Objectives To evaluate the efficacy and safety of Hylan G-F 20 over 9 months in the treatment of patients with knee osteoarthritis (OA).
Methods Patients with radiographically proven knee OA, pain on movement ³ 40 mm (VAS) and treated by at least two 10-day NSAIDs courses or by slow-acting anti-OA drugs within the previous 3 or 2 months respectively were enrolled by 81 centres (21 hospitals and 60 private rheumatologists). After stratification on known OA risk factors (patients? age, BMI,...), patients were centrally randomised in Synvisc (S) or in usual treatment (UT) groups. S-patients were treated by 3 intraarticular injections of Hylan GF 20 one week apart and encouraged to stop or spare any other OA treatments. If needed S-patients could be treated by Synvisc in both knees. Efficacy and safety data were collected at baseline, day 28, months 3, 6 and 9.
Results Out of 518 patients randomised, 506 (253 per group) were treated and evaluable. Demographic data (mean age = 66/66 years, female = 67/68%, BMI = 28/28 kg/m2, bilateral knee OA = 72/76% in S vs UT groups respectively) were comparable at baseline. Forty-five S-patients (18%) were treated in both knees.
S-patients showed a better improvement than UT-patients regarding all primary and secondary efficacy outcomes. More especially, mean (SD) changes in S-group versus UT-group were ?3.6 (4.1) vs ?1.6 (4.0) for Lequesne Index, ? 20.1 (19.3) vs ? 8.2 (20.5) mm for WOMAC total score and ? 37.4 (22.3) vs ? 24.4 (24.0) mm for pain on movement. Therefore additional improvements (p = 0.0001) were observed in S-group for Lequesne Index (+ 18.7%), WOMAC total (+ 24.4%), and pain on movement (+ 21.1%).
In S-group, global efficacy was assessed as good/satisfactory by 74% of patients and by 76% of investigators versus 51% and 48% respectively in UT-group, p < 0.0001.
Transient local adverse events (pain, swelling) after Synvisc injections were reported in 11.8% of injections. Gastrointestinal adverse events related to OA treatment were less frequently reported in S-patients (3.5%) as compared to UT-patients (11.9%) (p < 0.001).
Conclusion This large-scale study confirms the efficacy and safety of viscosupplementation by Synvisc in knee OA over a 9-month follow-up.
Acknowledgement Synvisc Experts Group: Prs. Bardin T., Dougados M., Kahan A. (Paris), Mazières B (Toulouse), Trèves R. (Limoges), Vignon E. (Lyon), Drs Auvinet B. (Laval), Naim C. (Marseille), Rossignol O. (Fontenay).
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