Efficacy and safety of tramadol/acetaminophen tablets (Ultracet®) as add-on therapy for osteoarthritis pain in subjects receiving a COX-2 nonsteroidal antiinflammatory drug:: A multicenter, randomized, double-blind, placebo-controlled trial

被引:0
作者
Emkey, R
Rosenthal, N
Wu, SC
Jordan, D
Kamin, M
机构
[1] Radiant Res Reading, Wyomissing, PA 19610 USA
[2] Ortho McNeil Pharmaceut, Raritan, NJ USA
关键词
osteoarthritis; pain; tramadol; acetaminophen; cyclooxygenase2; celecoxib; rofecoxib;
D O I
暂无
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective. To evaluate the efficacy and safety of tramadol 37.5 mg/acetaminophen 325 mg combination tablets (tramadol/APAP) as add-on therapy for subjects with osteoarthritis (OA) pain inadequately controlled by COX-2 nonsteroidal antiinflammatory drugs (NSAID). Methods. This 91-day, multicenter, randomized, double-blind, placebo-controlled trial enrolled subjects with symptomatic OA for greater than or equal to 1 year who experienced at least moderate pain [visual analog scale (VAS) score greater than or equal to 50/100 mm] despite treatment with stable doses of celecoxib ( greater than or equal to 200 mg/day) or rofecoxib ( greater than or equal to 25 mg/day). Tramadol/APAP or matching placebo was titrated to 4 tablets/day on Day 10 and thereafter as needed up to 8 tablets/day. The primary efficacy measure was final 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. Results. Of 307 subjects randomized, 306 taking celecoxib (56.5%) or rofecoxib (43.5%) were included in the intent-to-treat population (n = 153 tramadol/APAP, 153 placebo). Mean final VAS scores for tramadol/APAP plus COX-2 NSAID were significantly lower than placebo plus COX-2 NSAID (41.5 vs 48.3; p = 0.025) and mean final pain relief rating scores were significantly higher (p = 0.002). Subjects taking tramadol/APAP showed significant improvements compared with placebo in subject/investigator medication assessments, as well as in the WOMAC Physical Function and the Medical Outcome Study Short Form-36 Role-Physical measures. The most common treatment-related adverse events for tramadol/APAP were somnolence (6.5%), nausea (4.6%), and constipation (3.3%). Mean tramadol/APAP dose was 4.1 tablets (154 mg tramadol/ 1332 mg APAP). Conclusion. Tramadol 37.5 mg/APAP 325 mg combination tablets were effective and safe as add-on therapy with COX-2 NSAID for treatment of OA pain. (J Rheumatol 2004;31:150-6).
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页码:150 / 156
页数:7
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