Study Demonstrates One Administration of Synvisc Improves Osteoarthritis Pain

05-Dec-2006

Genzyme Corporation 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 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 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 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.

https://www.bionity.com/en/news/59876/study-demonstrates-one-administration-of-synvisc-improves-osteoarthritis-pain.html