BACKGROUND:Bariatric surgery leads to several anatomo-physiological modifications that may affect pharmacokinetic parameters and consequently alter the therapeutic effect of drugs, such as antibiotics. The pharmacokinetics of oral amoxicillinafter Roux-en-Y gastric bypass (RYGB) surgery is unknown. OBJECTIVES: The objective of this study was to evaluate the impact of bariatric surgery on the pharmacokinetics of amoxicillin. METHODS: This study was performed as a randomized, open-label, single-dose clinical trial, with two periods of treatment, in which obese subjects (n = 8) received anamoxicillin 500 mg capsule orally before and 2 months after the RYGB surgery. The amoxicillin plasma concentration was determined by liquid chromatography coupled to mass spectrometry (LC-MS/MS). RESULTS: After the surgery, the mean weight loss was 17.03 ± 5.51 kg, and mean body mass index (BMI) decreased from 46.21 ± 2.82 to 38.82 ± 3.32 kg/m2. The mean amoxicillin area under the plasma concentration versus time curve from time zero to the time of the last quantifiable concentration (AUC0-tlast) increased significantly (3.5-fold); the maximum plasma concentration (Cmax) increased 2.8-fold after the bariatric surgery. No correlation was found between amoxicillin absorption, BMI, and weight loss percentage. CONCLUSION: The alterations observed in the amoxicillin pharmacokinetics suggest that obese subjects included in this trial had a substantially increase in amoxicillin systemic exposure after RYGB surgery. However, despite this increase, its exposure was lower than the values reported for non-obese volunteers. TRIAL REGISTRATION: Identifiers: NCT03588273.
RCT Entities:
BACKGROUND: Bariatric surgery leads to several anatomo-physiological modifications that may affect pharmacokinetic parameters and consequently alter the therapeutic effect of drugs, such as antibiotics. The pharmacokinetics of oral amoxicillin after Roux-en-Y gastric bypass (RYGB) surgery is unknown. OBJECTIVES: The objective of this study was to evaluate the impact of bariatric surgery on the pharmacokinetics of amoxicillin. METHODS: This study was performed as a randomized, open-label, single-dose clinical trial, with two periods of treatment, in which obese subjects (n = 8) received an amoxicillin 500 mg capsule orally before and 2 months after the RYGB surgery. The amoxicillin plasma concentration was determined by liquid chromatography coupled to mass spectrometry (LC-MS/MS). RESULTS: After the surgery, the mean weight loss was 17.03 ± 5.51 kg, and mean body mass index (BMI) decreased from 46.21 ± 2.82 to 38.82 ± 3.32 kg/m2. The mean amoxicillin area under the plasma concentration versus time curve from time zero to the time of the last quantifiable concentration (AUC0-tlast) increased significantly (3.5-fold); the maximum plasma concentration (Cmax) increased 2.8-fold after the bariatric surgery. No correlation was found between amoxicillin absorption, BMI, and weight loss percentage. CONCLUSION: The alterations observed in the amoxicillin pharmacokinetics suggest that obese subjects included in this trial had a substantially increase in amoxicillin systemic exposure after RYGB surgery. However, despite this increase, its exposure was lower than the values reported for non-obese volunteers. TRIAL REGISTRATION: Identifiers: NCT03588273.
Authors: Julie De Smet; Pieter Colin; Peter De Paepe; Johannes Ruige; Hélène Batens; Yves Van Nieuwenhove; Dirk Vogelaers; Stijn Blot; Jan Van Bocxlaer; Luc M Van Bortel; Koen Boussery Journal: J Antimicrob Chemother Date: 2011-10-10 Impact factor: 5.790
Authors: J W Mouton; D F J Brown; P Apfalter; R Cantón; C G Giske; M Ivanova; A P MacGowan; A Rodloff; C-J Soussy; M Steinbakk; G Kahlmeter Journal: Clin Microbiol Infect Date: 2012-01-20 Impact factor: 8.067
Authors: Femke de Velde; Brenda C M de Winter; Birgit C P Koch; Teun van Gelder; Johan W Mouton Journal: J Antimicrob Chemother Date: 2016-06-20 Impact factor: 5.790
Authors: Cristina Longo; Gillian Bartlett; Brenda Macgibbon; Nancy Mayo; Ellen Rosenberg; Lyne Nadeau; Stella S Daskalopoulou Journal: Pharmacoepidemiol Drug Saf Date: 2013-06-04 Impact factor: 2.890
Authors: Jurjen S Kingma; Desirée M T Burgers; Valerie M Monpellier; Marinus J Wiezer; Heleen J Blussé van Oud-Alblas; Janelle D Vaughns; Catherine M T Sherwin; Catherijne A J Knibbe Journal: Br J Clin Pharmacol Date: 2021-06-03 Impact factor: 3.716