Eli Lilly and Daiichi Sankyo Co’s investigational anti-clotting drug, Prasugrel, was found to be more effective at preventing heart attacks than Plavix, but also caused excessive bleeding among patients in a clinical trial, according to a new report. This excessive bleeding may undermine its future success. However, Prasugrel was definitely better at reducing deaths from non-fatal heart attacks and strokes, compared to Plavix.
2.4% of patients in a trial involving 13,600 participants receiving Prasugrel experienced at least one major bleeding event – much higher than the 1.8% of those on Plavix.
Dr. Deepak Bhatt, Cleveland Clinic, author of the Editorial which accompanied the study, explained “When it comes to anti-clotting medications there is no free lunch. In order to reduce heart attack risk, there is a trade-off with increased bleeding.”
You can read about this trial in the New England Journal of Medicine (NEJM). Results were also announced in Orlando, Florida, during the annual meeting of the American Heart Association.
In two small trials, Eli Lilly had stopped giving Prasugrel to patients without fully explaining its reasons for this. The word is that the excessive bleeding looks like a likely cause.
For Prasugrel to be approved by the FDA one day, its safety would most likely have to improve – i.e. the excessive bleeding risk would have to come down significantly. Eli Lilly and Daiichi have plunged enormous amounts of money into the development of Prasugrel, in the hopes it would become a serious challenger for Bristol Myers Squibb’s and Sanofi’s Plavix, which earns over $6.5 billion annually for the two companies. Plavix is known as a “blockbuster” (a super selling drug).
Dr. Deepak Bhatt explained that this trial has demonstrated, despite the excessive bleeding, that the more powerful oral anti-platelet drugs further reduce coronary complications.
In this latest trial 9.9% of patients receiving Prasugrel experienced a non-fatal heart attack or stroke, compared to 12.1% of those who were given Plavix.
“Intensifying Platelet Inhibition – Navigating between Scylla and Charybdis”
Deepak L. Bhatt, M.D.
NEJM – 10.1056/NEJMe0706859
“Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes”
Stephen D. Wiviott, M.D., Eugene Braunwald, M.D., Carolyn H. McCabe, B.S., Gilles Montalescot, M.D., Ph.D., Witold Ruzyllo, M.D., Shmuel Gottlieb, M.D., Franz-Joseph Neumann, M.D., Diego Ardissino, M.D., Stefano De Servi, M.D., Sabina A. Murphy, M.P.H., Jeffrey Riesmeyer, M.D., Govinda Weerakkody, Ph.D., C. Michael Gibson, M.D., Elliott M. Antman, M.D., for the TRITON-TIMI 38 Investigators
NEJM – 10.1056/NEJMoa0706482
Written by – Christian Nordvqist