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Population Pharmacokinetics in Patients with Type 2 Diabetes Population pharmacokinetic analyses from 3 large clinical trials including 642 men and 405 women with type 2 diabetes (aged 35 to 80 years) showed that the pharmacokinetics of rosiglitazone are not influenced by age, race, smoking, or alcohol consumption. Both oral clearance (CL/ F) and oral steady-state volume of distribution (Vss/ F) were shown to increase with increases in body weight. Over the weight range observed in these analyses (50 to 150 kg), the range of predicted CL/ F and Vss/ F values varied by <1.7-fold and <2.3-fold, respectively. Additionally, rosiglitazone CL/ F was shown to be influenced by both weight and gender, being lower (about 15%) in female patients. Special Populations Text Continues Below
Age: Results of the population pharmacokinetic analysis (n = 716 <65 years; n = 331 65 years) showed that age does not significantly affect the pharmacokinetics of rosiglitazone. Gender Results of the population pharmacokinetics analysis showed that the mean oral clearance of rosiglitazone in female patients (n = 405) was approximately 6% lower compared to male patients of the same body weight (n = 642). As monotherapy and in combination with metformin, AVANDIA improved glycemic control in both males and females. In metformin combination studies, efficacy was demonstrated with no gender differences in glycemic response. In monotherapy studies, a greater therapeutic response was observed in females; however, in more obese patients, gender differences were less evident. For a given body mass index (BMI), females tend to have a greater fat mass than males. Since the molecular target PPAR is expressed in adipose tissues, this differentiating characteristic may account, at least in part, for the greater response to AVANDIA in females. Since therapy should be individualized, no dose adjustments are necessary based on gender alone. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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