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Title: Superior Relief Gained With Pantoprazole for Nocturnal Gastro-oesophageal Reflux Disease: Presented at UEGW

"Superior Relief Gained With Pantoprazole for Nocturnal Gastro-oesophageal Reflux Disease: Presented at UEGW"

By Chris Berrie PRAGUE, CZECH REPUBLIC -- September 29, 2004 -- The proton pump inhibitor pantoprazole is superior to esomeprazole, omeprazole, and nizatidine in its control of night-time symptoms of erosive gastro-oesophageal reflux disease (GORD), according to an analysis of pooled data from per protocol populations of six multicentre, randomised, double-blind trials. Hubert Doerfler, MD, international study manager, clinical research, Gastroenterology, Altana Pharma AG, Konstanz, Germany, presented the data here September 27th at the 12th United European Gastroenterology Week. A large amount of information is now available regarding GORD, although the understanding of nocturnal heartburn remains limited, said Dr. Doerfler. There is increasing evidence that night-time heartburn in patients with erosive GORD can lead to more severe injuries than just sleep disturbance and diminished quality of life, he said—these have been reported to include oesophagitis and stricture, Barrett's oesophagus or adenocarcinoma, and extra-oesophageal disorders. Dr. Doerfler and colleagues therefore analysed combined data from six clinical trials with comparable study designs to compare the treatment effects of four regimens: pantoprazole 40 mg OD in 1326 patients, esomeprazole 40 mg OD in 198 patients, omeprazole 40 mg OD in 270, nizatidine 150 mg BID in 136, and placebo in 68 patients. All patients had night-time heartburn and 63% of them were men. Patients provided a self-assessment of their relief of night-time heartburn either through daily diaries or drug-visit questionnaires. Final relief from night-time heartburn was calculated according to the Kaplan-Meier survival-time method, and comparisons of relief rates were made using 95% confidence intervals of differences and by log-rank testing. The demographic characteristics did not differ significantly among treatment groups. At the first comparison stage of 14 days, the pantoprazole regimen showed significantly higher relief rates compared with esomeprazole, omeprazole, nizatidine, and placebo (44% pantoprazole; 10%, 5%, 3%, 0%, respectively, P <.05). By day 56, pantoprazole and esomeprazole showed similar final relief rates from night-time heartburn (94% and 95%, respectively), which were both significantly higher than the other treatments (87%, 60%, 73%, respectively, P <.05). For the overall relief from heartburn calculated across all time points, pantoprazole had significantly superior overall relief from night-time heartburn than esomeprazole (P =.0006), omeprazole (P <.0001), nizatidine (P <.0001), and placebo (P <.0001). Dr. Doerfler stressed that this superior relief gained with pantoprazole for the treatment of nocturnal GORD should allow for better protection of these patients from further associated severe injuries. [Presentation title: "Pantoprazole Is Superior to Both Omeprazole and to Nizatidine With Regard to Overall Final Relief from Night-time Heartburn in Patients With Erosive Gastro-oesophageal Reflux Disease. Abstract MON-G-158." Abstract 424]

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