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Effect of Single Doses of Rabeprazole 20 mg and Pantoprazole 40 mg on 24-Hour Intragastric Acidity in Gastroesophageal Reflux Disease (GERD) Patients with Nocturnal Heartburn

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Lomax, Kathleen M.D.; Warrington, Steve M.D.; Lee, Douglas M.R.C.P.; Baisley, Kathy M.Sc., M.P.H.; Morocutti, Anna M.D., Ph.D.; DeLemos, Byron M.D.

American Journal of Gastroenterology: September 2005 - Volume 100 - Issue - p S37
Supplement Abstracts Submitted for the 70th Annual Scientific Meeting of the American College of Gastroenterology: ESOPHAGUS
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Medical Affairs, Eisai Inc., Teaneck, NJ; Hammersmith Medicines Research, Central Middlesex Hospital, London, United Kingdom; Medical Affairs, Eisai Ltd., London, United Kingdom and Medical Affairs, Janssen Pharmaceutica Inc., Titusville, NJ.

Purpose: PPIs with rapid and prolonged control of acid secretion may be useful for treating nocturnal GERD symptoms. This study compared the antisecretory effects of single doses of rabeprazole sodium (RAB) 20 mg and pantoprazole sodium (PAN) 40 mg tablets in patients with a clinical diagnosis of GERD and a history of nocturnal heartburn (≥1 episode/wk).

Methods: This open-label, randomized, 2-way crossover comparison enrolled H pylori-negative subjects to receive RAB 20 mg and PAN 40 mg (single oral doses) in the morning (≥14-day washout). Intragastric pH was measured from 24 h before (day 0) until 24 h after dosing (day 1). Patients fasted from 2200 h the evening before until ∼0900 h on day 0 and 1, and had standard meals/drinks 1, 4, and 10 h after dosing on day 1 and at corresponding times on day 0. Primary end point was 24-h area under intragastric pH–time curve (AUC0–24) on days 0 and 1. Secondary end points included AUC for 0–5, 5–11, 11–14, and 14–24 h;% time pH >3 and >4 over 24 h and for 0–14 and 14–24 h; and safety/tolerability.

Results: 31 patients (male, n = 19; mean age, 44 yr) were enrolled (evaluable population, n = 29). Preliminary results show that day-1 mean intragastric pH AUC0–24 was significantly higher for RAB vs PAN: 319,692 vs 259,921 pH units. sec, respectively (evaluable population; P < 0.0001). In the ITT and evaluable (Table 1) populations, mean pH AUC was significantly higher for RAB (P ≤ 0.024) in all time intervals studied, including overnight (14–24-h). Mean day 1% time pH >3 and >4 was significantly higher for RAB (P ≤ 0.004) during the 24 h after dosing and all time intervals (ITT and evaluable populations). Both treatments were well tolerated.

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Table

Conclusions: Overall and during all time intervals, including overnight, a single oral dose of RAB 20 mg increased intragastric pH more than did PAN 40 mg in GERD patients with nocturnal heartburn. Research supported by Eisai Ltd., London, UK; Eisai Inc., Teaneck, NJ, USA; and Janssen Pharmaceutica Inc., Titusville, NJ, USA.

© The American College of Gastroenterology 2005. All Rights Reserved.