Clinical experience with omeprazole: assessment of efficacy and safety

Abstract

After pharmacological studies showed that omeprazole had a marked and longlasting inhibitory effect on acid secretion, many clinical studies commenced. In duodenal ulcer, omeprazole in doses of 20-40 mg/day has been shown to give significantly higher healing rates than ranitidine or cimetidine. Omeprazole has given healing rates of 58-83% after treatment for 2 weeks and 84-100% after 4 weeks. A more pronounced effect on the relief of ulcer symptoms has also been observed. Similarly, in gastric ulcer several studies have been performed, all of which have shown higher healing rates with omeprazole both at 4 and 8 weeks. Symptom relief has also been faster and more pronounced with omeprazole. In patients with reflux oesophagitis, omeprazole has been shown to decrease the time with an acid milieu in the oesophagus. In several studies omeprazole in doses of 20-60 mg/day has consistently given healing rates approximately twice those of ranitidine in doses of 150 mg twice daily at 4 and 8 weeks. In addition, there has been a rapid improvement in the symptoms of oesophagitis. Omeprazole has been found to be very effective in the Zollinger-Ellison syndrome, with a prompt effect on acid secretion and symptoms. The accumulated experience exceeds 300 patients. More than 13,000 patients have taken part in the clinical investigations with omeprazole. Neither serious side-effects nor other side-effects which could be ascribed to treatment have been observed. There have not been any clinically significant changes in laboratory variables apart from those which are caused by the decrease in acid secretion.(ABSTRACT TRUNCATED AT 250 WORDS)