The effects of aceclofenac and nabumetone in osteoarthritis.
BACKGROUND
Aceclofenac, a NSAID is widely used in the treatment of pain and inflammation associated with osteoarthritis. Nabumetone, a recently developed preferential cyclo-oxygenase 2 inhibitor has also proved to be equally effective. The present study was undertaken to evaluate the 'real better' drug, amongst these with better efficacy and gastro-intestinal tolerability as well.


METHODS
Four hundred and twenty-three patients of either sex, aged 40-64 years with uncomplicated osteoarthritis of knee joint were randomly allocated into three equal groups receiving aceclofenac, nabumetone or placebo. A baseline pain measurement was done with Visual Analogue Scale (VAS: 0-10 scale) and Investigator Global Assessment of Disease status (IGADS: 0-4 point scale). Code was broken at the end of two weeks or earlier to eliminate any real fatal outcome. Final evaluation of efficacy was done at the end of four weeks. The significance of difference between the treatment outcomes was analyzed using one way ANOVA test.


RESULTS
During the active comparator controlled period, the most common reason for discontinuation was unacceptable adverse events. While 108 (76.6%) participants could take the full course of treatment with aceclofenac, 118 (83.7%) of the nabumetone group completed the study. Drop outs were highest in the placebo group (33.9%) followed by the aceclofenac group (12.1%) and nabumetone group (8.5%). Discontinuation due to G.I. intolerance was least in the placebo group (2.1%) followed by the nabumetone group (5%) and aceclofenac group (7.8%).


CONCLUSIONS
The preferential inhibition of cyclo-oxygenase 2 by nabumetone was postulated to afford better clinical efficacy and gastrointestinal tolerability in osteoarthritis as compared to aceclofenac.
Paul
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Department of Pharmacology, Medical College, Kolkata, West Bengal, India. drsuhritapaul@yahoo.co.in
Das
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Ghosh
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D000284:Administration, Oral; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D002074:Butanones / Q000008:administration & dosage*; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage*; D004008:Diclofenac / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077430:Nabumetone; D020370:Osteoarthritis, Knee / Q000188:drug therapy* / Q000503:physiopathology; D010147:Pain Measurement; D012189:Retrospective Studies; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D002074:Butanones; D052246:Cyclooxygenase 2 Inhibitors; D004008:Diclofenac; D000077430:Nabumetone; C056498:aceclofenac