News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

ZLB Behring Release: First International Census On Von Willebrand Disease (VWD): 77 Percent Of Patients With Severe Type 3 VWD Experience Significant Bleeding-Related Events



5/22/2006 11:26:24 AM

VANCOUVER, British Columbia, May 22 /PRNewswire/ -- More than three-fourths of patients with Type 3 von Willebrand disease (VWD), the most severe form of the most common hereditary bleeding disorder in the world, had bleeding events in the past year that required treatment, according to results of a study announced at the 2006 World Federation of Hemophilia (WFH) Annual Congress. The research also found that 22 percent of patients with Type 3 VWD had bleeding patterns severe enough to warrant preventive therapy. These findings were released from the first international census to examine the use of prophylaxis in treating VWD by the von Willebrand Disease Prophylaxis Network, a research group of 14 top bleeding disorder physicians and researchers from Europe and North America.

"The VWD Prophylaxis Network was established to help determine the optimal treatment of VWD patients, with a goal of minimizing bleeding-related morbidities," said Erik Berntorp, MD, PhD, principal investigator and Professor, Department of Hematology and Coagulation Disorders, Malmo University Hospital, Malmo, Sweden. "Using the data provided by our census registry and future studies, we hope to develop more effective regimens for the management of VWD."

The data collected by the Prophylaxis Network from 74 centers in Europe and North America include a total of 6,208 people with VWD: 4,687 with Type 1; 1,181 with Type 2; and 340 with Type 3, the most severe form of VWD. The census data show a significant difference in the distribution of types of VWD diagnosed in patients living in North America and those living in Europe -- with the more severe Type 2 and 3 VWD patients twice as likely to reside in Europe as in North America (32.1 vs. 16.0 percent). Researchers also found regional differences in the clinical management of people with Type 3 VWD.

The data registry also assessed measures to prevent and control VWD symptoms, a particular interest of the VWD Prophylaxis Network researchers. Of the 101 patients in the census registry under treatment with prophylaxis, 75 were Type 3 patients. The most common reasons for initiating prophylaxis were joint (40 percent), epistaxis/oral (23 percent) and gastrointestinal bleeding (14 percent).

"The findings of the VWD Prophylaxis Network highlight the risk of spontaneous bleeding faced by patients with Type 3 VWD and the need to better understand steps that can be taken to reduce bleeding episodes," said Miklos Fulop, chief executive officer and executive director of the WFH. "Raising awareness of VWD is a major goal of the Federation, and we welcome future findings of the Prophylaxis Network that may shed light on the best treatment options to help all those afflicted with this potentially serious bleeding disorder worldwide."

About von Willebrand Disease

Von Willebrand disease (VWD) is caused by a deficiency or abnormality of the von Willebrand factor, a protein in the blood that is necessary for normal blood clotting. Men and women are equally likely to be affected by VWD. VWD is classified by types, ranging from Type 1 (the most common and mild) to Type 3 (the most severe). VWD affects about 60 million people worldwide.

Women with VWD are more likely to experience heavy, prolonged menstruation. Other common symptoms of VWD include frequent nosebleeds and easy bruising. Bleeding can be mild or serious and can occur as a result of injury, or without any obvious cause. More serious symptoms include bleeding into joints and internal organs. The VWD patient may require special care during dental procedures, surgery and childbirth.

There is no cure for VWD, but it can be treated. Specific treatments may include desmopressin acetate to release stored von Willebrand factor, or von Willebrand factor replacement therapy, where required, with Humate-P(R), Antihemophilic Factor/von Willebrand Factor Complex (Human), the only product licensed by the FDA for the treatment of von Willebrand disease.

ZLB Behring's von Willebrand Factor (VWF)/factor VIII concentrate Humate- P(R) (marketed in Europe as Haemate(R) P) is a factor replacement therapy with more than 20 years of demonstrated safety and efficacy around the world. It is an injectable drug that works to achieve proper hemostasis by replacing the most active forms of VWF (high molecular weight VWF multimers) and factor VIII that are missing in patients with von Willebrand Disease (VWD).

