(CRME) Publishes Data Supporting Use of BRINAVESS™

Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) 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^® (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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