Navigation Links
Study Shows Vernakalant Hydrochloride is Effective in Conversion to Normal Heart Rhythm in Atrial Fibrillation Patients Following Cardiac Surgery
Date:11/7/2007

ORLANDO, Fla., Nov. 7 /PRNewswire/ -- Astellas Pharma US, Inc. today announced that the investigational agent vernakalant hydrochloride increased conversion to normal heart rhythm (sinus rhythm, or SR) in patients with atrial fibrillation (AF) following coronary artery bypass graft (CABG) or valvular surgeries. AF is a potentially serious condition characterized by an irregular heart rhythm and a high heart rate. The study results were presented at the annual meeting of the American Heart Association.

"Postoperative AF is common after cardiac surgery, occurring in up to 40% of patients and has a significant effect on both the intensive care unit and overall hospital length of stay," said Peter Kowey, MD, William Wikoff Smith Chair in Cardiovascular Research at the Main Line Health System. "This study shows that vernakalant may be an effective treatment option for converting AF to SR following CABG or valvular surgeries."

Study Results

The Atrial arrhythmia Conversion Trial or ACT II was a randomized, double-bind, placebo-controlled, parallel-group, multinational, multicenter study evaluating the efficacy and safety of vernakalant among patients who experienced AF or atrial flutter within 24 hours to 7 days after cardiac surgery.

Patients received vernakalant 3 mg/kg (n=107) or placebo (n=54) infused over 10 minutes. After 15 minutes, a second 10 minute infusion of vernakalant 2 mg/kg or placebo was given if AF or atrial flutter was present. The primary efficacy measure was the percentage of patients with treatment-induced conversion of AF/atrial flutter to SR for at least one minute within 90 minutes.

Patients demonstrating conversion within 90 minutes were categorized as responders. Other efficacy measures included time to conversion of all responders and percentage of AF patients demonstrating conversion to SR within 90 minutes for . one minute.

Following CABG or valvular surgery, a significantly higher percentage of patients with AF/atrial flutter given vernakalant (45 percent) demonstrated conversion to SR within 90 minutes compared to patients given placebo (15 percent), p=.0002. In the subset of patients with AF at baseline, conversion was observed in 47 percent treated with vernakalant compared with 14 percent given placebo, p=.0001. Median time to conversion among vernakalant responders was 12 minutes and SR was maintained for patients with AF/atrial flutter for 24 hours in 60 percent and for seven days in 57 percent. Seventy-five percent of vernakalant responders required only one dose of drug. Vernakalant is not effective in atrial flutter.

The most common adverse events (AEs) in patients given vernakalant were AF (20 percent), nausea (6 percent), constipation (5 percent), weight increase (5 percent) and dyspnea (5 percent). Rates of serious AEs over the entire study were similar with placebo (11 percent) and vernakalant (9 percent). In the first 24 hours, only 2 patients (2 percent) given vernakalant experienced a serious AE (complete AV block and hypotension). There were no deaths or cases of torsade de pointes.

About Atrial Fibrillation

AF is an interruption of the normal sinus rhythm (arrhythmia) of the heart in which the atria, the two uppermost chambers of the heart, beat irregularly and at an extremely rapid rate(1). During AF, rapid and uncoordinated electrical discharges are generated by the heart's natural pacemaker (sinoatrial node) and other parts of the atria. This causes ineffective contractions of the atria and reduces the ability of the heart to pump blood through the body. Symptoms include dizziness, heart palpitations, weakness, shortness of breath and angina (chest pain)(1). The number of AF patients is expected to triple over the next 50 years due to the increased prevalence of risk factors including hypertension, obesity, diastolic dysfunction, inflammation, diabetes and sleep apnea(2).

About Astellas

Astellas Pharma US, Inc., located in Deerfield, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. In the US, Astellas markets products in the areas of Immunology, Urology, Anti-Infectives, Cardiovascular and Dermatology. For more information about Astellas Pharma US, Inc., please visit our website at http://www.astellas.com/us.

References

1. Fuster V, Ryden LE, Cannom DS, et al. ACC/AHA/ESC guidelines for the

management of patients with atrial fibrillation. Journal of the

American College of Cardiology. 2006;48(4):854-906.

2. Miyasaka Y, Barnes ME, Gersh BJ, et al. Circulation. 2006;114:119-125.


'/>"/>
SOURCE Astellas Pharma US, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
3. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
4. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
5. Multiple Myeloma Research Consortium (MMRC) Partners with Novartis to Advance Phase II Study of Deacetylase Inhibitor
6. Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
7. Study Suggests High-Dose Fish Oil May Significantly Improve Behavior in Children with ADHD
8. MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study
9. Video: Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression
10. MacroGenics Begins Global Phase 2/3 Protege Study in Recent-onset Type 1 Diabetes Mellitus
11. Sarasotas Roskamp Institute Releases Study Defining a Mechanism for Development of Obesity and the Metabolic Syndrome, Forerunners of Type 2 Diabetes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... PALO ALTO, Calif. , Feb. 8, 2016 /PRNewswire/ ... manufacturing, and Kodiak Sciences Inc., a biopharmaceutical company designing ... disease, announced today agreements for the clinical supply of ... material at multiple sites, including Slough (UK), Visp (CH) ... --> Retinal diseases, such as age-related macular ...
(Date:2/8/2016)... -- Aoxing Pharmaceutical Company, Inc. (NYSE MKT: AXN) today announced that ... 31, 2015, the Company achieved revenue of $8,195,839, a 27% ... in fiscal 2015. --> --> ... 2016 was $2,068,635, or $.03 per share, up 265% from ... the Q2 of fiscal year 2015. Gross margin for the ...
(Date:2/8/2016)... Pa. , Feb. 8, 2016  Unilife Corporation ("Unilife" ... and supplier of injectable drug delivery systems, today announced that ... six months ended December 31, 2015 after market close on ... scheduled a conference call to discuss these financial results.    ... Unilife Corporation --> About Unilife Corporation ...
Breaking Medicine Technology:
(Date:2/8/2016)... ... February 08, 2016 , ... The Valentine’s Season is famous for gift giving with flowers, ... that they are loved. This year, for more than 5.6 million Americans suffering with ... won't be enough to remind them of the lives they’ve led and the people they’ve ...
(Date:2/8/2016)... ... February 08, 2016 , ... Steve Helwig & Associates Insurance & ... community enrichment program, has teamed up with Citizens Opposed to Domestic Abuse in support ... abuse. To support all those victimized by the fear of violence in their own ...
(Date:2/8/2016)... AUSTIN (PRWEB) , ... February 08, 2016 , ... Remember ... next time. , According to Perry A~, author of “Calcium Bentonite Clay” the ... a key role in balancing and detoxifying the body. , A former motivational speaker, ...
(Date:2/8/2016)... ... February 08, 2016 , ... ... this important news! AHCC and the Home Health and Hospice ICD-10 Transition Workgroup ... for official ICD coding guidance and clarifications, to address concerns over the use ...
(Date:2/8/2016)... ... February 08, 2016 , ... According to research by ... require dental technicians to be certified or obtain continuing education. To increase patient ... “What’s In Your Mouth?” campaign to inform dentists and patients about the possible ...
Breaking Medicine News(10 mins):