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By William T. Elliott, MD, FACP, and James Chan, PharmD, PhD
Lansoprazole has been granted a new indication by the FDA—it is the first proton pump inhibitor (PPI) approved for the treatment of NSAID-associated gastric ulcers. The drug was introduced in 1995 and marketed as Prevacid by TAP Pharmaceuticals.
Lansoprazole has gained FDA approval for the healing of NSAID-associated gastric ulcer in patients who continue NSAID use and for the risk reduction of NSAID-associated gastric ulcer with history of a documented gastric ulcer who require the use of a NSAID.
For the healing of NSAID-associated gastric ulcer, the recommended dose is 30 mg once daily for eight weeks. For the risk reduction of NSAID-associated gastric ulcer, the recommended dose is 15 mg once daily for up to 12 weeks.1
Lansoprazole is available as 15 mg and 30 mg capsules.
Lansoprazole is the first PPI approved for NSAID-associated gastric ulcer treatment in patients continuing NSAID therapy. Lansoprazole is more conveniently dosed once daily compared to 2-4 times a day dosing of misoprostol. The latter is FDA approved for the prevention of NSAID-induced gastric ulcers in patients at high risk of complication from gastric ulcers.
Lansoprazole (15 mg or 30 mg) is reported to be less effective than misoprostol in reducing the risk of NSAID-associated gastric ulcer.1 After 12 weeks of treatment, the percentages of patients remaining gastric ulcer free were 80%, 82%, and 92%, respectively, for lansoprazole 15 mg daily, lansoprazole 30 mg daily, and misoprostol 200 mcg four times daily.
PPIs are important agents for the treatment and prevention of NSAID-associated gastric and duodenal injury. Omeprazole, the first PPI marketed, is more efficacious than ranitidine in healing and preventing NSAID-associated gastroduodenal ulcers.2,3 Similarly, lansoprazole has been shown to be more effective than ranitidine in healing NSAID-associated gastric ulcers.4 Lansoprazole appears to be less effective than misoprostol (200 mcg 4 times a day) in preventing NSAID-associated gastric ulcer.1 Omeprazole has been reported to be comparable to a lower dose of misoprostol (200 mcg twice daily) in preventing gastric ulcers.5 Misoprostol, however, is generally not well tolerated due to diarrhea and abdominal pain, may be less effective in preventing duodenal ulcers, and requires multiple daily dosing.5 Lansoprazole is currently the only PPI approved for treatment of NSAID-associated gastric ulcers in patients continuing NSAID therapy. However, it is reasonable to believe that omeprazole is equally effective.
Studies have indicated that the attributable risk of ulcer complications for NSAID users is 25-35%.6 It was estimated that there are more than 100,000 annual hospitalizations for serious gastrointestinal (GI) complications due to NSAID use.2 Risk factors include age, male gender, past history of peptic ulcer disease, NSAID dose, and the use of corticosteroids or anticoagulants.6,7 For patients who need to continue NSAID therapy, a PPI is effective in healing gastric and duodenal ulcer in H. pylori-positive or -negative patients.2,6 For primary or secondary prophylaxis, concomitant treatment with a PPI or misoprostol are reasonable choices. Selective cyclooxygenase inhibitors, such as celecoxib or rofecoxib, may provide another alternative, although their role in patients with active GI disease has not been adequately studied as these were generally excluded in published studies.8,9 These patients may still require concomitant therapy with a PPI.6,10
1. Prevacid Product Information. TAP Pharmaceuticals. December 2000.
2. Wolfe M, et al. N Engl J Med 1999;340:1888-1899.
3. Yeomans ND, et al. N Engl J Med 1998;338:719-726.
4. Agrawal NM, et al. Arch Intern Med 2000;160:
5. Hawkey CJ, et al. N Engl J Med 1998;338:727-734.
6. Hawkey CJ. Gastroenterology 2000;119:521-535.
7. Hernandez-Diaz S, et al. Arch Intern Med 2000;160: 2093-2099.
8. Langman MJ, et al. JAMA 1999;282:1929-1933.
9. Simon LS, et al. JAMA 1999;282:1921-1928.
10. Sheiman JM. Curr Treat Options Gastroenterol 1999; 2(3):205-213.