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LIPOSORBER Treatment QA
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What is LIPOSORBER?

LIPOSORBER is an "extracorporeal" (blood taken outside the body) procedure to remove LDL cholesterol ("bad" cholesterol) from the blood. Back to Top

How is treatment performed?

Using a device known as the LIPOSORBER System, a portion of the patient's blood circulates outside the body. During the procedure, the plasma (the liquid in which the cells are suspended) is separated from the whole blood and the LDL cholesterol is then removed from the plasma. Then, the plasma and blood are recombined and returned back to the patient.The LIPOSORBER consists of disposable components (which are discarded after each treatment) and an automated computerized machine that controls and monitors the LIPOSORBER treatment.The LIPOSORBER treatment is described below:

  1. Access to Blood.
    Usually arm veins are used for the treatment, in which blood is taken from one arm and pumped through the LIPOSORBER System. The blood is then returned to the patient via the other arm.
  2. Anticoagulation (Blood Thinning)
    Anticoagulation is necessary for all treatments in which blood is removed from the body. Heparin is used to prevent the blood from clotting.
  3. Removal of LDL
    After the blood is thinned, it enters the LIPOSORBER System. All parts that come into contact with the patient's blood and plasma are sterile, used for one treatment only, and then discarded. The first step of the treatment is the separation of plasma from the whole blood. The plasma then flows to one of two dextran sulfate - cellulose adsorption columns, which removes the LDL cholesterol.
  4. Blood Return
    The LDL cholesterol is removed, the plasma is recombined with the other blood components and returned to the patient.

The entire procedure takes approximately two to three hours to perform. At any given time, only about 400 ml (less than 1 pint) of the patient's blood (170ml) and plasma (230ml) are circulating outside the patient's body. Back to Top

How does LIPOSORBER treatment affect elevated LDL cholesterol levels?

LIPOSORBER treatment can lower LDL cholesterol levels between 73 and 83 percent after a single treatment. However, this significant lowering of the LDL cholesterol level is not maintained. Because most patients being treated have a metabolic defect that causes the overproduction of LDL cholesterol, treatment cannot cure the underlying problem. Thus, the patient's LDL cholesterol level begins to increase (or rebound) after treatment, eventually returning to baseline (prior to LIPOSORBER treatment initiation) in about two to four weeks. Back to Top

Does LIPOSORBER treatment remove any other blood components beyond LDL cholesterol?

Although LIPOSORBER treatment is very selective in removing LDL cholesterol, there are other elements in the patient's plasma that may be reduced. The mean reductions of the most important of these plasma components are HDL cholesterol (4 - 13%), plasma proteins (15%), fibrinogen (29%), Vitamin E (55 - 63%) and platelets (17%). These reductions rarely pose a risk to the patient's health. However, physicians do periodically check the levels of these plasma components before and after treatment, in the event there are any changes of clinical significance. Back to Top

Who can benefit from LIPOSORBER treatment?

There are two groups of patients who are candidates for LIPOSORBER treatment. They are individuals who have not responded adequately to diet and maximum tolerated drug therapy for at least six months:

  1. Patients with an LDL cholesterol level above 300 mg/dl.
  2. Patients with an LDL cholesterol level between 160 - 300 mg/dl with coronary heart disease.

Please ask your doctor to confirm if you are a candidate for LIPOSORBER treatment. Back to Top

How often must patients undergo LIPOSORBER treatments?

In order for LIPOSORBER treatment to maintain a lower level of LDL cholesterol in the blood, patients should repeat the procedure regularly. In general, individuals with LDL cholesterol levels starting above 300 mg/dl after diet and maximum tolerated drug therapy should be treated once per week, and individuals with LDL cholesterol levels starting at 200 mg/dl will usually be treated once every two weeks. LIPOSORBER treatment is regarded as a lifelong therapy. Patients must continue their diet and cholesterol-lowering medications after starting LIPOSORBER treatment. Back to Top

Are there any side effects or adverse reactions resulting from LIPOSORBER treatment?

Approximately 300,000 treatments with the LIPOSORBER System have been performed worldwide on over 2,500 patients. Typically, the adverse reactions associated with LIPOSORBER treatment are those observed in any procedure involving the circulation of blood outside the body. These adverse reactions include hypotension (low blood pressure), nausea/vomiting, flushing/blotching, angina/chest pain, fainting, lightheadedness, anemia (not enough iron in the blood), abdominal discomfort, numbness/tingling, tachycardia (fast pulse), headache, shortness of breath, hemolysis (breaking of red blood cells), bradycardia (slow pulse), itching/hives, blurred vision, arrhythmia (irregular heartbeat), vasovagal reaction (nervous reaction often caused by emotional stress from fear or pain), prolonged bleeding due to the blood thinning agent, chills, diaphoresis (sweating) and blood loss.Hypotension or low blood pressure is the most common adverse reaction. In US clinical trials, hypotension occured in less than 1% of all treatments. Certain blood pressure lowering medications can enhance the likelihood of hypotension. If the patient is being treated with one of these drugs, his/her doctor may advise to hold the medication at least 24 hours prior to LIPOSORBER treatment. If an ACE (Angiotensin Converting Enzyme) -inhibitor is used to manage the patient's blood pressure, it should be held at least 24 hours or more prior to LIPOSORBER treatment. Also, if a patient does experience a hypotension reaction during LIPOSORBER treatment, this can be corrected by temporarily stopping the treatment, positioning the patient differently, and in some cases, giving IV fluids.Terminating the treatment generally stops most of the adverse events that may occur during LIPOSORBER treatment. (Healthcare professionals should refer to the Full Prescribing Information section of this web site). Back to Top

Is the cost of LIPOSORBER treatment covered by insurance? By managed care plans?

For the indicated patient population, LIPOSORBER treatment is considered medically necessary and is covered by many insurance and managed care plans. Kaneka is working closely with major insurance companies to ensure successful coverage. A Hot-line is available to assist all health care professionals and patients in obtaining appropriate reimbursement. Back to Top

 

 

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