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Omeprazole

An Update of its Pharmacology and Therapeutic Use in Acid-Related Disorders

  • Drug Evaluation
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Summary

Synopsis

Omeprazole, a gastric acid pump inhibitor, dose-dependently controls gastric acid secretion; the drug has greater antisecretory activity than histamine H2-receptor antagonists.

Omeprazole 20 to 40 mg/day is more effective than histamine H2-receptor antagonists in the short term treatment of duodenal ulcer, gastric ulcer and reflux oesophagitis. Available data suggest that omeprazole 10 to 40 mg/day is also more effective than ranitidine in the maintenance therapy of duodenal ulcer and reflux oesophagitis. The drug is also effective in patients with duodenal ulcer, gastric ulcer or reflux oesophagitis poorly responsive to histamine H2-receptor antagonists.

The efficacy of omeprazole 20 mg/day appears to be similar to that of lansoprazole 30 mg/day in the short term treatment of duodenal ulcer, gastric ulcer and reflux oesophagitis. However, most available studies have been reported in abstract form only, and 2 of 3 studies in patients with duodenal ulcer have shown greater healing rates at 2 (but not 4) weeks with lansoprazole.

Helicobacter pylori eradication decreases duodenal ulcer relapse rates and appears to be associated with improved duodenal ulcer healing rates. Evidence also suggests that H. pylori eradication is associated with reduced gastric ulcer relapse rates. Omeprazole monotherapy may suppress but does not eradicate H. pylori infection. Eradication rates with omeprazole 20 or 40mg twice daily plus amoxicillin usually up to 2 g/day (3 g/day in a few studies) for 2 weeks appear to be similar to those of standard triple therapy (bismuth salt plus metronidazole, plus tetracycline or amoxicillin) or omeprazole plus clarithromycin, although eradication rates vary widely. Omeprazole plus amoxicillin appears to be better tolerated than triple therapy and represents a first-line treatment alternative in patients with H. pylori-associated peptic ulcer disease. Omeprazole plus amoxicillin plus metronidazole appears to be more effective than omeprazole plus amoxicillin in patients with metronidazole-sensitive H. pylori infection.

Omeprazole remains a treatment of choice in patients with Zollinger-Ellison syndrome. The dosage should be adjusted according to individual response. However, relatively low dosages of 10 to 40 mg/day may be sufficient in some patients. The drug has also shown promise in the treatment of children with severe reflux oesophagitis, in patients with reflux oesophagitis and coexisting systemic sclerosis, and in the prevention of aspiration pneumonia. Evidence suggests that omeprazole is more effective than ranitidine in patients with nonsteroidal anti-inflammatory drug (NSAID)-induced gastric damage who continue to take NSAIDs, especially in patients with large gastric ulcers; however, completion of ongoing studies is required to verify this.

Omeprazole is generally well tolerated during short (<12 weeks) and long (up to 10 years or more) term treatment. The most common, albeit infrequent, adverse effects are gastrointestinal in nature and are similar to those with histamine H2-receptor antagonists.

Thus, omeprazole is a first-line agent in the short and long term treatment of reflux oesophagitis, Zollinger-Ellison syndrome, and the short and long term treatment of peptic ulcer disease. Omeprazole plus amoxicillin appears to be of similar efficacy to, and better tolerated than, bismuth-containing triple therapy in eradicating H. pylori infection. Simultaneous ulcer healing, symptom resolution and H. pylori eradication is likely to become the management strategy of choice in H. pylori-positive duodenal ulcer disease, with omeprazole poised to play a substantial role in such therapy.

Pharmacological Properties

Omeprazole inhibits H+, K+-ATPase (the gastric acid pump), dose-dependently suppressing basal and stimulated gastric acid secretion. The drug has a prolonged duration of action and is more effective than histamine H2-receptor antagonists in suppressing gastric acid secretion. The short term acid-suppressing effects of omeprazole are maintained in the long term (6 to 12 months).

Acid inhibition following omeprazole therapy results in moderate increases in plasma gastrin levels in most patients which are greater than those with histamine H2-receptor antagonists and, in animals, are similar to those with lansoprazole.

