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Clin Drug Investig. 2002;22(2):99-109. doi: 10.2165/00044011-200222020-00004.

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

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  • 1Division of Gastroenterology and Hepatology, Northwestern University Medical School, 676 N. St Clair Avenue, Suite 880, Chicago, IL, 60611, USA.

Abstract

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.

PMID:
23315397
[PubMed]
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