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Title: Rabeprazole Decreases Gastro-Oesophageal Reflux Symptoms in Adolescents: Presented at ACG

"Rabeprazole Decreases Gastro-Oesophageal Reflux Symptoms in Adolescents: Presented at ACG"

By Deborah Brauser ORLANDO, Fla -- October 10, 2008 -- Rabeprazole effectively relieves gastro-oesophageal reflux disease (GERD) symptoms and improves quality of life in adolescents, according to results from a multicentre, open-label trial presented here at the American College of Gastroenterology (ACG) 73rd Annual Scientific Meeting. Although the pharmacokinetics of rabeprazole has been investigated in adolescents, this is the first study to evaluate the use of rabeprazole for treatment of GERD in this age group, said Yufang Yu, MD, Eisai Global Clinical, Ridgefield Park, New Jersey. In a poster session on October 6 Dr. Yu said, "We know that in the real world, physicians are prescribing to adolescents. And we know a lot of adolescents have the weight and overall GERD symptoms manifesting similar to what we see in adults. So it is [important] to explore how these products that do well in adults are tolerated by adolescents." In their study, Dr. Yu and colleagues enrolled 111 patients 12 to 16 years old (mean age, 14 years) with clinical symptom of GERD or endoscopic evidence of GERD. Patients were randomised to receive a daily dose of rabeprazole 10 mg (n = 54) or 20 mg (n = 57) for 8 weeks. Two weeks after discontinuing treatment, subjects returned for a final follow-up visit. Safety evaluations included vital signs, physical examinations, laboratory tests (haematology, clinical chemistry, and urinalysis), and adverse events (AEs). Efficacy variables included change from baseline in GERD symptom frequency and severity, quality of life (QOL), and use of antacid medications. Subjects recorded their symptoms in daily electronic diaries and completed questionnaires to evaluate QOL. At the trial's conclusion, both treatment groups reported decreases in the frequency and severity of daytime and nighttime GERD symptoms. Among subjects with symptoms at baseline, the proportion experiencing complete relief ranged from 28.0% to 40.0% for the 10-mg group and ranged from 38.1% to 45.2% in the 20-mg group. For the proportion with 50% or greater relief of GERD-related symptoms, the ranges were 77.4% to 100% for the 10-mg group and 83.9% to 100% for the 20-mg group. Significant increases in QOL scores over baseline also were observed ([P < .05).

As for adverse events, 57.4% of patients reported AEs in the 10-mg dose group and 61.4% reported AEs in the 20-mg group. Most AEs were mild to moderate in severity. No subject discontinued treatment due to AEs.

Changes in laboratory values, vital signs, and weight did not suggest a clinically relevant effect of rabeprazole. No meaningful differences from baseline in antacid use were reported.

Dr. Yu concluded that the safety and efficacy results for rabeprazole in adolescents with GERD are similar to what has been seen in adults with GERD.

Funding for this presentation was provided by Eisai Inc.

[Presentation title: An Open-Label, Multicenter Study of Rabeprazole Safety and Efficacy for Gastroesophageal Reflux Disease (GERD) in Adolescents. Abstract P-388]

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