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

BMC Gastroenterology

Research Article

Christelle Volteau¹  Kafia Belhocine²  Yann Touchefeu²  Fabienne Vavasseur²  Stanislas Bruley des Varannes³  Laurent Flet⁴ 

[1] Délégation à la Recherche Clinique et à l’Innovation - CHU Hôtel Dieu, 44093, Nantes, Cedex, France;Institut des Maladies de l’Appareil Digestif – CHU Hôtel Dieu, 44093Cedex, Nantes, France;CIC Inserm – 04, CHU Hôtel Dieu, 44093, Nantes, Cedex, France;Institut des Maladies de l’Appareil Digestif – CHU Hôtel Dieu, 44093Cedex, Nantes, France;CIC Inserm – 04, CHU Hôtel Dieu, 44093, Nantes, Cedex, France;UMR Inserm U913, Université de Nantes, CHU Hôtel Dieu, 44093, Nantes, Cedex, France;Pharmacie, CHU Hôtel Dieu, 44093, Nantes, Cedex, France;

关键词: Obesity;    Treatment;    Pharmacology;    Proton pump inhibitor;    Gastroesophageal reflux disease;   

DOI  :  10.1186/1471-230X-14-128

 received in 2013-12-25, accepted in 2014-05-06,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundObesity 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.MethodsGastric 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.Results24-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).ConclusionsIn 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 registrationClinicalTrial.gov: NCT01136317

【 授权许可】

Unknown   
© Belhocine et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.