Drugs

, Volume 54, Issue 3, pp 473–500 | Cite as

Lansoprazole

An Update of its Pharmacological Properties and Clinical Efficacy in the Management of Acid-Related Disorders
Drug Evaluation

Summary

Synopsis

Lansoprazole is a proton pump inhibitor that reduces gastric acid secretion. It has proved effective in combination regimens for the eradication of Helicobacter pylori and as monotherapy to heal and relieve symptoms of gastric or duodenal ulcers and gastro-oesophageal reflux. After initial healing, it may be used to prevent recurrence of oesophageal erosions or peptic ulcers in patients in whom H. pylori is not the major cause of ulceration and to reduce basal acid output in patients with Zollinger-Ellison syndrome. Usual dosages are 15 to 60 mg/day, although dosages of ≤ 180 mg/day have been used in patients with hypersecretory states.

In patients with duodenal or gastric ulcer, short term lansoprazole monotherapy was similar to omeprazole and superior to histamine H2 receptor antagonists in achieving healing rates >90%. Lansoprazole was as effective a component of H. pylori eradication regimens as omeprazole, tripotassium dicitrato bismuthate (colloidal bismuth subcitrate) or ranitidine.

Lansoprazole was superior to ranitidine in symptom relief and healing of gastro-oesophageal reflux disease and tended to relieve symptoms more rapidly than omeprazole, although initial healing was similar. As maintenance treatment, lansoprazole was similar to omeprazole and superior to ranitidine in relieving symptoms and preventing relapse. Lansoprazole was also superior to ranitidine in healing and relieving symptoms of oesophageal erosions associated with Barrett’s oesophagus; healing was maintained for a mean of 2.9 years in ≥ 70% of patients. Lansoprazole was also superior to ranitidine in prophylaxis of redilatation of oesophageal strictures.

After ≥ 4 years of use in patients with Zollinger-Ellison syndrome, lansoprazole 60 to 180 mg/day effectively controlled basal acid output. Dosages may be reduced in some patients once healing and symptom relief has been achieved. Preliminary studies of lansoprazole in patients at risk of aspiration pneumonia or stress ulcers show promise. Although studies show lansoprazole is potentially effective in treating gastrointestinal bleeding, future studies should assess patients’ H. pylori status.

Lansoprazole has been well tolerated in clinical trials, with headache, diarrhoea, dizziness and nausea appearing to be the most common adverse effects. Tolerability of lansoprazole does not deteriorate with age and the drug is well tolerated in long term use (≤ 4 years) in patients with Zollinger-Ellison syndrome or reflux disease.

Thus, lansoprazole is an important alternative to omeprazole and H2 receptor antagonists in acid-related disorders. In addition to its efficacy in healing or maintenance treatment, it may provide more effective symptom relief than other comparator agents.

Pharmacological Properties

Lansoprazole provides dose-related inhibition of gastric acid secretion via inhibition of H+/K+-adenosine triphosphatase in gastric parietal cells, with doses of 30 to 60mg producing similar acid suppression to omeprazole 40mg. Mean 24-hour gastric pH levels are higher when lansoprazole is given in 2 divided doses rather than 1 dose daily. Lansoprazole is 2 to 8 times more potent than omeprazole in inhibitory effects on H. pylori in vitro and is associated with dose-dependent killing of the bacterium.

Orally administered lansoprazole is well absorbed, with peak plasma concentrations (Cmax) linear over the dose range from 15 to 60mg. Sucralfate does reduce and food may reduce absorption of lansoprazole, and lansoprazole may reduce concentrations of theophylline. Both lansoprazole and the 14-hydroxy metabolite of clarithromycin are found in greater concentrations in plasma when administered together with amoxicillin. The drug is hepatically biotransformed and excreted through the bile and kidneys. The elimination half-life is ≈1 hour. Although clearance is reduced in poor metabolisers of S-mephenytoin, elderly patients and those with hepatic cirrhosis or undergoing haemodialysis, dosage adjustments are usually not considered except for patients with severe liver failure. For ease of administration, the enteric-coated granules in lansoprazole capsules may be mixed with apple sauce or juice before administration, with no major changes in pharmacokinetics.

Clinical Efficacy

In peptic ulcer healing and symptom relief, lansoprazole 15 to 60 mg/day monotherapy for 4 to 8 weeks was similar or superior in efficacy to omeprazole 20 to 40 mg/day. Lansoprazole 30 mg/day was similar or superior to ranitidine and superior to famotidine in ulcer healing. When used in combination with ≥2 antibacterials, lansoprazole 30 to 60 mg/day was an effective part of regimens capable of achieving eradication of H. pylori in ≥90% of patients, although lansoprazole monotherapy was ineffective. The probability of achieving eradication in ≥90% of patients was highest in regimens incorporating ≥2 antibacterial agents and using ≤4 weeks of lansoprazole 60 mg/day. Healing rates seen in a subset of ≥1300 patients from these H. pylori eradication studies (receiving mono-, dual or triple therapy) were similar to those seen in earlier lansoprazole monotherapy trials. Healing was not affected by the number of agents in the regimen, the lansoprazole dosage or the ability of the regimen to eradicate H. pylori. As part of regimens with ≥2 antibacterial agents, lansoprazole 60 mg/day was as effective as omeprazole 40 mg/day, tripotassium dicitrato bismuthate 120mg 4 times daily or ranitidine 300 mg/day in H. pylori eradication and was similar to omeprazole and tripotassium dicitrato bismuthate but superior to cimetidine in achieving ulcer healing.

