An international, multicentre, double-blind, randomized study (DISSCO): effect of diacerein vs celecoxib on symptoms in knee osteoarthritis
| Autor: | Eva Dokoupilova, Patrice Paiement, Johanne Martel-Pelletier, Louis Bessette, Marc Dorais, Frédéric Morin, Jean-Pierre Raynauld, Jean-Pierre Pelletier, Karel Pavelka |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
musculoskeletal diseases
Male medicine.medical_specialty WOMAC Population Anthraquinones Osteoarthritis law.invention 03 medical and health sciences 0302 clinical medicine Double-Blind Method Rheumatology Randomized controlled trial law Internal medicine medicine Humans Pharmacology (medical) 030212 general & internal medicine Diacerein education Adverse effect Pain Measurement 030203 arthritis & rheumatology education.field_of_study business.industry Anti-Inflammatory Agents Non-Steroidal Clinical Science Middle Aged Osteoarthritis Knee medicine.disease Arthralgia Clinical trial Celecoxib Female business medicine.drug |
| Zdroj: | Rheumatology (Oxford) |
| ISSN: | 1462-0332 1462-0324 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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