Stroke drugs:

Every year brings nearly 800,000 new
stroke patients in North America.
That's one every 40 seconds.

The largest single cause of severe
neurological disability and the third-
leading cause of death in the United
States, stroke accounts for an
estimated $74 billion annually in
related costs, including treatment and
additional assistance for the three of
every four stroke patients whose ability
to perform the activities of daily life is

Strokes are caused by a sudden drop
in the flow of blood to the brain
resulting from a clot or, less often,
bleeding. One of every three stroke
patients is under the age of 65. In all,
there are 5.4 million stroke survivors in
the United States and 15 million

A stroke is a medical emergency and
can cause permanent neurological
damage, complications, and death. It is
the leading cause of adult disability in
the United States and Europe and it is
the number two cause of death

Boehringer Ingelheim’s Pradaxa has
become the first drug in 50 years to be
approved in Europe for stroke
prevention in atrial fibrillation (AF)  

Pradaxa is already approved for
preventing blood clots in adults who
have undergone elective total hip or
elective total knee replacement

But it can now be used in the EU for
the prevention of stroke and systemic
embolism in adult patients with non-
valvular AF with one or more risk
factors – an indication it has already
achieved in the US, Canada, Japan
and Australia.

Along with Bayer’s Xarelto and
Pfizer/BMS’s apixiban, the direct
thrombin inhibitor is part of a new class
of drugs whose manufacturers’ eyes
are on replacing the longstanding
standard of care, warfarin.

They are helped by various sticking
points with warfarin treatment: it
requires regular monitoring, and there
are food-drug and drug-drug
interactions which mean that only half
of eligible patients actually receive it.

In the RE-LY trial, which included
18,000 patients, Pradaxa 150mg
reduced the risk of stroke and
systemic embolism by 35% and
significantly lowered the risk of
intracranial bleeding compared to

Up to three million people worldwide
suffer strokes related to AF each year.
“AF-related strokes are particularly
severe and disabling, with one half of
this population dying within one year
after a stroke,” explained Trudie
Lobban, chief executive of the AF

While the 150mg bid dose of Pradaxa
is most commonly recommended,
110mg is available for those aged 80
years or above, or for patients at
increased risk of bleeding and for
those given Pradaxa with the calcium
channel blocker verapamil.

As of August 2011 Pradaxa is available
in the UK. The pill  costing less than £3
a day is being hailed as the biggest
breakthrough in stroke prevention in
50 years.

The drug, which slashes the risk of
suffering a stroke by over a third, will
help more than a million Britons.

In trials it was found to significantly
reduce the risk of a stroke in patients
with an irregular heartbeat, known as
atrial fibrillation. This is one of the main
causes of strokes.

The drug, taken twice a day at a cost
of £2.52, already prevents thousands
of deaths each year from blood clots
after hip or knee replacement surgery.

Now European regulators have given
the makers of the drug permission to
use it for the prevention of strokes in
patients with AF, who have one or
more risk factors such as having
already ­suffered a stroke.

Pradaxa will now be assessed by the
Government’s drug rationing body, the
National Institute for Health and Clinical
Excellence, to determine whether it
should be widely used in the NHS for
stroke prevention.

But it is immediately available if
purchased privately or if prescribed at
a doctor’s discretion.

Bristol-Myers Squibb Co. and Pfizer
Inc.  stopped a clinical trial early
because the data so far suggest an
experimental drug for irregular heart
rhythm was superior to aspirin.
The drug, apixaban, is designed to
prevent clotting of the blood. The  drug
makers studied apixaban in people
with atrial fibrillation, a disease
involving irregular heartbeat that
increases the risk for stroke.
The study compared apixaban with
aspirin in people who are unable to
take a commonly used anti-clotting
drug, warfarin.
The study included about 5,600
patients in 36 countries.

In April 2011 the Stanford University
School of Medicine and SanBio Inc.  
announced the initiation of a Phase
1/2a clinical trial testing the safety and
efficacy of a novel  cell therapy
product, SB623, on patients suffering
from stable deficits resulting from
previous stroke injuries.

Chronic, stable stroke patients have
no existing alternative treatments after
rehabilitation therapy. SB623, a
modified stem cell preparation, has
been shown to improve motor function
when administered in animal models of
stable stroke. Safety studies in animals
have shown no adverse events
attributed to SB623.

Key entry criteria for this study, in
addition to 6-24 months post-ischemic
stroke, include moderately severe
symptoms--e.g., difficulty standing or
walking, and/or difficulty using arms or
hands, and/or speech impediments.

SB623 is derived from bone marrow
stromal cells isolated from healthy
adult donors and genetically
engineered. The trial will test the
safety of SB623 when implanted in the
damaged regions of the brains of
stable stroke patients.

In cell biology, stromal cells are
connective tissue cells of an organ.
Fibroblasts, immune cells, pericytes,
endothelial cells, and inflammatory
cells are the most common types of
stromal cells.

SanBio’s NDR technology uses genetic
manipulation of bone marrow stromal
cells that, when administered to
damaged tissue, promote functional
recovery. Bone marrow cells from a
single donor can be used to treat
thousands of patients.

SanBio is a privately held San
Francisco Bay Area biotechnology
company focused on the discovery
and development of new regenerative
cell therapy products.

Patients following a stroke often have
weakness on one side of the upper
body (hemiparesis), which can make
daily life more difficult. Robotic
rehabilitation is increasingly available,
and holds promise for enhancing
traditional post-stroke interventions.
Because robots never tire, they can
provide massive and intensive training
in a consistent manner without fatigue,
with programming precisely tailored to
each patient's needs.

Kinetic Muscles, Inc. of Arizona, an
innovator of stroke rehabilitation
therapies,  produces the Hand Mentor
and Foot Mentor therapy robots which
have been clinically shown to help
patients recover function following
stroke or traumatic brain injury. More
than 150 leading neurorehabilitation
clinics already use the Hand Mentor
and Foot Mentor in their stroke
treatment programs.