Download 89. When other options have failed... There is a therapy that can H

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When other options have failed...
There is a therapy that can HELP
A Patient Guide to LDL Apheresis Therapy
The HELP System
(Heparin-induced Extracorporeal Lipoprotein Precipitation)
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By now you’ve heard
that high LDL-cholesterol –
the “bad” cholesterol –
is a serious threat to your
health and longevity.
Time
Contents
Lowering Blood Cholesterol: Some People Need Extra Help
High LDL-Cholesterol: The Enemy Within
What is LDL Apheresis – and How Does It Work?
What Results Can I Expect From LDL Apheresis?
How Safe is LDL Apheresis?
Do I Qualify for LDL Apheresis Therapy?
How Do I Get Started?
The information in this guide is provided for general educational
purposes only.
You should confer with your physician about your particular medical
condition, and to get his or her recommendation of the best treatment
options for you.
LDL apheresis therapy with the HELP System must be prescribed
by a physician and supervised by a physician trained in its use.
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You’ve faithfully eaten the right foods and taken
the cholesterol-lowering medications your doctor
prescribed. Yet your LDL-cholesterol (“LDL-C”)
level is still much too high.
doctors describe as “maximum tolerated drug
and dietary therapy.” Without effective treatment, progressive damage to arteries can lead,
by middle age or earlier, to severe angina,
heart attack and strokes.
You’re not alone. You are among the one in
every 500 people with an inherited disorder
in cholesterol metabolism called familial
h y p e r c h o l e s t e r o l e m i a, or “FH.”
To reduce your LDL-C to a safer range – and
keep it down – your physician has recommended
LDL apheresis therapy – a highly effective
treatment that directly removes harmful
amounts of “bad” LDL-C from your blood.
For some people with FH, the LDL-C level
remains stubbornly high, despite trying what
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Lowering Blood Cholesterol:
Some People Need Extra Help.
You can consider yourself fortunate for two
reasons. First, you are fully aware of your diagnosis and the health threat posed by your high
LDL-C level. Many others remain undiagnosed,
or don’t understand the damage their very high
cholesterol is doing — day in and day out.
to reduce their LDL-cholesterol levels, and thus
reduce their risk of heart attack, stroke and
premature death.
This guide explains some of the health risks of
high blood LDL-cholesterol, and how regular LDL
apheresis treatments with the HELP System reduce
and maintain a lower LDL-cholesterol level.
Second — if you qualify — you have access
toa proven LDL apheresis technology called
the HELP System. This procedure has been used
in Europe since 1986, and was approved by
the FDA for patient use in the U.S. in 1997.
More than 200,000 HELP treatments have
enabled people with treatment-resistant FH
Most importantly, this guide and
consultation with your physician will help
you determine if you’re a good candidate
for LDL apheresis therapy.
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HELP THERAPY ALLOWS
YOU TO KEEP PURSUING
YOUR GOALS
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High LDL-Cholesterol:
The Enemy Within
Your heart quietly and efficiently pumps blood
to every organ and cell in your body, including
the hard-working muscle of the heart itself.
That life-giving blood courses through a network
of flexible, smooth-walled arteries and veins
to deliver oxygen and nutrients to your brain,
heart and other vital organs, as well as to
your muscles and skin.
white blood cells migrate through that cell layer
and take up oxidized LDL particles, in a failing
effort to repair the damage. The result is deposition
of a fatty streak in the arterial wall. When the
LDL level remains too high, this disease process
progresses to produce a hard fibrous plaque.
Over a period of years, painful angina can develop,
as the coronary arteries narrow and less and less
blood reaches the heart muscle. But these thick
arterial plaques also set up the conditions for
sudden, life-threatening thrombosis (blood clotting).
When a fibrous plaque becomes unstable and breaks
or tears, a thrombus may almost instantly form
on the surface of the plaque, and block the artery.
But when the LDL level in the blood is much
higher than the optimal, healthy range, a
disease process called atherosclerosis (athero
= fatty and sclerosis = scarring or hardening)
progressively damages the major arteries.
Progression of atherosclerosis
When a sudden thrombosis occurs in a coronary
artery supplying blood, it can cause a myocardial
i n f a r c t i o n, or heart attack. A similar event in
the arteries supplying the brain causes a stroke.
LDL (low-density lipoprotein) is a normal carrier
of cholesterol. But when the blood LDL-C concentration is too high, more of it is oxidized.
Some of that oxidized LDL-C appears to enter
and injure the thin, single layer of cells that
lines the inner walls of the arteries. Apparently,
In 1992, a landmark study reported on the
relationship between blood cholesterol levels
and survival of over 360,000 American men for
12 years,1 and found that the rate of death from
coronary heart disease climbed proportionally
as the measured LDL-C level increased.
