Evidence for therapeutic equivalence of lansoprazole 30mg and esomeprazole 40mg in the treatment of erosive oesophagitis.

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.