FDA approves antihypertensive for children
The FDA has expanded indications for olmesartan medoxomil, an
angiotensin II receptor blocker, to include children aged 6 to 16 years, after
data from a phase-3 trial indicated that it safely and effectively reduced BP
in pediatric patients, according to a press release.
The approval comes days after first lady Michelle Obama announced the
launch of a campaign —
Let’s Move — to address the growing problem of
childhood obesity.
Previous studies have indicated that the national average BP for
American children has been on the rise since the late 1980s and has increased
proportionately along with the average childhood weight. Furthermore, the link
between the two is well documented, with obese children at an approximate
threefold higher risk for hypertension than children who are not obese,
according to the release.
Treating hypertension during childhood and adolescence is crucial, as
studies have shown that presence of the condition in childhood is an
independent risk factor for adult hypertension and is associated with early
markers of CVD.
Olmesartan medoxomil (Benicar, Daiichi Sankyo) may be used as initial
therapy, alone or with other antihypertensive agents, according to the release.
The expanded indication for olmesartan medoxomil to include children is
both good and bad news. The good news is that it will heighten the awareness of
angiotensin II receptor blockers being efficacious and safe drugs for the
treatment of childhood hypertension. Clearly, childhood hypertension is no
indication for diuretics and beta-blockers because both of these drug classes
carry substantial metabolic baggage.
The bad news is of course the fact that, because of the obesity
epidemic, we are facing more and more teenagers and children who have
hypertension that will substantially shorten their lifespan unless they are
effectively treated.
– Franz Messerli, MD
Hypertension Program
Director
St. Luke's-Roosevelt Hospital Center, New York