The pharmacokinetic profile of omeprazole is well established. Since the last review of omeprazole in Drugs the pharmacokinetic parameters of omeprazole in patients with Zollinger-Ellison syndrome have been shown to be similar to those in healthy volunteers and patients with peptic ulcer disease except for elimination half-life which is increased approximately 2-fold. The metabolism of omeprazole to its hydroxy derivative is reduced in patients who are poor hydroxylators of S-mephenytoin.

Dosage adjustments do not appear to be necessary in patients with renal impairment or in the elderly amd are not considered to be necessary in patients with hepatic impairment, despite a reduction in the hepatic clearance of omeprazole. Pharmacokinetic data in children remain scarce.

Effects on Helicobacter pylori

Most cases of peptic ulcer disease are causally associated with Helicobacter pylori gastritis, but the exact pathogenetic mechanism of H. pylori-induced gastroduodenal damage is unknown. Omeprazole monotherapy may suppress but does not eradicate H. pylori. Although eradication rates vary between studies, omeprazole plus amoxicillin appears to eradicate H. pylori in a similar number of patients as standard triple therapy (bismuth salt plus metronidazole plus amoxicillin) or omeprazole plus clarithromycin. Omeprazole 20mg twice daily plus amoxicillin up to 2 g/day for 2 weeks is the currently recommended regimen of these agents, although preliminary evidence suggests that higher dosages of amoxicillin (up to 3 g/day) in combination with omeprazole 20mg twice daily for 2 weeks may be more effective. Evidence suggests that omeprazole plus amoxicillin plus metronidazole is more effective than omeprazole plus amoxicillin in patients with metronidazole-sensitive H. pylori. However, the search for the optimal treatment regimen for the eradication of H. pylori continues.

Therapeutic Use

Data published since the last review of omeprazole in Drugs confirm the significantly superior efficacy of 2 to 4 weeks’ treatment with omeprazole 20 mg/day, in terms of both healing rates and symptom resolution, compared with ranitidine 300 mg/day, cimetidine 800 mg/day or famotidine 40 mg/day in the short term treatment of duodenal ulcer. A meta-analysis of nearly 45 000 patients with duodenal ulcer found that healing rates with omeprazole were significantly greater than those with histamine H2-receptor antagonists, prostaglandin analogues, site-protective agents or placebo. Recent data also confirm that omeprazole is more effective than high dose ranitidine in patients with duodenal ulcers poorly responsive to standard dosages of histamine H2-receptor antagonists, and confirm the superior efficacy of omeprazole 10 to 20 mg/day in the maintenance treatment of duodenal ulcer.

Duodenal ulcer healing rates at 4 weeks appear to be similar with omeprazole 20 mg/day or lansoprazole 30 mg/day. However, healing rates at 2 weeks were greater with lansoprazole in 2 of the 3 published studies.

H. pylori eradication is associated with decreased relapse rates of duodenal and gastric ulcer. Eradication of H. pylori also appears to be associated with higher duodenal ulcer healing rates than persistent H. pylori infection, although further study is needed to confirm this.

Recent data confirm that omeprazole 20 mg/day is more effective than ranitidine 300 mg/day or cimetidine 800 mg/day, and is similar to that of lansoprazole 30 mg/day, in the short term treatment of gastric ulcer. The efficacy of omeprazole appears to be superior to that of ranitidine in patients with nonsteroidal anti-inflammatory drug (NSAID)-induced gastric damage who continue to take NSAIDs, especially in patients with large (>2cm in diameter) ulcers.

The superior efficacy of omeprazole 20 or 40 mg/day in terms of healing and symptom resolution compared with ranitidine 150mg twice daily in the short term treatment of all grades of reflux oesophagitis, including histamine H2-receptor antagonist-refractory disease, has also been confirmed in recent studies. Available data suggest that the efficacy of omeprazole is superior to that of ranitidine in combination with cisapride or metoclopramide, and similar to that of lansoprazole in the short term treatment of reflux oesophagitis. Recent data confirm the superiority of omeprazole over ranitidine in the prevention of recurrence of reflux oesophagitis. Further study with a low omeprazole dosage of 10 mg/day in the prevention of reflux oesophagitis recurrence is underway. Omeprazole has also shown promise in the treatment of patients with reflux oesophagitis and coexisting systemic sclerosis or peptic oesophageal strictures, and in children with severe gastro-oesophageal reflux. Although omeprazole has been shown to improve oesophagitis in patients with Barrett’s oesophagus, data on regression of the metaplasia are inconclusive.

