Therapy with Omeprazole in Patients With Peptic Ulcerations Resistant to Extended High-Dose Ranitidine Treatment

Abstract

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.

Treatment of Reflux Oesophagitis Resistant to H₂-Receptor Antagonists

“…Thereafter, no further increase in serum gastrin levels could be observed, even up to 4 years of con tinuous observation [49], Our results are similar for most of the patients, although in a few patients high serum gastrin levels (more than 600 pg/ml) were observed. Pathological changes in the argyrophil cell population of the gastric oxyntic mucosa during long-term treatment with omeprazole have not been detected [50], Until now no adverse side effects which could be attributed to the drug have been reported.…”

‘Difficult’ Duodenal Ulcer Patients: Clinical and Therapeutic Problems

“…These theoretical properties have been widely confirmed, first in a series of open studies [34,35], in which 100% 4-week heal ing rates were recorded (table 5) and later, in a controlled trial in which omeprazole 40 mg/day proved significantly more effec tive than bb-antagonists [13], The sole ex ception is a French multicenter trial in which the drug, administered at the dosage of 20 mg/day. failed to prove significantly su perior to ranitidine, 300 mg. in refractory duodenal ulcers [8],…”

“…A number of recent uncontrolled trials with omeprazole 20 or 40 mg/day would appear, however, to indicate very low relapse rates [35,38], Thus it seems that maintenance treat ment of these ulcers is as yet far from being codified, although very important informa tion can be gleaned from the previous trials: refractory duodenal ulcers, once healed, tend to relapse very early and presumably, there fore, constitute a more severe ulcer diathesis, possibly requiring more aggressive pharma cological maintenance treatment.…”

Effect of Omeprazole on Nocturnal Intragastric pH in Cirrhotics with Inadequate Antisecretory Response to Ranitidine

“…Omeprazole is a very potent antisecretory drug [12][13][14] which has been successfully administered in duodenal [17,18] and gas tric [ 19,20] ulcer and reflux esophagitis [21 -25] and proved effective even in H2-receptor antagonist resistant ulcers and reflux esopha gitis [26][27][28][29][30][31][32][33], and Zollinger-Ellison syn drome [34][35][36][37],…”