94 patients with peptic ulcerations of duodenum, stomach, and esophagus, who did not respond to 3 or more months high-dose (450 or 600 mg) treatment with ranitidine, were treated orally with 40 mg omeprazole daily. After healing all patients were offered long-term maintenance therapy with the same dose for 5 years. In 75 patients the peptic ulcerations healed within 4 weeks, in 13 patients within 8 weeks, and in 3 patients only after an increase to 60 mg omeprazole daily. In 3 patients the ulcers did not heal. So far 83 patients have entered long-term maintenance therapy. 59 of these patients are on the drug between 1 and 4 years. During maintenance therapy with 40 mg omeprazole no relapses have occurred up to now as demonstrated by endoscopy and no drug-related adverse effects were observed. Routine laboratory tests remained without significant changes in all patients including 18 patients with concomitant liver cirrhosis. Serum gastrin levels were already elevated during the initial high-dose ranitidine treatment (106 ± 15.4 pg/ml). 4 weeks after the start of omeprazole treatment serum gastrin levels rose to 4 times normal levels (195 ± 28 pg/ml). Thereafter, no further increase in serum gastrin was observed even up to 4 years of continuous observation. It is therefore concluded that omeprazole is highly effective in healing ranitidine-resistant peptic ulcerations and that omeprazole maintenance therapy with 40 mg omeprazole is safe during the time observed and highly effective in the prevention of ulcer recurrence.
Patients (106) with peptic ulceration of the oesophagus, stomach and duodenum, unresponsive to 3 or more months of high‐dose treatment with ranitidine, were initially given pantoprazole (40‐80 mg, p.o.) daily. In 96.7% of the patients ulcers healed within 2 to 8 weeks, and in 2.3% of patients the ulcers healed within 12 weeks. In just one patient with severe oesophagitis, the lesion took more than 6 months to heal. After ulcer healing, patients (98 to date) were treated with pantoprazole (40 mg/day) as long‐term maintenance therapy. Eighty‐eight of the 98 patients have been taking pantoprazole for 6 months to 3 years. During maintenance therapy, peptic disease was kept in remission in most patients with 40 mg pantoprazole. Twelve patients with oesophagitis and two patients with gastric ulcers needed higher doses (80‐120 mg) to control the disease. One female patient developed peripheral oedema which disappeared quickly after stopping treatment. No further drug‐ related adverse effects were observed. Seven patients withdrew from the study and two patients died, all for non‐drug‐related reasons. Routine laboratory tests remained without significant changes in all patients. Mean (+/‐ S.E.M.) serum gastrin levels were already elevated during the initial high‐dose ranitidine treatment (128 +/‐ 23 pg/ml). Within one year of the start of the pantoprazole treatment, serum gastrin levels rose to 3 times normal values (189 +/‐ 32 pg/ml). Thereafter, no further increases in serum gastrin were observed for up to 2.5 years. Enterochromaffin‐like (ECL) cell density increased very slightly from 0.19% to 0.24% within one year.(ABSTRACT TRUNCATED AT 250 WORDS)
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