Efficacy and safety of the angiotensin receptor blocker valsartan in children with hypertension aged 1 to 5 years

The efficacy and safety of valsartan were studied in 90 children ( mean age: 3.2 years; 60% male; 30% black) with systolic blood pressure ( SBP) >= 95th percentile. Nineteen percent received valsartan in addition to previous antihypertensive therapy. Subjects were randomly assigned to low-, medium-, or high- dose valsartan for 2 weeks ( phase 1) and then reassigned randomly to placebo or to remain on the same valsartan dose for 2 additional weeks ( phase 2). After this, subjects were enrolled into a 52- week, open- label phase during which valsartan was dosed to achieve SBP >= 95th percentile. Statistically significant reductions in SBP and diastolic blood pressure of approximate to 8.5 mm Hg and 5.7 mm Hg, respectively, were observed at the end of phase 1 in all of the valsartan dose groups. SBP and diastolic blood pressure were also significantly lower during phase 2 in valsartan recipients compared with placebo recipients. SBP < 95th percentile was achieved in 77.3% of subjects during the open- label phase. Adverse events were minor and occurred at similar frequencies in each of the 3 dose groups in phase 1 and at equal frequencies in the valsartan and placebo arms in phase 2. Serious adverse events and drug- related adverse events occurred infrequently during both the double- blind ( 2.2% and 5.6%, respectively) and open- label ( 14.8% and 6.8%, respectively) portions of the study. Valsartan treatment had no demonstrable negative effects on growth and development. In this study, the first trial of an antihypertensive agent conducted in children < 6 years of age, valsartan effectively lowered SBP and diastolic blood pressure compared with placebo.