BRISTOL, Tenn. and COLLEGEVILLE, Pa., Sept. 3 /PRNewswire-FirstCall/ --
King Pharmaceuticals, Inc. (NYSE: KG) and Wyeth Pharmaceuticals (NYSE: WYE)
today reported the release of the results of the Heart Outcomes Prevention
Evaluation - The Ongoing Outcomes (HOPE-TOO).
HOPE-TOO looked at the effect of ALTACE(R) (ramipril), an ACE (angiotensin
converting enzyme) inhibitor, and of vitamin E on the prevention of
cardiovascular disease in a high-risk population. After seven years of
follow-up, the HOPE-TOO study has demonstrated a sustained effect of ramipril
on reducing the risk of cardiovascular events.
ALTACE has previously been found to significantly reduce the risk of
cardiovascular disease in high-risk patients 55 or older, including those with
diabetes mellitus.
Charles L. Pamplin, III, M.D., Vice President, Medical Affairs of King
stated, "We are very pleased with the results of the HOPE-TOO study which add
to the extensive supporting clinical data for our leading product ALTACE. The
release of the HOPE-TOO data, and its emphasis on the sustained effect of
ALTACE in reducing the risk of cardiovascular events, provides further
evidence of the importance of this product."
"It is encouraging to see that the results of HOPE-TOO show that long-term
ALTACE use continued to offer real gains for patients in cardiovascular risk
reduction," says Dr. Victoria Kusiak, Vice President, Clinical Affairs and
North American Medical Director of Wyeth Pharmaceuticals.
About HOPE-TOO
The results of the HOPE-TOO study, released today by the Population Health
Research Institute at McMaster University and Hamilton Health Sciences in
Hamilton, Ontario, Canada, are as follows:
Sustained Prevention of Cardiovascular Events and Diabetes with Ramipril
No Impact of Vitamin E on Cardiovascular Disease or Cancer
After seven years of follow-up, the HOPE-TOO study has demonstrated a
sustained effect of ramipril on the prevention of cardiovascular disease and
no preventive effects of vitamin E on either cancer or cardiovascular disease.
HOPE-TOO is a continuation of the HOPE (Heart Outcomes Prevention
Evaluation) study begun in 1994. The study looked at the effects of ramipril,
an angiotensin-converting-enzyme inhibitor, and vitamin E on the prevention of
cardiovascular disease in a high-risk population.
The HOPE-TOO results were presented today at the European Society of
Cardiology Meeting in Vienna, Austria. The study was conducted by the
Population Health Research Institute at McMaster University and Hamilton
Health Sciences in Hamilton, Ontario, Canada.
The ramipril arm of the study was stopped 6 months early in April 1999 due
to clear reductions (a 22% risk reduction) in heart attacks, stroke or death
due to cardiovascular causes. The vitamin E arm of the study completed the
five-year course as scheduled, and while there was no evidence of protection
against cardiovascular disease, the data as to whether or not vitamin E would
prevent cancer were unclear.
The HOPE-TOO (HOPE-The Ongoing Outcomes) study began in November 1999 and
evaluated whether the cardiovascular benefits seen with 4.5 years of treatment
with ramipril were sustained and, secondly, whether longer-term treatment with
vitamin E was protective against the development of cancer and cardiovascular
disease. Of the original 9,541 patients and 267 centres entered in HOPE,
6,786 patients and 174 centres agreed to extended follow-up until September
2002.
There was continued benefit in the prevention of major cardiovascular
events for those people originally on ramipril. At the end of the seven-year
follow-up there was a 19 per cent risk reduction for those who were originally
assigned to the ramipril group. There appeared to be incremental reductions in
heart attacks as well as in the development of diabetes. This incremental
benefit was observed in spite of the fact that 67 per cent of those in placebo
group started taking ramipril in 1999, when the ramipril arm of the study
closed.
