Pfizer Updates Preliminary Results of Torcetrapib/Atorvastatin Clinical Trials as Abstract for Phase 3 Study is Released
October 31 2006 - 9:20AM
PR Newswire (US)
NEW YORK, Oct. 31 /PRNewswire-FirstCall/ -- Pfizer Inc today
provided an update on the preliminary results of its
torcetrapib/atorvastatin clinical trials in connection with the
release of an American Heart Association abstract of a Phase 3
study in patients with heterozygous familial hypercholesterolemia
(HeFH) that shows the drug significantly raising 'good' (HDL)
cholesterol (56 percent) and additionally lowering 'bad' (LDL)
cholesterol (27 percent) versus patients taking atorvastatin alone.
The HeFH study also showed patients in the torcetrapib/atorvastatin
group experienced an average increase in systolic blood pressure of
about two millimeters versus patients taking atorvastatin alone.
The HeFH study, in patients with an increased risk of heart
disease, will be presented at the American Heart Association Annual
Scientific Sessions on November 15. "We are pleased with the
results of the HeFH study, and our overall lipid results from all
the trials completed are very positive," said Dr. Joseph Feczko,
Pfizer's chief medical officer. "They generally show
torcetrapib/atorvastatin significantly increasing 'good'
cholesterol by 55 to 60 percent and additionally lowering 'bad'
cholesterol by 10 to 15 percent over atorvastatin alone (leading to
a combined reduction in LDL of 50 to 60 percent), which supports
our fundamental premise: this innovative medicine really can 'do
both' and manage total cholesterol successfully. "Our overall Phase
3 results to date, which are incomplete and must be rigorously
analyzed when all the lipid and imaging trials are finished, also
show an average increase in systolic blood pressure of
approximately one millimeter of mercury above the two-to-three
millimeter range that was observed in Phase 2 studies, which we
believe will not alter the favorable clinical profile of
torcetrapib/atorvastatin in the treatment of cardiovascular
disease. "We would like to underscore that our studies are far from
complete, and the early results cover less than 25 percent of all
the patients in the entire clinical program. With a new abstract
being posted today we want to ensure that these results are put in
the appropriate perspective. No final conclusions on the efficacy
and safety of torcetrapib/atorvastatin can be drawn until we
complete the lipid and imaging studies and do the accompanying
statistical analysis. The torcetrapib/atorvastatin trials completed
to date vary in duration and size, and preliminary data at this
stage may not represent the final results when Phase 3 is
completed." The next release of clinical trial results will occur
in March at the American College of Cardiology meetings, when the
results of three vascular imaging studies will be released. The
abstract for the torcetrapib/atorvastatin study in patients with
heterozygous familial hypercholesterolemia is being posted today on
the website of the American Heart Association at
http://scientificsessions.americanheart.org/portal/scientificsessions/ss.
DISCLOSURE NOTICE: The information contained in this release is as
of October 31, 2006. The Company assumes no obligation to update
any forward- looking statements contained in this release as the
result of new information or future events or developments. This
release contains forward-looking information about a product
candidate, including its potential benefits, that involves
substantial risks and uncertainties. Such risks and uncertainties
include, among other things, the uncertainties inherent in research
and development; decisions by regulatory authorities regarding
whether and when to approve any drug applications that may be filed
for the product candidate as well as their decisions regarding
labeling and other matters that could affect its availability or
commercial potential; and competitive developments. A further
description of risks and uncertainties can be found in Pfizer's
Annual Report on Form 10-K for the fiscal year ended December 31,
2005 and in its reports on Form 10-Q and Form 8-K. DATASOURCE:
Pfizer Inc CONTACT: Andy McCormick, +1-212-733-5469 Web site:
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