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The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients Before and One Year After Bariatric Surgery.

ABSTRACT: Bariatric surgery is nowadays commonly applied as treatment for morbid obesity (BMI?>?40 kg/m(2)). As information about the effects of this procedure on a drug's pharmacokinetics is limited, we aimed to evaluate the pharmacokinetics of CYP3A probe substrate midazolam after oral and intravenous administration in a cohort of morbidly obese patients that was studied before and 1 year post bariatric surgery.Twenty morbidly obese patients (aged 26-58 years) undergoing bariatric surgery participated in the study of which 18 patients returned 1 year after surgery. At both occasions, patients received 7.5 mg oral and 5 mg intravenous midazolam separated by 160?±?48 min. Per patient and occasion, a mean of 22 blood samples were collected. Midazolam concentrations were analyzed using population pharmacokinetic modeling.One year after bariatric surgery, systemic clearance of midazolam was higher [0.65 (7%) versus 0.39 (11%) L/min, mean?±?RSE (P?

SUBMITTER: Brill MJ

PROVIDER: S-EPMC4628089 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients Before and One Year After Bariatric Surgery.

Brill Margreke J MJ van Rongen Anne A van Dongen Eric P EP van Ramshorst Bert B Hazebroek Eric J EJ Darwich Adam S AS Rostami-Hodjegan Amin A Knibbe Catherijne A CA

Pharmaceutical research 20150723 12

<h4>Purpose</h4>Bariatric surgery is nowadays commonly applied as treatment for morbid obesity (BMI > 40 kg/m(2)). As information about the effects of this procedure on a drug's pharmacokinetics is limited, we aimed to evaluate the pharmacokinetics of CYP3A probe substrate midazolam after oral and intravenous administration in a cohort of morbidly obese patients that was studied before and 1 year post bariatric surgery.<h4>Methods</h4>Twenty morbidly obese patients (aged 26-58 years) undergoing ...[more]

PMID: 26202517

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Project description:IntroductionBariatric surgery performed at high volume centers decreases length of stay, cost, and morbidity and mortality. The effect of a high volume of bariatric surgery procedures on outcomes may extend not just to bariatric surgery but to any general surgical procedure in morbidly obese patients. We hypothesized that patients with morbid obesity (body mass index >40 kg/m2) undergoing common, nonbariatric general surgery would have decreased morbidity and mortality at centers performing high volumes of bariatric surgery.MethodsThe 2016 National Inpatient Sample (NIS) was used to identify the number of laparoscopic gastric bypass and sleeve gastrectomy performed at each hospital. Hospitals were classified as high volume bariatric hospitals (HVBH) ≥10 reported cases (50 actual)/year or low volume bariatric hospitals (LVBH) <10 reported cases (50 actual)/year, as NIS reports a 20% sample of actual cases. Patients with morbid obesity undergoing laparoscopic or open appendectomy, cholecystectomy, or ventral hernia repair were included for analysis. Propensity scores were developed based on available demographics, comorbidities, and hospital procedure volume. Postoperative complications during the index hospital admission, determined by ICD-10 code, were compared using inverse propensity weights. Differences were considered significant with a p value of <0.05.ResultsThe total number of general surgery patient cases analyzed was 14,028 from 2,482 hospitals, representing 70,140 admissions. The cohort of patients undergoing operations treated at HVBH were younger (p=0.03) with higher rates of COPD (p=0.04). Patients at LVBH had higher rates of nicotine dependence (p=0.0001) and obstructive sleep apnea (p < 0.001). On propensity-weighted analysis adjusting for preoperative comorbidities and hospital procedure volume, there were significantly higher rates of multiple postprocedure complications at LVBH, specifically, postprocedure respiratory failure for patients undergoing elective laparoscopic cholecystectomy, elective ventral hernia repair with mesh and appendectomy.ConclusionPatients with morbid obesity may have an advantage in having general surgery procedures at HVBH. HVBH may have a volume-outcomes relationship where the hospital and staff familiarity with the management principles required to minimize the postoperative risk associated with morbid obesity and improve patient outcomes.

Dataset Information

The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients Before and One Year After Bariatric Surgery.

Publications

The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients Before and One Year After Bariatric Surgery.

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