Jean-Pierre Pelletier1, Jean-Pierre Raynauld2, Marc Dorais3, Louis Bessette4, Eva Dokoupilova5, Frédéric Morin6, Karel Pavelka7, Patrice Paiement8, Johanne Martel-Pelletier1. 1. Osteoarthritis Research Unit, University of Montréal Hospital Research Centre (CRCHUM). 2. Institut de Rhumatologie de Montréal, Montréal, Québec. 3. StatSciences Inc., Notre-Dame-de-l'Île-Perrot. 4. Groupe de Recherche en Rhumatologie et Maladies Osseuses, Sainte-Foy, Québec, Canada. 5. MEDICAL PLUS s.r.o., Uherske Hradiste, Faculty of Pharmacy, Department of Pharmaceutics, University of Veterinary and Pharmaceutical Sciences, Brno, Czech Republic. 6. Centre de Recherche Musculosquelettique, Trois-Rivières, Québec, Canada. 7. Institute of Rheumatology and Clinic of Rheumatology, Prague, Czech Republic. 8. Imaging Research & Development, ArthroLab Inc, Montréal, Québec, Canada.
Abstract
OBJECTIVE: The objective of this study was to investigate whether diacerein has comparable efficacy with celecoxib in pain reduction for treatment in symptomatic knee OA patients. METHODS: This randomized double-blind multicentre non-inferiority trial evaluated diacerein vs celecoxib treatment in patients with Kellgren-Lawrence grade 2-3 and pain scoring ≥4 (10-cm VAS). Patients were randomized to 6 months of treatment with diacerein 50 mg (n = 187) once daily for 1 month and twice daily thereafter, or celecoxib 200 mg (n = 193) once daily. The primary outcome was the change in WOMAC pain score (0-50 cm) at 6 months, and the secondary outcomes were WOMAC sub-scores, VAS pain score, and the OMERACT-OARSI responder rate. RESULTS: In the per protocol population, the adjusted mean change from baseline in the WOMAC pain score was -11.1 ( 0.9) with diacerein (n = 140) and -11.8 (0.9) with celecoxib (n = 148). The intergroup difference was 0.7 (95% CI: -1.8, 3.2; P = 0.597), meeting the non-inferiority margin. Supportive analysis of the intention-to-treat population gave similar results. Other outcomes showed no significant difference between treatment groups. The incidence of treatment-related adverse events was low and balanced between groups, but a greater incidence of diarrhoea occurred with diacerein (10.2% vs 3.7%). Diarrhoea was considered mild-to-moderate in all but one case with complete resolution. CONCLUSIONS: Diacerein was non-inferior to celecoxib in reducing knee OA pain and improving physical function. Diacerein also demonstrated a good safety profile. TRIAL REGISTRATION: A multicentre study on the effect of DIacerein on Structure and Symptoms vs Celecoxib in Osteoarthritis is a National Institutes of Health (NCT02688400) and European Clinical Trial Database (2015-002933-23) registered phase III (Canada) or IV (Europe) study.
OBJECTIVE: The objective of this study was to investigate whether diacerein has comparable efficacy with celecoxib in pain reduction for treatment in symptomatic knee OA patients. METHODS: This randomized double-blind multicentre non-inferiority trial evaluated diacerein vs celecoxib treatment in patients with Kellgren-Lawrence grade 2-3 and pain scoring ≥4 (10-cm VAS). Patients were randomized to 6 months of treatment with diacerein 50 mg (n = 187) once daily for 1 month and twice daily thereafter, or celecoxib 200 mg (n = 193) once daily. The primary outcome was the change in WOMAC pain score (0-50 cm) at 6 months, and the secondary outcomes were WOMAC sub-scores, VAS pain score, and the OMERACT-OARSI responder rate. RESULTS: In the per protocol population, the adjusted mean change from baseline in the WOMAC pain score was -11.1 ( 0.9) with diacerein (n = 140) and -11.8 (0.9) with celecoxib (n = 148). The intergroup difference was 0.7 (95% CI: -1.8, 3.2; P = 0.597), meeting the non-inferiority margin. Supportive analysis of the intention-to-treat population gave similar results. Other outcomes showed no significant difference between treatment groups. The incidence of treatment-related adverse events was low and balanced between groups, but a greater incidence of diarrhoea occurred with diacerein (10.2% vs 3.7%). Diarrhoea was considered mild-to-moderate in all but one case with complete resolution. CONCLUSIONS: Diacerein was non-inferior to celecoxib in reducing knee OA pain and improving physical function. Diacerein also demonstrated a good safety profile. TRIAL REGISTRATION: A multicentre study on the effect of DIacerein on Structure and Symptoms vs Celecoxib in Osteoarthritis is a National Institutes of Health (NCT02688400) and European Clinical Trial Database (2015-002933-23) registered phase III (Canada) or IV (Europe) study.
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Authors: N Bhala; J Emberson; A Merhi; S Abramson; N Arber; J A Baron; C Bombardier; C Cannon; M E Farkouh; G A FitzGerald; P Goss; H Halls; E Hawk; C Hawkey; C Hennekens; M Hochberg; L E Holland; P M Kearney; L Laine; A Lanas; P Lance; A Laupacis; J Oates; C Patrono; T J Schnitzer; S Solomon; P Tugwell; K Wilson; J Wittes; C Baigent Journal: Lancet Date: 2013-05-30 Impact factor: 79.321