Reginster JY, et al. – This study explored the effectiveness of chondroitin sulfate 800 mg/day (CS) pharmaceutical–grade in the management of symptomatic knee osteoarthritis (OA). Investigations displayed that a 800 mg/day pharmaceutical–grade CS was superior to placebo and similar to celecoxib in reducing pain and improving function over 6 months in symptomatic knee OA patients. Hence, this formulation of CS should be considered a first–line treatment in the medical management of knee OA.

Methods

• A prospective, randomised, 6–month, 3–arm, double–blind, double–dummy, placebo and celecoxib (200 mg/day)–controlled trial assessing changes in pain on a Visual Analogue Scale (VAS) and in the Lequesne Index (LI) as coprimary endpoints.
• Secondary endpoints were Minimal–Clinically Important Improvement (MCII), Patient–Acceptable Symptoms State (PASS).

Results

• This study enrolled 604 patients (knee osteoarthritis) diagnosed according to American College of Rheumalogy (ACR) criteria.
• These patients were followed for 182 days.
• In evaluation, CS and celecoxib showed a greater significant reduction in pain and LI than placebo.
• In the intention–to–treat (ITT) population, pain reduction in VAS at day 182 in the CS group (–42.6 mm) and in celecoxib group (–39.5 mm) was significantly greater than the placebo group (–33.3 mm) (p=0.001 for CS and p=0.009 for celecoxib), while no difference observed between CS and celecoxib.
• Similar trend for the LI, as reduction in this metric in the CS group (–4.7) and celecoxib group (–4.6) was significantly greater than the placebo group (–3.7) (p=0.023 for CS and p=0.015 for celecoxib), no difference was observed between CS and celecoxib.
• In the CS and celecoxib groups, both secondary endpoints (MCII and PASS) at day 182 improved significantly.
• All treatments demonstrated excellent safety profiles.