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WARNINGS
Fetal/Neonatal Morbidity and Mortality
Drugs that act directly on the renin-angiotensin system can cause fetal
Losartan’s bioavailability is about 32%.
Losartan undergoes significant first-pass metabolism to produce 5-carboxylic acid metabolite, designated as EXP3174. This metabolite is long-acting (6 to 8 hr), noncompetitive antagonist at the AT1 receptor and contribute to the pharmacological effects of Losartan. It is 10-40 times more potent in blocking AT1 receptors than Losartan.
Business Editors/Health/Medical Writers
WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–March 25, 2003
In the landmark LIFE trial, once daily COZAAR significantly
reduced the risk of stroke
Merck & Co., Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved another new indication for Merck’s antihypertensive drug COZAAR(R) (losartan potassium tablets).
The new label states that COZAAR is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy (LVH), but there is evidence that this benefit does not apply to black patients. LVH, a thickening of the heart’s main pumping chamber (the left ventricle), is the most common cardiac abnormality associated with longstanding hypertension. No angiotensin II receptor blocker (ARB) other than COZAAR is indicated to reduce the risk of stroke in patients with hypertension and LVH.
The new indication is based on the landmark LIFE (Losartan Intervention for Endpoint Reduction in Hypertension) study published last March in The Lancet. In this 9,193 patient study, treatment with a regimen based on COZAAR significantly reduced the risk of stroke (fatal and nonfatal) by 25 percent in patients with hypertension and LVH versus treatment with a regimen based on the beta-blocker atenolol (p=0.001). There were 232 fatal and nonfatal strokes in the group treated with COZAAR, and 309 in the atenolol group. The LIFE trial, with COZAAR, marks the first time an antihypertensive treatment regimen has demonstrated a reduction in the risk of stroke versus another antihypertensive treatment regimen in hypertensive patients with LVH. Other findings from the LIFE study showed no significant difference between the treatment groups in the risk of heart attack or cardiovascular death.
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In the LIFE trial, black patients with hypertension and LVH had a lower risk of stroke on atenolol than on COZAAR. Given the difficulty in interpreting subset differences in large trials, it cannot be known whether the observed difference is the result of chance. However, the LIFE study does not provide evidence that the benefits of COZAAR on reducing the risk of cardiovascular events in hypertensive patients with left ventricular hypertrophy apply to black patients.
Stroke: A pressing national health issue
“Stroke is a leading cause of serious, long-term disability in the United States and for the victims of stroke and their families the impact can be devastating,” said Richard B. Devereux, M.D., co-chairman of the LIFE study and professor of medicine at Cornell University in New YorAny type of cozaar for You.
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