ASCOT Study Which Included Perindopril Stopped Early Due to Significant Benefit in Treatment Arm of Study
December 15 2004 - 4:02PM
PR Newswire (US)
ASCOT Study Which Included Perindopril Stopped Early Due to
Significant Benefit in Treatment Arm of Study Perindopril Marketed
as ACEON(R) in United States PALO ALTO, Calif., Dec. 15
/PRNewswire/ -- The Anglo-Scandinavian Cardiac Outcomes Trial
(ASCOT), evaluating the effectiveness of a treatment regimen with
the calcium channel blocker amlodipine and the angiotensin
converting enzyme (ACE) inhibitor perindopril compared to a
treatment regimen with the beta blocker atenolol and the diuretic
bendroflumethiazide, has been stopped early by the ASCOT steering
committee due to significant benefits observed in the amlodipine
plus perindopril arm of the study, according to those conducting
the study. In the United States, perindopril is marketed under the
brand name ACEON(R). CV Therapeutics, Inc. (NASDAQ:CVTX) and Solvay
Pharmaceuticals, Inc. recently entered into a co-promotion
agreement for ACEON(R), an ACE inhibitor with tissue activity
approved in the United States for the treatment of patients with
essential hypertension. In Europe, perindopril is marketed under
the brand name Coversyl(R). About the ASCOT Study The
antihypertensive arm of the multi-national, randomized ASCOT study
compared the ability of two different treatment regimens to reduce
a composite endpoint of nonfatal myocardial infarction and fatal
coronary heart disease in more than 19,000 hypertensive patients.
Patients were randomized to receive a treatment regimen of the beta
blocker atenolol and the diuretic bendroflumethiazide or a
treatment regimen of the calcium channel blocker amlodipine and the
ACE inhibitor perindopril. The study's steering committee stopped
the study early after observing significant benefit in the
amlodipine plus perindopril arm, which would have made it unethical
to continue the study. Results from ASCOT are expected to be
presented at an upcoming medical conference. This study was neither
funded nor sponsored by CV Therapeutics, Inc. or Solvay
Pharmaceuticals, Inc., holder of the ACEON(R) Tablets IND and NDA
in the United States. Further information on the study can be found
at http://www.ascotstudy.org/ . About ACE Inhibitors ACE inhibitors
act to reduce hypertension by interfering with the conversion of
angiotensin I to artery-constricting, angiotensin II. Blocking the
production of angiotensin II results in arterial vasodilation and
an accompanying reduction in blood pressure. ACE inhibitors
currently are recommended as first-line therapy for hypertension in
certain patient populations, because of their safety and efficacy.
Most recently, the Seventh Report of the Joint National Committee
on Prevention, Detection, Evaluation, and Treatment of High Blood
Pressure has recommended ACE inhibitors as one of the initial
therapy choices for compelling indications such as heart failure,
postmyocardial infarction, high coronary disease risk, diabetes,
chronic kidney disease and recurrent stroke prevention. ACEON(R) is
only indicated for the treatment of patients with essential
hypertension. Certain ACE inhibitors, including ACEON(R), which
have been shown to have an enhanced affinity for the tissues, are
known as tissue-ACEs. About ACEON(R) ACEON(R) is an ACE inhibitor
indicated for the treatment of essential hypertension. It offers
continuous 24-hour blood pressure control with once-daily dosing
for hypertensive patients. ACEON(R) may be used alone or with other
classes of antihypertensives. ACEON(R) is contraindicated in
patients known to be hypersensitive to this product or to any other
ACE inhibitors and in patients with a history of angioedema related
to previous treatment with an ACE inhibitor. When used in pregnancy
during the second and third trimesters, ACE inhibitors can cause
injury and even death to the developing fetus. When pregnancy is
detected, ACEON(R) should be discontinued as soon as possible.
About CV Therapeutics CV Therapeutics, Inc., headquartered in Palo
Alto, California, is a biopharmaceutical company focused on
applying molecular cardiology to the discovery, development and
commercialization of novel, small molecule drugs for the treatment
of cardiovascular diseases. CV Therapeutics has entered into an
agreement with Solvay Pharmaceuticals to co-promote ACEON(R)
(perindopril erbumine) for the treatment of hypertension, and CV
Therapeutics currently has four clinical development drug
candidates. CV Therapeutics has received an approvable letter from
the U.S. Food and Drug Administration (FDA) relating to its new
drug application for Ranexa for the potential treatment of chronic
angina, and has submitted an application for the approval of
ranolazine for the potential treatment of chronic angina to the
European Medicines Agency. Regadenoson is a selective A2A-adenosine
receptor agonist for potential use as a pharmacologic stress agent
in cardiac perfusion imaging studies. Tecadenoson is a selective
A1-adenosine receptor agonist for the potential reduction of rapid
heart rate during atrial arrhythmias. Adentri(TM) is a selective
A1-adenosine receptor antagonist for the potential treatment of
heart failure and has been licensed to Biogen Idec Inc. For more
information, please visit CV Therapeutics' website at
http://www.cvt.com/. Ranexa, regadenoson, tecadenoson and Adentri
have not been approved for marketing by the FDA or any foreign
regulatory authorities. These products are currently under
investigation in clinical trials subject to United States
Investigational New Drug applications, and as applicable,
appropriate clinical trial applications to regulatory authorities
outside the United States. Except for the historical information
contained herein, the matters set forth in this press release,
including statements as to development, clinical studies,
regulatory review, and commercialization of products, are forward-
looking statements within the meaning of the "safe harbor"
provisions of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially,
including, early stage of development; regulatory review and
approval of our products; the conduct and timing of clinical
trials; the dependence on collaborative and licensing agreements;
commercialization of products; and other risks detailed from time
to time in CVT's SEC reports, including its most recent Annual
Report on Form 10-K, and its most recent Quarterly Report on Form
10-Q. CVT disclaims any intent or obligation to update these
forward-looking statements. DATASOURCE: CV Therapeutics, Inc.
CONTACT: investors, Christopher Chai, Treasurer & Executive
Director, Investor Relations, +1-650-384-8560, or media, John
Bluth, Senior Director, Corporate Communications, +1-650-384-8850,
both of CV Therapeutics, Inc. Web site: http://www.cvt.com/
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