Pharmacokinetics of irbesartan are not altered in special populations.

Abstract

Studies were conducted to determine whether pharmacokinetics of irbesartan (IRBE), a potent, long-acting angiotensin (AT)-II receptor antagonist selective for AT-II type 1 receptor subtype, are altered in patients with renal impairment (RI), hepatic impairment (HI), or heart failure (HF) or by patient gender, age, or race. IRBE pharmacokinetics and blood pressure (BP) response in hypertensive (HT) children and adolescents were also studied. HI or RI (including end-stage renal disease requiring hemodialysis) had no effect on IRBE pharmacokinetics after single or repeated dosing. IRBE was not removed by hemodialysis. In patients with New York Heart Association class II or III HF, IRBE single-dose pharmacokinetics were not altered following either oral or IV administration. There were no clinically significant differences in IRBE pharmacokinetics between men and women, elderly and young, or black and white patients. No accumulation of IRBE occurred with repeated dosing in RI or HI patients or in HT men or women. In a pediatric study, IRBE pharmacokinetics were comparable between 6- to 12-year and 13- to 16-year age groups and to that previously determined for adult subjects receiving the same dose; accumulation of IRBE was minimal during multiple dosing. IRBE lowered BP in the pediatric population. Adverse event profile with IRBE was similar in all patient groups. Based on these pharmacokinetic and safety data, no dosage adjustments of IRBE are necessary for patients with RI, HI, or HF, or based on patient age, gender, or race. IRBE may be a treatment option for pediatric HT patients. The pharmacokinetic profile of IRBE and lack of necessary dosage adjustments in special populations suggest that IRBE is an excellent choice for management of hypertension across all patient groups.