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The efficacy of tramadol/acetaminophen combination tablets (Ultracet®) as add-on and maintenance therapy in knee osteoarthritis pain inadequately controlled by nonsteroidal anti-inflammatory drug (NSAID)
Clinical Rheumatology, 08/10/2011
Clinical Article
Park KS et al. – In those subjects who showed favorable response to tramadol/APAP and NSAID combination therapy, both tramadol/APAP and NSAIDs were effective at maintaining the pain-reduced state and there was no significant difference in efficacy between tramadol/APAP and NSAIDs.
Methods- Compare efficacy of tramadol 37.5 mg/acetaminophen 325 mg combination tablets (tramadol/APAP) with that of NSAIDs as maintenance therapy following tramadol/APAP and NSAID combination therapy in knee OA pain which was inadequately controlled by NSAIDs
- Subjects with knee OA for over 1 year and moderate pain (numerical rating scale [NRS] ≥5) despite at least 4 weeks’ NSAID therapy (meloxicam 7.5 mg or 15 mg qd or aceclofenac 100 mg bid) received tramadol/APAP add-on (combination with NSAID) for 4 weeks
- Subjects with significant pain improvement (NRS <4) were randomized to receive either tramadol/APAP or NSAID for 8 weeks
- On days 29 and 57, Western Ontario and McMaster Universities (WOMAC) OA index score measured
- Secondary measures included pain intensity (NRS), pain relief score, and subjects’ and investigators’ overall medication assessments
- Of 143 subjects enrolled, 112 completed 4-week tramadol/APAP and NSAID combination phase and 97 (67.8%) experienced significant pain improvement
- Of 97 subjects randomized, 36 in tramadol/APAP group and 47 in NSAID group completed the 8-week comparator study
- On days 29 and 57, WOMAC scores and pain intensities did not increase in both groups compared to measurements immediately after combination therapy
- At these 2 time points, there were no significant differences in WOMAC scores, pain intensities, and other secondary measures between the 2 groups
- Overall AE rates were similar in both groups
- Tramadol/APAP add-on significantly improved knee OA pain which had been inadequately controlled by NSAIDs
