Background Combined glucosamine hydrochloride (GH) and chondroitin sulfate (CS) was found to be efficacious compared with placebo in subjects with knee osteoarthritis (OA) with severe pain in the GAIT trial1. The proportion of OA patients who achieved after 6 months a 20% improvement in pain was similar between GH+CS and Celecoxib (CE) 200mg.
Objectives To extend the findings of GAIT, a clinical trial was designed to assess whether GH+CS has comparable efficacy to CE to reduce severe pain in knee OA patients after 6 months of treatment. Secondary objectives included comparison of other outcomes related to signs and symptoms of knee OA and to tolerability and safety.
Methods MOVES was an international multicentric, phase IV, double-blind, non-inferiority, randomized trial to compare efficacy and safety of combined GH+CS (Droglican®, Bioiberica) vs CE in patients with knee OA with severe pain. Patients received either 2 capsules of Droglican (GH250mg and CS200mg) TID or CE200mg and 5 placebo capsules. Patients were eligible if ≥40years, fulfilled the ACR criteria for knee OA, had KL grade 2 or 3 and WOMAC pain>301 (0-500scale). Patients with gastrointestinal or cardiovascular risk were excluded. The primary outcome was the mean decrease in WOMAC Pain after 6 months.
Results 763 patients were screened, 606 randomized to receive GH+CS (N=304) or CE (N=302), 522 (86.1%) completed the trial and included in the PP non-inferiority analysis. There was no difference in proportion completing between groups. Mean (SD) age was 62.7 (8.9) years, 438(83.9%) were women; KL grade 2 was present in 327 (62.6%).
The mean WOMAC pain at randomization was 372.0 (41.8) in GH+CS and 370.6 (41.4) in CE. At 6 months, pain decreased ∼50% in both groups to 185.8 (7.4) in GH+CS and 184.7 (7.6) in CE, SEM difference of 1.11 (10.63) units (95%CI-21.99,19.76) (p=0.917) respecting non-inferiority margin. These results were robust in sensitivity analyses using the ITT population and BOCF imputation in PP and ITT populations.
There was no difference in secondary outcomes after the 6-month treatment with WOMAC stiffness of 69.1 (3.0) and 65.8 (3.0) (p=0.434), WOMAC function of 617.0 (23.5) and 595.8 (24.1) (p=0.53), VAS pain of 37.9 and 37.6 (p=0.924) and OMERACT-OARSI responders of 79.7% and 79.2% (p=0.908) in GH+CS and CE groups respectively. Both arms elicited a reduction>50% in joint swelling (p=0.53) and effusion (p=0.61). Overall, there was similar rescue medication consumption in both arms.
There was no significant difference in the proportion of patients with treatment-emergent AEs between groups (50.7% overall); no deaths occurred. All the results are consistent with those from the GAIT.
Conclusions The MOVES demonstrated clinical efficacy of a combination of GH and CS and good safety profile in the symptomatic treatment of patients with severe knee OA.
N Engl J Med 2006Feb23;354(8):795-808
Disclosure of Interest None declared
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