Pharmacokinetic considerations for patients with a history of bariatric surgery

Lloret‐Linares, Célia

doi:10.1080/17425255.2017.1290796

Cited by 11 publications

(7 citation statements)

References 15 publications

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“…The location of drug absorption, its solubility, the importance of intestinal enzymes and efflux pumps are all criteria that also determine the extent of its absorption after bariatric surgery. In addition, in the post‐surgical period, weight loss, dietary adjustments and the reduction of chronic inflammatory conditions associated with obesity may be responsible for variable disturbances in PK and PD over time [7]. The metabolic and excretory capacities of the individual can change in either direction [37].…”

Section: Types Of Bariatric Surgical Proceduresmentioning

confidence: 99%

“…Bariatric surgery is the therapeutic strategy that gives the best results in terms of sustainable weight loss and improvement of associated comorbidities [5,6]. However, the anatomical and physiological changes resulting from these surgeries, whether primarily restrictive or malabsorptive, raise questions about the pharmacokinetics (PK) and benefit/risk ratio of oral drugs in this emerging population [7].…”

Section: Introductionmentioning

confidence: 99%

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Impact of bariatric surgery on oral anticoagulants pharmacology, and consequences for clinical practice: a narrative review

Leven

Hoffmann

Roche³

et al. 2020

Fundamemntal Clinical Pharma

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The prevalence of obesity has been steadily increasing in recent years worldwide. At the same time bariatric surgery, the best therapeutic strategy to date in terms of sustainable weight loss and improvement of associated comorbidities has been also increasing. However, these surgeries, whether primarily restrictive or malabsorptive, raise questions about the pharmacology of oral drugs. Among widely used drugs, anticoagulants are the referent therapy to treat some cardiovascular diseases such as atrial fibrillation and venous thromboembolism. How bariatric surgery may impact pharmacological properties of oral anticoagulants, and more specifically, direct oral anticoagulants (DOACs) are difficult to anticipate. In this review, we describe available data concerning the potential impact of bariatric surgery on the pharmacology of oral anticoagulants. The vitamin K antagonists (VKAs) requirements for the same international normalized ratio target are reduced after bariatric surgery. Limited data available for dabigatran 150 mg twice daily indicate a risk of insufficient efficacy in atrial fibrillation after gastric bypass due to probable impaired absorption. Data for rivaroxaban at the prophylactic dose of 10 mg per day suggest no impact of bariatric surgery from 3 days to 8 months post‐surgery. However, no conclusive data are available for other anticoagulants or the use of DOACs at therapeutic doses. To date, DOACs are not recommended in patients who have undergone bariatric surgery, because of limited available data. Pending new studies to confirm the predictable pharmacokinetics and safety of DOACs in this population, especially at therapeutic doses, VKAs remain the first option for chronic anticoagulation.

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Section: Types Of Bariatric Surgical Proceduresmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Impact of bariatric surgery on oral anticoagulants pharmacology, and consequences for clinical practice: a narrative review

Leven

Hoffmann

Roche³

et al. 2020

Fundamemntal Clinical Pharma

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“…The pharmacokinetics of some, but not all, drugs are altered following RYGB [16][17][18][19][20][21][22]. Some of the anatomical and physiological changes that result from surgery include a bypass of the majority of the stomach, the entire duodenum, and the proximal jejunum [1].…”

Section: Introductionmentioning

confidence: 99%

Lisdexamfetamine Pharmacokinetic Comparison Between Patients Who Underwent Roux-en-Y Gastric Bypass and Nonsurgical Controls

