FDA Approves Olmesartan for the Treatment of Pediatric Hypertension
By Yael Waknine
Medscape Medical News
February 12, 2010 — The US Food and Drug Administration (FDA) has approved an expanded indication for olmesartan medoxomil (Benicar tablets, Daiichi Sanyo, Inc) for the treatment of hypertension in pediatric patients aged 6 to16 years. The angiotensin II receptor blocker previously was reserved for use in adults.
About 3.6 million American children have hypertension that often goes undiagnosed. An analysis of national survey data suggests that the prevalence of pediatric hypertension has been increasing since the late 1980s, in parallel with increases in children's weight. Treatment is important because the condition represents an independent risk factor for adult hypertension and is associated with early markers of cardiovascular disease.
"As hypertension is on the rise also in a younger population, Daiichi Sankyo believes it is important to help doctors meet the challenge of treating these pediatric patients by providing a treatment option to help people effectively manage their hypertension," said Reinilde Heyrman, MD, vice president clinical development–operations, Daiichi Sankyo Pharma Development, in a company news release.
The approval was based on data from a randomized, double-blind study of pediatric patients (n = 302; 112 black and 190 mixed racial heritage) with hypertension of predominantly essential origin. Patients who weighed from 20 to less than 35 kg were randomly assigned to receive 2.5 or 20 mg of olmesartan once daily; those who weighed 35 kg or more were randomly assigned to a daily dose of 5 or 40 mg. After 3 weeks, patients were reassigned to continued olmesartan therapy or placebo.
Results of the initial dose-response phase showed that olmesartan significantly reduced both systolic and diastolic blood pressure in a weight-adjusted dose-dependent manner. Overall, the 2 dose levels of olmesartan (low and high) significantly reduced systolic blood pressure by 6.6 and 11.9 mm Hg from the baseline, respectively. These reductions in systolic blood pressure included both drug and placebo effect.
During the randomized withdrawal to placebo phase, mean systolic and diastolic blood pressure at trough were significantly lower in patients continuing olmesartan therapy than in those withdrawn to placebo (Δ, 3.2 mm Hg and 2.8 mm Hg, respectively). As observed in adult populations, blood pressure reductions were smaller in black patients.
Pediatric use of olmesartan was well-tolerated; adverse events were similar to those reported in adult studies, with dizziness most commonly reported (incidence, 3%).
Pediatric dosing of olmesartan is based on body weight. The recommended starting and maintenance doses for patients weighing from 20 to less than 35 kg are 10 mg and 20 mg once daily, respectively; patients weighing 35 kg or greater should receive an adult starting dose of 20 mg once daily and be maintained at a daily dose of 20 to 40 mg. An extemporaneous suspension may be prepared for children unable to swallow tablets.
