Considerations for clinical evaluation of the effects of bariatric surgery on the pharmacokinetics of orally administered drugs.
Sungyeun BaeJungJin OhIldae SongKyung-Sang YuSeung Hwan LeePublished in: Translational and clinical pharmacology (2022)
Obesity has been a growing worldwide concern, and surgical intervention including bariatric surgery is considered as one of the options for treatment. However, there still is controversy over the change in pharmacokinetics (PKs) of drugs after the surgery. To investigate the potential covariates that can influence the area under the curve (AUC) and maximum plasma concentration (C max ), the design of previous studies was reviewed based on pre-determined eligibility criteria. Each study calculated the ratios of the AUC and C max before and after bariatric surgery. These studies investigated whether the PK parameters were affected by the time after the surgery or by the type of control group. The ratio of the AUC calculated in the early and late follow-up period was similar across Roux-en Y gastric bypass patients. No significant difference in the PK parameters was found between the pre-surgical patients and matched healthy subjects. However, certain control groups could be preferable depending on the purpose of the clinical trial. Although C max was inconsistent compared to the AUC, insufficient sampling of the time points may have caused such an inconsistency. This is the first article exploring the appropriate methodology in designing clinical studies for changes in the PK characteristics of orally administered drugs in patients with bariatric surgery.
Keyphrases
- bariatric surgery
- weight loss
- roux en y gastric bypass
- obese patients
- gastric bypass
- clinical evaluation
- minimally invasive
- clinical trial
- coronary artery bypass
- end stage renal disease
- ejection fraction
- randomized controlled trial
- newly diagnosed
- weight gain
- type diabetes
- case control
- chronic kidney disease
- metabolic syndrome
- prognostic factors
- insulin resistance
- surgical site infection
- mass spectrometry
- study protocol
- combination therapy
- double blind
- drug induced
- human health
- coronary artery disease
- percutaneous coronary intervention
- climate change