Clinical drug investigation · 2002
Evidence for therapeutic equivalence of lansoprazole 30mg and esomeprazole 40mg in the treatment of erosive oesophagitis.
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Howden Colin W, Ballard E David, Robieson Weining
Аннотация
OBJECTIVE: To compare the effectiveness of lansoprazole 30mg once daily and esomeprazole 40mg once daily on healing and symptom relief in patients with erosive oesophagitis.
DESIGN: Phase IV, randomised, double-blind, active-controlled, multicentre study.
PATIENTS AND PARTICIPANTS: 284 patients with endoscopically confirmed erosive oesophagitis (grade ≥2).
METHODS: Patients were randomised to treatment with lansoprazole or esomeprazole. The primary efficacy endpoint was the healing of erosive oesophagitis (defined as grade 0 or 1) at week 8. Healing rates at week 4 and the percentages of patients reporting no daytime or night-time heartburn after 1 day, 3 days and 1 week of treatment, as well as the rate of healing or improvement of oesophagitis by two grades, were also analysed.
RESULTS: Healing rates and 95% confidence intervals (CIs) at week 8 were 91.4% (85.4, 95.5%) for lansoprazole 30mg once daily and 89.1% (82.7, 93.8%) for esomeprazole 40mg once daily, respectively. For any baseline grade, greater than 90% of lansoprazole-treated and 81% of esomeprazole-treated patients exhibited healing or improvement of erosive oesophagitis by two grades from baseline to week 8. Healing rates at week 4 were also comparable: 77.0% (95% CI 69.1, 83.7%) for lansoprazole 30mg and 78.3% (95% CI 70.4, 84.8%) for esomeprazole 40mg. The percentages of heartburn-free patients after 1 day, 3 days and 1 week of treatment were slightly higher for lansoprazole compared with esomeprazole, although the differences did not reach statistical significance (p > 0.05). Both treatments were well tolerated.
CONCLUSIONS: In erosive oesophagitis, lansoprazole 30mg once daily and esomeprazole 40mg once daily are equally effective in healing erosions and relieving heartburn.
DESIGN: Phase IV, randomised, double-blind, active-controlled, multicentre study.
PATIENTS AND PARTICIPANTS: 284 patients with endoscopically confirmed erosive oesophagitis (grade ≥2).
METHODS: Patients were randomised to treatment with lansoprazole or esomeprazole. The primary efficacy endpoint was the healing of erosive oesophagitis (defined as grade 0 or 1) at week 8. Healing rates at week 4 and the percentages of patients reporting no daytime or night-time heartburn after 1 day, 3 days and 1 week of treatment, as well as the rate of healing or improvement of oesophagitis by two grades, were also analysed.
RESULTS: Healing rates and 95% confidence intervals (CIs) at week 8 were 91.4% (85.4, 95.5%) for lansoprazole 30mg once daily and 89.1% (82.7, 93.8%) for esomeprazole 40mg once daily, respectively. For any baseline grade, greater than 90% of lansoprazole-treated and 81% of esomeprazole-treated patients exhibited healing or improvement of erosive oesophagitis by two grades from baseline to week 8. Healing rates at week 4 were also comparable: 77.0% (95% CI 69.1, 83.7%) for lansoprazole 30mg and 78.3% (95% CI 70.4, 84.8%) for esomeprazole 40mg. The percentages of heartburn-free patients after 1 day, 3 days and 1 week of treatment were slightly higher for lansoprazole compared with esomeprazole, although the differences did not reach statistical significance (p > 0.05). Both treatments were well tolerated.
CONCLUSIONS: In erosive oesophagitis, lansoprazole 30mg once daily and esomeprazole 40mg once daily are equally effective in healing erosions and relieving heartburn.