NEW YORK, May 21 /PRNewswire/ -- Pfizer Inc said today that results from a
major new study further demonstrate the value of its calcium channel blocker
Norvasc (amlodipine besylate) in treating high blood pressure in patients with
diabetes and severe renal disease.
In the landmark Irbesartan in Diabetic Nephropathy Trial (IDNT), initiated
by the Collaborative Study Group, 1,715 patients received either placebo, an
Angiotensin II Receptor Blocker (ARB), Avapro (irbesartan) or Norvasc.
Patients also received additional medications -- except other ARBs or
Angiotensin Converting Enzyme Inhibitors (ACE-Is) -- to further reduce blood
pressure to goal if necessary. The patients assigned to the placebo group
were mainly treated with diuretics and beta-blockers.
"These new data dispel the notion that in diabetic patients with high
blood pressure, calcium channel blockers like Norvasc might not be as
effective as diuretics, beta-blockers or ARBs in preventing the cardiovascular
complications of hypertension," said Dr. Murray Epstein, Professor of
Medicine, Renal Division, University of Miami School of Medicine.
The study's primary objective was to determine the effects of these
treatments on the progression of renal disease. As expected, irbesartan was
shown to slow the progression of renal disease. The effects of treatment on
cardiovascular complications such as heart attacks and stroke also were
examined, as diabetics are two to four times more likely to have heart disease
or suffer from stroke than non-diabetics.
"Therapy with multiple medications is indispensable to bring blood
pressure to goal in the vast majority of these difficult-to-treat patients.
The IDNT results clearly support the use of Norvasc to reach these goals,"
said Dr. Hubert Pouleur, Pfizer's Senior Medical Director, Cardiovascular
Group.
"Patients with diabetic nephropathy are fragile," Dr. Pouleur said. "ARBs
or ACE-Is alone rarely bring blood pressure down to levels recommended in
these patients, and often we have to use two or even three drugs to reach goal
levels."
In the IDNT study, which was sponsored by Bristol-Myers Squibb/Sanofi,
Norvasc was shown to be effective in helping to lower blood pressure in renal
patients. Cardiovascular complications of high blood pressure such as death,
heart attack, stroke, congestive heart failure and amputation were similar in
patients taking Norvasc (23%), irbesartan (24%) or traditional medications
(25%) such as beta-blockers or diuretics. ARBs and ACE-Is share some
mechanisms of action, and many clinical investigators believe both ACE-Is and
ARBs provide direct vascular and cardiac protection.
"What we can say is that amlodipine appeared to be safe and effective in
lowering blood pressure in these patients," said Dr. Edmund Lewis, principal
investigator of IDNT and Director of Nephrology at Rush-Presbyterian-St.
Luke's Medical Center, Chicago, at a press conference Saturday during the
American Society of Hypertension annual meeting, where the results were
presented.
The ability of Norvasc to reduce the risk of the long-term complications
of high blood pressure is being studied in over 43,000 patients in the
National Institutes of Health ALLHAT trial, which is the largest study ever
undertaken in hypertension. In clinical trials, the most common side effects
for Norvasc versus placebo were edema (8.3% vs. 2.4%), headache
(7.3% vs. 7.8%), fatigue (4.5% vs. 2.8%) and dizziness (3.2% vs. 3.4%).
Pfizer Inc discovers, develops, manufactures and markets leading
prescription medicines, for humans and animals, and many of the world's best
known over-the-counter brands. Pfizer had global revenues of $29.6 billion in
2000. Pfizer plans to make a research and development investment of about
$5 billion in 2001.
MAKE YOUR OPINION COUNT -- Click Here
SOURCE Pfizer Inc
 back to top
Related links:
http://www.pfizer.com
Company News On-Call:
http://www.prnewswire.com/comp/688250.html or fax,
800-758-5804, ext. 688250
Photo Notes:A free corporate logo to accompany this
story is available immediately via Wieck Photo Database to any
media with telephoto receiver or electronic darkroom, PC or
Macintosh, that can accept overhead transmissions. To retrieve a
logo, please call 972-392-0888.
Company News On-Call: Pfizer's press releases are
available at no charge through PR Newswire's Company News On-Call
fax service and on PRN's Web Site. For a menu of Pfizer press
releases or to retrieve a specific release, call 800-758-5804,
extension 688250, or http://www.prnewswire.com on the
Internet.
CONTACT:
Vanessa McGowan, 212-733-3784, or Mariann
Caprino, 212-733-4554, both of Pfizer Inc
|
