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Title: Comparable Time to First and Sustained Symptom Relief with Pantoprazole and Esomeprazole in Patients with GERD: Presented at UEGW

"Comparable Time to First and Sustained Symptom Relief with Pantoprazole and Esomeprazole in Patients with GERD: Presented at UEGW"

By Chris Berrie COPENHAGEN, DENMARK -- October 21, 2005 -- A 40-mg dosing with pantoprazole appears to be non-inferior to an equal dose of esomeprazole for both time to first symptom relief and for sustained symptom relief in patients with erosive gastroesophageal reflux disease (GERD). Christo Van Rensburg, MD, Principal Investigator and Head, Gastroenterology Unit, University of Stellenbosch, Tygerburg, Republic of South Africa, presented the findings of a multicentre, randomised, double-blind, parallel-group comparison study here on October 17[^th at the 13^th United European Gastroenterology Week (UEGW).

"We wanted to see whether pantoprazole at 40 mg was similar to esomeprazole at 40 mg for symptom relief and also sustained symptom relief in patients with erosive gastroesophageal reflux disease," Dr. Van Rensburg said.

Of the 2714 patients with endoscopically confirmed Los Angeles classification GERD grades A to D, 2326 patients were randomised to receive 40 mg once daily of one of the two proton-pump inhibitors (PPI) -- pantoprazole or esomeprazole. The full intention-to-treat population for the analysis consisted of 1157 patients in each arm. Baseline demographic characteristics and GERD classification grades in the two arms were similar.

The primary variable was time to first symptom relief, and the secondary variable was time to sustained symptom relief as assessed using the ReQuest(TM) reflux questionnaire.

Dr. Van Rensburg said that non-inferiority was demonstrated at 3.9 days for pantoprazole and 3.7 days for esomeprazole in the intention-to-treat population (P < .0001). Similarly, sustained symptom relief was obtained after 9.9 days of treatment with pantoprazole and 9.1 days with esomeprazole (P < .001).

The researchers also noted that these two variables showed no variation with respect to H. pylori status or GERD grade.

This demonstration of non-inferiority of pantoprazole versus esomeprazole for patients with erosive GERD leaves the choice of treatment open, Dr. Van Rensburg concluded. "Here you are anyway dealing with very effective treatments for symptom relief, whatever the patient takes, whatever the PPI," he said.

ALTANA Pharma AG provided financial support for this study.

[Study title: Comparable Time to First and Sustained Symptom Relief Assessed by Request(tm) for the Treatment with Pantoprazole 40 Mg or Esomeprazole 40 Mg in Patients with GERD. Abstract MON-G-117]

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