Cardiome
announces publication of positive data from an observational, retrospective study
of BRINAVESS. During
the observation period, 70% of the AF patients treated with BRINAVESS
converted with a median time of 11 minutes. Conversion efficacy was 76% in
patients with AF duration <10 hours. The median time spent in the ER for
patients who converted on BRINAVESS was 6.5 hours.
Full Press Release Below.
SOURCE: Cardiome
VANCOUVER, October 7, 2013
/PRNewswire/ --Cardiome Pharma Corp. (NASDAQ: CRME /
TSX: COM) today announced publication of positive data from an observational,
retrospective study performed at the Skåne University Hospital in Malmö,
Sweden. The study included 251 recent-onset atrial fibrillation (AF) patients
who received 355 BRINAVESS™ treatments during the period between January 15,
2011 and April 15, 2013. During the observation period, 70% of the AF
patients treated with BRINAVESS converted with a median time of 11 minutes.
Conversion efficacy was 76% in patients with AF duration <10 hours. The
median time spent in the ER for patients who converted on BRINAVESS was 6.5
hours. These results are published in the October 2013 issue of The European
Journal of Cardiovascular Medicine.
"It is exciting to see that
patients treated in the clinically critical first 48 hours after AF onset
appear to continue to derive better-than-expected benefit from BRINAVESS and
that they also prefer this therapy over DC cardioversion," stated
William Hunter, M.D., Chief Executive Officer of Cardiome Pharma Corp.
"The high conversion efficacy coupled with short hospital stay we
believe makes BRINAVESS a practical option for physicians and patients who
value rapid relief from AF."
"Skåne University Hospital
developed a "fast-track" AF program in the emergency room where
patients with short duration AF were promptly treated with BRINAVESS, which
likely contributed to the higher efficacy seen in this setting compared to
the ACT and AVRO clinical trials," stated Dr. Steen Juul-Möller, the
study's Principal Investigator and Cardiome's Medical Director. "The
finding that 75% of successfully treated BRINAVESS patients remained in
normal sinus rhythm after a one year follow-up period - was an extremely
interesting and important finding that requires further investigation,"
added Dr. Juul-Möller.
Patients with recent-onset AF and
whom cardioversion was considered were evaluated for BRINAVESS treatment.
Over the period of the study, 251 patients received 355 treatments. In all
patients, 70% of BRINAVESS treatments were successful and 70% of the patients
responded at least once with conversion to sinus rhythm. The conversion rate
was higher at 76% among patients with AF duration <10 hours compared to
66% in those with AF >10 hours (P<0.05). Transient bradycardia and
hypotension were seen in 5 patients (1.4%) occurring within minutes after
conversion and were judged as a response to the change in heart rhythm. No
ventricular tachyarrhythmias, including Torsade-des-Pointes were seen.[
1 ]
Those patients who did not respond to
BRINAVESS treatment were subsequently treated with DC cardioversion. All
patients who had experienced both BRINAVESS and DC cardioversion were given a
questionnaire to assess cardioversion preference and were followed up for a
maximum period of 27 months (BRINAVESS [n = 156]; DC cardioversion [n=91]).
Among those who converted with BRINAVESS, 72% would prefer this treatment, in
patients who did not convert with BRINAVESS, 61% said they would prefer DC
cardioversion if they experienced a relapse (P<0.001). Furthermore, among
BRINAVESS responders, 78% were satisfied or very satisfied with the
treatment. In the follow up portion of the study, after 12 months, 75%
of BRINAVESS responders were still in sinus rhythm, compared to 45% of
patients that required DC cardioversion (P<0.001).
References:
1. Juul-Möller, S. Vernakalant in
recently developed Atrial Fibrillation: How to translate pharmacological
trials into clinical practice. European Journal of Cardiovascular Medicine . Vol. 2,
Issue 4. Published online October 4, 2013.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a
biopharmaceutical company dedicated to the discovery, development and
commercialization of new therapies that will improve the health of patients around
the world. Cardiome has one marketed product, BRINAVESS[ TM
] (vernakalant IV), approved in Europe and other territories for
the rapid conversion of recent onset atrial fibrillation to sinus rhythm in
adults.
Cardiome is traded on the NASDAQ
Capital Market (CRME) and the Toronto Stock Exchange (COM). For more
information, please visit our web site at http://www.cardiome.com.
Forward-Looking Statement Disclaimer
Certain statements in this news
release contain forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 or forward-looking information under
applicable Canadian securities legislation that may not be based on
historical fact, including without limitation statements containing the words
"believe", "may", "plan", "will",
"estimate", "continue", "anticipate",
"intend", "expect" and similar expressions. Forward-
looking statements may involve, but are not limited to, comments with respect
to our objectives and priorities for the remainder of 2013 and beyond, our
strategies or future actions, our targets, expectations for our financial
condition and the results of, or outlook for, our operations, research and
development and product and drug development. Such forward-looking statements
involve known and unknown risks, uncertainties and other factors that may
cause the actual results, events or developments to be materially different
from any future results, events or developments expressed or implied by such
forward-looking statements. Many such known risks, uncertainties and other
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forward-looking statements and include, among others, the following: general
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that could impact our existing products or our ability to develop and
commercialize future products; competition; existing governmental legislation
and regulations and changes in, or the failure to comply with, governmental
legislation and regulations; availability of financial reimbursement coverage
from governmental and third-party payers for products and related treatments;
adverse results or unexpected delays in pre-clinical and clinical product
development processes; adverse findings related to the safety and/or efficacy
of our products or products; decisions, and the timing of decisions, made by
health regulatory agencies regarding approval of our technology and products;
the requirement for substantial funding to expand commercialization
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results expressed or implied by the forward-looking statements in this
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risks include: our ability to attract and retain qualified personnel; our
ability to successfully complete pre-clinical and clinical development of our
products; changes in our business strategy or development plans; intellectual
property matters, including the unenforceability or loss of patent protection
resulting from third-party challenges to our patents; market acceptance of
our technology and products; our ability to successfully manufacture, market
and sell our products; the availability of capital to finance our activities;
and any other factors described in detail in our filings with the Securities
and Exchange Commission available at http://www.sec.gov
and the Canadian securities regulatory authorities at http://www.sedar.com. Given these risks,
uncertainties and factors, you are cautioned not to place undue reliance on
such forward-looking statements and information, which are qualified in their
entirety by this cautionary statement. All forward-looking statements and
information made herein are based on our current expectations and we
undertake no obligation to revise or update such forward-looking statements
and information to reflect subsequent events or circumstances, except as
required by law.
For further information:
Cardiome
Investor Relations
+1-604-676-6993 or Toll Free: 1-800-330-9928
Email: ir@cardiome.com
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Monday, October 7, 2013
Cardiome Publishes Study Data, AF Patients
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