Effectiveness and safety of repeat courses of hylan G-F 20 in patients with knee osteoarthritis

SummaryObjectiveTo compare the effectiveness and safety of repeat treatment with hylan G-F 20 based on data from a randomized, controlled trial [Raynauld JP, Torrance GW, Band PA, Goldsmith CH, Tugwell P, Walker V, et al. A prospective, randomized, pragmatic, health outcomes trial evaluating the incorporation of hylan G-F 20 into the treatment paradigm for patients with knee osteoarthritis (Part 1 of 2): clinical results. Osteoarthritis Cartilage 2002;10:506–17]. The hypotheses tested were whether the single-course and repeat-course subgroups would be superior to appropriate care and not different from each other.MethodA total of 255 patients with knee osteoarthritis were randomized to “appropriate care with hylan G-F 20” or “appropriate care without hylan G-F 20”. The hylan G-F 20 group was partitioned into two subgroups: (1) patients who received a single course of hylan G-F 20; and (2) patients who received two or more courses of hylan G-F 20.ResultsFor the primary effectiveness measure, change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score as a percent of baseline, the single-course subgroup improved by 41%, the repeat-course subgroup by 35%, and the appropriate care group by 14%. Both subgroups improved significantly more than the appropriate care group (P