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Antihypertensive effect and pharmacokinetics of nitrendipine in children
1Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock.
Insights
Nitrendipine effectively treated severe hypertension in children, significantly lowering blood pressure. This calcium-channel antagonist demonstrated safety and efficacy in pediatric patients with resistant hypertension.
Area of Science:
- Pharmacology
- Pediatric Medicine
- Cardiovascular Research
Background:
- Severe hypertension in children is a critical health concern requiring effective treatment options.
- Calcium-channel antagonists represent a class of drugs with potential for managing pediatric hypertension.
- Limited data exists on the efficacy and pharmacokinetics of nitrendipine in pediatric populations.
Purpose of the Study:
- To evaluate the efficacy and safety of nitrendipine in treating severe hypertension in children.
- To assess the pharmacokinetic profile of nitrendipine in pediatric patients.
- To determine optimal dosing strategies for nitrendipine in infants and children.
Main Methods:
- A prospective study involving 25 children (6 months to 17 years) with severe hypertension.
- Administration of oral nitrendipine at doses of 0.25 to 0.5 mg/kg every 6 to 12 hours.
- Monitoring of blood pressure, heart rate, and adverse effects; pharmacokinetic analysis in 13 children.
Main Results:
- Significant reductions in systolic and diastolic blood pressure were observed within 24 hours and sustained for 2 weeks.
- Transient reflex tachycardia was noted in the first week; other adverse effects were uncommon.
- Pharmacokinetic data indicated variable absorption and bioavailability, with food potentially reducing absorption.
Conclusions:
- Nitrendipine is an effective and safe treatment for resistant hypertension in infants and children.
- Dosing of 0.25 to 0.5 mg/kg every 6 to 12 hours appears appropriate for pediatric use.
- Further research into nitrendipine's pharmacokinetics in children is warranted to optimize its use.
Abstract:
Nitrendipine, a new calcium-channel antagonist, was used to treat 25 children (aged 6 months to 17 years) with severe hypertension. Systolic and diastolic blood pressures (mean +/- SEM) fell from 148 +/- 2/99 +/- 2 mm Hg to 128 +/- 4/77 +/- 3 mm Hg after 24 hours and to 121 +/- 2/75 +/- 2 mm Hg after 2 weeks. No further reductions in systolic or diastolic blood pressure were observed after continued therapy. Transient reflex tachycardia occurred during the first week of therapy. Other adverse effects were uncommon and included headaches, flushing, palpitations, and edema. Pharmacokinetic parameters were estimated at steady state after an oral dose of 0.56 +/- 0.04 mg/kg in 13 children. Although absolute oral bioavailability could not be determined, estimates of the area under the plasma concentration versus time curve, the apparent peak serum concentration, and the apparent time at which the peak serum concentration occurred indicated that both the rate of absorption and oral bioavailability are variable. Coadministration of nitrendipine with food decreased the rate of absorption and may have reduced oral bioavailability. A relationship between age and the apparent plasma elimination half-life of nitrendipine was not observed. Nitrendipine, 0.25 to 0.5 mg/kg per dose administered orally every 6 to 12 hours, appeared to be an effective and safe treatment for resistant hypertension in infants and children.