JACC Publishes Long-Term Safety and Tolerability Data from Ranolazine Open Label Experience (ROLE) Program
March 14 2007 - 8:00AM
PR Newswire (US)
PALO ALTO, Calif., March 14 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) announced today that the Journal
of the American College of Cardiology (JACC) has published data
from the Ranolazine Open Label Experience (ROLE) program, which
showed long-term therapy with Ranexa(R) (ranolazine
extended-release tablets) to be safe and well tolerated in patients
with chronic stable angina who completed one of two phase 3
clinical trials, and enrolled in the ROLE program. These data also
suggest no evidence of increased mortality attributable to Ranexa
based on two year survival rates of ROLE participants compared with
published outcomes of similar cohorts used as a reference
population. Because ROLE was an open label study, and not a placebo
controlled clinical trial with a comparator group, it does not
allow for a rigorous analysis for mortality and it is difficult to
fully characterize the implications of the deaths reported in the
study. The ROLE program evaluated 746 patients with chronic angina
who chose to receive Ranexa(R) following their participation in the
phase 3 Monotherapy Assessment of Ranolazine In Stable Angina
(MARISA) or the phase 3 Combination Assessment of Ranolazine In
Stable Angina (CARISA) clinical studies with Ranexa. More than 85
percent of eligible MARISA patients and more than 80 percent of
eligible CARISA patients chose to receive Ranexa in the ROLE
program. The mean duration of follow-up was 2.82 years and more
than 75 percent of ROLE patients completed at least two years of
Ranexa therapy. Two years after initial dosing, 9.7 percent of
patients had discontinued Ranexa due to adverse events. No
treatment discontinuations occurred due to QT prolongation and no
cases of torsades de pointes were reported. The most commonly
reported adverse events, other than angina, were dizziness (11.8
percent) and constipation (10.9 percent). "The high rate of
patients choosing to continue on ranolazine in the ROLE program
suggests they were perceiving a benefit from ranolazine. It is also
comforting that the long term ROLE data show favorable safety and
tolerability over an average follow up period of nearly three
years," said Michael Koren, M.D., CEO of the Jacksonville Center
for Clinical Research and principal investigator of the ROLE
program. Study Details Patients with severe functional impairment
from angina who completed either the MARISA or CARISA trial, and
who elected to participate in the long- term, open label ROLE
program, were enrolled at 123 sites in 12 countries. Physicians
titrated patients to the optimal dose of Ranexa between 500mg and
1000mg twice daily. Safety and tolerability assessments included
vital signs, electrocardiograms, laboratory tests and adverse event
reporting. Data were available and analyzed from a total of 2,372
patient-years of follow-up from the 942 patients exposed to
ranolazine in MARISA, CARISA and the ROLE program, incorporating
2,233 patient-years of Ranexa treatment exposure. Mortality in the
ROLE program was compared against a Duke Treadmill Score (DTS)
predictive model and other contemporary cohorts of high risk heart
disease patients. When extending observations to all patients
exposed to ranolazine in the double-blind trials preceding the ROLE
program, annual mortality was 2.8 percent, compared with greater
than five percent, as predicted by DTS. About Angina Chronic angina
is a serious and debilitating heart condition, usually associated
with coronary artery disease and marked by repeated and sometimes
unpredictable attacks of chest pain. Approximately 8.9 million
people in the United States have chronic angina, and 400,000 new
cases are diagnosed annually, according to the American Heart
Association. Ranexa has anti- ischemic effects which do not depend
on changes in heart rate or blood pressure. 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 asthma and other
conditions. These product candidates have not been determined by
any regulatory authorities to be safe or effective in humans for
any use. Complete prescribing information for Ranexa, including
detailed safety and dosage information are available at
http://www.ranexa.com/. 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 regulatory review and approval of our products; the
conduct, timing and results of clinical trials, including the
MERLIN TIMI-36 study; commercialization of products; market
acceptance of products; product labeling; and other risks detailed
from time to time in CV Therapeutics' SEC reports, including its
including its Annual Report on Form 10-K for the year ended
December 31, 2006. CV Therapeutics disclaims any intent or
obligation to update these forward-looking statements. DATASOURCE:
CV Therapeutics, Inc. CONTACT: Investor and Media Contact: John
Bluth, Senior Director, Corporate Communications and Investor
Relations, CV Therapeutics, Inc., +1-650-384-8850 Web site:
http://www.cvt.com/
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