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Omeprazole

A Pharmacoeconomic Evaluation of its Use in Duodenal Ulcer and Reflux Oesophagitis

  • Pharmacoeconomic Drug Evaluation
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Abstract

Synopsis

Omeprazole regulates gastric add secretion and is an effective treatment of acute duodenal ulcer and reflux oesophagitis, achieving more rapid healing and symptomatic relief than histamine H2-receptor antagonists. When administered as maintenance therapy, omeprazole reduces the incidence of relapse. The drug is also highly effective in patients poorly responsive to histamine H2-receptor antagonists. The daily acquisition cost of omeprazole is higher than that of histamine H2-receptor antagonists in many countries, and thus it is important to evaluate the pharmacoeconomic impact of omeprazole in the short and long term treatment of duodenal ulcer and reflux oesophagitis. Pharmacoeconomic analyses have been performed in several clinical settings using pooled data from clinical trials or simulated models of clinical practice.

In a single analysis using Finnish cost data, omeprazole was more cost effective than ranitidine in the treatment of duodenal ulcer disease over a 6-month period. The cost effectiveness of omeprazole was comparable to that of sucralfate-containing regimens, with patients receiving omeprazole being healed more quickly and experiencing a greater number of healthy days. Using a computer-model simulation and Swedish cost data, omeprazole was more cost effective than ranitidine when administered as intermittent treatment of duodenal ulcer over 5 years. Preliminary reports indicate that regimens which eradicate Helicobacter pylori are more cost effective than those which do not.

As short term treatment of reflux oesophagitis, omeprazole 20 to 40 mg/day was the dominating treatment strategy, being less costly and more effective than ranitidine 300 to 1200 mg/day. Omeprazole 20 mg/day produced symptom-free days more cost effectively than either cimetidine 1.6 g/day or ranitidine 300 mg/day. More importantly, as long term (maintenance or intermittent) treatment of reflux oesophagitis, omeprazole 20 mg/day more cost effective than both ranitidine 150mg twice daily and ‘phase 1’ therapy (diet and antacids) over 6 and 12 months.

Thus, based on analyses evaluated, omeprazole appears to be more cost effective than ranitidine in the short term treatment of duodenal ulcer. Results for long term treatment are less clear cut, but full details from some studies are not yet available. For the short term treatment of reflux oesophagitis omeprazole is more cost effective than ranitidine or cimetidine and for long term treatment omeprazole is more cost effective than ranitidine. As treatment for reflux oesophagitis, omeprazole is considered to be the dominating treatment strategy.

Disease Considerations

It is estimated that 5% of females and 10% of males in the US will develop peptic ulcer during their lifetime and, similarly, approximately 5 to 10% of the Western population will present with reflux oesophagitis. The pathogenesis of both disorders is multifactorial; gastric Helicobacter pylori colonisation appears to be important in the pathogenesis of duodenal ulcer disease, while prolonged oesophageal exposure to gastric contents, as a result of defective lower sphincter function, is important in the development of reflux oesophagitis.

Medical treatment remains the management option of choice for both duodenal ulcer and reflux oesophagitis; however, surgical management of resistant or complicated disease may be required. Relapse following withdrawal of short term therapy is a hallmark of both disorders, but it appears that eradication of H. pylori markedly reduces relapse rates in duodenal ulcer disease.

Clinical Efficacy and Tolerability

In the treatment of duodenal ulcer disease, omeprazole 20 mg/day is more effective than ranitidine 300 mg/day, cimetidine 800 to 1200 mg/day and famotidine 40 mg/day. Omeprazole 20 mg/day achieves significantly greater healing after 2 weeks than histamine H2-receptor antagonists, and relieves symptoms more rapidly. Omeprazole 40 mg/day is also more effective than histamine H2-receptor antagonists in the treatment of poorly responsive duodenal ulcer.

Omeprazole 20 mg/day provides more effective healing, and greater relief of symptoms, than ranitidine 150mg twice daily or cimetidine 400mg 4 times daily in the treatment of reflux oesophagitis. Furthermore, it is effective in the treatment of reflux oesophagitis poorly responsive to histamine H2-receptor antagonists. Relapse of reflux oesophagitis can be reduced by daily administration of omeprazole 20mg.

