrin or alterations in gastric endocr ine cells. (C) 2001 by Am. Coll. of Gastroenterology.