NASDAQ: CRME TSX: COM
VANCOUVER, Feb. 13, 2014 /PRNewswire/ - Cardiome Pharma Corp. (NASDAQ: CRME) (TSX: COM) today announced that a poster titled "Medical conversion with Vernakalant on postoperative cardio-surgical patients" by Thöne, M. et al., from the Department of Cardiovascular Surgery at the Heinrich-Heine-University Düsseldorf located in Düsseldorf, Germany, was presented at the 43rd Annual Meeting of the Germany Society for Thoracic and Cardiovascular Surgery held in Freiburg February 9-12, 2014. The study was an independent, investigator-led investigation that demonstrated real-world cardioversion experience with BRINAVESS™ (vernakalant IV) in patients who developed post-cardiac surgery atrial fibrillation (AF).
This was a prospective, non-randomised, single-arm study in 50 patients with a variety of cardiac surgical procedures, ranging from coronary artery bypass graft (CABG) alone to complicated combination surgeries such as aortic valve (AV) and mitral valve (MV) replacement. The primary outcome was the conversion of atrial fibrillation to sinus rhythm (SR) at 90 minutes post-BRINAVESS infusion. BRINAVESS was successful in cardioverting 74% of the patients.1
"We are extremely pleased with the real-world effectiveness that BRINAVESS demonstrated in cardioverting post-cardiac surgery patients," said Dr. Steen Juul-Möller, Cardiome's Medical Director. "This real-world experience of cardioverting 74% of AF patients is similar to what was demonstrated in Malmö, where 70% of non-cardiac surgery patients were effectively cardioverted with BRINAVESS. The high cardioversion efficacy coupled with its long term durability through patient discharge up to 8 days later makes BRINAVESS a valuable option for the management of post-cardiac surgery AF."
About the Study1
Between October 2011 and October 2013, 50 patients (64% males) with new onset AF received BRINAVESS according to the labelled indication and dosing schedule. The patients (mean age 72 years old) underwent the following interventions: CABG (n=30); MV surgery (n=6); AV surgery (n=8); CABG + MV surgery (n=2); CABG + AV surgery (n=3); AV surgery + MV surgery (n= 1). The primary outcome was the conversion of AF to SR at 90 minutes post infusion. The secondary outcome was the proportion of those responders in whom sinus rhythm was maintained post-operation day 8.
BRINAVESS successfully cardioverted 74% of the patients at 90 minutes. Within the initial non-responders, 6 additional patients had returned to SR at day 8 (spontaneous conversion (n=1), electric cardioversion (n=1) and conversion by additional Amiodarone administration (n=4)). At the time of discharge, a total of 43 patients (86%) were successfully converted to SR.
BRINAVESS conversion efficacy varied by procedure, as shown in the table below:
|Procedure||Patients (n)||Conversion Rate (at 90 minutes)|
(AV, MV or AV + MV)
CABG + Valvular
There were no serious adverse events or deaths reported in the study group.
The authors concluded that BRINAVESS with a conversion rate of 74% appears to be well-tolerated and is a promising option compared to current methods.
Thöne, M. et al. Medical conversion with Vernakalant on postoperative
cardio-surgical patients. Abstract #380, presented at the 43rd Annual Meeting of the German Society for Thoracic and Cardiovascular
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a specialty pharmaceutical company dedicated to the development and commercialization of cardiovascular therapies that will improve the quality of life and health of patients suffering from heart disease. Cardiome has two marketed, in-hospital, cardiology products, BRINAVESS™ (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 our web site at 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 2014 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 factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: general economic and business conditions in the United States, Canada, Europe, and the other regions in which we operate; market demand; technological changes 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 activities; and any other factors that may affect our performance. In addition, our business is subject to certain operating risks that may cause any results expressed or implied by the forward-looking statements in this presentation to differ materially from our actual results. These operating 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 www.sec.gov and the Canadian securities regulatory authorities at 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.
SOURCE Cardiome Pharma Corp.