ArticlePharmacotherapy2015
Proximal Roux-en-Y gastric bypass alters drug absorption pattern but not systemic exposure of CYP3A4 and P-glycoprotein substrates.
Article in Pharmacotherapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
27 citing papers in PubMed, 4 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Effects of Bariatric Surgery on the Pharmacokinetics of Cardiovascular Drugs: A Systematic Review and Meta-Analysis.Obesity surgery · 2026Pooled it
- The effect of obesity, macronutrients, fasting and nutritional status on drug-metabolizing cytochrome P450s: a systematic review of current evidence on human studies.European journal of nutrition · 2021Pooled it
- The influence of bariatric surgery on oral drug bioavailability in patients with obesity: A systematic review.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2019Pooled it
- Systematic review of drug bioavailability following gastrointestinal surgery.European journal of clinical pharmacology · 2018Pooled it
- Short- and long-term effects of body weight, calorie restriction and gastric bypass on CYP1A2, CYP2C19 and CYP2C9 activity.British journal of clinical pharmacology · 2022Trial
- Application of Virtual Twin PBPK Models in Individuals with Obesity via CYP3A4 Phenotyping Using Endogenous Biomarker Data.Clinical pharmacology and therapeutics · 2026Article
- Effect of Testosterone Therapy on Cytochrome P450 3A and P-Glycoprotein Activities Using Midazolam and Digoxin as Probe Substrates Among Transgender Adults.Pharmacotherapy · 2026Article
- Medication Adjustment After Bariatric and Metabolic Surgery: A Review of Current Evidence and Clinical Practice Trends.Journal of metabolic and bariatric surgery · 2025Review
- Dietary lifestyle changes unexpectedly causing digoxin intoxication with cardiogenic shock: a grand round case report.European heart journal. Case reports · 2025Article
- Changes in Antidepressant Absorption After Metabolic Bariatric Surgery.Obesity surgery · 2025Article
- Digoxin Pharmacokinetics in Patients with Obesity Before and After a Gastric Bypass or a Strict Diet Compared with Normal Weight Individuals.Clinical pharmacokinetics · 2024Article
- PBPK Modeling of Azithromycin Systemic Exposure in a Roux-en-Y Gastric Bypass Surgery Patient Population.Pharmaceutics · 2023Article
- Impact of Bariatric Surgery in the Short and Long Term: A Need for Time-Dependent Dosing of Drugs.Obesity surgery · 2023Review
- Considerations for clinical evaluation of the effects of bariatric surgery on the pharmacokinetics of orally administered drugs.Translational and clinical pharmacology · 2022Article
- Drug absorption in bariatric surgery patients: A narrative review.Health science reports · 2022Review
- Short- and long-term effects of body weight loss following calorie restriction and gastric bypass on CYP3A-activity - a non-randomized three-armed controlled trial.Clinical and translational science · 2022Article
- Psychotropic Medications in Metabolic and Bariatric Surgery: Research Updates and Clinical Considerations.Current psychiatry reports · 2022Review
- Serum concentrations of antidepressants, antipsychotics, and antiepileptics over the bariatric surgery procedure.European journal of clinical pharmacology · 2021Article
- Managing the Unpredictable: Mechanistic Analysis and Clinical Recommendations for Lamotrigine Treatment after Bariatric Surgery.Journal of clinical medicine · 2021Article
- PBPK modeling of CYP3A and P-gp substrates to predict drug-drug interactions in patients undergoing Roux-en-Y gastric bypass surgery.Journal of pharmacokinetics and pharmacodynamics · 2020Article
Corrections and comments
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Authors and funding
9 authors at 1 institution in 1 country.
Funding
Abstract
STUDY
objectivesTo evaluate the effect of Roux-en-Y gastric bypass surgery (RYGB) on the pharmacokinetics of midazolam (a CYP3A4 substrate) and digoxin (a P-glycoprotein substrate).
designProspective, nonblinded, longitudinal, single-dose pharmacokinetic study in three phases: presurgery baseline and postoperative assessments at 3 and 12 months. PATIENTS: Twelve obese patients meeting current standards for bariatric surgery. MEASUREMENTS AND MAIN
resultsAt each study visit, patients received a single dose of oral digoxin and midazolam at 8 a.m. Blood samples were collected at regular intervals for 24 hours after dosing. Continuous 12-lead electrocardiogram (EKG), heart rate, blood pressure, and respiratory rate were monitored, and pharmacokinetic parameters from the three visits were compared. The peak plasma concentration (Cmax ) of midazolam increased by 66% and 71% at 3- and 12-month post-RYGB (p=0.017 and p=0.001, respectively), whereas the median time to peak concentration (Tmax ) was reduced by 50%. The mean Cmax for 1'-hydroxymidazolam increased by 87% and 80% at 3 and 12 months (p=0.001 and p<0.001, respectively). However, neither the area under the concentration-time curve (AUC) for midazolam nor the metabolite-to-parent AUC ratio changed significantly over time. For digoxin, the median Tmax decreased from 40 minutes at baseline to 30 and 20 minutes at 3 and 12 months, respectively. The mean AUC for digoxin, heart rate, and EKG patterns were similar across the three study phases.
conclusionContemporary proximal RYGB increases the rate of drug absorption without significantly changing the overall exposure to midazolam and digoxin. The Cmax of a CYP3A4 substrate with a high extraction ratio was substantially increased after RYGB.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.