Ciencia Y Salud

The efficacy, safety and carry-over effect of diacerein in the

treatment of painful knee osteoarthritis: a randomised,

double-blind, NSAID-controlled study1

W. Louthrenoo M.D.y*, S. Nilganuwong M.D.z, S. Aksaranugraha M.D.x,

P. Asavatanabodee M.D.k, S. Saengnipanthkul M.D.{ and the Thai Study Group

y Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine,

Chiang Mai University, Chiang Mai, Thailand

z Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine,

Siriraj Hospital, Mahidol University, Bangkok, Thailand

x Department of Rehabilitation Medicine, Chulalongkorn University, Bangkok, Thailand

k Rheumatic Disease Unit, Department of Internal Medicine, Pramongkutklao Hospital and

College of Medicine, Bangkok, Thailand

{ Department of Orthopaedics, Khon Kaen University, Khon Kaen, Thailand

Summary

Objective: To evaluate the efficacy, safety and carry-over effect of diacerein, in comparison to piroxicam, in the treatment of Thai patients with

symptomatic knee osteoarthritis (OA).

Design: This was a double-blind, randomised, piroxicam-controlled, parallel-group study. A 7-day non-steroidal anti-inflammatory drug washout

period was followed by a 16-week treatment period with either diacerein 100 mg/day or piroxicam 20 mg/day, and an 8-week treatmentfree

observation period. The primary efficacy criterion was pain on Western Ontario and McMaster University Osteoarthritis (WOMAC) A. The

secondary criteria included WOMAC B, C and total WOMAC, paracetamol intake, Short Form-36 questionnaire and global judgements on

efficacy and tolerability by patients and investigators.

Results: Of 171 randomised patients, 150 completed the study and 161 were analysed in the intent-to-treat population (diacerein: 82, piroxicam:

79). Pain (WOMAC A) decreased to a similar extent in both groups at Week 16 (diacerein: 69.7% 31.5%; piroxicam: 74.1  26.2%;

P ¼ n.s.). On treatment discontinuation, pain increased in the piroxicam group at Weeks 20 (47%  47.8%) and 24 (26.8%  60.6%) while

improvements persisted in the diacerein group at Weeks 20 (66.9%  35.9%) and 24 (69.5% 33.7%), with a significant difference in

favour of diacerein at Weeks 20 and 24, demonstrating the carry-over effects of the drug. The incidence of adverse events was similar in

both groups but more patients from the piroxicam group dropped out of the study due to these events.

Conclusions: Diacerein was as effective as piroxicam in reducing pain and improving function but, unlike piroxicam, displayed a carry-over

effect and a better safety profile.

ª 2007 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Key words: Diacerein, Osteoarthritis, RCT, Piroxicam, SYSADOA, NSAID.

Introduction

Osteoarthritis (OA) is characterised by a progressive degradation

and loss of articular cartilage accompanied by subchondral

bone remodelling, osteophyte formation and

synovial membrane inflammation. The clinical manifestations

are a gradual development of joint pain, swelling,

instability, stiffness and loss of motion. The incidence of

knee OA in some Western European countries has been estimated

to be 18e25% in men and 24e40% in women between

60e79 years of age and there are about 100 million

persons with knee OA in the European Union1. An epidemiological

study of an urban Thai population suggested that

the prevalence of symptomatic knee OA in Thailand is

34.5% among persons over 60 years of age2.

The main objectives in the management of OA are to

reduce symptoms, minimise functional disability,

...