Possible adverse events with the use of Humate-P include allergic reaction, urticaria (hives), chest tightness, rash, pruritus (itching) and edema (swelling). Anaphylactic reaction can occur in rare instances. Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement therapy, especially in patients with known risk factors for thrombosis. In these patients, caution should be exercised and antithrombotic measures should be considered.

Humate-P is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated. Please visit http://www.zlbbehring.com to read the prescribing information for Humate-P.

About the von Willebrand Disease Prophylaxis Network

Founded in 2001, the Von Willebrand Disease Prophylaxis Network is an international study group of VWD physicians and researchers formed with the goals of investigating the role of prophylaxis measures in protecting against or preventing bleeding episodes in clinically severe VWD, and educating healthcare professionals and consumers about VWD. The VWD Prophylaxis Network steering committee is made up of 14 top bleeding disorder physicians and researchers (six European, eight North American), including:

Chair: Erik Berntorp, MD, PhD, Malmo University Hospital, Sweden

Co-Chair: Thomas Abshire, MD, AFLAC Cancer Center and Blood Disorders Service, US

Data Coordination and Statistics: Sharyne Donfield, PhD, Rho, Inc., US -- Manuel Carcao, MD, Hemophilia Program, Hospital for Sick Children, Canada -- Joan Cox Gill, MD, The Blood Research Institute, US -- Jorge DiPaola, MD, Great Plains Regional Hemophilia Treatment Center, US -- Peter Kouides, MD, Mary M. Gooley Hemophilia Center, US -- Karin Kurnik, MD, Dr. von Haunersches-Children's Hospital, Germany -- Frank Leebeek, MD, Erasmus Medical Center, The Netherlands -- Stefan Lethagen, MD, Copenhagen Hemophilia Center, Denmark -- Michael Makris, MD, Royal Hallamshire Hospital, UK -- Pier Mannucci, MD, Angelo Bianchi Bonomi Hemophilia / Thrombosis Center, Italy -- Prasad Mathew, MD, Ted R. Montoya Hemophilia Center, US -- Rochelle Winikoff, MD, Ste-Justine Hospital, Canada

The VWD Prophylaxis Network is supported by an unrestricted grant from ZLB Behring.

About ZLB Behring

ZLB Behring is a global leader in the plasma protein biotherapeutics industry. Dedicated to improving the quality of life for patients throughout the world, ZLB Behring provides safe and effective plasma-derived and recombinant products and offers patients a wide range of related services. The company's broad portfolio of life-saving therapeutics is used in the treatment of individuals with hemophilia and other bleeding disorders, immune deficiency disorders and inherited emphysema; the prevention of hemolytic diseases for the newborn; cardiac surgery patients; and shock and burn victims. Additionally, ZLB Behring operates one of the world's largest, fully owned plasma collection networks. ZLB Behring is a subsidiary of CSL Limited, a biopharmaceutical company that operates worldwide from its headquarters in Melbourne, Australia. For more information, please visit http://www.ZLBBehring.com. The website http://www.AllAboutBleeding.com is a resource dedicated to increasing awareness about VWD.

Media Contacts: Sheila A. Burke Director, Public Relations & Communications Worldwide Commercial Operations ZLB Behring +1-610-878-4209 Sheila.Burke@zlbbehring.com Tracy Pleva Hill MCS +1-800-477-9626 mobile: +1-908-642-5727 tracyph@mcspr.com

ZLB Behring

CONTACT: Sheila A. Burke, Director, Public Relations & Communications,Worldwide Commercial Operations, ZLB Behring, +1-610-878-4209,Sheila.Burke@zlbbehring.com; Tracy Pleva Hill, of MCS, 1-800-477-9626,mobile: +1-908-642-5727, tracyph@mcspr.com, for ZLB Behring


Read at BioSpace.com


comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES