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Senior Citizen Health & Medicine
Bystolic Approved by FDA as New Beta Blocker to
Treat High Blood Pressure
About 65% of hypertension patients not reducing
blood pressure to acceptable range
 Dec. 19, 2007 – Bystolic (nebivolol), a new
beta-blocker drug, has been approved by the Food and Drug Administration
for the treatment of high blood pressure (hypertension). It joins the
battle against hypertension that is fought by 72 million U.S. adults,
mostly senior citizens. Recent studies show that about 65 percent of
patients are failing to reduce their blood pressure to the acceptable
range.
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Hypertension can increase the risks for stroke,
heart failure, heart attack, kidney failure, and death. A beta blocker,
a well-established class of medications, reduces blood pressure by
reducing the force with which the heart pumps.
"High blood pressure is often called the 'silent
killer' because it usually has no symptoms until it causes damage to the
body," said Douglas C. Throckmorton, M.D., FDA's deputy director of the
Center for Drug Evaluation and Research.
"Bystolic offers a new treatment option for people
who need to control their high blood pressure."
Bystolic is a once-daily medication that can be
used alone or in combination with other hypertension treatments,
according to Forest Laboratories, Inc. and Mylan Bertek Pharmaceuticals
Inc. Forest licensed U.S. and Canadian rights to Bystolic from Mylan in
January 2006. Mylan licensed these rights from Janssen Pharmaceutica N.V.,
Belgium in 2001.
The safety and efficacy of Bystolic in lowering
blood pressure was assessed in three randomized, double-blind,
multi-center, placebo-controlled clinical trials that ran for up to
three months, according to the FDA.
A fourth placebo-controlled clinical trial
demonstrated additional blood pressure-lowering effects when Bystolic
was given with up to two other antihypertensive medications in patients
with inadequate blood pressure control. In total, more than 2,000 people
received Bystolic during the trials. Its efficacy during the trials was
similar to those of other FDA-approved beta blockers.
The most common side effects reported by patients
taking Bystolic in clinical trials were headache, fatigue, dizziness and
diarrhea.
"Bystolic is the newest beta blocker approved for
the treatment of hypertension in the U.S. and should prove useful due to
its efficacy in a broad range of patients and its favorable side effect
profile," said Michael Weber, MD, Professor of Medicine at SUNY
Downstate College of Medicine. "These features will be attractive to
both physicians and patients."
Howard Solomon, Chairman and Chief Executive of
Forest, commented: "We, along with our partner Mylan, are pleased to
have received final Food and Drug Administration marketing approval for
Bystolic. Bystolic represents an important advance for patients with
hypertension and the physicians who treat them and will be an important
new product for our Company."
Bystolic is already approved and successfully
marketed for the treatment of hypertension in more than 50 countries
outside of North America.
Forest expects Bystolic to be available to
physicians, patients, and pharmacies in January 2008.
For more information
What is High Blood Pressure? — National Heart Lung and Blood Institute
www.nhlbi.nih.gov/health/dci/Diseases/Hbp/HBP_WhatIs.html
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