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Chulalongkorn Medical Journal

Abstract

Background : Recent systematic meta-analyses provide evidence for the efficacy ofdiacerein 100 mg/day in the treatment of knee and hip osteoarthritis(OA). However, as diacerein may cause acceleration in intestinal transittime during the first 2 weeks of treatment, it is recommended to startwith 50 mg/day for 4 weeks then increase the dose to 100 mg/day.However, no study has been performed on the treatment regimen. Thisstudy was conducted in order to assess the efficacy of diacereinaccording to the recommended regimen.Objective : To assess the efficacy and safety of diacerein in reducing pain andfunctional impairment in patients with painful tibiofemoral osteoarthritisof the knee over a six-month period.Design : Prospective studySetting : Orthopedics Clinic, King Chulalongkorn Memorial Hospital.Methods : Thirty patients between 50 and 65 years old with painful knee osteoarthritis(grade I to III severity on Kellgren - Lawrence radiological scale) wererecruited into the study. After a 1-week NSAIDs washout period,the subjects received diacerein 50 mg/day for 1 month then increasedto 100 mg/day until the end of the study. No other OA and/or pain-killermedication was allowed during the study except ibuprofen atthe maximum dose of 1,600 mg/day when pain was unbearable; and,the number of tablets taken per day was recorded. The efficacyparameters were pain on walking (VAS), Lequesne index for function,intake of ibuprofen and overall efficacy were evaluated by the investigatorsand patients. These parameters were assessed at baseline (Day 0),Day 28, 56, 84, and 168. Routine hematology, urinalysis and clinicalchemistry examinations were carried out at baseline and the end of study.The occurrence of adverse event was recorded at each visit.Results : There was a significant reduction of pain from baseline (mean value:59.9 mm VAS) to the last visit (mean value: 27.7 mm VAS), (p <0.001).The Lequesne index also showed a significant decrease from a baselinevalue of 12.5 to 5.8 on Day 168 (p <0.001). At the end of the study,about 80% of the subjects and investigators evaluated treatment efficacyas moderate to very effective. There was significant decrease inibuprofen consumption from 678.7 mg/day at baseline to 207.6 mg/dayat the end of the study. Three mild to moderate severity adverse eventsrelated to diacerein were observed which were flatulence, GI upset anddiarrhea. There were no variations in the laboratory parameters measured.Conclusion : The results of this study exhibited efficacy and safety of diacerein inthe recommended regimen in the treatment of knee osteoarthritis over asix-month period.

Publisher

Faculty of Medicine, Chulalongkorn University

First Page

275

Last Page

287

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