In both short and long term trials omeprazole has been well tolerated. The early fears of omeprazole causing enteroehromaffin-like cell carcinoids appear to be groundless: no evidence of enterochromaffin-like cell dysplasia has been observed in patients treated with omeprazole for up to 6 years.

Pharmacoeconomic Considerations

Pooled data from clinical trials and models for patient management have been used for analyses of the cost effectiveness of omeprazole in short and long term treatment of duodenal ulcer. In the short term analysis using Finnish cost data, omeprazole treatment resulted in considerably more healthy days over a 6-month period than either ranitidine- or sucralfate-containing treatment regimens. Cost-effectiveness analyses proved omeprazole to be more cost effective than ranitidine, with its average cost-effectiveness ratio being similar to that achieved with sucralfate.

When used as intermittent treatment of acute duodenal ulcer over 5 years, omeprazole was more cost effective than ranitidine, based on the results of computer simulation using Swedish cost data. It is assumed that eradication of H. pylori will decrease the costs of long term treatment of duodenal ulcer disease. The preliminary report of a pharmacoeconomic evaluation of an omeprazole/amoxicillin combination has shown the omeprazole regimen to be more cost effective than maintenance therapy with ranitidine. Further details of this analysis are awaited with interest. Similarly, preliminary results of a study undertaken in the UK suggest that eradication of H. pylori by treatment with colloidal bismuth subcitrate is more cost effective than omeprazole monotherapy over 5 and 10 years.

Several pharmacoeconomic analyses have been undertaken 10 assess the economic benefits of using omeprazole in the short and long term treatment of reflux oesophagitis. Based on the results of these analyses, omeprazole 20 to 40 mg/day was more cost effective than ranitidine 300 to 1200 mg/day in the short term treatment of disease, whether the measure of efficacy was healed oesophagitis, symptomatic relief or a combination of both. Even when asymptomatic patients were assumed to be healed, omeprazole 20 mg/day was more cost effective than cimetidine 1.6 g/day administered in 4 divided doses or ranitidine 150mg administered twice daily. Of greater clinical relevance, omeprazole 20 mg/day was more cost effective than ranitidine 300 mg/day or phase 1 therapy (diet and antacids) in the long term treatment of reflux oesophagitis. In studies that included sensitivity analyses, omeprazole retained its superior cost effectiveness. As omeprazole was less costly than other therapeutic options analysed, and more effective in the treatment and prevention of reflux oesophagitis, it was considered to be the dominating treatment strategy.

Prospective pharmacoeconomic analyses are required to confirm these results. However, based on the data available to date, omeprazole appears to be more cost effective than ranitidine in the short and possibly long term intermittent treatment of patients with duodenal ulcer. In the short term treatment of patients with reflux oesophagitis omeprazole is more cost effective than ranitidine or cimetidine. In the long term treatment of reflux oesophagitis, compared with ranitidine, omeprazole is the dominating treatment strategy.

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    Lee B. Barradell & Donna McTavish

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  1. Lee B. Barradell
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Various sections of the manuscript reviewed by: T. Ashton, School of Medicine, University of Auckland, Auckland, New Zealand; C.M. Bate, Department of Gastro-Enterology, The Royal Albert Edward Infirmary, Wigan, England; J. Dent, Gastroenterology Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia; L.S. Friedman, Department of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA; H. Glise, Department of Surgery, Norra Älvsborgs Länssjukhus, Trollhättan, Sweden; B. Hallerbäck, Department of Surgery, Norra Älvsborgs Länssjukhus, Trollhättan, Sweden; R.C. Heading, Department of Medicine, The University of Edinburgh, Royal infirmary, Edinburgh, Scotland; C.W. Howden, Division of Digestive Diseases & Nutrition, Department of Medicine, The University of South Carolina, Columbia Campus, Columbia, South Carolina, USA; B. Jönsson, Department of Economics, Centre for Health Economics, Stockholm School of Economics, Stockholm, Sweden; J.B. Marshall, School of Medicine, Division of Gastroenterology, University of Missouri-Columbia, Columbia, Missouri. USA; S.L. Sankey, Department of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA; H. Sintonen, Department of Health Policy and Management, University of Kuopio, Kuopio, Finland.

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Barradell, L.B., McTavish, D. Omeprazole. Pharmacoeconomics 3, 482–510 (1993). https://doi.org/10.2165/00019053-199303060-00008

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