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| |  UEGW: Esomeprazole Provides Greater Symptom Resolution and Remission Maintenance in Erosive Oesophagitis Than Pantoprazole By Chris Berrie PRAGUE, CZECH REPUBLIC -- September 29, 2004 -- The proton pump inhibitor esomeprazole appears to be more effective than pantoprazole in providing symptom resolution and maintenance of remission of gastro-oesophageal reflux disease (GORD) in patients with erosive oesophagitis. Joachim Labenz, MD, international principal investigator and chief, Department of Internal Medicine, Jung-Stilling Hospital, Siegen, Germany, presented the results of a multicentre randomized, double-blind, parallel-group study September 27th at the 12th United European Gastroenterology Week. Patients with erosive oesophagitis often have GORD symptoms, such as heartburn, acid regurgitation, epigastric pain and dysphagia; and esomeprazole has already been seen to heal significantly more patients than both omeprazole and lansoprazole, while achieving greater resolution of heartburn. In describing the background to these PPI studies, Dr. Labenz said previous trials have suggested that PPIs, on a milligram basis, have essentially the same efficacies, although changes in gastric pH levels are different among the different PPIs. In addition, he said, research has suggested that PPIs with a greater antisecretory effect will work better in a clinical setting. Dr. Labenz and colleagues therefore conducted a study on the healing and maintenance phases of treatment designed to determine if a PPI that has a greater effect on gastric pH levels would result in a greater clinical efficacy. In a previous study presented at the 2004 Canadian Digestive Disease Week (A Comparison of Esomeprazole 40 Mg Once-Daily and Pantoprazole 40 Mg Once-Daily for the Healing of Erosive Esophagitis. Abstract 147), Dr. Labenz showed significantly improved healing with esomeprazole versus pantoprazole in patients who received acute treatment for 4 to 8 weeks. His team then followed this by a re-randomization of the healed and asymptomatic patients for a continuation/crossover esomeprazole/pantoprazole maintenance regimen. Of the 3170 patients enrolled with endoscopically confirmed erosive oesophagitis, 3161 patients with a mean age of 50.6 years who were 63% male were included in the intent-to-treat population. In the initial symptom resolution phase, 1567 patients were randomized to receive a 4-week to 8-week schedule of 40 mg of esomeprazole and 1594 to receive 40 mg of pantoprazole once daily. All the baseline demographic and clinical characteristics were similar between these esomeprazole and pantoprazole groups. At week 4, the patients were assessed on a 4-grade scale for epigastric pain, acid regurgitation and dysphagia. This revealed that a significantly greater proportion of esomeprazole-treated patients had achieved complete resolution of symptoms compared with those on pantoprazole (73.0% vs. 67.5%, respectively, P =.001). Further, a significant proportion of the esomeprazole versus pantoprazole patients with complete resolution of investigator-assessed heartburn were healed for erosive oesophagitis (86.4% vs. 82.6%, respectively, P <.05). Following this initial demonstration of the improved effectiveness of esomeprazole over pantoprazole for providing resolution and healing of erosive oesophagitis patients, all of the 2766 patients with healed erosive oesophagitis who were free of moderate to severe heartburn and acid regurgitation in the preceding 7 days proceeded into a maintenance regimen. They were randomized to either of 20 mg/day of the same PPI or of a crossover to 20 mg/day of the alternate PPI, according to their randomisation at baseline. The proportion of patients remaining in remission at 6 months was significantly greater for those treated with 20 mg/day esomeprazole (87.0%) versus 20 mg/day pantoprazole (74.9%, P <.0001). In addition, after 6 months of treatment, significantly more esomeprazole patients remained free from heartburn than pantoprazole patients (94.5% vs. 90.5% pantoprazole, P <.0001). In a further study with 1569 of these patients, the researchers also compared more directly the outcomes of the same drug, acute and maintenance phases as evaluated using the Los Angeles (LA) classification, which describes four grades of oesophagitis severity (A to D), based on the extent of oesophageal lesions known as "mucosal breaks." Again, the researchers found that esomeprazole was superior to pantoprazole across baseline LA grades (all grades: esomeprazole 40/20 mg, 70.9% of 547 patients; pantoprazole 40/20 mg, 59.6% of 475; P <.0001). Dr. Labenz concluded that esomeprazole provides greater symptom resolution and maintenance of remission in erosive oesophagitis than pantoprazole, although he added that, "There are some new drug classes in the pipeline that appear to offer more potent acid inhibition than the PPIs, which might lead to some further improvements."
[Presentation titles: Esomeprazole 40 mg Compared With Pantoprazole 40 mg for Providing Resolution of GORD symptoms in Patients With Erosive Oesophagitis. Abstract MON-G-186; A Comparison of Esomeprazole and Pantoprazole for Maintenance Treatment of Healed Erosive Oesophagitis. Abstract MON-G-175. Esomeprazole and Pantoprazole : A Comparison in the Management of Patients With Erosive Esophagitis Over Acute and Maintenance Phases. Abstract MON-G-185. Presentation #670]
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