Aciphex

[Rabeprazole]

Gastric Acid Parameters

ACIPHEX® Versus Placebo After 7 Days of Once Daily Dosing
Parameter ACIPHEX® (20 mg QD) Placebo
Basal Acid Output (mmol/ hr) 0.4* 2.8 Stimulated Acid Output (mmol/ hr) 0.6* 13.3

% Time Gastric pH> 3 65* 10 *( p< 0.01 versus placebo)

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Compared to placebo, ACIPHEX®, 10 mg, 20 mg, and 40 mg, administered once daily for 7 days significantly decreased intragastric acidity with all doses for each of four meal-related intervals and the 24-hour time period overall. In this study, there were no statistically significant differences between doses; however, there was a significant dose-related decrease in intragastric acidity. The ability of rabeprazole to cause a dose-related decrease in mean intragastric acidity is illustrated below.

AUC Acidity (mmol ° hr/ L) ACIPHEX® Versus Placebo on Day 7
of Once Daily Dosing (mean± SD)
Treatment

AUC interval (hrs) 10 mg RBP (N= 24) 20 mg RBP (N= 24) 40 mg RBP (N= 24) Placebo (N= 24)
08: 00 – 13: 00 19.6± 21.5* 12.9± 23* 7.6± 14.7* 91.1± 39.7
13: 00 – 19: 00 5.6± 9.7* 8.3± 29.8* 1.3± 5.2* 95.5± 48.7
19: 00 – 22: 00 0.1± 0.1* 0.1± 0.06* 0.0± 0.02* 11.9± 12.5
22: 00 – 08: 00 129.2± 84* 109.6± 67.2* 76.9± 58.4* 479.9± 165
AUC 0-24 hours 155.5± 90.6* 130.9± 81* 85.8± 64.3* 678.5± 216
*( p< 0.001 versus placebo)

After administration of 20 mg ACIPHEX® once daily for eight days, the mean percent of time that gastric pH> 3 or gastric pH> 4 after a single dose (Day 1) and multiple doses (Day 8) was significantly greater than placebo (see table below). The decrease in gastric acidity and the increase in gastric pH observed with 20 mg ACIPHEX® administered once daily for eight days were compared to the same parameters for placebo, as illustrated below:

Gastric Acid Parameters ACIPHEX® Once Daily Dosing Versus Placebo on Day 1 and Day 8
ACIPHEX®
20 mg QD Placebo
Parameter Day 1 Day 8 Day 1 Day 8
Mean AUC0-24 Acidity 340.8* 176.9* 925.5 862.4 Median trough pH (23-hr) a 3.77 3.51 1.27 1.38 % Time Gastric pH> 3 b 54.6* 68.7* 19.1 21.7 % Time Gastric pH> 4 b 44.1* 60.3* 7.6 11.0

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