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Tramadol/Acetaminophen Add-On Therapy Benefits Patients With Osteoarthritis
Combination tablets of tramadol 37.5 mg/acetaminophen 325 mg (tramadol/APAP) appear to be effective and safe as add-on therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) for treatment of osteoarthritis pain.
COX-2 selective NSAIDs are commonly prescribed as monotherapy for osteoarthritis (OA) pain; however, this strategy alone may not adequately relieve pain, whereas combining analgesics may potentially improve efficacy and safety.
Ronald Emkey, MD, with Radiant Research/Reading, Wyomissing, Pennsylvania, United States, and colleagues conducted a 91-day multicentre trial in subjects who had symptomatic OA for 1 year or more. Patients experienced at least moderate pain despite treatment with stable doses of celecoxib (200 mg/day or more) or rofecoxib (25 mg/day or more).
Tramadol/APAP or placebo was titrated to 4 tablets/day on day 10 and up to 8 tablets/day thereafter as needed. The primary efficacy measure was final visual analog scale (VAS) score; secondary measures included final pain relief rating scores, subject/investigator overall medication assessments, rate and time to discontinuation due to lack of efficacy, and selected quality-of-life/physical functioning scores.
Of 307 subjects randomised, 306 taking celecoxib (56.5%) or rofecoxib (43.5%) were included in the intent-to-treat population (n = 153 tramadol/APAP, 153 placebo). Mean tramadol/APAP dose was 4.1 tablets (154 mg tramadol/ 1332 mg APAP).
Mean final VAS scores for tramadol/APAP plus COX-2 NSAID were significantly lower than placebo plus COX-2 NSAID (P = .025), and mean final pain relief rating scores were significantly higher (P = .002). In addition, several other measures indicated that subjects taking tramadol/APAP significantly improved compared to those taking placebo.
The most common treatment-related adverse events for tramadol/APAP were somnolence (6.5%), nausea (4.6%), and constipation (3.3%), the researchers note.
Source : www.medicinenet.com
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