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Investigations on the Influence of Bariatric Surgery on the Metabolism and Absorption of Atorvastatin

01:35 EDT 18th April 2014 | BioPortfolio

Summary

Altered bioavailability of drugs will potentially affect both drug efficacy as well as safety. In patients subjected to bariatric surgery due to morbid obesity the gastro intestinal tract is considerably reconstructed and a change in drug bioavailability is very likely. Getting further knowledge on important mechanisms responsible for altered bioavailability would help in predicting clinically relevant consequences on different drugs.

In the present study we aim to investigate the effect of bariatric surgery on atorvastatin bioavailability. Atorvastatin is subjected to both extensive metabolism and drug transport and will potentially be a good predictor for mechanisms relevant for other drugs as well.

In addition will the expression of different enzymes and transporters be measured in the gastrointestinal tract and in the liver to elucidate on mechanism behind the eventual effects.

Description

The primary objective of the study is to compare the effect of gastric bypass and BPD+DS operations on atorvastatin bioavailability.

Secondary objectives are to determine the relative change in atorvastatin bioavailability following gastric bypass as well as BPD+DS operations. In addition will the individual CYP3A4, CYP3A5 and P-gp activity in the different organs from where biopsies can be obtained be descriptively compared with atorvastatin pharmacokinetic variables.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label

Conditions

Morbid Obesity

Intervention

Bariatric surgery

Location

Hospital in Vestfold
Tønsberg
Norway
3103

Status

Active, not recruiting

Source

University of Oslo School of Pharmacy

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

Surgical procedures aimed at producing major WEIGHT REDUCTION in patients with MORBID OBESITY.

The condition of weighing two, three, or more times the ideal weight, so called because it is associated with many serious and life-threatening disorders. In the BODY MASS INDEX, morbid obesity is defined as having a BMI greater than 40.0 kg/m2.

Activities related to WEIGHT REDUCTION in patients with OBESITY. Treatment methods include DIET; EXERCISE; BEHAVIOR MODIFICATION; medications; and BARIATRIC SURGERY.

Surgical procedures involving the STOMACH and sometimes the lower ESOPHAGUS to correct anatomical defects, or to treat MORBID OBESITY by reducing the size of the stomach. There are several subtypes of bariatric gastroplasty, such as vertical banded gastroplasty, silicone ring vertical gastroplasty, and horizontal banded gastroplasty.

The discipline concerned with WEIGHT REDUCTION in patients with OBESITY.

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