The approved cholesterol-lowering drug Zocor (simvastatin)
was recently approved by FDA for a new use -
reducing deaths and preventing heart attacks in
people with heart disease and high cholesterol. It
is the first cholesterol-lowering drug approved for
this use.
Marketing with the new use was approved
by FDA las June. Zocor was first approved in 1988 as
an adjunct to diet to reduce elevated total and
low-density lipoprotein cholesterol in patients with
high cholesterol. Other drugs in its class include
Lescol (fluvastatin), (Mevacor (lovastatin), and
Pravachol (provastatin).
Approval of the new use was based on results of
the Scandinavian Simvastatin Survival Study, also
known as the 4S study. The study assessed 4,444
patients with coronary heart disease and cholesterol
levels of 212 to 309 milligrams per deciliter of
blood over an average of 5.4 years. Zocor reduced
overall deaths by 30 percent. Specifically, the drug
reduced coronary heart disease deaths by 42 percent
and reduced the occurrence of hospital-verified,
nonfatal heart attacks by 37 percent.
Side effects associated with Zocor were generally
mild and included: headache, abdominal pain,
constipation, flatulence, and diarrhea.
Zocor is manufactured by Merck & Co. Inc.,
Whitehouse Station, N.J.
(For more information on cholesterol, see
"Lowering Cholesterol," in the March 1994 FDA
Consumer.)
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