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Biotech / Medical : wla(warner lambert)
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To: radman33 who wrote (535)2/17/1999 2:12:00 PM
From: Anthony Wong   of 942
 
Lipitor Approved In Canada For Three New Indications
February 17, 1999

TORONTO, ON. -- Health Canada has approved three new indications for
Parke-Davis' and Pfizer Canada Inc.'s cholesterol-lowering drug Lipitor(R)(atorvastatin
calcium) to include use as an adjunct to diet for the following conditions:
dysbetalipoproteinemia (Type III); hypertriglyceridemia (Type IV); and homozygous
familial hypercholesterolemia (as an adjunct to LDL apheresis if available, otherwise as
monotherapy).

Lipitor is also indicated as an adjunct to diet to reduce elevated total-C, LDL-C, apo B
and TG levels in patients with primary hypercholesterolemia and mixed dyslipidemia.

The recommended starting dose of Lipitor is 10mg once daily. The dosage range is 10 to
80 mg once daily.

Lipitor has been shown in clinical studies to produce reductions in LDL-cholesterol in
patients with elevated cholesterol of 39 percent to 60 percent across the dose range of
10 to 80 mg. Reductions in triglycerides of 19 percent to 37 percent were reported in
clinical trials in patients with mild to moderate hypercholesterolemia across the same
dose range. Furthermore, in clinical trials with Lipitor (10 to 80 mg) in patients with
hypertriglyceridemia show further reductions of triglycerides by 25 to 56 percent.

Lipitor is generally well tolerated. Adverse reactions are similar to other statins and have
usually been mild and transient, with fewer than two percent of patients being
discontinued from clinical trials due to side effects related to Lipitor. This rate of
discontinuation was comparable to that of placebo. The most frequent adverse events of
atorvastatin reported during clinical trials are constipation, flatulence and dyspepsia. It is
recommended that liver functions tests be performed prior to initiating therapy and
periodically thereafter. Myopathy should be considered in any patient with diffuse
myalgias, muscle tenderness or weakness, and/or marked elevation of creatine
phosphokinase, which may be more frequent when co-administered with drugs that
inhibit the cytochrome P-450 metabolising enzyme system.

pslgroup.com
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