One of the main companies who make a synovial fluid replacement product is Genzyme they have recently announced a new approach and a new version of their product.
Genzyme say that they are seeking approval to use a single treatment of Synvisc-One to treat osteoarthritis of the knee for up to six months. Synvisc treatment is currently approved to be given in three separate doses at once weekly intervals. Synvisc-One combines those doses in one treatment. This means that patients will need only one injection and not three as at present.
A number of companies make synovial fluid replacement products.
As explained earlier synovial fluid is the natural "oil" that we all have in our joints. When osteoarthritis develops the supply of synovial fluid dries up and the joint becomes dry and stiff. The idea behind synvisc and related drugs is to replace the missing synovial fluid and thus to provide lubrication, better movement and pain relief.
Synvisc-One Study Findings
Patients in the study were randomized to receive one six-milliliter treatment of Synvisc or one six-milliliter injection of placebo (saline). In the primary endpoint, patients were evaluated over six months according to the WOMAC A scale, a validated and commonly used measurement of osteoarthritis pain. These data resulted in statistically significant improvement in pain from osteoarthritis of the knee over 26 weeks when compared to pain relief for patients receiving placebo treatment. Data from the study also show that Synvisc-One demonstrated a 36 percent reduction in pain over 26 weeks as compared to baseline.
The statistically significant findings of the primary endpoint were supported by a number of secondary outcomes, most notably a statistically significant treatment effect in favor of Synvisc-One in assessments completed by patients and their physicians of the severity of knee osteoarthritis symptoms. Both patients and physicians completing these assessments were blinded, meaning that they were unaware of whether the patient had received Synvisc-One or placebo.
In addition to the treatment advantage seen in the Synvisc-One group, data showed comparable safety information between the treatment and placebo arms. Eight patients (6.5) in the placebo group experienced procedure or study treatment related AEs following initial treatment. Four patients (3.3) in the placebo group experienced mild to moderate adverse events determined to be related to the study treatment in the first course, and one patient (1.3%) experienced target knee adverse events determined to be related to the study treatment in the repeat course.
Synvisc is indicated for the treatment of pain due to osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, for example, acetaminophen. Synvisc is currently approved in Europe and Canada to treat pain due to osteoarthritis in the knee and hip, and also approved in Europe for the ankle and shoulder indications.
In clinical trials, the most commonly reported adverse events were transient local pain, swelling, and/or effusion in the injected knee. In some cases, these symptoms have been extensive. Other side effects such as rash have been reported rarely. Synvisc is contraindicated in patients with known hypersensitivity to hyaluronan products or patients with infections in or around the knee. Healthcare practitioners should exercise caution when using Synvisc in patients allergic to avian proteins, feathers, or egg products; who have evidence of venous or lymphatic stasis in the leg to be treated; or who have severe inflammation in the knee joint to be treated. Patients should be advised to avoid strenuous or prolonged weight-bearing activities after treatment. Strict adherence to aseptic technique must be followed to avoid joint infection. The safety and effectiveness of Synvisc in children and in pregnant or lactating women have not been established. It is unknown whether Synvisc is excreted in human milk.
Back Trouble UK
Terry has worked in General Medicine for over 30 years, starting out as a Medical Officer in HM Forces, serving just over 15 years.Links:http://www.BackDoctor.org.ukhttp://www.BackTrouble.co.uk
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