jueves, 1 de agosto de 2013

Efficacy and safety of diacerein and diclofenac in knee osteoarthritis in Indian patients- a prospective randomized open label study

Objectives: To determine the effi cacy and carryover effects of diacerein vs diclof- enac in Indian population with knee osteoarthritis (OA). Study design: After one week NSAID’s washout period, patients received either diacerein or diclofenac or combination for 12 weeks with 4 weeks follow-up to determine the carryover effects of the drugs. The primary effi cacy end point was the change from baseline in 100mm visual analog scale (VAS) score after 20 meters walk. The secondary effi cacy end points were the percent change from baseline in pain, stiffness, function and total WOMAC scores. Lequesne impairment index (LII), Knee society score (KSS), and acetaminophen intake. Results: Out of 189 patients screened, 81 patients with painful knee OA were randomized and 77 completed the study. At 16 wks, diacerein showed superior- ity to both diclofenac and the combination therapy as assessed (95% CI) with 100mm VAS score (p<0.05), WOMAC scores (p<0.001), as well as LII, KSS and acetaminophen consumption (p<0.001), demonstrating the carryover effect of the drug. Intra-group comparison showed signifi cant difference in all WOMAC scores from baseline score in each group. Diacerein was safe, well tolerated and caused diarrhea as the frequent adverse effect. Conclusions: Diacerein is safe and effective with long carryover effect.

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