Essential hypertension in pediatric patients may require pharmacological treatment. There is a need for efficacious, safe, and well-tolerated
antihypertensive agents with a once-a-day dosing regimen in children and adolescents. The aim of the trial was to evaluate the dose-response and tolerability of the
dihydropyridine calcium channel blocker,
felodipine extended-release
tablets (
felodipine ER), given once daily to pediatric patients with
essential hypertension. A randomized double-blind, parallel-group, multi-center clinical study comparing
felodipine ER (2.5, 5, or 10 mg once daily) and placebo was performed on pediatric patients with a baseline systolic (SBP) or diastolic blood pressure (DBP) above the 95th percentile for age, sex, and height. Of 133 randomized patients, 128 (96.2%) completed the 3 weeks of double-blind treatment. The study population included 50% children 6-12 years of age or Tanner stage <or=3, 39% black, and 40% female patients. All doses of
felodipine ER and placebo decreased both SBP and DBP. The 5-mg dose of
felodipine ER resulted in a significant decline in trough sitting, standing, and supine DBP (placebo-adjusted, -4.6, -5.06, and -5.05 mmHg, respectively, P<0.05) compared with placebo. However, there was no significant decline in SBP. The 2.5- and 10-mg doses showed no significant differences compared with placebo in lowering BP. The effect of
felodipine ER was comparable in patient subgroups by age, race, and gender. The
drug was well tolerated. The study failed to show a dose response of
felodipine ER in pediatric patients with
essential hypertension. This finding might be explained in part by the limitations of study design. The spectrum of side effects in pediatric patients was comparable with that in adults, except for a lower incidence of peripheral
edema. Further studies are needed to clarify the role of
felodipine ER in the management of children and adolescents with
essential hypertension.