The efficacy of omeprazole in the treatment of patients with Zollinger-Ellison syndrome is well established. Relatively low omeprazole dosages of 10 to 40 mg/day may be sufficient in some patients although dosage titration is advised.

Oral omeprazole 40mg on the evening before surgery plus oral omeprazole 40mg on the morning before surgery, or intravenous omeprazole 40mg 1 hour before induction of anaesthesia reduces the risk of aspiration pneumonitis during general anaesthesia.

Tolerability

The favourable tolerability profile of short term (<12 weeks) omeprazole therapy is well established, and is similar to that of short term ranitidine or cimetidine therapy. The most commonly reported adverse effects with short term omeprazole therapy are diarrhoea (1 to 3% of patients), headache (0.5 to 2.4%), nausea (0.9 to 2%), abdominal pain (0.4 to 2%), flatulence (1.5%) and dizziness/vertigo (0.5 to 1%). These adverse effects are generally mild, self-limiting and unrelated to dosage.

The adverse event profile of long term omeprazole therapy is similar to that seen in the short term; however, there is a trend towards a lower incidence of diarrhoea and headache. There have been no reports of serious adverse effects with long term omeprazole therapy. Mucosal cell hyperplasia and atrophic gastritis may occur in some patients receiving long term omeprazole therapy.

Omeprazole plus amoxicillin and omeprazole plus amoxicillin plus metronidazole appear to be better tolerated and associated with greater compliance than conventional bismuth-based triple therapy in patients with H. pylori infection.

Dosage and Administration

The recommended dosage of omeprazole in patients with reflux oesophagitis, or duodenal or gastric ulcer is 20 mg/day for 2 to 8 weeks. A dosage of 40 mg/day may be required in patients with conditions poorly responsive to histamine H2-receptor antagonists or in patients unhealed after 8 weeks’ omeprazole 20 mg/day therapy.

An omeprazole dosage of 10 to 20 mg/day has been shown to prevent recurrence of duodenal ulcer, and omeprazole 10 to 40 mg/day is also effective in the prevention of reflux oesophagitis relapse. Omeprazole 20mg twice daily plus amoxicillin up to 2 g/day is the currently recommended dosage regimen of these agents for the eradication of H. pylori infection.

The recommended dosage of omeprazole in patients with Zollinger-Ellison syndrome is 60 mg/day, although lower dosages (10 to 40 mg/day) are effective in some patients. Oral omeprazole 40mg in the evening before surgery plus oral omeprazole 40mg on the morning of surgery, or intravenous omeprazole 40mg 1 hour before induction of anaesthesia have shown promise in the prevention of aspiration pneumonia during general anaesthesia.

Dosage reductions are not necessary in patients with hepatic or renal impairment, or in the elderly.

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    Michelle I. Wilde & Donna McTavish

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Various sections of the manuscript reviewed by: G.D. Bell, Department of Medicine, Ipswich Hospital, Ipswich, England; F. Catalano, Istituto di Medicina Medica, Ospedale Garibaldi, Catania, Italy; W. Creutzfeldt, Division of Gastroenterology and Endocrinology, Department of Medicine, Georg-August- University Göttingen, Göttingen, Germany; J.G. Hatlebakk, Medical Department A, Haukeland Hospital, Bergen, Norway; C.J. Hawkey, Department of Medicine, Division of Gastroenterology, University Hospital, Nottingham, England; J. Labenz, Department of Internal Medicine, Elisabeth Hospital, Essen, Germany; M.J.S. Langman, Department of Internal Medicine, Queen Elizabeth Medical Centre, Birmingham, England; K. Lauritsen, Department of Medical Gastroenterology S, Odense University Hospital, Odense, Denmark; R.P.H. Logan, St Charles Hospital, London, England; I.N. Marks, Gastrointestinal Clinic, Groote Schuur Hospital, Cape Town, South Africa; A. Tucci, Istituto di Clinica Medica E Gastroenterologia dell’ Università di Bologna, Bologna, Italy; P. Unge, Department of Internal Medicine, Sandviken Hospital, Sandviken, Sweden; K.G. Wormsley, Ninewells Hospital, Dundee, Scotland.

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Wilde, M.I., McTavish, D. Omeprazole. Drugs 48, 91–132 (1994). https://doi.org/10.2165/00003495-199448010-00008

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