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A Randomized, Single-Blind Comparison of the Efficacy and Tolerability of Hylan G-F 20 and Triamcinolone Hexacetonide in Patients with Osteoarthritis of the Knee
DAVID CABORN, JOEL RUSH, WILLIAM LANZER, DENNIS PARENTI, and CHRISTOPHER MURRAY, on Behalf of the Synvisc 901 Study Group
ABSTRACT.
Methods. Patients with OA were treated with typical regimens of HG-F 20 (n = 113) and TH (n = 102). Primary assessments were the WOMAC question A1 (pain walking on a flat surface), and a 100 mm visual analog scale (VAS) for patient and investigator overall assessments. Total WOMAC and WOMAC domain C (function) scores were also assessed. The intent-to-treat population was analyzed using a last-observation carried forward approach. Results. Maximum pain relief occurred at 1–2 weeks for TH and at Week 12 for HG-F 20. At Weeks 12 and 26, HG-F 20 was significantly better than TH for the WOMAC question A1 responses (p = 0.0071 and p = 0.0129, respectively), and patient VAS (p < 0.0001 and p < 0.0001) and investigator VAS (p < 0.0300 and p = 0.0004) assessments. Similar significant (p < 0.01) results were observed at Weeks 12 and 26 for total WOMAC and domain C scores. While 15 TH-treated patients discontinued the study due to lack of efficacy, none did so with HG-F 20 treatment (p < 0.01). Both agents were well tolerated with similar adverse event profiles. Conclusion. Viscosupplementation with HG-F 20 resulted in a longer duration of effect than TH with a comparable tolerability profile. These data support the preferential use of HG-F 20 over TH for treatment of chronic OA knee pain. (J Rheumatol 2004;31:333-43) Key Indexing Terms:
HYALURONIC ACID
From the Department of Orthopaedic Surgery, University of Louisville, Louisville, Kentucky; Park Place Orthopaedics and Rehabilitation, Plantation, Florida; Orthopedics International, Seattle, Washington; and Wyeth Pharmaceuticals, Collegeville, Pennsylvania, USA. Sponsored by Wyeth Pharmaceuticals. Hylan G-F 20 used in this study was generously provided by Genzyme Biosurgery, Ridgefield, NJ, USA. D.N. Caborn, MD, Chief of Sports Medicine, Professor of Orthopaedic Surgery, Department of Orthopaedic Surgery, University of Louisville, Louisville, KY; J.L. Rush, DO, Clinical Associate Professor, Department of Orthopedic Surgery, Nova Southeastern University of the Health Sciences, Fort Lauderdale, FL; W.L. Lanzer, MD, Clinical Associate Professor, University of Washington, Seattle, WA; D.L. Parenti, MD, Assistant Vice President of Musculoskeletal Products (current address McNeil Pharmaceuticals, Fort Washington, PA, USA); C.W. Murray, PhD, Director of Musculoskeletal Products, Global Medical Affairs, Wyeth Pharmaceuticals, Collegeville, PA, USA. Address reprint requests to Dr. D.N. Caborn, Department of Orthopaedic Surgery, University of Louisville, Suite 1003, 210 East Gray Street, Louisville, KY 40202. E-mail: david.caborn@louisville.edu Submitted February 21, 2003; revision accepted July 15, 2003. |