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Tramadol/Acetaminophen Combination Tablets for the Treatment of Pain Associated with Osteoarthritis Flare in an Elderly Patient Population

2004; Wiley; Volume: 52; Issue: 3 Linguagem: Inglês

10.1111/j.1532-5415.2004.52108.x

1532-5415

Norman Rosenthal, Joel C. Silverfield, Shu‐Chen Wu, Donna Jordan, Marc Kamin,

Pain Mechanisms and Treatments

Objectives: To evaluate the efficacy and safety of adding tramadol 37.5 mg/acetaminophen (APAP) 325 mg combination tablets (tramadol/APAP) to existing therapy for painful osteoarthritis (OA) flare in a subset of elderly patients. Design: Randomized, double‐blind, placebo‐controlled, 10‐day add‐on study. Setting: Thirty outpatient centers. Participants: Of 308 patients with painful OA flare, a subset of 113 patients aged 65 and older. Measurements: Average daily pain intensity and pain relief scores for Days 1 through 5 and secondary quality‐of‐life measures and medication assessments. Methods: Patients received one or two tramadol/APAP tablets or placebo four times per day for 10 days during ongoing nonselective or cyclooxygenase (COX)‐2–selective nonsteroidal antiinflammatory drug (NSAID) therapy. Results: Tramadol/APAP (n=69) was significantly superior to placebo (n=44) for average daily pain intensity ( P =.034) and pain relief ( P =.010) for Days 1 through 5 and Days 1 through 10 ( P =.012 and P =.019, respectively). Tramadol/APAP had significantly better investigator ( P <.001) and patient ( P =.001) overall medication assessments and significantly better scores on three of four Western Ontario and McMaster Universities Osteoarthritis Index measures ( P ≤.027). Most common adverse events with tramadol/APAP were nausea (18.8%), vomiting (13.0%), dizziness (11.6%), and constipation (4.3%), with an incidence similar to that of the overall study population. Mean daily dose of tramadol/APAP was 4.5 tablets (168 mg/1,458 mg). Conclusion: Tramadol/APAP add‐on therapy effectively managed painful OA flare in this elderly subset and was generally well tolerated.