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New Triple-Therapy Regimen Eradicates Helicobacter Pylori: Presented at DDW

By Mike Fillon

ORLANDO, FL -- May 25, 2003 -- Triple therapy with rabeprazole, clarithromycin and amoxicillin is highly effective in eradicating Helicobacter pylori (Hp), according to a new study presented here on May 19^th at Digestive Disease Week.

"Combining these antibiotics with a proton-pump inhibitor [is] the gold standard for treatment in Brazil," said lead researcher Schlioma Zaterka, MD, from Sao Paulo State University at Campinas, in Campinas, Brazil.

His multicenter, open-label parallel-group study enrolled 86 men and 126 women with an average age of 39.1 years. Most of the patients were free of gastric ulcers and duodenal ulcers. H. pylori status was assessed by rapid urease test and a C-urea breath test.

Patients received one of three treatment regimens. Seventy patients in Group A received a twice daily regimen of rabeprazole 20 mg, clarithromycin 500 mg and amoxicillin 1000 mg twice daily; 70 patients in Group B received rabeprazole 20 mg twice daily, levofloxacin 500 mg once daily, and amoxicillin 1000 mg twice daily; 72 patients in Group C received rabeprazole 20 mg, levofloxacin 500 mg daily, and amoxicillin 1000 mg twice daily.

The analysis included an intent-to-treat (ITT) population and a per protocol (PP) population. Dr. Zaterka presented results of an interim analysis on the 141 patients in the PP population.

H. pylori eradication rates were much higher for Group A than the other two groups. No significant difference in eradication rates was found between Group B and C.

The substitution of levofloxacin for clarithromycin produced eradication rates of less than 80% -- a level deemed unacceptable by all consensus standards, Dr. Zaterka said. Twice-daily dosing of rabeprazole with levofloxacin was no more effective than once-daily dosing, suggesting that twice-daily dosing may be unnecessary in these patients.

Funding for this research was provided by Eisai Inc. of Teaneck, New Jersey, and Janssen-Cilag, of São Paulo, Brazil.


[Study title: A Multicenter Study to Compare the Efficacy and Safety of 3 7-Day Rabeprazole (RAB)-Based Triple Therapy Regimens for Helicobacter pylori (Hp) Eradication. Abstract M-1494]

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