Study Evidence Supports New Drug to Prevent Blood Clotting
The blood clot preventer Eliquis, sold by
Pfizer Inc and Bristol-Myers Squibb Co,
proved as effective as widely used
warfarin in treating a dangerous condition
known as venous thromboembolism and
caused far less bleeding, according to data
from a large clinical trial.
The Pfizer and Bristol-Myers pill met the
main goal of the study by showing it
worked just as well as conventional
treatment with warfarin, a generic blood
thinner, in reducing recurrence of the
condition and related deaths.
Eliquis also led to a nearly 70 percent
reduction in the risk of major bleeding
and more than a 50 percent reduction in a
category known as clinically relevant non-
major bleeding. Bleeding is typically the
most troubling side effect of extended use
of blood thinning drugs.
Dr. Giancarlo Agnelli, the study's lead
investigator, called the bleeding results
"a remarkable real advantage" for
Eliquis.
"This is to me the most striking finding of
this study in terms of potential changes to
clinical practice," Agnelli, who presented
the data on Monday at the International
Society on Thrombosis and Hemostasis
(ISTH) meeting in Amsterdam, said in a
telephone interview. The results were
also published in the New England
Journal of Medicine.
"This really makes apixaban a really safe
compound," he added, using the chemical
name for Eliquis.
Venous thromboembolism (VTE) is a
potentially fatal condition consisting of
blood clots in the leg, known as deep vein
thrombosis, and clots in the lungs, known
as pulmonary embolism. About 900,000
Americans and 1 million patients in the
European Union are diagnosed with the
condition each year. The condition recurs
in up to 10 percent of patients.
Slow Uptake For Some
Eliquis belongs to a new class of blood
clot preventers meant to replace warfarin,
which has been in use for decades and
requires rigorous monitoring. It competes
directly with Xarelto from Bayer AG and
Johnson & Johnson, and Boehringer
Ingelheim's Pradaxa.
Some doctors have been reluctant to
switch to the new medicines in part
because their blood-thinning effect is not
easily reversed in case emergency medical
treatment, such as surgery, is needed.
Companies are testing agents that could
be used to reverse the blood thinning
effect if necessary.
Eliquis is already approved to prevent
strokes and blood clots in patients with a
common, but dangerous irregular
heartbeat known as atrial fibrillation - by
far the largest market for the new blood
thinners.
ISI Group analyst Mark Schoenebaum
forecast eventual peak annual sales of
USD 3 billion for the drug. If approved for
venous thromboembolism, it would add
an important, if smaller, use for the
medicine.
While doctors are comfortable using
warfarin, it requires careful patient
monitoring of levels of the drug in the
blood and dose
