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Olmesartan medoxomil appears efficacious, safe for pediatric patients with hypertension, study finds

Wednesday, June 16 2010 | Comments

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What's This? Olmesartan medoxomil appears to be well-tolerated and is associated with dose-dependent reductions in blood pressure (BP) in children with hypertension, according to findings from a double-blind study.

The trial included 2 cohorts of children aged 6 to 16 years with hypertension. The first cohort included 190 children of varying races/ethnicities (white children, 62%; black children, 18%; Asian children, 10%; other races, 14%) and the second cohort included 112 black children.

Following a screening and washout period, the participants were randomized to receive low-dose (2.5 mg/day or 5 mg/d, depending on weight) or high-dose (20 mg/d or 40 mg/d, depending on weight) olmesartan medoxomil for 3 weeks. Subsequently, participants were randomized to receive continued treatment with olmesartan medoxomil or placebo for an additional 2 weeks.

Efficacy variables included seated cuff systolic and diastolic BP.

Results of the intention-to-treat analyses showed that, during the first phase of the study, olmesartan medoxomil was associated with significant dose-dependent reductions in seated trough systolic and diastolic BP in both cohorts (multiracial cohort, P=.0008 for systolic BP and P=.0026 for diastolic BP; black cohort, P=.0032 and P=.0125, respectively).

Specifically, in the multiracial cohort, mean BP declined 7.8/5.5 mm Hg with low-dose olmesartan medoxomil and 12.6/9.5 mm Hg with the higher doses. In the cohort of black children, the corresponding declines in mean BP were 4.7/3.5 mm Hg and 10.7/7.6 mm Hg. These dose-dependent responses remained significant in analyses adjusted for body weight.

During the second phase of the study, in the multiracial cohort, mean systolic BP increased 4.9 mm Hg among the patients who switched to placebo compared with an increase of 0.4 mm Hg among those who continued active treatment (P=.0093). Similarly, in the cohort of black children, mean systolic BP increased more in the placebo group (3.8 mm Hg) than it did in the active-treatment group (1.4 mm Hg), but the between-group difference was not statistically significant. Similar patterns were observed in an analysis of diastolic BP.

The study authors noted that the lack of statistical significance in the black cohort was not unexpected given the sample size. Alternatively, they acknowledged, this might reflect a reduced response among black children to agents that block the renin-angiotensin-aldosterone system, a finding that has been reported in cohorts of black adults.

Overall, the researchers noted, the efficacy data for this trial suggest that higher doses of olmesartan medoxomil might be required for pediatric patients in clinical practice.

During the first phase of the study, the percentages of patients experiencing treatment-emergent adverse events were similar between the low- and high-dose groups in both cohorts. Drug-related adverse events in the multiracial cohort included headache (n=5), dizziness (n=4), tachycardia (n=1), diarrhea (n=1), hypoesthesia (n=1), and insomnia (n=1). The only drug-related adverse event in the cohort of black children was headache (n=1).

During the second phase of the study, in the multiracial cohort, 35.5% of the patients in the olmesartan medoxomil group experienced treatment-emergent adverse events compared with 30.3% of placebo-treated patients who did so. The corresponding percentages in the black cohort were 13.2% and 14.8%. Drug-related adverse events in the multiracial cohort included hyperkalemia, headache, and dizziness. One patient in the black cohort experienced 2 drug-related adverse events (renal impairment and moderate hypotension). (Hazan L, et al. Hypertension 2010;55:1323-1330.)

This study was funded by Daiichi Sankyo Inc., which markets olmesartan medoxomil under the brand name Benicar. In February of this year, the Food and Drug Administration approved Benicar for the treatment of hypertension in pediatric patients aged 6 to 16 years.

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