[HSF] [Fwd: [ccm-l] levosimendan gone]

[prasannasimha]

-------- Original Message --------

Plug Gets Pulled on Heart Failure Drug

 

By Peggy Peck, Managing Editor, MedPage Today

 

May 02, 2007

 

ABBOTT PARK, Ill., May 2 -- A heart failure drug called levosimendan 
(Simdax), which has been in clinical trials, has been withdrawn from 
development by Abbott Laboratories and its Finnish partners.

 

In the 1,327-patient SURVIVE study (Survival of Patients with Acute 
Heart Failure in Need of Intravenous Inotropic Support), levosimendan 
failed to significantly increase survival compared with dobutamine.

 

The SURVIVE findings, first reported at the American Heart Association 
meeting in 2005, have just been published in the May 2 issue of the 
Journal of the American Medical Association.

 

All-cause mortality was 26% in the levosimendan arm versus 28% in the 
dobutamine arm despite the fact that levosimendan treatment was 
associated with a significant decrease in B-type natriuretic peptide at 
24 hours and persisting for five days (P<0.001).

 

In a statement, Abbott said that further development of the drug was not 
"commercially reasonable" because the FDA demanded additional phase III 
trials as a condition of approval.

 

Levosimendan is licensed in more than 40 countries but is not yet 
approved in England, France, or Germany.

 

 

 

 

Joe Lex, MD, FAAEM

Giant Steps in Emergency Medicine

Cape Cod - Mattu, Sharieff, Lex, DeBlieux

June 28th - July 1st, 2007

www.GiantSteps-EM.com