An international, multicentre, double-blind, randomized study (DISSCO): effect of diacerein vs celecoxib on symptoms in knee osteoarthritis.

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.

• Authors: Jean-Pierre Pelletier, Jean-Pierre Raynauld, Marc Dorais, Louis Bessette, Eva Dokoupilova, Frédéric Morin, Karel Pavelka, Patrice Paiement, Johanne Martel-Pelletier, DISSCO Trial Investigator Group
• Journal: Rheumatology (Oxford, England) (Rheumatology (Oxford)) Vol. 59 Issue 12 Pg. 3858-3868 (12 01 2020) ISSN: 1462-0332 [Electronic] England
• PMID: 32521015 (Publication Type: Equivalence Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: [email protected].

Chemical References

• Anthraquinones
• Anti-Inflammatory Agents, Non-Steroidal
• diacerein
• Celecoxib

Topics

• Anthraquinones (therapeutic use)
• Anti-Inflammatory Agents, Non-Steroidal (therapeutic use)
• Arthralgia (drug therapy)
• Celecoxib (therapeutic use)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Osteoarthritis, Knee (drug therapy)
• Pain Measurement