As initial treatment of gastro-oesophageal reflux disease (GORD), lansoprazole 15 to 60 mg/day is superior to ranitidine 150mg twice daily in 2-week symptom relief and 4-week healing. Lansoprazole 30 mg/day and famotidine 40 mg/day for 4 weeks achieved similar healing rates, but relapse was more common in patients subsequently maintained on famotidine. No statistically significant differences in GORD healing rates were seen between omeprazole 20 or 40 mg/day and lansoprazole 15 or 30 mg/day, but lansoprazole tended to relieve symptoms more rapidly than omeprazole. Although clear dose-response effects have not been seen in GORD healing across trials, superior symptom relief appears to accompany 30 or 60 mg/day dosages. Following initial GORD healing, lansoprazole 15 and 30 mg/day or omeprazole 20 mg/day for 12 months did not differ in prevention of symptoms or relapse, although both drugs were superior to ranitidine or placebo. Lansoprazole also heals and maintains healing of erosions resistant to H2 receptor antagonists.

Greater rates of endoscopically confirmed healing and relief of symptoms of oesophageal erosions associated with Barrett’s oesophagus were found with lansoprazole 30 to 60 mg/day than with ranitidine 150mg twice daily for 8 weeks. 70% of patients achieved healing and symptom relief during long term (mean 2.9 years) treatment of Barrett’s oesophagus with lansoprazole 60 mg/day. Fewer lansoprazole 30 mg/day than ranitidine 300 mg/day recipients with oesophageal strictures required redilatation during 12 months of treatment, but most of those required the procedure during the first 6 months of treatment.

In patients treated for up to 4 years, lansoprazole 60 to 180 mg/day effectively reduced basal acid output by 95% or to <10 mmol/h and healed ulcers in patients with Zollinger-Ellison syndrome. Preliminary studies of lansoprazole in patients at risk of stress ulcers or of aspiration pneumonia suggest that this treatment has promise; lansoprazole 30mg on the evening before and morning of surgery was similar in efficacy to ranitidine 150mg on the morning of surgery in preventing aspiration pneumonitis. Preliminary results showing that lansoprazole 30 to 60 mg/day can halt or reduce the risk of gastrointestinal bleeding are encouraging for future studies in this indication.

Tolerability

In clinical trials involving >5000 patients receiving lansoprazole 7.5 to 60 mg/day monotherapy or comparators only 2.1 % of lansoprazole recipients withdrew from treatment (vs 2.6% receiving ranitidine, 1.2% on famotidine or 1.6% on omeprazole). The most common adverse events included headache (8.8%), diarrhoea (3.5%), nausea (2.0%), dizziness (1.6%), vomiting (1.4%) and constipation (1.0%). However, when non-drug-related adverse events were excluded, only headache, diarrhoea, dizziness and nausea occurred in >1 % of patients. There was no increase in adverse events in elderly patients, in whom headache (4%), diarrhoea (4.7%), nausea (2.9%), dizziness (2.9%) and constipation (2.9%) were most common. Serious adverse events occurred in only 0.6% of lansoprazole recipients in clinical trials and no patterns occurred to suggest a specific mechanism for these events.

Lansoprazole is generally well tolerated in long term treatment in patients with GORD or Zollinger-Ellison syndrome. No significant differences in the number of adverse events with lansoprazole compared with omeprazole, ranitidine or placebo have been observed in long term studies. Diarrhoea appeared to be the most commonly reported adverse event associated with long term lansoprazole treatment.

Pharmacoeconomic Assessment

In H. pylori eradication regimens in Canada, lansoprazole and omeprazole triple therapies appear less expensive than other triple therapy, dual therapy or H2 receptor antagonist monotherapy regimens. A UK model assessing direct medical costs after lansoprazole, ranitidine or omeprazole therapy reported these 3 agents to be similarly cost effective in peptic ulcer or dyspepsia patients. Lansoprazole, however, was clearly more cost effective than the other 2 agents in the treatment of GORD.

In the US, lansoprazole was shown to be a less costly treatment of GORD than omeprazole, laparoscopic fundoplication surgery or brandname H2 receptor antagonists. However, generic ranitidine or cimetidine were less expensive than lansoprazole in GORD treatment.

In the prevention of GORD relapse, lansoprazole was more cost effective than high dose H2 receptor antagonists and similar to standard doses of H2 receptor antagonists in some patients.

Dosage and Administration

Usual dosages of lansoprazole for use in the treatment of gastric or duodenal ulcer (ulcer healing or H. pylori eradication) or reflux oesophagitis healing are 15 to 60 mg/day for 4 to 8 weeks, with dosages of 15 to 30 mg/day for maintenance treatment, where indicated. The drug is generally administered before meals and is given either once daily in the morning or in divided doses morning and evening. Patients with Zollinger-Ellison syndrome usually receive 60 mg/day initially, with the dose then titrated to reduce basal acid output to <5 or <10 mmol/L. Dosage adjustments may be considered in patients with severe liver disease, but are not required for elderly patients or those with renal insufficiency. The use of lansoprazole in children has not been fully studied.

Keywords

Omeprazole Duodenal Ulcer Ranitidine Lansoprazole Triple Therapy 

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Copyright information

© Adis International Limited 1997

Authors and Affiliations

  1. 1.Adis International LimitedMairangi Bay, Auckland 10New Zealand

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