You did not post the entire release -- consequently your post was quite misleading !!
FDA advisory panel backs Merck heart drug
BETHESDA, Md., April 10 (Reuters) - A new drug to help prevent heart attacks was backed by a Food and Drug Administration (FDA) advisory panel Friday.
Aggrastat, to be sold by Merck & Co. <MRK.N> , prevents blood platelets from clumping into dangerous clots that can block arteries.
The panel said the drug could be used in combination with the blood thinner heparin in patients who come to emergency rooms with chest pain known as unstable angina.
The FDA is not bound by advisory panel recommendations but usually accepts them.
Unstable angina is the leading cause of U.S. hospital admissions and is usually treated with aspirin or heparin. Left untreated, clots can grow or break off, leading to a heart attack or death.
Drugs like Aggrastat are designed to delay or avoid the need for heart bypass surgery or artery-widening angioplasty procedures.
Although a majority of the advisory panel found the results of an intial study to be weak, a second trial call PRISM-PLUS was stronger.
Patients in PRISM-PLUS had worse disease, and because there there initially seemed to be more deaths in those taking Aggrastat alone, they were given heparin in addition.
In the end, 773 patients taking the combination were compared to 797 patients getting heparin alone.
After a week, Aggrastat reduced the combined risk of death, heart attack and chest pain by 34 percent. About half these patients avoided angioplasty or bypass while a third had angioplasty and 23 percent had bypass.
The FDA panel declined to vote on backing Aggrastat's use during angioplasy to prevent heart attack, repeat procedures and abrupt artery closure after reviewing results of a separate study called RESTORE.
The FDA told COR Therapeutics Inc. <CORR.O> last week that its similar glycoprotein IIb/IIIa blocker, Integrilin, will soon be approved to use during angioplasty and for unstable angina.
Eli Lilly and Co.'s <LLY.N> Reopro, is already FDA-approved for angioplasty, but not for unstable angina.
15:41 04-10-98
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