Europace Publishes Data Supporting Use of BRINAVESS(TM) (Vernakalant) as a First Line Agent for Pharmacological Cardioversion of Atrial Fibrillation

Vancouver, British Columbia (ots/PRNewswire) -

NASDAQ: CRME TSX: COM

Cardiome Pharma Corp. today announced that a publication titled,
Pharmacological Cardioversion of Atrial Fibrillation with
Vernakalant: Evidence in Support of the ESC Guidelines, was published
in Europace, the official Journal of the European Heart Rhythm
Association, and was made available in the advanced online article
access section. The authors conclude that BRINAVESS is an efficacious
and rapid acting pharmacological cardioversion agent, for
recent-onset atrial fibrillation (AF,) that can be used first line in
patients with little or no underlying cardiovascular disease and in
patients with moderate disease, such as stable coronary and
hypertensive heart disease.

"The recent update of the ESC Guidelines on atrial fibrillation
includes a discussion of the evidence base for the use of BRINAVESS
and recommends its use as a first line agent for the conversion of AF
to sinus rhythm," stated Dr. John Camm, Professor of Clinical
Cardiology at St. George's University in London, UK. "Based on
completed clinical trials, BRINAVESS is effective, fast acting and
well tolerated, and provides acute care physicians with an
opportunity to pharmacologically cardiovert recent-onset AF patients
including those with no or moderate structural heart disease."

In this publication, Savelieva et al., point out that
pharmacological cardioversion would be the preferred method of
converting patients from AF to sinus rhythm provided there was a
safe, effective and fast acting pharmacological agent available on
the market. Older agents have treatment limitations, including
contraindications which prevent use in structural heart disease for
some, proarrhythmia or slow onset of action which may explain the
need for longer hospital stays in others.

The authors of this publication explain that the benefits of
pharmacological cardioversion include no need for general
anaesthesia, conscious sedation, or fasting as well as a lower risk
of immediate recurrence of AF and possibly lower psychological impact
on some patients. They point out that the choice of an antiarrhythmic
drug for AF cardioversion is determined by the underlying heart
disease. In a subgroup analysis in 274 patients with ischaemic heart
disease (41% with previous myocardial infarction) enrolled in ACT
I-IV trials, no increased risk of serious adverse events was
associated with BRINAVESS when compared to patients without ischaemic
heart disease. In addition, there were no drug related cases of
torsade de pointes, ventricular fibrillation, or death in the
subgroup with ischaemic heart disease, and the placebo-extracted
efficacy of vernakalant was comparable (45.7% vs. 47.3% ischemic vs.
non-ischaemic).

According to the 2012 focused update of the ESC Guidelines on the
management of AF, BRINAVESS was granted a Class I recommendation with
a level of evidence A for cardioversion of AF patients with
structurally normal hearts or minimal heart disease and a Class IIb
recommendation with a level of evidence B for cardioversion of AF
patients with moderate structural heart disease.[1],[2] The
development program for BRINAVESS has provided evidence to support
recent recommendations, in the updated ESC Guidelines, to use the
drug as a first line agent for the management of AF patients
including those with moderate structural heart disease which is
described as heart failure NYHA class I-II, stable coronary artery
disease, and moderate left ventricular hypertrophy.

In this publication, the authors refer to a Buccelletti
publication in which a meta-analysis of five controlled studies,
(CRAFT, ACT I, ACT II, ACT III, AVRO) in 810 recent-onset AF
patients, showed that BRINAVESS was 8.4 times more likely to convert
AF to sinus rhythm when compared to placebo or amiodarone (95% CI,
4.4-16.3,) without excess risk of serious adverse events (risk ratio,
0.91; 95% CI, 0.6-1.36).Over 95% of patients that cardioverted to
sinus rhythm after receiving BRINAVESS remained in sinus rhythm at 24
hours.Furthermore while discussing the efficacy of BRINAVESS,
Savelieva et al., referred to a real world experience, observational
study from a single centre in Malmö, Sweden, where the drug has been
used in AF patients since 2011. In this study 70% of 251 patients
treated with BRINAVESS in the emergency room converted to sinus
rhythm within 2 hours after start of the infusion with a median time
to conversion of 11 minutes.

In the publication by Savelieva et al., BRINAVESS is presented as
an efficacious, fast acting, and well tolerated pharmacological agent
for the cardioversion of recent-onset AF with strong evidence
supporting its recommendations for use in the ESC Guidelines for the
Management of AF.

References:

1) Savelieva, I. et al. Pharmacological Cardioversion of Atrial Fibrillation
with Vernakalant: Evidence in Support of the ESC Guidelines. Europace. Advance access
published Oct 9, 2013, doi: 10.1093/europace/eut274.
2) Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH et al.
Focused Update of the ESC Guidelines for the Management of Atrial Fibrillation: an
Update of the 2010 ESC Guidelines for the Management of Atrial Fibrillation. Europace.
2012; 14: 1385-413.

About Cardiome Pharma Corp. Cardiome Pharma Corp. is a specialty
biopharmaceutical company dedicated to the development and
commercialization of new therapies that will improve the health of
patients suffering from heart disease around the world. Cardiome has
two marketed products, BRINAVESS[TM] (vernakalant IV), approved in
Europe and other territories for the rapid conversion of recent onset
atrial fibrillation to sinus rhythm in adults, and AGGRASTAT(R)
(tirofiban HCl) a reversible GP IIb/IIIa inhibitor indicated for use
in Acute Coronary Syndrome patients.

Cardiome is traded on the NASDAQ Capital Market (CRME) and the
Toronto Stock Exchange (COM). For more information, please visit
http://www.cardiome.com.

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