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Symptom-relieving Effect of Esomeprazole 40 mg Daily in Patients with Heartburn

Symptom-relieving Effect of Esomeprazole 40 mg Daily in Patients with Heartburn Background: To assess symptom relief in patients with heartburn following treatment with esomeprazole 40 mg daily. Methods: Patients with heartburn (for ≥6 months) were assessed in this double-blind, multicenter study. After a 3-day single-blind placebo run-in, 440 patients were randomized to esomeprazole 40 mg o.d., esomeprazole 20 mg b.i.d. or placebo for 14 days. Heartburn symptoms were recorded daily; as insufficient patients had data available from days 13 and 14, analyses included data up to day 12. Gastroesophageal reflux disease (GERD) was diagnosed by upper GI endoscopy and 24-h pH- monitoring. The primary end-point was total heartburn relief defined as no heartburn symptoms during the preceding 24-h period. Results: 240 patients had erosive esophagitis (EO) and 114 patients had GERD defined by pH-monitoring. Proportions of patients with total heartburn relief increased during the first days of treatment and stabilized after Day 4. Total heartburn relief occurred in 67%-73%, 62%-70%, and 21%-32% of patients in the esomeprazole 40 mg o.d., esomeprazole 20 mg b.i.d., and placebo groups, respectively, between days 6 and 12. Proportions of patients with total heartburn relief were higher in patients with EO (71%-80% of patients from Day 4 onwards) compared to those without EO (52%-67% of patients from Day 4 onwards). Figures for patients diagnosed by pH-monitoring were 65%-73% of those with a positive diagnosis and 51%-58% with a negative diagnosis. Conclusion: Esomeprazole 40 mg o.d. treatment produces total heartburn relief in a high proportion of patients with GERD. Once-daily esomeprazole 40 mg dosing is recommended as no advantage was gained by splitting the dose. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Scandinavian Journal of Gastroenterology Taylor & Francis

Symptom-relieving Effect of Esomeprazole 40 mg Daily in Patients with Heartburn

Symptom-relieving Effect of Esomeprazole 40 mg Daily in Patients with Heartburn

Scandinavian Journal of Gastroenterology , Volume 38 (4): 7 – Jan 1, 2003

Abstract

Background: To assess symptom relief in patients with heartburn following treatment with esomeprazole 40 mg daily. Methods: Patients with heartburn (for ≥6 months) were assessed in this double-blind, multicenter study. After a 3-day single-blind placebo run-in, 440 patients were randomized to esomeprazole 40 mg o.d., esomeprazole 20 mg b.i.d. or placebo for 14 days. Heartburn symptoms were recorded daily; as insufficient patients had data available from days 13 and 14, analyses included data up to day 12. Gastroesophageal reflux disease (GERD) was diagnosed by upper GI endoscopy and 24-h pH- monitoring. The primary end-point was total heartburn relief defined as no heartburn symptoms during the preceding 24-h period. Results: 240 patients had erosive esophagitis (EO) and 114 patients had GERD defined by pH-monitoring. Proportions of patients with total heartburn relief increased during the first days of treatment and stabilized after Day 4. Total heartburn relief occurred in 67%-73%, 62%-70%, and 21%-32% of patients in the esomeprazole 40 mg o.d., esomeprazole 20 mg b.i.d., and placebo groups, respectively, between days 6 and 12. Proportions of patients with total heartburn relief were higher in patients with EO (71%-80% of patients from Day 4 onwards) compared to those without EO (52%-67% of patients from Day 4 onwards). Figures for patients diagnosed by pH-monitoring were 65%-73% of those with a positive diagnosis and 51%-58% with a negative diagnosis. Conclusion: Esomeprazole 40 mg o.d. treatment produces total heartburn relief in a high proportion of patients with GERD. Once-daily esomeprazole 40 mg dosing is recommended as no advantage was gained by splitting the dose.

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References (23)

Publisher
Taylor & Francis
Copyright
© 2003 Taylor and Francis Group, LLC
ISSN
1502-7708
eISSN
0036-5521
DOI
10.1080/00365520310002157
Publisher site
See Article on Publisher Site

Abstract

Background: To assess symptom relief in patients with heartburn following treatment with esomeprazole 40 mg daily. Methods: Patients with heartburn (for ≥6 months) were assessed in this double-blind, multicenter study. After a 3-day single-blind placebo run-in, 440 patients were randomized to esomeprazole 40 mg o.d., esomeprazole 20 mg b.i.d. or placebo for 14 days. Heartburn symptoms were recorded daily; as insufficient patients had data available from days 13 and 14, analyses included data up to day 12. Gastroesophageal reflux disease (GERD) was diagnosed by upper GI endoscopy and 24-h pH- monitoring. The primary end-point was total heartburn relief defined as no heartburn symptoms during the preceding 24-h period. Results: 240 patients had erosive esophagitis (EO) and 114 patients had GERD defined by pH-monitoring. Proportions of patients with total heartburn relief increased during the first days of treatment and stabilized after Day 4. Total heartburn relief occurred in 67%-73%, 62%-70%, and 21%-32% of patients in the esomeprazole 40 mg o.d., esomeprazole 20 mg b.i.d., and placebo groups, respectively, between days 6 and 12. Proportions of patients with total heartburn relief were higher in patients with EO (71%-80% of patients from Day 4 onwards) compared to those without EO (52%-67% of patients from Day 4 onwards). Figures for patients diagnosed by pH-monitoring were 65%-73% of those with a positive diagnosis and 51%-58% with a negative diagnosis. Conclusion: Esomeprazole 40 mg o.d. treatment produces total heartburn relief in a high proportion of patients with GERD. Once-daily esomeprazole 40 mg dosing is recommended as no advantage was gained by splitting the dose.

Journal

Scandinavian Journal of GastroenterologyTaylor & Francis

Published: Jan 1, 2003

Keywords: Esomeprazole; gastroesophageal reflux disease; heartburn; symptom relief

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