Controlling on-demand gastric acidity in obese subjects: a randomized, controlled trial comparing a single dose of 20 mg rabeprazole and 20 mg omeprazole

Kafia Belhocine, Fabienne Vavasseur, Christelle Volteau, Laurent Flet, Yann Touchefeu, Stanislas Bruley des Varannes, Kafia Belhocine, Fabienne Vavasseur, Christelle Volteau, Laurent Flet, Yann Touchefeu, Stanislas Bruley des Varannes

Abstract

Background: Obesity is associated with a risk of gastroesophageal reflux disease. The pharmacodynamic efficacy of proton pump inhibitors has not been specifically evaluated in obese subjects. The aim of this study was to compare the antisecretory response to a single oral dose of 20 mg rabeprazole, 20 mg omeprazole and placebo in obese subjects.

Methods: Gastric pH was monitored for 24 hours on three separate occasions in eighteen H. pylori-negative, asymptomatic obese subjects. Subjects were given omeprazole, rabeprazole or placebo in a randomized order and in a double-blind fashion. The main analysis criterion was 24-h percent of time post dose with intragastric pH above 3; secondary criteria were percentage of time above pH 4, median pH, [H+] concentrations and nocturnal acid breakthrough (NAB). Results were analyzed using linear mixed models and Wilks test comparing variances.

Results: 24-h median [IQ] percentages of time with gastric pH above 3 and 4 were higher with rabeprazole than omeprazole (46 [37-55] vs. 30 [15-55] %, 9 [5-11] % for placebo) but the differences did not reach statistical significance (p = 0.11 and 0.24, respectively). Median acid concentrations were significantly lower with rabeprazole than with omeprazole and placebo (22 [14-53] vs. 54 [19-130] and 95 [73-170] mmoles/l, p < 0.01) for all periods. The number of NAB was significantly lower with rabeprazole than with omeprazole (median 1 [1,2] vs. 2 [1-3], p = 0.04). Variances of 24-h data (pH above 3 and 4, median pH, [H+] concentrations) were significantly lower with rabeprazole than with omeprazole (p < 0.0001).

Conclusions: In asymptomatic obese subjects the gastric antisecretory response to a single dose of rabeprazole and omeprazole was strong and not significantly different between drugs despite a significantly more homogeneous response with rabeprazole.

Trial registration: ClinicalTrial.gov: NCT01136317.

Figures

Figure 1
Figure 1
Box plots of percentage of time spent above pH 3 (A), pH 4 (B), median gastric pH (C) and median gastric acid concentration (D) in 18 obese volunteer subjects after a single oral dose (20 mg) of rabeprazole, omeprazole or placebo during 24-hour gastric pH monitoring.
Figure 2
Figure 2
Twenty-four hour median pH individual values in 18 obese volunteer subjects after a single oral dose (20 mg) of rabeprazole, omeprazole or placebo during 24-hour gastric pH monitoring.

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