Jackie Bosch, project manager and assistant clinical professor at McMaster
University said, "Not only were the benefits of ramipril sustained, but the
benefits in reducing heart attacks and diabetes were further enhanced."
After seven years of treatment with vitamin E there was no impact on
cancer or on cardiovascular disease. However there was a statistically
significant 17 per cent increase in the risk of congestive heart failure. Dr.
Eva Lonn, co-principal investigator and professor of medicine at McMaster
University said, "The lack of benefit of vitamin E on cancer and
cardiovascular disease, coupled with the increase in heart failure raises
concerns about the use of vitamin E."
Dr. Salim Yusuf, co-principal investigator and professor of medicine at
McMaster University, said the additional study period was beneficial.
"This extension emphasizes that to understand the full benefits or full
harm from various prevention or treatment strategies often requires extended
observation of patients for several years after the end of trials. The HOPE-
TOO results confirm the sustained value of ramipril and lack of benefit of
vitamin E."
The Population Health Research Institute conducts research internationally
in the areas of prevention and treatment of cardiovascular disease and
diabetes. It is currently conducting over 15 major studies in 66 countries.
The HOPE and HOPE-TOO studies were supported by grants from the Canadian
Institutes of Health Research, the Heart and Stroke Foundation of Ontario,
Aventis Pharmaceuticals, the Natural Source Vitamin E Association, Astra-
Zeneca, King Pharmaceuticals and NEGMA.
About ALTACE
ALTACE is marketed by Monarch Pharmaceuticals, Inc., a wholly owned
subsidiary of King Pharmaceuticals, and Wyeth Pharmaceuticals in the United
States and Puerto Rico pursuant to a co-promotion agreement. ALTACE is
indicated in patients 55 years or older at high risk of developing a major
cardiovascular event either because of a history of coronary artery disease,
stroke or peripheral vascular disease or because of diabetes that is
accompanied by at least one other cardiovascular risk factor (hypertension,
elevated total cholesterol levels, low HDL levels, cigarette smoking, or
documented microalbuminuria), to reduce the risk of stroke, myocardial
infarction, or death from cardiovascular causes.
ALTACE can be used in addition to other needed treatments (such as
antihypertensive, antiplatelet or lipid-lowering therapies). Prescription
ALTACE is not for everyone. ALTACE may cause swelling of the mouth, tongue,
or throat, which could cause extremely serious risk and requires immediate
medical care. ALTACE may lower blood sugar if taken for diabetes. A
physician should be contacted if one experiences symptoms of low blood sugar
such as sweating or shakiness. Common side effects include persistent dry
cough, dizziness, and light-headedness due to low blood pressure. ALTACE
should not be taken during pregnancy, as death or injury to an unborn child
may result, or if serious side effects related to previous ACE inhibitors have
occurred.
King, headquartered in Bristol, Tennessee, is a vertically integrated
pharmaceutical company that develops, manufactures, markets, and sells branded
prescription pharmaceutical products. King, an S&P 500 Index company, seeks
to capitalize on opportunities in the pharmaceutical industry through the
development, including through in-licensing arrangements and acquisitions, of
novel branded prescription pharmaceutical products in attractive markets and
the strategic acquisition of branded products that can benefit from focused
promotion and marketing and product life-cycle management.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
areas of women's health care, cardiovascular disease, central nervous system,
inflammation, hemophilia, oncology and vaccines. Wyeth is one of the world's
largest research-driven pharmaceutical and health care products companies. It
is a leader in the discovery, development, manufacturing, and marketing of
pharmaceuticals, vaccines, biotechnology products and non-prescription
medicines that improve the quality of life for people worldwide. The
Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer
Healthcare and Fort Dodge Animal Health.
SOURCE King Pharmaceuticals, Inc.
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Related links:
http://www.kingpharm.com
CONTACT:
James E. Green of King Pharmaceuticals,
+1-423-989-8125, or Douglas Petkus of Wyeth Pharmaceuticals,
+1-484-865-5140
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