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

Abstract

AbstractAim: 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) to baseline in both two groups. Significant improvement (P < 0.05) was also observed for the secondary criteria, which included tenderness on palpation, Western Ontario and McMaster Universities OA index (WOMAC) and Short‐Form Health Survey (SF‐36). In the follow‐up period, there were no obvious changes in the above parameters in the diacerein group. However, in the diclofenac group, pain on walking 20 m, tenderness on palpation and WOMAC became worse after withdrawing the medications for 4 weeks. Moreover, the consumption of paracetamol was significantly lower in the diacerein group than in the diclofenac group during the follow‐up period. The incidence of related adverse events were 35.7% in diacerein and 45.1% in diclofenac group (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.