Efficacy of amlodipine in pediatric patients with hypertension

Abstract

We designed a study to determine the efficacy and safety of amlodipine given once daily in the pediatric population. Twenty-one patients (mean age 13.1 years) with either essential (n=160) or renal (n=5) hypertension, and newly diagnosed (n=15) or poorly controlled or intolerant on existing antihypertensive therapy (n=6), were included. Patients received amlodipine once daily at a starting mean dose of 0.07+/-0.04 mg/kg per day. The total daily dose of amlodipine was increased 25%-50% every 5-7 days if the mean home blood pressure measurements (HBPM) were above the 95th percentile for age and gender. A baseline followed by a repeat 24-h ambulatory blood pressure monitor study (ABPM) was performed in 20 patients when the mean HBPM was below the 95th percentile goal. The mean titrated dose required to control BP was 0.29+/-0.11 mg/kg per day for those < 13 years, 0.16+/-0.11 mg/kg per day for those > or = 13 years, 0.23+/-0.14 mg/kg per day for essential, hypertension and 0.24+/-0.13 mg/kg per day for renal hypertension. The ABPM demonstrated that amlodipine provided effective BP control as primary therapy in 14 essential patients. Adverse effects included fatigue (n=6), headache (n=5), facial flushing (n=4), dizziness (n=3), edema (n=3), abdominal pain (n=3), chest pain (n=2), nausea (n=1), and vomiting (n=1). Quality of life appeared to improve during therapy. Amlodipine was an effective once daily antihypertensive agent with an acceptable safety profile. Higher doses of amlodipine were required for younger patients, and monotherapy was effective in patients with essential hypertension.

Antihypertensive efficacy of amlodipine in children with chronic kidney diseases

“…11,19 The side effects noted in our paediatric patients given amlodipine are similar to those reported in adults and children treated with amlodipine or other dihydropyridines. [1][2][3][4]18,[20][21][22][23] These vasodilators lead in 10 to 20% of patients to one or more of the following: headache, dizziness or lightheadedness, flushing, and peripheral oedema. The peripheral oedema is related to redistribution of fluid from the vascular space into the interstitium, possibly induced by vasodilatation which allows more of the arterial pressure to be transmitted to the capillary circulation.…”

“…Finally dose adjustment is superfluous in renal impairment. [1][2][3][4]16,17 Paediatric use of amlodipine has previously been reported, 12,18,[20][21][22][23] but previous reports have been limited by small patient numbers 12,[20][21][22][23] and rather heterogenous patient populations, that included both in-and outpatients 18,20 or both renal and non renal hypertension. 12,18,20,21 In conclusion the results of the present experience in paediatric outpatients with chronic kidney diseases support the view that amlodipine is an effective and rather well tolerated antihypertensive drug when given once a day in a dosage of 7 to 10 mg/m 2 body surface area and suggest that it has obvious advantages over other dihydropyridines.…”

Ambulatory Blood Pressure Monitoring in Children and Adolescents: Recommendations for Standard Assessment

“…123 In a separate trial of 21 adolescents, ABPM was used to demonstrate the efficacy of amlodipine, a calcium channel blocker, as an effective once-daily antihypertensive agent. 124 Despite the paucity of data on the use of ABPM in monitoring hypertensive treatment in children, a recent survey of 438 North American pediatric nephrologists found that the majority favor use of ABPM for this purpose. 125 The increasing clinical use of ABPM is likely to spur further interest in the use of ABPM in pediatric antihypertensive trials.…”

Ensuring Safe and Effective Medication Use in Pediatric Patients

“…Amlodipine studies 14 showed larger dose requirement per kilogram for patients younger than 13 years vs an older group ( Table 2). The only oral hypoglycemic drug approved for children with type 2 diabetes was metformin.…”