CV Therapeutics, Inc.
(Nasdaq: CVTX) announced that data from a prospectively identified
analysis of 2,220 diabetic patients from the MERLIN TIMI-36 study showed
that Ranexa(R) (ranolazine extended-release tablets) significantly reduced
hemoglobin A1c (HbA1c), increased the number of patients achieving the
clinical HbA1c treatment target of 7.0 percent or less and reduced the
incidence of newly increased HbA1c in patients without diabetes at
baseline.
The findings were presented today at the American Heart Association
Scientific Sessions in Orlando, Florida by Dr. David Morrow of the TIMI
Study Group.
In patients with diabetes treated with Ranexa in the study, at four
months HbA1c had declined approximately 0.7 percentage points, from a
starting mean baseline of 7.5 to 6.8 percent, and 0.43 percentage points
compared to placebo (p
Study Design
MERLIN TIMI-36 (Metabolic Efficiency with Ranolazine for Less Ischemia
in Non-ST Elevation Acute Coronary Syndromes) was a multi-national,
double-blind, randomized, placebo-controlled, parallel-group clinical trial
designed to evaluate the efficacy and safety of Ranexa during acute and
long-term treatment in 6,560 patients (3,279 received ranolazine, 3,281
received placebo) with non-ST elevation ACS treated with standard therapy.
Within 48 hours of the onset of angina due to ACS, eligible
hospitalized patients were enrolled in the study and randomized to receive
intravenous Ranexa or placebo, followed by long-term outpatient treatment
with Ranexa extended-release tablets or placebo. All patients also received
standard therapy during both hospital-based and outpatient treatment. The
doses of Ranexa extended-release tablets used in MERLIN TIMI-36 have been
studied in previous Phase 3 clinical trials.
Participants in the MERLIN TIMI-36 study received current standard
therapy, with approximately 96 percent of patients on aspirin,
approximately 89 percent on beta blockers and approximately 82 percent on
statins. Approximately 59 percent of study participants received coronary
angiography during their initial hospitalization.
Previously published data from the MERLIN TIMI-36 study has shown that
Ranexa was safe in this population of patients with coronary artery
disease, which included nearly 1,100 patients with prior heart failure.
Potential Diabetes Mechanism
Substantial published data suggest that the anti-ischemic effects of
Ranexa result from the drug's activity to inhibit the late sodium current
in cardiac cells. Preclinical work to identify the potential mechanism of
action of Ranexa in diabetes has shown that ranolazine increased glucose
stimulated insulin secretion in pancreatic islets. In separate experiments
using preclinical models of insulin resistance, ranolazine also improved
glucose homeostasis.
These data could illustrate an underlying potential first in class
mechanism of action for the statistically significant reductions in HbA1c
levels observed with Ranexa in cardiovascular patients with diabetes from
the Phase 3 CARISA (n=189 with angina and diabetes) and MERLIN TIMI-36
(n=2,220 with acute coronary syndromes and diabetes) clinical trials.
In CARISA (Combination Assessment of Ranolazine in Stable Angina),
Ranexa reduced HbA1c levels by an average of up to 0.7 percentage points in
angina patients with diabetes. The reduction in HbA1c was not associated
with increased hypoglycemia.
The Company plans to submit data from these new preclinical experiments
for publication later this year.
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' approved product, Ranexa(R) (ranolazine
extended-release tablets), is indicated for the treatment of chronic angina
in patients who have not achieved an adequate response with other
antianginal drugs, and should be used in combination with amlodipine,
beta-blockers or nitrates.
CV Therapeutics also has other clinical and preclinical drug
development candidates and programs, including regadenoson, which is being
developed for potential use as a pharmacologic stress agent in myocardial
perfusion imaging studies, and CVT-6883, which is being developed as a
potential treatment for cardiopulmonary diseases. Regadenoson and CVT-6883
have not been determined by any regulatory authorities to be safe or
effective in humans for any use.
Except for the historical information contained herein, the matters set
forth in this press release 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 operating losses and fluctuations in operating
results; capital requirements; regulatory review and approval of our
products; special protocol assessment agreement; the conduct and timing of
clinical trials; commercialization of products; market acceptance of
products; product labeling; concentrated customer base; reliance on
strategic partnerships and collaborations; uncertainties in drug
development; uncertainties regarding intellectual property; and other risks
detailed from time to time in CV Therapeutics' SEC reports, including its
Quarterly Report on Form 10-Q for the quarter ended June 30, 2007. CV
Therapeutics disclaims any intent or obligation to update these
forward-looking statements.
CV Therapeutics, Inc.
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View drug information on Ranexa.