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Pantoprazole Tops Ranitidine for Prevention of Rebleeding in High-Risk Ulcer Patients: Presented at DDW

By Bruce Sylvester

NEW ORLEANS, LA - May 21, 2004 -- Pantoprazole (Protonix) is significantly more effective than ranitidine for prevention of rebleeding in ulcer patients at high risk and who had presented symptoms of active arterial bleeding, researchers reported here in an oral presentation on May 18^th at Digestive Diseases Week 2004.

Alan Barkun, MD, Professor of Gastroenterology, McGill University Health Centre, Montreal, Quebec, Canada, noted that up to 20% of patients with peptic ulcer have bleeding from eroded blood vessels, and that about one fourth of these patients will undergo procedures such as endoscopic hemostasis therapy to enable clotting of eroded blood vessels.

Stomach acid, however, can digest the clots that have helped seal the eroded vessels. Such cases require acid suppression drug therapy for several days following endoscopy, Dr. Barkun explained. With colleagues, he designed a study to compare the value of the proton-pump inhibitor pantoprazole and the H₂-receptor antagonist ranitidine for patients requiring acid suppression following endoscopic hemostatis.

The researchers analyzed a cohort of subjects who underwent endoscopic hemostasis therapy and developed bleeding peptic ulcer and endoscopic findings suggesting a high risk of rebleeding or non-bleeding visible vessels. They randomized these patients to treatment with pantoprazole 80 mg bolus followed by 8 mg/h in a continuous infusion (618 intent-to-treat [ITT], 533 procedures performed [PP]) or ranitidine 50 mg bolus followed by a 13.3-mg/h continuous infusion (626 ITT, 525 PP) for 72 hours.

The primary efficacy criterion was rebleeding measured during a 72-hour period with a 5-point rebleeding scale -- none, need for endoscopy with or without hemostatic therapy, surgery, or death.

Results show that for the 98 high-risk patients with arterial spurting ulcer, pantoprazole was more effective that ranitidine for preventing rebleeding (11% vs. 35%, P < .01). Among 441 patients with gastric ulcers, rebleeding incidence was much lower in the pantoprazole cohort than the ranitidine subjects, (5.3% vs. 10.7%, P = .052).

Dr. Barkun also noted that while pantoprazole showed numerical superiority to ranitidine for preventing rebleeding in patients with bleeding peptic ulcer, the differences were not statistically significant (P=0.318 PP; P=0.083 ITT).

Safety data was similar between cohorts. In most cases, adverse events did not appear to be related to the study medications. Mild to moderate thrombophlebitis was the most frequently reported adverse event (5.3% pantoprazole and 0.5% ranitidine). The number of serious adverse events was similar in both groups, with 7 pantoprazole subjects and 19 ranitidine subjects withdrawing due to adverse events (P < .05).

Pantoprazole sodium for injection (Protonix IV), marketed by Wyeth-Ayerst Laboratories, is approved by the United States Food and Drug Administration for short-term treatment (7-10 days) of gastroesophageal reflux disease in patients with a history of erosive esophagitis, and as an alternative to oral therapy.

Wyeth-Ayerst provided funding for Dr. Barkum's study.


[Presentation title: "Prevention of Peptic Ulcer Rebleeding Using Continuous Infusion of Pantoprazole vs. Ranitidine: A Multicenter, Multinational, Randomized, Double-Blind, Parallel-Group Comparison."]

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