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100
90
80
70
60
50
40
30
20
10w
0
80
w
w w
w
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w
w
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The newest National Cholesterol Educational
Program (NCEP) guidelines define an LDL level
of less than 100 milligrams per deciliter of
blood as “optimal,” while 130 to 159 milligrams
is “borderline high,” and 160 to 189 milligrams
is “high.” 5
w
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NCEP Classification of LDL-Cholesterol Levels
Optimal
120
160
200
240
280
LDL-Cholesterol (mg/dL)
Death rate from coronary heart disease in relating
to LDL-C over a 12-year period (in 361,662
U.S. men)
<100
Near Optimal
100-129
Borderline High
130-159
High
160-189
Very High
>190
For patients with established heart disease,
the NCEP guidelines now recommend lowering
LDL-cholesterol to less than 100 mg/dL. On a
“time-averaged” basis, that low level is probably
not realistic for you even with LDL apheresis, but
the more you can reduce your LDL-cholesterol
level, the more you reduce your risk of heart
attack and premature death.
Several other studies have confirmed that, for a
rise of each 20 milligrams per deciliter(mg/dL)
in the total cholesterol level, one’s risk of death
increases by more than 20%.2,3
In 1996, another major clinical study proved that
long-term treatment to reduce LDL-cholesterol – in
this case using an LDL-lowering drug – saves lives.4
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What is LDL Apheresis —
and How Does it Work?
Blood withdrawn from the
patient is continuously
separated into plasma and
cellular components by
passage through a
capillary plasma filter.
Cellular components are
returned directly to the patient.
You are already taking one or more medications
which work in different ways to reduce your
LDL-C level. If you are a qualified candidate
for LDL apheresis, you will continue on your
drug and dietary regimen.
Third Phase:
The “cleaned” plasma then passes through
other filters to remove excess heparin and fluids,
and finally is returned (along with your blood
cells) to your circulation through a vein in the
other arm.
LDL apheresis works differently than drug therapy,
by physically removing the LDL-C from your
blood. LDL apheresis involves three phases.
B U F F E R / H E PA R I N
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First Phase:
A small portion of whole blood is drawn, usually
from an arm vein, and passed through tubing
into the HELP System device. Oxygen-carrying
red cells and other blood cells are separated
from the liquid plasma component of your blood.
You leave your appointment with nearly all
of the blood you came in with – minus about
60% of the harmful LDL- cholesterol that
had accumulated in your circulation.
Most people can be treated every two weeks,
but people with very high LDL-C levels, including
those with a rare “homozygous” form of FH,
often require weekly treatments.
Second Phase:
A solution containing heparin is added to the
plasma. The heparin adheres to many LDL-cholesterol molecules, causing them to “precipitate”
as a sticky yellow material. A container containing
small-pored filters captures that yellowish mass
of excess LDL-C, which is later discarded. Your
“cleaned” plasma passes through this filter.
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P R E C I P I TAT E
F I LT E R
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Physiologic pH of LDL- and
heparin-free plasma is corrected
with bicarbonate dialysis, followed
by ultrafiltration to correct volume.
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THE PROCESS
Basic HELP treatment process to physically remove LDL-C
Your LDL apheresis staff will give you specific
instructions, including a reminder to eat and drink
well before each appointment. They will also
make every effort to assure that your appointments
are as comfortable and pleasant as possible.
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When pH is adjusted to 5.12,
lipoprotein complexes form
a precipitate.
PLASMA
CAPILLARY
PLASMA FILT E R
U LT R A - F I LT E R
This process is repeated a number of times during
your treatment session, which usually takes one
to two hours.
A mixture of sodium acetate
buffer (pH 4.85) and heparin
(100 IU/ml) are added to the
plasma in equivalent parts
by volume.
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H E PARIN
ADSORBER
4
The precipitated
lipoprotein
complexes are
captured in the
precipitate filter,
which is later
discarded.
Residual heparin is removed
from the LDL-free plasma by
a heparin adsorber.
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What Results Can I Expect
From LDL Apheresis?
When you leave your treatment session, your LDL-C
level will be reduced by roughly 60%, down to
about 40% of the pre-treatment level. But because
this blood-cleaning treatment doesn’t change the
underlying metabolic problem, your LDL-C level
will immediately begin to increase, or rebound.
Again, reduction of this “bad cholesterol” has been
shown in many clinical studies to reduce the risk
of coronary heart disease and premature death.
HELP therapy also reduces blood fibrinogen (a
clotting protein) and triglycerides. The level of HDLcholesterol usually dips by 10-15%, but generally
recovers within two days to pretreatment levels.6
Without regular LDL apheresis treatments, your
LDL-C concentration will rise to close to its pretreatment level within less than two weeks. Thus,
frequent, regularly scheduled treatments are
required to keep your average LDL level in
a lower, healthier range.
Pre-treatment
Post-treatment
LDL-C
-60 to 64%*
Triglycerides
H E LP therapy immediately reduces LDL-C levels
and maintains a lower level over time.
Fibrinogen
-36 to 47%*
-58 to 65%*
*Extent of reduction varies by individual
In a German study evaluating the HELP System
in 39 patients with existing coronary heart
disease, the share of patients who were free
of angina increased from 18% prior to HELP
therapy, to 38% over just two years of
regular treatment.7
HELP THERAPY ALLOWS
YOU TO KEEP DOING
THE THINGS YOU LOVE.
