According to World Health Organisation osteo-
arthritis is the second commonest musculoskeletal problem in the world.
Diacerein has been recently introduced in India for the treatment of osteo-
arthritis. In view of the ulcerogenic potential of
NSAIDs and the
cardiotoxicity problems associated with
COX-2 inhibitors,
diacerein has the potential of being a non-ulcerogenic and non-cardiotoxic alternative respectively to
NSAIDs and of
COX-2 inhibitors in the treatment of osteo-
arthritis. The present study was, therefore, undertaken to evaluate the efficacy and tolerability of
diacerein in the treatment of osteo-
arthritis. A total 7923 patients with osteo-
arthritis of the knee fulfilling the selection criteria were enrolled in this open-label, multicentric postmarketing surveillance study. After a wash-out period of one week, patients were treated with 50mg
diacerein tablets administered twice daily for 12 weeks. The primary efficacy variable of the present study was to assess the improvement in the visual analogue scale (VAS) scores for
pain. The secondary variable was improvement in patients' and physicians' global assessment of efficacy of
therapy. Results indicated that over the 12-week study period,
diacerein 50mg
tablets provided significant and sustained reduction the VAS
pain scores. At baseline, VAS scores were 6.70 +/- 1.78. By the end of the 4th week, there was a significant reduction in the mean VAS scores by 21.8% and by the end of the study the mean VAS scores were further significantly reduced by 59.9%. As per the patients global assessment of treatment, 82.3% of the patients reported good to very good improvement at the end of 12 weeks
therapy with
diacerein. Similar responses were also recorded by the treating patients. Thus by the end of 12 weeks
therapy, according to the physicians 85.5% of the total cases treated with
diacerein were rated as having good to very good improvement.
Therapy with
diacerein was well tolerated and only 5.44% of the patients had an adverse event
after treatment with
diacerein. The most common adverse events were diarrhoea (2.3%),
gastritis (0.99%),
nausea (0.61%),
abdominal pain or discomfort (0.44%) and
vomiting (0.3%). The severity of the adverse events was mild in all the cases and disappeared with continued treatment. None of the patients dropped out of the study on account of adverse events or lack of efficacy. Thus, in conclusion, the results of the present study in a large population of Indian patients indicates that
diacerein constitutes a novel approach to the treatment for the short- and long-term symptomatic management in Indian patients with osteo-
arthritis of the knee.