EAS MEETING: Lipitor More Effective Than Zocor And Baycol For Lowering Cholesterol
ATHENS, GREECE - May 27, 1999 -- Building on
existing data, two new studies presented at the annual
congress of the European Atherosclerosis Society (EAS),
now provide further evidence of the superior
cholesterol-lowering efficacy of Parke-Davis' and
Pfizer's Lipitor(R) (atorvastatin calcium tablets).
In the first study known as Triple A (Australian
Atorvastatin Assessment), a significantly greater number
of patients reached total cholesterol goals on Lipitor than
patients taking Zocor(R) (simvastatin). In the second
study, Atorvastatin Versus Cerivastatin (Baycol[R]),
Lipitor demonstrated a greater cholesterol-lowering effect
than cerivastatin. This study completes the comparative
review of Lipitor versus all available statin therapies.
"Atorvastatin is the most efficacious of the HMG-CoA
reductase inhibitors at reducing low density lipoprotein
[LDL-C] cholesterol," said professor Phillip Barter,
department of medicine, University of Adelaide, South
Australia. "These studies provide further evidence of the
impressive cholesterol-altering effects of atorvastatin."
In the Atorvastatin Versus Cerivastatin study, atorvastatin
was found to be a more effective cholesterol-lowering
therapy at its starting dose of 10 mg/day than cerivastatin
at its maximum approved dose of 300 micrograms/day in
patients with high cholesterol. Cerivastatin is the latest
addition to the class of drugs known as statins.
Compared with the maximum approved dose of
cerivastatin, the 10 mg starting dose of atorvastatin
produced significantly greater reductions from baseline in
LDL-C (37.7 percent versus 30.2 percent), total
cholesterol (TC) (27.5 percent versus 22.2 percent) and
apolipoprotein B (Apo B) (28.6 percent versus 21.2
percent) and a significantly greater increase from baseline
in high density lipoprotein cholesterol (HDL-C) (6.8
percent versus 4.3 percent).
Both atorvastatin and cerivastatin were well tolerated with
safety profiles similar to other members of the statin class.
In the six-week, multicentre, open-label, parallel-arm
study, a total of 215 patients with high cholesterol were
randomised to receive either atorvastatin 10 mg once
daily or cerivastatin 300 micrograms once daily. Efficacy
was determined by measuring changes in lipid
parameters.
The Australian Atorvastatin Assessment (Triple A) study
supports the superiority of 10 mg of atorvastatin in
achieving TC targets compared with 10 mg of simvastatin
regardless of baseline cholesterol. Atorvastatin took
significantly more patients to TC target of less than 5.0
mmol/L than simvastatin at all points within the study
regardless of baseline cholesterol. After 24 weeks, 83.1
percent of atorvastatin treated patients reached target
versus 65.9 percent on simvastatin (plus or minus
cholestyramine).
"The Triple A results are exciting because they show that
the 10 mg starting dose of atorvastatin is an effective
treatment for primary care patients with varying levels of
baseline cholesterol," said Dr. Richard O'Brien,
department of medicine, Monash University, Victoria,
Australia.
The 24-week, open-label, randomised study enrolled
1,028 hypercholesterolaemic men and women aged 18 to
76. Designed to replicate the real world where these
patients are treated by general practitioners, the study
involved more than 240 general practice offices. Patients
with comparable baseline lipid levels were randomised to
either atorvastatin or simvastatin. An initial drug dose of
10 mg daily for each agent was doubled at six-week
intervals if the target TC level of less than 5.0 mmol/L
(190 mg/dL) had not been achieved. The maximum dose
of atorvastatin was 80 mg, while the maximum dose of
simvastatin was 40 mg supplemented if necessary with 4
g of cholestyramine. Once a patient achieved the target of
less than 5.0 mmol/L, the dose remained constant until the
end of the six months.
Atorvastatin is 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
atorvastatin is 10 mg once daily. The dosage range is 10
mg to 80 mg once daily. Atorvastatin is generally well
tolerated. Adverse reactions usually have been mild and
transient, with fewer than 2 percent of patients being
discontinued from clinical trials due to side effects related
to atorvastatin. This rate of discontinuation was
comparable to that of placebo. The most frequent
adverse effects of atorvastatin are constipation, flatulence,
dyspepsia and abdominal pain.
It is recommended that liver function tests be performed
prior to and at 12 weeks following both the initiation of
therapy and any elevation of dose, and periodically
thereafter. Myopathy should be considered in any patient
with diffuse myalgias, muscle tenderness or weakness
and/or marked elevation of creatine phosphokinase
(CPK).
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