et al. 2021

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Introduction/Purpose The objective of this research was to characterize the impact of Roux-en-Y gastric bypass (RYGB) on the pharmacokinetic properties of the pro-drug lisdexamfetamine and its active metabolite, d-amphetamine. Materials and Methods A case-control design was used where patients who had undergone RYGB 9-24 months prior were matched on sex, age, and body mass index (BMI) to nonsurgical controls who had no history of weight loss surgery. Each participant received a single 50 mg dose of lisdexamfetamine, and plasma samples were collected over a 24-h period following dosing. Noncompartmental analyses were used to compare pharmacokinetic measures between groups. Results There were no significant differences between the RYGB (n = 10) and NSC groups (n = 10) on sex (70% female), age (40.9 ± 9.6 vs. 41.3 ± 8.9 years), BMI (30.3 ± 5.2 vs. 31 ± 5.9 kg/m 2 ), or ethnicity (100% vs. 80% White). The pharmacokinetic parameters between the RYGB and NCS groups were found to be equivalent for lisdexamfetamine and d-amphetamine, including maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), and area under the plasma concentration-time curve (AUC (0-∞) ). Conclusion These data suggest that there is no need to routinely adjust lisdexamfetamine dosing following RYGB. However, given the potential for inter-individual differences, patients who undergo RYGB should be clinically monitored and individualized dosing strategies should be considered for concerns surrounding efficacy or toxicity.

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“…It is important to individualise drug doses in order to both obtain an adequate effect and minimise side effects. 14 For most drugs, dose individualisation is performed by dosing per kg total body weight, although this may not necessarily be the best approach. 15 In patients with morbid obesity, systemic clearance of a cytochrome P450 3A (CYP3A) substrate was found to be similar, while oral bioavailability and volume of distribution were higher compared with patients with normal weight.…”

Section: Introductionmentioning

confidence: 99%

Impact of body weight, low energy diet and gastric bypass on drug bioavailability, cardiovascular risk factors and metabolic biomarkers: protocol for an open, non-randomised, three-armed single centre study (COCKTAIL)

et al. 2018

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IntroductionRoux-en-Y gastric bypass (GBP) is associated with changes in cardiometabolic risk factors and bioavailability of drugs, but whether these changes are induced by calorie restriction, the weight loss or surgery per se, remains uncertain. The COCKTAIL study was designed to disentangle the short-term (6 weeks) metabolic and pharmacokinetic effects of GBP and a very low energy diet (VLED) by inducing a similar weight loss in the two groups.Methods and analysisThis open, non-randomised, three-armed, single-centre study is performed at a tertiary care centre in Norway. It aims to compare the short-term (6 weeks) and long-term (2 years) effects of GBP and VLED on, first, bioavailability and pharmacokinetics (24 hours) of probe drugs and biomarkers and, second, their effects on metabolism, cardiometabolic risk factors and biomarkers. The primary outcomes will be measured as changes in: (1) all six probe drugs by absolute bioavailability area under the curve (AUCoral/AUCiv) of midazolam (CYP3A4 probe), systemic exposure (AUCoral) of digoxin and rosuvastatin and drug:metabolite ratios for omeprazole, losartan and caffeine, levels of endogenous CYP3A biomarkers and genotypic variation, changes in the expression and activity data of the drug-metabolising, drug transport and drug regulatory proteins in biopsies from various organs and (2) body composition, cardiometabolic risk factors and metabolic biomarkers.Ethics and disseminationThe COCKTAIL protocol was reviewed and approved by the Regional Committee for Medical and Health Research Ethics (Ref: 2013/2379/REK sørøst A). The results will be disseminated to academic and health professional audiences and the public via presentations at conferences, publications in peer-reviewed journals and press releases and provided to all participants.Trial registration numberNCT02386917.

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Pharmacokinetic considerations for patients with a history of bariatric surgery

Cited by 11 publications

References 15 publications

Impact of bariatric surgery on oral anticoagulants pharmacology, and consequences for clinical practice: a narrative review

Impact of bariatric surgery on oral anticoagulants pharmacology, and consequences for clinical practice: a narrative review

Lisdexamfetamine Pharmacokinetic Comparison Between Patients Who Underwent Roux-en-Y Gastric Bypass and Nonsurgical Controls

Impact of body weight, low energy diet and gastric bypass on drug bioavailability, cardiovascular risk factors and metabolic biomarkers: protocol for an open, non-randomised, three-armed single centre study (COCKTAIL)

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