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

Stanislas Bruley des Varannes²  Yann Touchefeu³  Laurent Flet⁴  Christelle Volteau¹  Fabienne Vavasseur³  Kafia Belhocine³ 

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

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

Others  :  1121873
DOI  :  10.1186/1471-230X-14-128

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

【 摘 要 】

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

【 授权许可】

   
2014 Belhocine et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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