ATLANTA, March 13 /PRNewswire-FirstCall/ -- In response to inquiries from the news media about the ASTEROID trial for Crestor presented today at the American College of Cardiology, Pfizer issued the following statement:
-- Only Lipitor has demonstrated significant LDL reductions and
cardiovascular benefits for a wide range of patients, with an excellent
efficacy and safety profile across the full dose range.
-- This is not the first time a statin has demonstrated plaque regression.
The REVERSAL trial compared treatment with Lipitor 80mg to another
lipid lowering agent over 18 months. In a subset of high-plaque burden
patients, Lipitor demonstrated a 5.9% (P<.001) total plaque reduction
with excellent toleration.
-- It is not possible to compare the findings from ASTEROID with REVERSAL
given ASTEROID's open label, single-arm design did not include a
comparator. In contrast, Lipitor has demonstrated significant LDL and
cardiovascular benefits in well controlled clinical trials such as
PROVE IT, TNT and IDEAL.
-- Treatment practice has evolved significantly in the past several years,
strongly supported by the results of the Lipitor clinical outcomes
trials. Studies like PROVE IT, TNT and IDEAL have conclusively
demonstrated the benefit of intensive lipid lowering with Lipitor.
-- The LDL levels reached in these studies, ranging from 60 to 80 mg/dL,
are attainable only through intensive lipid lowering to a degree that
cannot be matched with older, less efficacious therapies such as
simvastatin.
-- Lipitor has a proven record of safety and over 115 million patient
years of experience that cannot be matched by any other medicine.
-- Pfizer is using the IVUS technology in its large-scale Phase III
torcetrapib/atorvastatin clinical trials program, which is studying
some 25,000 patients at hundreds of medical centers worldwide.
-- The results from these trials, which will report out in the near
future, will provide additional information on the lipid hypotheses
alluded to in ASTEROID in a well-controlled manner.
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Website: http://www.pfizer.com/