Abstract

Drug dosage recommendations in obese patients are largely lacking, as data on dosages are generally derived from clinical studies conducted in healthy subjects of average body weight. As morbid obesity (i.e. body mass index ≥ 40 kg/m2) is associated with comorbidities affecting drug pharmacokinetics, relatively few obese subjects are included in clinical studies. To insure optimal drug dosages in obese patients, efficacy and safety trials should provide subgroup analysis of data in patients with varying degrees of obesity. The body-size descriptor used to determine the optimal drug dosage in obese patients should be based on the pharmacological properties of the drug, the clinical context and other factors, and should be clearly specified (including the method of conversion from total body weight to the appropriate body-size descriptor).

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