Considerations for clinical evaluation of the effects of bariatric surgery on the pharmacokinetics of orally administered drugs

다국어 초록 (Multilingual Abstract)

Obesity has been a growing worldwide concern, and surgical inter vention including bariatricsurger y is considered as one of the options for treatment. However, there still is controversyover the change in pharmacokinetics (PKs) of drugs after the surger y. To investigate thepotential covariates that can influence the area under the cur ve (AUC) and maximum plasmaconcentration (Cmax), the design of previous studies was reviewed based on pre-determinedeligibility criteria. Each study calculated the ratios of the AUC and Cmax before and afterbariatric surger y. These studies investigated whether the PK parameters were affected bythe time after the surger y or by the type of control group. The ratio of the AUC calculated inthe early and late follow-up period was similar across Roux-en Y gastric bypass patients. Nosignificant difference in the PK parameters was found between the pre-surgical patients andmatched healthy subjects. However, certain control groups could be preferable dependingon the purpose of the clinical trial. Although Cmax was inconsistent compared to the AUC,insufficient sampling of the time points may have caused such an inconsistency. This is thefirst article exploring the appropriate methodology in designing clinical studies for changesin the PK characteristics of orally administered drugs in patients with bariatric surger y.

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