BRISTOL, Tenn., Sept. 6 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) today reported the publication of the results of the Heart
Outcomes Prevention Evaluation - The Ongoing Outcomes ("HOPE-TOO"). The HOPE-
TOO results are published in an article entitled "Long-Term Effects of
Ramipril on Cardiovascular Events and on Diabetes" which appears in the August
30, 2005 issue of Circulation, a publication of the American Heart
Association.
After seven years of patient follow-up, the HOPE-TOO trial demonstrates
the sustained effect of ALTACE(R) ("ramipril"), an angiotensin converting
enzyme ("ACE") inhibitor, on reducing the risk of cardiovascular events and
sustained vascular and metabolic benefits for patients treated with ramipril.
The authors of the article also concluded that the data indicated that a
patient's earlier use of ramipril therapy provided a longer-term protective
effect compared with the later initiation of such therapy. These benefits were
consistent regardless of patient risk or ancillary treatments.
Prior to HOPE-TOO, the Heart Outcomes Prevention Evaluation ("HOPE") trial
demonstrated that ramipril reduced the risk of stroke, myocardial infarction,
or death from cardiovascular causes in high risk patients 55 years of age or
older. The main objective of the HOPE-TOO trial was to evaluate whether the
reduction in risk of major cardiovascular events and of new diagnosis of
diabetes in patients treated with ramipril during the HOPE trial was
maintained with a longer duration of observation.
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 clinical data for our leading product ALTACE. The HOPE-TOO
data emphasizes the importance of patients continuing their ALTACE therapy due
to the sustained effect in reducing the risk of cardiovascular events and
mortality."
Dr. Pamplin continued, "The HOPE-TOO results also validate the importance
of initiating early treatment and the need for continued study of the possible
revascularization and metabolic benefits of ALTACE. The currently ongoing
Diabetes REduction Assessment with ramipril and rosiglitazone Medication
("DREAM") trial, a large, international, multicenter, randomized, double-
blind, placebo-controlled trial, should determine if ALTACE and/or
rosiglitazone reduce the risk for onset of Type II diabetes."
The HOPE-TOO trial was conducted by the Population Health Research
Institute at McMaster University and Hamilton Health Sciences in Hamilton,
Ontario, Canada.
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 mortality were further enhanced."
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."
The Population Health Research Institute conducts research internationally
in the areas of prevention and treatment of cardiovascular disease and
diabetes. It is currently conducting studies in 66 countries at over 800 study
centers.
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.
The investigational DREAM trial is being coordinated by the Canadian
Cardiovascular Collaboration based at McMaster University, and is jointly
funded by the Canadian Institutes of Health Research, King Pharmaceuticals,
Sanofi-Aventis, Glaxo SmithKline, and Wyeth Pharmaceuticals. The study
commenced in July 2001 and has completed randomization of 5,269 pre-diabetic
patients with impaired glucose tolerance at 191 study centers in 21 countries
worldwide. The completion of the trial is scheduled for 2006.
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 the leading branded ACE inhibitor with a broad spectrum of
indications. ALTACE is indicated for the treatment of hypertension. ALTACE
has also been shown to reduce the risk of death in stable patients who have
demonstrated clinical signs of congestive heart failure within the first few
days after sustaining acute myocardial infarction. Based upon the results of
the landmark HOPE trial, ALTACE is also 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.
For a copy of the ALTACE prescribing information, please visit
http://www.altace.com.
About King Pharmaceuticals
King, headquartered in Bristol, Tennessee, is a vertically integrated
branded pharmaceutical company. 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.
SOURCE King Pharmaceuticals, Inc.
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Related links:
http://www.kingpharm.com
http://www.altace.com
Company News On-Call:
http://www.prnewswire.com/comp/120319.html
CONTACT:
James E. Green, Executive Vice President,
Corporate Affairs, +1-423-989-8125, or David E. Robinson, Senior
Director, Corporate Affairs, +1-423-989-7045, both of King
Pharmaceuticals, Inc.
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