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Title: Tramadol/Acetaminophen Helpful as Add-On Therapy for Arthritis Patients Taking COX-2 NSAIDS: Presented at APS

"Tramadol/Acetaminophen Helpful as Add-On Therapy for Arthritis Patients Taking COX-2 NSAIDS: Presented at APS"

By Jill Stein Special to DG News BALTIMORE, MD -- March 18, 2002 --The combination analgesic tramadol/acetaminophen (APAP) can safely provide additional pain relief for osteoarthritis patients who are taking COX-2 non-steroidal anti-inflammatory agents (NSAID). Dr. Norman Rosenthal and associates at Ortho-McNeil Pharmaceutical in Raritan, New Jersey, United States, described the results of a 91-day, multi-center, randomized double-blind study. Participants were outpatients with symptomatic osteoarthritis and inadequately controlled pain of the knee or hip (pain visual analog (PVA) score greater than or equal to 50 mm) despite COX-2 NSAID therapy for at least two weeks. The study's findings were presented at the 21st Annual Scientific Meeting of the American Pain Society (APS) Following a wash-out phase of all non-COX-2 NSAID analgesics, patients were randomized to receive add-on tramadol/APAP or placebo, 37.5 mg/375 mg. The medication was titrated by one tablet every three days to a total of four tablets per day on day ten, and then as needed to a maximum of eight tablets per day. The intent-to-treat population consisted of 306 patients, most of whom had knee pain. The baseline mean PVA scores were 69.0 for tramadol/APAP and 69.5 for placebo. Tramadol/APAP demonstrated significantly superior efficacy compared to placebo for the primary efficacy variable, the final PVA score; the mean final PVA score was 41.5 mm in the tramadol/APAP group and 48.3 mm in the placebo group. The mean change from baseline PVA score was larger in the tramadol/APAP group (-27.5 mm) than in the placebo group (-21.2 mm). The mean final pain relief score was significantly higher in the tramadol/APAP group than in the placebo group. Most adverse events were mild to moderate, and there did not appear to be a specific drug interaction between tramadol/APAP and any COX-2 NSAID. Overall, the data indicate that the combination analgesic tablet tramadol/APAP is better than placebo for the treatment of pain associated with osteoarthritis in patients for whom COX-2 NSAIDs provide insufficient pain relief.

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