A number of other studies have also shown
that LDL-lowering therapies may slow, halt and
even reverse the progression of atherosclerotic
plaques in the coronary arteries.
Time
As you can see, regular, ongoing LDL apheresis
therapy will effectively reduce your average
LDL-cholesterol level.
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Do I Qualify for
Apheresis Therapy?
How Safe is LDL
Apheresis?
Over more than 20 years of use, LDL apheresis
has proven itself to be a very safe method for
treating excessive LDL-cholesterol levels.
Other minor adverse events which occurred in at
least 0.1% of procedures (1 in every 1,000) include:
To date, there have been no reported patient
deaths attributable to HELP LDL apheresis therapy.
A German study of 51 patients who received
4,330 HELP treatments over a two-year period
documented no serious adverse events.7
Adverse Event
Number (%)
Nevertheless, like any drug or medical intervention,
adverse reactions or events do infrequently occur.
Chills/Shivering
9 (0.3%)
Fatigue
8 (0.3%)
In most instances, these adverse reactions are
easily managed, and don’t require discontinuation
of the treatment.
Prolonged PTT or ACT
7 (0.2%)
Nausea/Vomiting
7 (0.2%)
Chest Heavy/Pain
4 (0.1%)
Adverse reactions associated with HELP therapy
are those typically expected with any procedure
involving circulation of blood outside the body.
In the U.S. HELP trial involving more than 2,800
treatments, hypotension (low blood pressure)
was the most common adverse reaction. This
minor temporary reaction can usually be managed by giving the patient intravenous fluids,
and the treatment completed.
Dizziness/Syncope
4 (0.1%)
Headache
4 (0.1%)
Elevated Temperature
3 (0.1%)
Others (single events)
14 (0.5%)
Total = 2,826 treatments
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At this point, your doctor has tried prescribing
different combinations of lipid-lowering medications and you’ve adhered to a prescribed diet.
But despite this, your LDL-C level is still much
too high.
• Heterozygous FH patients whose LDL-C
level exceeds 300 mg/dL
Your physician has recommended LDL apheresis
therapy to help you manage your LDL-C level.
But unfortunately not every patient with high
LDL-cholesterol is a good candidate for this
lifelong treatment.
LDL apheresis is an ongoing therapy that
requires commitment on your part for the long
haul. Successful candidates are people who
fully understand the importance of lowering
their LDL-C levels, and commit to making
their apheresis visit part of their routine.
• Heterozygous FH patients whose LDL-C
exceeds 500 mg/dL
H E LP LDL apheresis therapy is indicated when at
least six months of maximum tolerated drug
and dietary therapy fails to achieve lowering
of the LDL-C level below certain thresholds.
The three subgroups include:
Your doctor will be happy to answer any questions you have, and may also ask you a number
of questions to make sure you are a motivated
candidate, willing to commit to long-term LDL
apheresis therapy.
• Heterozygous FH patients whose LDL-C level
exceeds 200 mg/dL and have angina, or a
history of coronary heart disease (CHD)*
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How do I Get Started?
You and your doctor need to obtain some specific
information to make sure that LDL apheresis is
appropriate, practical and affordable for you.
Venous Access.
Before you can begin LDL apheresis therapy, your
physician will examine your arm veins. For some
people whose veins are “fragile” from years of
cardiovascular disease, alternatives to simple
arm vein access may be appropriate.
“Baseline” Blood Test.
Your doctor will order blood tests to establish
your current “baseline” LDL-C level. This “lipid
panel” of tests also includes total cholesterol,
HDL-cholesterol, and triglycerides.
Insurance Verification.
As this is an FDA-approved therapy, most insurance policies cover LDL apheresis. Insurers will
ask your doctor to provide specific information
about your treatment history and laboratory
results before they can authorize payment.
You and your physician will review your blood
test results together, to determine whether you’re
an appropriate candidate for LDL apheresis therapy.
Finally, you’re ready to start on your new
path to a healthier future.
REFERENCES
Neaton JD, Wentworth D. Arch Int Med 1992; 152:56-64.
2
Verschuren WMM, Jacobs DR et al. JAMA 1995; 274(2):131-6.
3
Anderson KM, Castelli WP and Levy D. JAMA 1987; 257(16):2176-80.
4
Cholesterol and Recurrent Events (CARE) Trial Investigators. N Engl J Med 1996; 335:1001-1009.
5
Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. JAMA 2001; 285(19);2486-2509.
6
Lane DM, Alaupovic P, Knight-Gibson C et al. Am J Cardiol 1995; 75:1124-29.
7
S c h u ff - Werner P, Gohlke H, Bartmann U et al. Eur J Clin Investig 1994; 24:724-32.
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B. Braun Medical Inc.
Rx only
HELP is a trademark of B.Braun Medical Inc.
Copyright 2004 B.Braun Medical Inc.
HELP.002L 10/04
824 Twelfth Avenue
Bethlehem, PA 18018
1-800-848-2066
email: [email protected]
www.bbraunusa.com