By Jill Stein
CHICAGO, IL -- May 21, 2007 -- Valsartan appears to be safe and effective for the treatment of hypertension in children and teenagers, researchers announced here at the 22nd Annual Meeting of the American Society of Hypertension (ASH).
Thomas Wells, MD, professor, pediatrics division, University of Arkansas, Little Rock, United States, and associates examined valsartan's effect on systolic blood pressure in hypertensive children ranging from six through 16 years of age.
"Hypertension is a significant health issue in children, and estimates suggest that about 1% to 3% of individuals under 18 years of age have hypertension and many more are thought to have pre-hypertension," Dr. Wells said. "In addition, recent studies have shown that the prevalence of hypertension has increased substantially as a risk factor for cardiovascular disease and contributes substantially to premature mortality."
Although cardiovascular disease occurs more frequently in older patients, exposure to risk factors in childhood may contribute to future disease development, he continued. In addition, elevations in blood pressure have been shown to significantly correlate between childhood and adulthood.
Dr. Wells also noted that while numerous studies have demonstrated that valsartan is effective for lowering blood pressure in adults, the drug has not been extensively studied in children.
For the double-blinded trial, 261 patients were randomised in a 2:1 ratio to one of three treatment groups:
· The low-dose group included patients under 35 kg who received valsartan 10 mg once daily and patients who weighed 35 kg or more who received valsartan 20 mg once daily for 2 weeks.
· The medium-dose group included patients under 35 kg who receive valsartan 40 mg once daily and patients 35 or more kg who received valsartan 80 mg once daily for 2 weeks.
· The high-dose group included patients under 35 kg who received valsartan 80 mg once daily and patients 35 kg or more who received valsartan 160 mg once daily for 2 weeks.
In the second phase of the trial, patients were randomised in a 1:1 ratio to continue the treatment or switch to placebo for an additional 2 weeks.
In phase 1, valsartan treatment resulted in dose-dependent reductions in systolic and diastolic blood pressure. The systolic blood pressure reductions were 7.9 mmHg, 9.6 mmHg, and 11.5 mmHg for the low-, medium- and high-dose groups. The diastolic blood pressure reductions were 4.6 mmHg, 5.8 mmHg, and 7.4 mmHg, for the three groups, respectively.
In Phase 2, systolic and diastolic blood pressure were lower in valsartan-treated children than in those receiving placebo (least square mean difference VAL vs. PL: SBP= -2.7 mmHg, p=0.0386; DBP= -3.0 mmHg, p=0.0047).
Overall, the results support the blood pressure-lowering efficacy of valsartan in pediatric patients, Dr. Wells said. Valsartan was generally safe and well tolerated also.
The study was sponsored by Novartis.
[Presentation Title: Safety and Effectiveness of Valsartan (VAL) in Hypertensive children Ages 6-16 years. Abstract Number P-185]
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