my personal edition > h. pylori/ulcer > news


  E-Mail this DGDispatch to a colleague

DGDispatch

Pantoprazole Treatment Prevents Relapse over Three Years in Erosive Esophagitis: Presented at DDW

By Ed Susman

ORLANDO, FL -- May 19, 2003 -- Researchers said treatment gains achieved with pantoprazole to heal erosive oesophagitis are retained for at least 3 years for more patients than for with ranitidine.

In a poster presentation at Digestive Disease Week 2003 here May 18^th, Dr. Polly Fraga, MD, a researcher for Wyeth Research, of Collegeville, Pennsylvania, said her study pooled data from two pivotal studies which demonstrated that pantoprazole was more effective in healing erosive oesophagitis than did ranitidine.

"But what was also impressive was that after 3 years, about 76% of the ranitidine patients had dropped out [of the study] -- most of the time because of ineffectiveness -- compared with 47% in the pantoprazole group; 13% for lack of effectiveness."

"Pantoprazole 40 mg was well tolerated, maintained healing at a high rate over 3 years, and was superior to ranitidine 150 mg in healing maintenance at all time points," she said at the meeting, which was jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract.

In the two identical, multicenter, randomised, double-blind studies conducted in the United States and sponsored by Wyeth Research, researchers randomised 721 patients into one of four twice-daily treatment arms: 10 mg, 20 mg and 40 mg once-daily doses of pantoprazole and 150 mg of ranitidine.

The drugs were evaluated for their ability to prevent relapse of erosive esophagitis. The healing of erosive esophagitis was documented by endoscopy.

At 12 months, remission rates were significantly higher for pantoprazole 40 mg -- reaching 84% in one study and 81% in the other -- than for ranitidine, which had remission rates of 32% in the first study and 33% in the second.

Patients had an average age of 49 years; about 60% were women; more than 85% were white; about 14% had Helicobacter pylori infection. No adverse event had a significantly higher incidence in any pantoprazole group compared with ranitidine.

After 3 years, 20% of the original 185 patients on ranitidine remained on the study drug. Among the pantoprazole patients, 54% of 179 patients remained on the 40 mg dose of the drug after 3 years; 42% of the 182 patients on the 20 mg dose remained in the study; 33% of the 175 patients on the 10 mg dose were still in the study.

"The withdrawal rate for pantoprazole was one-fourth that of ranitidine," Dr. Fraga said, "reflecting pantoprazole's superior effect in maintaining healing of erosive esophagitis.


[Study title: Comparison of the Clinical Efficacy and Safety of Pantoprazole Vs Ranitidine Over Three Years to Prevent Relapse in Patients with Healed Erosive Esophagitis. Abstract S1613]

E-Mail this DGDispatch to a colleague

To print, use this version