The clinical utility and safety of omeprazole

Abstract

More than 13,000 individuals with duodenal ulcer, gastric ulcer or reflux oesophagitis have now taken part in controlled clinical studies with omeprazole. In duodenal ulcer, treatment with omeprazole, 20 mg daily or more, has resulted in healing rates of 58%-83% after 2 weeks and 84%-100% after 4 weeks. In all of these studies, healing rates with omeprazole have been higher than with either ranitidine or cimetidine. Omeprazole has also had a more pronounced effect on ulcer symptoms. Although the first comparative study on gastric ulcer showed only marginally higher healing rates with omeprazole than with an H2-receptor antagonist, later studies have all shown significantly higher healing rates with omeprazole. Healing rates of the order of 70% or more have been achieved within 4 weeks, rising to over 88% after 8 weeks. Symptom relief has also been faster with omeprazole. In both duodenal ulcer and gastric ulcer, almost every patient can be healed, including those resistant to treatment with H2-receptor antagonists. The influence of omeprazole on the healing of reflux oesophagitis has been investigated in several studies comparing omeprazole with ranitidine. Healing rates have been markedly higher with omeprazole in all studies. These unprecedentedly high healing rates (81%-96% at 8 weeks) have also been accompanied by rapid symptom relief. In clinical studies with omeprazole, no clinically significant side-effects which could be ascribed to treatment, nor indeed any serious side-effects, have been observed, neither have any clinically significant changes in laboratory variables been seen. Furthermore, no pathological changes of the gastric mucosa have been detected after long-term treatment with omeprazole.