Clinical Drug Investigation

, Volume 23, Issue 2, pp 69–84 | Cite as

Lansoprazole and Esomeprazole in Symptomatic GERD

A Double-Blind, Randomised, Multicentre Trial in 3000 Patients Confirms Comparable Symptom Relief
Original Research Article

Abstract

Objective

To evaluate the onset and degree of symptom relief in a population of patients with symptomatic gastro-oesophageal reflux disease (GERD) treated with lansoprazole 30mg or esomeprazole 40mg, each administered once daily.

Design

This was a phase IIIb, prospective, randomised, double-blind, active-controlled, multicentre study of patients with a history of symptomatic GERD.

Methods

Patients with symptomatic GERD based on preset criteria were randomised in a 1: 1 ratio to lansoprazole or esomeprazole for 2 weeks. Efficacy endpoints were the percentage of patients without daytime heartburn after the first treatment day, the percentage of patients without night-time heartburn after the first treatment day, and symptom relief (measured as percentage of days and nights without heartburn) and average symptom severity after the first day, during the first 3 days (primary efficacy endpoint), during the first week and during the 2-week treatment period.

Results

3034 patients were randomised to lansoprazole 30mg (n = 1520) or esomeprazole 40mg (n = 1514). Patients in both treatment groups reported increases from baseline in the percentages of days and nights without heartburn and decreases in the average daytime and night-time heartburn severity during the 2-week treatment period. No statistically significant differences were observed between the lansoprazole 30mg and esomeprazole 40mg treatment groups in heartburn relief parameters on day 1 or during the first 3 days, the first week or the 2-week treatment period after adjusting for differences in baseline heartburn severity. Both treatments were well tolerated. Significantly higher percentages of patients treated with esomeprazole as compared with those treated with lansoprazole reported treatment-emergent dry mouth (0.5% vs 0.1 %, p = 0.021) and vomiting (0.5% vs 0.1%, p = 0.038). The most common treatment-related adverse events were diarrhoea (lansoprazole 1.4%, esomeprazole 1.8%), flatulence (lansoprazole 0.7%, esomeprazole 1.0%) and abdominal pain (lansoprazole 1.1%, esomeprazole 1.3%).

Conclusion

Lansoprazole 30mg once daily or esomeprazole 40mg once daily for 2 weeks effectively increase the percentage of days and nights patients with symptomatic GERD are without heartburn and reduce the average severity of daytime and night-time heartburn.

Notes

Acknowledgements

This research was supported by a grant from TAP Pharmaceutical Products Inc., Lake Forest, Illinois, USA.

We wish to thank the participating investigators (see Appendix) for their contribution to the study, and TAP Pharmaceutical Products Inc., Lake Forest, Illinois, USA for their support.

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Copyright information

© Adis International Limited 2003

Authors and Affiliations

  1. 1.University of Michigan Health SystemAnn ArborUSA
  2. 2.Abbott LaboratoriesAbbott ParkUSA
  3. 3.TAP Pharmaceutical Products Inc.Lake ForestUSA

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