Source: Cancer  |  Posted 5 years ago

By Chris Berrie

BERLIN, GERMANY -- October 27, 2006 -- With esomeprazole showing a significantly increased rate of endoscopic remission over pantoprazole at the end of healing plus maintenance therapy in patients with reflux esophagitis, a significantly increased likelihood of endoscopic remission was also associated with positive Helicobacter-pylori status and older age.

The converse was seen for patients with more severe reflux esophagitis at baseline or a higher body mass index (BMI), according to the Efficacy of Healing and Maintenance Treatment with Esomeprazole and Pantoprazole in Subjects with Reflux Esophagitis (EXPO) study.

The multicentre, randomised, double-blind EXPO study was presented here on October 25[^]th[] by principal investigator Joachim Labenz, MD, head of internal medicine and gastroenterology, Ev. Jung-Stilling Hospital, Siegen, Germany, at the United European Gastroenterology Week (UEGW).

Reflux esophagitis is a chronic condition and one of the main goals of treatment is to achieve initial healing, with maintenance of remission throughout subsequent long-term therapy. While the full study considered this aspect more directly, as Dr. Labenz indicated, "We were interested to see here whether the choice of drug was the only important predictor or whether there are other effectors related to the outcome of treatment."

The study enrolled adults with endoscope-documented reflux esophagitis and more than 6 months of gastroesophageal reflux disease (GERD) symptoms.

The full study design started with the initial randomisation to esomeprazole or pantoprazole for the week-4 to -8 healing phase. For the 6-month maintenance phase, the 1562 patients on esomeprazole 40 mg OD and 1589 on pantoprazole 40 mg OD were then re-randomised to receive either continuation of their initial treatment at a reduced dose of 20 mg OD, or crossover to the alternate treatment, again at 20 mg OD.

As a subanalysis for the significant factors associated with the likelihood of endoscopic remission, this study compared the 772 patients that received esomeprazole (50.1 years; male, 62.3%) and 797 that received pantoprazole (50.4 years; male, 61.0%) throughout both healing and maintenance phases.

Full baseline demographics and clinical characteristics of the intention-to-treat (ITT) populations of each of these treatment groups showed no significant differences, including history of GERD symptoms, severity of heartburn (Los Angeles grade), Barrett's esophagus (16.6% vs 15.8%, respectively), and H. pylori status (positive, 28.0% vs 26.0%).

In the multiple logistics regression analysis of these 2 subgroups, esomeprazole showed a slightly higher rate of endoscopic remission than pantoprazole at the end of the combined healing plus maintenance phases (odds ratio [OR], 1.62; 95% confidence interval [CI], 1.30-2.01; []P[] less than or equal to .001).

H. pylori status (positive vs negative/ missing; OR, 1.36; 95% CI, 1.06-1.74; []P[] < .05) and older age (per year; OR, 1.02; 95% CI, 1.01-1.02; []P[] less than or equal to .001) were also associated with a significantly increased likelihood of endoscopic remission.

In contrast, patients with more severe reflux esophagitis at baseline (Los Angeles grade C or D; OR, 0.55; 95% CI, 0.43-0.77; []P[] less than or equal to .001) or higher body mass index (BMI greater than or equal to 30 kg/m[^]2[]; OR, 0.73; 95% CI, 0.58-0.92; []P[] less than or equal to .001) were significantly less likely to achieve endoscopic remission at the end of the healing and maintenance phases. The presence of Barrett's esophagus at baseline also showed a trend towards not achieving endoscopic remission (OR, 0.73; 95% CI, 0.53-1.02).

Therefore, these multiple regression analyses for the factors with significant influence on endoscopic remission of these specific treatment subgroups from the EXPO study were able to highlight not just the drug treatment, esomeprazole versus pantoprazole, but also a positive H. pylori status and an older age as beneficial factors, with more severe reflux esophagitis and higher BMI at baseline providing worse prognosis.

"I think it is important to look more carefully at the patients who present with reflux esophagitis, as it is not just one disease? such that in the future we may arrive at a more individual treatment of the disease," Dr. Labenz noted.

This study was supported by AstraZeneca R&D, Sweden.

[Presentation title: Factors That Influence Endoscopic Remission After Healing and Maintenance Therapy for Reflux Esophagitis: Results From the EXPO study. Abstract Wed-G-132]