CHICAGO – Valsartan significantly reduced both systolic and diastolic blood pressure without significant adverse events in the first trial of an angiotensin II receptor blocker in children younger than 6 years.
Valsartan is indicated for the treatment of hypertension and heart failure in adults, but had never been studied in children. In November 2006, the Food and Drug Administration approved safety labeling revisions for valsartan tablets to advise of the risk of fetal and neonatal morbidity when used by pregnant women.
Dr. Joseph Flynn and associates presented preliminary results in a poster at the annual meeting of the American Society of Hypertension from a multicenter, placebo-controlled study evaluating three doses of valsartan in 90 children with a mean seated systolic BP greater than or equal to the 95th percentile of the National High Blood Pressure Education Program normative BP values for children.
After a 1-week placebo washout screening phase, the children were randomized to low, medium, and high doses of valsartan for 2 weeks (phase 1), then rerandomized to placebo or valsartan for 2 more weeks (phase 2).
In phase 1, the doses were 5, 20, or 40 mg/day for those children weighing less than 18 kg, and 10, 40, or 80 mg/day for those weighing more than 18 kg. Half of the children stayed on the same dose in phase 2, and half were withdrawn to placebo.
At admission, the children's mean age was 3 years; 60% were boys, and 30% were black. Most children (79%) had hypertension related to renal disease; some (3%) were hypertensive because of heart disease, and 18% because of other causes.
In phase 1, valsartan significantly reduced both systolic and diastolic BP at all three doses, reported Dr Flynn, who conducted the study while at Children's Hospital at Montefiore, New York, and is now a professor of pediatrics at Children's Hospital and Regional Medical Center, in Seattle.
In phase 2, systolic and diastolic BP was significantly lower in children receiving valsartan, compared with those receiving placebo. The mean difference between valsartan and placebo was −4.1 mm Hg for systolic BP and −3.7 mm Hg for diastolic.
“Since many of these children have hypertension due to underlying renal disease, valsartan may be well suited for treatment of hypertension in this age group,” Dr. Flynn said in an interview.
Adverse events, such as cold symptoms, were minor and were similar between the different dose groups, he said. In all, 29% of children experienced an adverse event in phase 1 and 39% in phase 2. No participants discontinued treatment because of an adverse event.
The investigators will undertake a further analysis of the 1-year open-label extension phase of the study to learn how well valsartan worked over a longer period of time. Studies of valsartan in children with proteinuria are also planned to evaluate its safety and effectiveness in reducing proteinuria.