Efficacy and safety of diacerein in osteoarthritis of the knee: a randomized, multicenter, double‐dummy, diclofenac‐controlled trial in China

Aim:  To evaluate the efficacy and safety of diacerein in patients with knee osteoarthritis (OA). Methods:  A total of 223 patients fulfilling the American College of Rheumatology criteria for knee OA were enrolled in this 17-week, randomized, double-dummy, diclofenac-controlled trial, with diacerein dosages of 100 mg/day and diclofenac sodium administered at 75 mg/day. Result:  After 12 weeks of treatment, the total efficacy rates of patient/physician global assessment in diacerein and diclofenac groups were 65.4%/61.6% and 61.2%/61.2% respectively (P > 0.05). In the intent-to-treat population, the primary criterion (visual analogue scale [VAS] assessment of pain on walking 20 m) was significantly superior (P   0.05). Mild-to-moderate gastrointestinal disorders were the most frequent adverse events. Conclusion:  Diacerein was shown to be as effective as diclofenac sodium in treating patients with knee OA, coupled with a carry-over effect. Diacerein was generally well tolerated, with a good safety profile. No severe adverse events were occurred.