Navigation Links
Pharmaceutical study: Less hemorrhaging after stroke, but not fewer deaths
Date:6/11/2008

An international study published in May 2008 in the New England Journal of Medicine has shown that the coagulation factor VIIa can limit the extent of a cerebral hemorrhage. However, in the long term it does not prevent death or severe impairment.

Further studies must clarify whether the new treatment with the genetically engineered substance is suitable for a special group of patients who as the study suggests could profit from therapy in spite of this. These are patients with a limited hemorrhage size (delta 60ml), with limited amounts of blood in the cerebrospinal fluid space (delta 5ml), who are not over an age 70 years and who will be treated within 2.5 hours or less.

Some 841 patients in 73 centers in 20 countries took part in the study. Member of the steering committee, study coordinator for Europe, and co-author of the published article is Professor Dr. Thorsten Steiner, Senior Physician at the Department of Neurology, University of Heidelberg Hospital (Medical Director: Professor Dr. Werner Hacke).

Cerebral hemorrhages account for 15 percent of all strokes. They are often fatal; some 80 percent of the surviving patients are severely disabled. Especially problematic is further increase of the hematoma, which occurs in one third of patients in the first four hours. Thus far there is no way of treating.

An earlier study proved reduction of outcome and mortality

Three years ago, a phase-2 study with recombinant coagulation factor VIIa with the trade name NovoSeven, which is not yet approved for clinical use, showed that the compound could lower the death rate after a hemorrhage and limit impairment. This study was also published in the "New England Journal".

The new study compares the effectiveness of factor VIIa in two dosages (20 and 80 micrograms) with a placebo. The extent of the hemorrhage visible on a CT scan was noticeably larger (26%) in the placebo group than in the patients treated with 80 micrograms (11%) and 20 micrograms (18%). But there was still no difference in the number of patients who died after a stroke or were severely disabled by it. However, patients who were treated with the higher dosage of factor VIIa suffered more frequently from thromboses and embolisms.

Fewer high-risk patients in the placebo group / New study on a certain patient group?

"A decisive reason for the negative result is the fact that there were more high-risk patients in the patient groups treated with factor VIIa than in the placebo group," stated Professor Steiner. These patients more frequently had intraventricular hemorrhages (bleeding in the spaces of the brain containing cerebral spinal fluid) and high blood pressure. "Intraventricular bleeding increases the mortality by a factor of 4 to 5 and high blood pressure increases the risk of a secondary hemorrhage," said Professor Steiner. The age of the patients and timing of treatment were also factors.

"We have also determined that after a cerebral hemorrhage reaches a certain size, clinical improvement is very unlikely, irrespective of treatment," continued Professor Steiner. It is possible that the medication is effective mainly in patients whose hemorrhages have not yet exceeded a certain size, who have no or only a limited amount of blood in the ventricle, and do not exceed a certain age. This should be examined in another study.

"We would welcome a decision of the manufacturer of this medication decide to conduct a study on this special group of patients," said Professor Steiner. To what extent high blood pressure increases the risk of secondary hemorrhaging in the acute phase of a hemorrhagic stroke is currently being examined in another study.


'/>"/>

Contact: Dr. Annette Tuffs
annette.tuffs@med.uni-heidelberg.de
49-622-156-4536
University Hospital Heidelberg
Source:Eurekalert

Related medicine news :

1. Alaven Pharmaceutical Introduces Kit for UC Patients
2. GlaxoSmithKline Acquires Sirtris Pharmaceuticals, Inc., a World Leader in Sirtuin Research and Development
3. Renhuang Pharmaceuticals, Inc. Holds Trade Show for Tianma Pills; Signs Letters of Intent
4. Pioneering Safe Medication Return Initiative Reviewed During Pharmaceutical Disposal Summit
5. Cline Davis & Mann Launches Platform Advisors(TM), a New Division to Provide Integrated Strategic and Scientific Consulting Services for the Pharmaceutical, Biotechnology, and Medical Device Industry
6. Indevus Pharmaceuticals Provides Update on NEBIDO(R) NDA Status
7. MAP Pharmaceuticals to Present at the Goldman Sachs Twenty-Ninth Annual Global Healthcare Conference
8. Cadence Pharmaceuticals CEO Theodore Schroeder to Present at the Seventh Annual Needham & Company, LLC Biotechnology and Medical Technology Conference on June 11, 2008 in New York
9. The Scientific Business of Thomson Reuters Publishes Pharma Matters - a Series of Reviews Covering Various Aspects of the Pharmaceutical Pipeline
10. Kiss One-Size-Fits-None Goodbye: Archi-Tech Systems Offers First SFA Solution Targeted to Pharmaceutical Sales Organizations
11. Antipodean Pharmaceuticals Announces FDA Acceptance of IND for MitoQ(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... ... 2016 , ... FileHold's document management software has been implemented ... hosted environment for FileHold software that is pay per user subscription-based and also ... the FileHold web services API. DocuSyst also advises clients on fully functioning back ...
(Date:2/8/2016)... ... February 08, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating to ... are derived from a cluster of melanin when exposed to sunlight. Although most moles ... a lifetime of embarrassment. Historically, mole removal has involved a painful, often ...
(Date:2/8/2016)... (PRWEB) , ... February 08, 2016 , ... ... (NADL), only four states in the U.S. require dental technicians to be certified ... in the dental industry, NADL created the “What’s In Your Mouth?” campaign to ...
(Date:2/7/2016)... ... February 07, 2016 , ... ... has added Kybella® to his medical and surgical expertise. Technically known as deoxycholic ... injectable medication used as a non-surgical alternative for reduction of fat below the ...
(Date:2/6/2016)... ... February 06, 2016 , ... Shark Finds and ... launch of a new DRTV campaign with Belly Bands. , Having a dog is ... sprays to puppy pads and find nothing works, get Belly Bands, the easiest ...
Breaking Medicine News(10 mins):
(Date:2/5/2016)... , Feb. 5, 2016  As people age, ... The multitude of recommended screenings and tests that are ... a priority. However, for the majority of aging individuals, ... health planning. For the 37.5 million American adults who ... the present to make hearing health a 2016 healthy ...
(Date:2/5/2016)... , Feb. 5, 2016  Aralez Pharmaceuticals Inc. ("Aralez") ... POZEN Inc. ("POZEN") and Tribute Pharmaceuticals Canada Inc. ("Tribute") following ... shareholders of Tribute. The combined company will operate under ... with operations in Canada , ... States . Under the terms of the Agreement ...
(Date:2/5/2016)... , Feb. 5, 2016 Aethlon Medical, Inc. (Nasdaq: ... Chairman and CEO, will be presenting at Source Capital Group,s ... York, NY at 2:15 p.m. ET on Wednesday, ... Immunotherapy Panel discussion taking place at 3:15 p.m. ET. ... approximately one hour after the conclusion of the live event. ...
Breaking Medicine Technology: