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Erschienen in:
01.09.2004 | Adis Drug Profile
Delayed-Release Lansoprazole plus Naproxen
Erschienen in: Drugs | Ausgabe 17/2004
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▴ A combination package containing delayed-release capsules of the proton pump inhibitor lansoprazole (15mg once daily) and tablets of the NSAID naproxen (375 or 500mg twice daily) has been approved for reducing the risk of NSAID-associated gastric ulcers in NSAID-requiring patients with a documented history of gastric ulcer.
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▴ In a large, 12-week trial in NSAID (including naproxen)-requiring patients with a documented history of gastric ulcer, significantly more recipients of delayed-release lansoprazole 15mg once daily than placebo recipients were free from gastric ulcer (p < 0.001). At week 12, the percentages of patients who were free from gastric ulcer were 80% with lansoprazole 15mg and 51% with placebo.
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▴ In a subgroup analysis of recipients of naproxen (89% received 750–1000 mg/day), the percentage of patients free from gastric ulcer after 12 weeks of treatment was significantly higher with delayed-release lansoprazole 15mg than with placebo (89% vs 33%; p < 0.001).
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▴ In NSAID (including naproxen)-requiring patients with a documented history of gastric ulcer, the incidence of treatment-related adverse events in recipients of delayed-release lansoprazole 15mg once daily was low (7%), and similar to that in recipients of placebo (10%).