Efficacy, safety and pharmacokinetics of candesartan cilexetil in hypertensive children from 1 to less than 6 years of age

• DOI: 10.1097/hjh.0b013e328336b86b
• Publication Date: 2010-03-23T06:43:39Z
• Authors: Franz Schaefer; Johan van de Walle; Aleksandra Zurowska; Charlotte Gimpel; Koen van Hoeck; Dorota Drozdz; Giovanni Montini; Ingretta V Bagdas...; Jonathan Sorof; Jennifer Sugg; Renli Teng; James W Hainer
• Keywords: Candesartan

Few antihypertensive drugs are available in appropriate formulations for infants.We investigated candesartan cilexetil liquid suspension a 4-week, randomized double-blind dose-ranging study followed by 1-year open-label treatment phase (NCT00244621). The drug was administered at 0.05, 0.2 or 0.4 mg/kg per day 93 hypertensive children aged 1-5 years, of whom 74 had underlying renal disorders.A single-dose pharmacokinetic profile obtained 10 patients. At 4 weeks, SBP declined dose dependently 6, 9 and 12 mmHg the three groups (P = 0.01), DBP 5, 8 11 0.03). During follow-up, responder rates (both < 95th percentile) ranged from 48.2 to 54.1%. Candesartan lowered blood pressure regardless age, sex, BMI cause hypertension. independent sex weight, similar that older adults. In participants with proteinuric disease (urinary albumin/creatinine ratio >30 mg/g), 57% median decline observed which related 0.007) persisted long-term administration. There were no notable electrocardiographic laboratory abnormalities. A mild estimated glomerular filtration rate weeks not progressive dosing. generally well tolerated; two patients withdrew adverse events (fatigue worsening glomerulopathy). One patient died, probably acute-on-chronic failure.Candesartan dose-dependently decreases albuminuria infants is tolerated.