Pharmacokinetic Profiles of Lansoprazole in Patients With Morbid Obesity Post-Roux-en-Y Gastric Bypass Surgery

IF 3.1 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL
Suthep Udomsawaengsup, Sathienrapong Chantawibul, Naranon Boonyuen, Sarunnuch Panyavorakhunchai, Pattharasai Kachornvitaya, Wasu Wisanuyothin, Pittawat Somvanapanich, Warittha Lertwatthiphong, Napatsanan Tanathitiphuwarat, Pajaree Chariyavilaskul
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引用次数: 0

Abstract

Data on the effects of Roux-en-Y gastric bypass (RYGB) surgery on lansoprazole pharmacokinetics in morbidly obese patients are limited. This study aimed to evaluate the impact of RYGB surgery on the pharmacokinetic profile of lansoprazole in Thai morbidly obese patients. Participants received 30 mg of lansoprazole twice daily for 7 days before surgery and continued the regimen for 6 weeks post-surgery. Plasma lansoprazole concentrations were measured at predose (0), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 8 h after dosing, both pre- and post-surgery, using a validated high-performance liquid chromatography technique. CYP2C19 genotyping classified participants as normal metabolizers (*1/*1) or intermediate metabolizers (*1/*2 and *1/*3). Pharmacokinetic parameters, including the area under the plasma concentration-time curve from 0 to 8 h (AUC0–8 h), maximum plasma concentration (Cmax), and time to maximum concentration (Tmax), were compared before and after surgery. A total of 13 patients (mean age 37.0 ± 3.9 years; body mass index 54.0 ± 4.8 kg/m2) were enrolled. Post-surgery, AUC0–8 h and Cmax decreased by 16% (p = 0.009) and 31% (p = 0.003), respectively, while Tmax remained unchanged. A 30% reduction in Cmax (p = 0.007) was observed in CYP2C19 normal metabolizers, whereas no significant changes were noted in intermediate metabolizers. In conclusion, RYGB surgery significantly reduced lansoprazole systemic exposure, particularly in CYP2C19 normal metabolizers. Further studies are needed to explore the clinical implications of these pharmacokinetic changes and develop optimized treatment strategies for post-RYGB patients.

Trial Registration: ClinicalTrials.gov identifier: TCTR20220118001

Abstract Image

兰索拉唑在鲁氏-Y 胃旁路手术后的病态肥胖患者中的药代动力学特征
Roux-en-Y胃旁路手术(RYGB)对病态肥胖患者兰索拉唑药代动力学影响的数据有限。本研究旨在评估RYGB手术对泰国病态肥胖患者兰索拉唑药代动力学的影响。参与者在手术前接受30毫克兰索拉唑,每天两次,持续7天,并在手术后继续治疗6周。在给药前(0)、0.5、1、1.5、2、2.5、3、4、6和8小时,以及手术前后,使用高效液相色谱技术测量血浆兰索拉唑浓度。CYP2C19基因分型将参与者分为正常代谢者(*1/*1)和中间代谢者(*1/*2和*1/*3)。比较手术前后药代动力学参数,包括0 ~ 8 h血药浓度-时间曲线下面积(auc0 ~ 8 h)、最大血药浓度(Cmax)、至最大血药浓度时间(Tmax)。共13例患者(平均年龄37.0±3.9岁;体重指数(54.0±4.8 kg/m2)均入组。术后AUC0-8 h和Cmax分别下降16% (p = 0.009)和31% (p = 0.003),而Tmax保持不变。在CYP2C19正常代谢者中观察到30%的Cmax降低(p = 0.007),而在中间代谢者中没有明显变化。总之,RYGB手术显著减少了兰索拉唑的全身暴露,特别是在CYP2C19正常代谢者中。需要进一步的研究来探讨这些药代动力学变化的临床意义,并为rygb后患者制定优化的治疗策略。试验注册:ClinicalTrials.gov标识符:TCTR20220118001
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来源期刊
Cts-Clinical and Translational Science
Cts-Clinical and Translational Science 医学-医学:研究与实验
CiteScore
6.70
自引率
2.60%
发文量
234
审稿时长
6-12 weeks
期刊介绍: Clinical and Translational Science (CTS), an official journal of the American Society for Clinical Pharmacology and Therapeutics, highlights original translational medicine research that helps bridge laboratory discoveries with the diagnosis and treatment of human disease. Translational medicine is a multi-faceted discipline with a focus on translational therapeutics. In a broad sense, translational medicine bridges across the discovery, development, regulation, and utilization spectrum. Research may appear as Full Articles, Brief Reports, Commentaries, Phase Forwards (clinical trials), Reviews, or Tutorials. CTS also includes invited didactic content that covers the connections between clinical pharmacology and translational medicine. Best-in-class methodologies and best practices are also welcomed as Tutorials. These additional features provide context for research articles and facilitate understanding for a wide array of individuals interested in clinical and translational science. CTS welcomes high quality, scientifically sound, original manuscripts focused on clinical pharmacology and translational science, including animal, in vitro, in silico, and clinical studies supporting the breadth of drug discovery, development, regulation and clinical use of both traditional drugs and innovative modalities.
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