SYNVISC IMPROVES OSTEOARTHRITIS PAIN.
Genzyme Corporation (NASDAQ NASDAQ
in full National Association of Securities Dealers Automated Quotations
U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :GENZ), Cambridge, Mass. has announced that preliminary results from a new study indicate that patients using Synvisc (hylan G-F 20) through a single-dose regimen achieved a statistically significant improvement in pain from osteoarthritis osteoarthritis
or osteoarthrosis or degenerative joint disease
Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. of the knee over 26 weeks compared with those using placebo. Currently Synvisc is delivered through three intra-articular administrations given at one-week intervals. Genzyme undertook the current trial in an attempt to improve patient care by reducing the burden of treatment and the overall cost of therapy.
The prospective double-blind placebo-controlled study involved 253 patients at 21 sites in Europe. Patients were randomized ran·dom·ize
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment. to receive one six-milliliter dose of Synvisc or one six-milliliter dose of placebo (saline). In the primary endpoint, patients were evaluated over 26 weeks according to the WOMAC WOMAC Western Ontario McMaster University Osteoarthritis Index Rheumatology An arthritic pain scoring system ranging from 0–no pain/disability to 100–most severe pain/disability A scale, a validated and commonly used measurement of osteoarthritis pain.
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 in assessments completed by patients and their physicians of the severity of osteoarthritis symptoms. Both patients and physicians completing this assessment were blinded, meaning that they were unaware of whether the patient had received Synvisc or placebo. Analysis of the full set of secondary endpoints is ongoing.
In addition to the treatment advantage seen in the Synvisc group, preliminary data showed comparable safety information between the treatment and placebo arms.
"We are very encouraged by these results, which add to the growing body of evidence in support of Synvisc and reflect our commitment to continued innovation on behalf of patients and physicians," said Ann Merrifield, president of the Genzyme Biosurgery division. "We believe that delivering the benefits of Synvisc through one administration rather than three will provide additional options for physicians and patients that will reduce the cost and burden of multiple injections."
Genzyme will prepare the full set of data for publication in 2007 and presentation at upcoming orthopaedics and rheumatology rheumatology /rheu·ma·tol·o·gy/ (-tol´ah-je) the branch of medicine dealing with rheumatic disorders, their causes, pathology, diagnosis, treatment, etc.
n. conferences. Based on the results, Genzyme plans in the first half of 2007 to submit this new information to regulatory agencies and request an amendment to the Synvisc product label in the United States and Europe to include this type of administration.
These new data add to the growing clinical evidence that further supports Synvisc's use in treating the pain from osteoarthritis. Recently announced results from an independent investigator's clinical study found Synvisc to be superior in magnitude and duration of pain relief, functional improvement and patient satisfaction to another viscosupplementation product in treating patients with OA of the knee. These independent data were presented last June at the European League Against Rheumatism rheumatism (r`mətĭzəm), general term for a number of disorders that cause inflammation and pain in muscles, bones, joints, or nerves. (EULAR) meeting in Amsterdam, The Netherlands, at the British Orthopaedic Association congress held last month in Glasgow, and at the American College of Rheumatology (ACR See riser card. ) meeting this month in Washington.
In addition to its efficacy in relieving OA knee pain, Synvisc, as a non-systemic treatment, has the advantage of avoiding some of the side effects associated with some non-steroidal anti-inflammatory drugs Non-steroidal anti-inflammatory drugs (NSAIDs)
Aspirin, ibuprofen, naproxen, and many others.
Mentioned in: Mastocytosis including the COX-2 inhibitors.
Synvisc is marketed in more than 60 countries and has been used to treat more than 3 million people.
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 Analgesics Definition
Analgesics are medicines that relieve pain.
Analgesics are those drugs that mainly provide pain relief. , for example, acetaminophen acetaminophen (əsēt'əmĭn`əfĭn), an analgesic and fever-reducing medicine similar in effect to aspirin. It is an active ingredient in many over-the-counter medicines, including Tylenol and Midol. . Synvisc is currently approved in Europe and Canada to treat pain due to osteoarthritis in the knee and hip, and has recently received approval 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 effusion /ef·fu·sion/ (e-fu´zhun)
1. escape of a fluid into a part; exudation or transudation.
2. effused material; an exudate or transudate. 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 hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. 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 lymphatic /lym·phat·ic/ (lim-fat´ik)
1. pertaining to lymph or to a lymphatic vessel.
2. a lymphatic vessel.
adj. 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 aseptic /asep·tic/ (-tik) free from infection or septic material.
Of, relating to, or characterized by asepsis. technique must be followed to avoid joint infection. The safety and effectiveness of Synvisc in children and in pregnant or lactating lac·tate 1
intr.v. lac·tat·ed, lac·tat·ing, lac·tates
To secrete or produce milk.
[Latin lact women have not been established. It is unknown whether Synvisc is excreted in human milk.
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