ABSTRACT
This prospective open-label study evaluated the efficacy and tolerability of a second
course of hylan G-F 20 for the treatment of osteoarthritic knee pain over a 12-month
period in patients who previously experienced a beneficial initial course of therapy.
Men or women aged ≥40 years with knee osteoarthritis received 3 weekly injections
of hylan G-F 20. Consecutive patients requesting a second course of therapy were enrolled
from October 2000 to January 2001. The mean time between the first and second courses
of hylan G-F 20 was 19.6 months. All efficacy parameters significantly improved (P<.001) from baseline at weeks 1, 2, 4, 8, 12, 26, and 52. Improvements from baseline
to weeks 26 and 52 for the Western Ontario and McMaster Universities Osteoarthritis
Index (WOMAC) index question A1, WOMAC domain C, and total WOMAC were 1.39±0.11 and
1.1±0.12,18.50±1.43 and 13.69±1.54, and 26.77±1.97 and 19.8±2.13, respectively. Significant
improvements from baseline were maintained for patient and physician VAS to week 26
(patient: 48.66±2.52; investigator: 51.51±2.34) and week 52 (patient: 46.10±2.73;
investigator: 47.23 ±2.52). A second course of hylan G-F 20 therapy was generally
well-tolerated; the types of local events observed in this study were not qualitatively
different from those in the current product information and published literature.
For continued relief of osteoarthritic knee pain, this study supports repeat use of
hylan G-F 20 in patients who had a previous successful course of therapy.
