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Single-dose hylan G-F 20 shows significant pain reduction compared to saline

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SAN FRANCISCO — A new multicenter study shows that a single 6-mL intra-articular injection of hylan G-F 20 may provide up to 6 months of pain relief in patients with symptomatic knee osteoarthritis.

"This study demonstrates a favorable risk/benefit profile for Synvisc single injection of 6 mL when compared to a saline control, including a statistically significant reduction in WOMAC A pain scores over 6 months, which was the primary endpoint in this study," Joerg Jerosch, MD, said during his presentation here at the American Academy of Orthopaedic Surgeons 75th Annual Meeting.

"We also had a clinical benefit of the primary endpoint further supported by secondary endpoints, and we specifically had a good safety profile with no major differences between Synvisc 6-mL injections and saline control."

In a prospective, double-blind randomized study, Jerosch and his colleagues compared the results of 232 patients with a primary diagnosis of osteoarthritis who received either a single intra-articular injection of hylan G-F 20 (Synvisc, Genzyme) or a saline injection for knee pain. The groups had comparable patient demographics such as age, gender and body mass index.

An intention-to-treat analysis revealed significantly better mean change from baseline WOMAC A Likert pain scores during 26 weeks in the hylan G-F 20 group compared to the saline group (P=.047).

"Statistically significant differences favoring hylan G-F 20 were also reported for most of the secondary efficacy criteria like the WOMAC A-1 over 26 weeks, patient global assessment over 26 weeks as well as clinical observer global assessment in the 26 weeks," Jerosch said.

The investigators also found no serious adverse events in either group.

For more information:

• Jerosch J, van Dijk CN, Verdonk R, et al. Efficacy of hylan G-F 20 (single dose) vs. placebo in patients with pain due to knee osteoarthritis. Paper #219. Presented at the American Academy of Orthopedic Surgeons 75th Annual Meeting. March 5-9, 2008. San Francisco.