NEW YORK, Sept. 4 Forest Laboratories, Inc.(NYSE: FRX) announced the results of a controlled clinical trial, published inthe September 2007 issue of the Journal of Clinical Hypertension, whichdemonstrated that nebivolol, a selective beta 1-blocker with vasodilatingproperties, significantly reduced sitting diastolic and systolic bloodpressure among patients with mild-to-moderate hypertension. The study - thefirst to evaluate the drug in a U.S. population - also found that nebivololwas well tolerated in comparison to placebo and was not associated withadverse changes in blood glucose levels. Nebivolol is currently under reviewby the U.S. Food and Drug Administration (FDA) for the treatment ofhypertension.
"Next-generation beta blockers, such as nebivolol, represent a stepforward in the treatment of hypertension," said Robert J. Weiss, M.D.,Director Cardiovascular Research, Maine Clinical Research. "As we saw in thestudy, nebivolol demonstrated efficacy with a low incidence of side effectstypical of traditional beta blockers, such as fatigue, erectile dysfunction,and depression. In addition, there were no clinically significant changes inglucose levels, which makes nebivolol useful in patients with certainmetabolic disorders."
In the double-blind, placebo-controlled study, a total of 909 patientswere randomized to receive placebo (81 patients) or nebivolol (828 patients)dosed at 1.25mg, 2.5mg, 5mg, 10mg, 20mg or 40mg once daily for up to 12 weeks.The 40mg dose was included to study safety only. The study concluded thatnebivolol, at doses of 1.25mg to 20mg once daily, significantly reduced bothtrough sitting diastolic and systolic blood pressure. Additionally, the studydemonstrated that nebivolol was well tolerated by comparison to placebotreatment. Headache was the most common treatment-related adverse eventexperienced by 7.1% of the pooled nebivolol-treated patients (dosages of1.25mg to 40mg once daily) and 7.4% of the placebo-treated patients. Of note,in the pooled nebivolol group, the incidence of AEs commonly associated withtraditional beta blocker use, including fatigue (3.6% vs. 2.5% with placebo),erectile dysfunction (0.2%), and depression (0.2%) was low. Moreover,nebivolol was not associated with adverse changes in blood glucose values.
"The publication of nebivolol's first U.S. clinical trial furtherreinforces its longstanding use in patients worldwide," said Neil Shusterman,M.D., Senior Vice President, Clinical Development, Forest Research Institute."The majority of Americans afflicted with this disease are still notcontrolled, so clearly there is a need for more treatment options. This studyshowed that nebivolol significantly lowered blood pressure in patients withmild-to-moderate hypertension and we anticipate it will be an importanttherapy for physicians."
Hypertension, also known as high blood pressure, affects approximately 72million people in the U.S. and 65 percent of patients diagnosed withhypertension have not reduced their blood pressure to an acceptable range. Ifleft untreated, hypertension can eventually damage important organs such asthe heart, brain, eyes or kidneys. High blood pressure greatly increases therisk of certain health problems such as stroke, heart attack, and kidneyfailure.
Nebivolol is a selective beta 1-blocker with vasodilating properties andis already approved and successfully marketed for the treatment ofhypertension in more than 50 countries outside of North America.
About Forest Laboratories and Its Products
Forest Laboratories is a US-based pharmaceutical company dedicated toidentifying, developing, and delivering products that make a positivedifference in peoples' lives. Forest Laboratories' growing product lineincludes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults forthe initial and maintena