The pharmacokinetics of irbesartan in hypertensive children and adolescents.
An open-label study was conducted to characterize the pharmacokinetics and antihypertensive response to irbesartan in children (1-12 years) and adolescents (13-16 years) with hypertension. Patients received single once-daily oral doses of irbesartan 2 mg/kg (maximum of 150 mg once daily) for 2 to 4 weeks (+/- nifedipine or hydrochlorothiazide). Plasma irbesartan concentrations were determined by a validated high-performance liquid chromatography/fluorescence method from blood samples taken predose, up to 24 hours after dosing on Day 1, and up to 48 hours after the final dose. The plasma concentration-time profiles were similar between the 6- to 12-year and the 13- to 16-year age groups and to that previously determined from a study of adult subjects receiving approximately 2 mg/kg (i.e., 150 mg) oral irbesartan once daily. Mean reductions in systolic/diastolic blood pressure were 16/10 mmHg at Day 28 with irbesartan monotherapy (n = 8). Irbesartan was well tolerated and may be a treatment option for pediatric hypertensive patients.
Sakarcan
A
A
Louisiana State University Health Sciences Center, Shreveport, USA.
Tenney
F
F
Wilson
J T
JT
Stewart
J J
JJ
Adcock
K G
KG
Wells
T G
TG
Vachharajani
N N
NN
Hadjilambris
O W
OW
Slugg
P
P
Ford
N F
NF
Marino
M R
MR
D000284:Administration, Oral; D000293:Adolescent; D000959:Antihypertensive Agents / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use; D019540:Area Under Curve; D001713:Biphenyl Compounds / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D005260:Female; D006207:Half-Life; D006801:Humans; D006973:Hypertension / Q000188:drug therapy; D007223:Infant; D007408:Intestinal Absorption; D000077405:Irbesartan; D008297:Male; D008657:Metabolic Clearance Rate; D013777:Tetrazoles / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use
D000959:Antihypertensive Agents; D001713:Biphenyl Compounds; D013777:Tetrazoles; D000077405:Irbesartan