"The blood pressure reductions produced by valsartan were clinically relevant and did not cause adverse effects," Dr. Joseph T. Flynn, from Children's Hospital and Regional Medical Center, Seattle, Washington, told Reuters Health.
Hypertension is rare in young children, typically caused by underlying kidney disease or other secondary causes. The current study provides the first clinical trial results of a blood pressure-lowering medication in children younger than 6 years.
The study involved 90 children with high blood pressure who were an average of 3 years old. In most of them, high blood pressure was caused by kidney disease. During the 54-week study, children took either valsartan at different doses or a dummy pill.
Valsartan treatment led to statistically significant reductions in blood pressure in the majority of children, Flynn and colleagues found.
According to the investigators, all of the valsartan doses evaluated were well tolerated. The overall incidence of drug-related side events was low and did not differ significantly for placebo- and valsartan-treated children, and the majority of adverse events were mild or moderate and transient in nature.
In particular, valsartan had no demonstrable negative effects on growth, weight gain, or progression of head circumference -- a key indicator of brain growth in young children, Flynn and colleagues report in the journal Hypertension, published by the American Heart Association.
The study was funded by Novartis Pharmaceuticals.
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