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Wiley InterScience | |||||||
  Journal of the American Geriatrics SocietyVolume 52 Issue 3, Pages 374 - 380 Published Online: 12 Feb 2004 Journal compilation 2010 The American Geriatrics Society/Wiley Periodicals, Inc.
Abstract | References | Full Text: HTML, PDF (Size: 99K) | Related Articles | Citation Tracking  Tramadol/Acetaminophen Combination Tablets for the Treatment of Pain Associated with Osteoarthritis Flare in an Elderly Patient Population Copyright © 2004 by the American Geriatrics Society KEYWORDS nonsteroidal antiinflammatory drug (NSAIDS) • COX-2–selective NSAIDs • elderly • osteoarthritis • painful OA flare • tramadol/acetaminophen • ULTRACET ABSTRACTObjectives: 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. | 
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