Tramadol 37.5-mg/acetaminophen 325-mg combination tablets added to regular therapy for rheumatoid arthritis pain: A 1-Week, randomized, double-blind, placebo-controlled trial

Clinical Therapeutics

Volumn 28, Issue 12, 2006, Pages 2052-2060

  Lee, Eun Young ^a   Lee, Eun Bong ^a   Park, Byung Joo ^a   Lee, Chang Keun ^b   Yoo, Bin ^b   Lim, Mi Kyoung ^c   Shim, Seung Cheol ^c   Sheen, Dong Hyuk ^c   Seo II, Young ^d   Ah Kim, Hyun ^d   Baek, Han Joo ^e   Song, Yeong Wook ^a  

^a Seoul National University College of Medicine   (South Korea)

^b Asan Medical Center   (South Korea)

^c Eulji University School of Medicine   (South Korea)

^d Hallym University   (South Korea)

^e Gachon University College of Medicine   (South Korea)

Author keywords

acetaminophen; combination therapy; pain; rheumatoid arthritis; tramadol

Indexed keywords

ANALGESIC AGENT; AZATHIOPRINE; BUCILLAMINE; CYCLOSPORIN; DISEASE MODIFYING ANTIRHEUMATIC DRUG; GLUCOCORTICOID; HYDROXYCHLOROQUINE; LEFLUNOMIDE; METHOTREXATE; NONSTEROID ANTIINFLAMMATORY AGENT; PARACETAMOL; PLACEBO; SALAZOSULFAPYRIDINE; TRAMADOL;

ABDOMINAL PAIN; ADD ON THERAPY; ADULT; ANALGESIA; ANOREXIA; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FORMULATION; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FUNCTIONAL ASSESSMENT; HEADACHE; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; OUTCOME ASSESSMENT; PAIN; POPULATION MODEL; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; RHEUMATOID ARTHRITIS; SCORING SYSTEM; SOMNOLENCE; STATISTICAL ANALYSIS; THORAX PAIN; TREATMENT PLANNING; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; VISUAL ANALOG SCALE; VOMITING;

ACETAMINOPHEN; ADULT; AGED; ANALGESICS; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; MALE; MIDDLE AGED; PAIN; PAIN MEASUREMENT; RECOVERY OF FUNCTION; TABLETS; TRAMADOL; TREATMENT OUTCOME;

EID: 33846794530     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2006.12.019     Document Type: Article

References (25)

1. Smolen J.S., Aletaha D., and Keystone E. Superior efficacy of combination therapy for rheumatoid arthritis: Fact or fiction?. Arthritis Rheum. 52 (2005) 2975-2983
2. Suresh E., and Lambert C.M. Combination treatment strategies in early rheumatoid arthritis. Ann Rheum Dis. 64 (2005) 1252-1256
3. Newsome G., and American College of Rheumatology. Guidelines for the management of rheumatoid arthritis: 2002 Update. J Am Acad Nurse Pract. 14 (2002) 432-437
4. Payne R. Limitations of NSAIDs for pain management: Toxicity or lack of efficacy?. J Pain 1 Suppl 3 (2000) 14-18
5. [published correction appears in N Engl J Med. 1999;341:548]. Wolfe M.M., Lichtenstein D.R., and Singh G. Gastrointestinal toxicity of nonsteroidal anti inflammatory drugs. N Engl J Med. 340 (1999) 1888-1899
6. Perneger T.V., Whelton P.K., and Klag M.J. Risk of kidney failure associated with the use of acetaminophen, aspirin, and nonsteroidal anti inflammatory drugs. N EngI J Med. 331 (1994) 1675-1679
7. Svensson B., Boonen A., Albertsson K., et al. Low-dose prednisolone in addition to the initial disease-modifying antirheumatic drug in patients with early active rheumatoid arthritis reduces joint destruction and increases the remission rate: A two-year randomized trial. Arthritis Rheum. 52 (2005) 3360-3370
8. Wassenberg S., Rau R., Steinfeld P., and Zeidler H. Very lowdose prednisolone in early rheumatoid arthritis retards radiographic progression over two years: A multicenter, double-blind, placebo-controlled trial. Arthritis Rheum. 52 (2005) 3371-3380
9. American Medical Directors Association. Chronic Pain Management in the Long-Term Care Setting: Clinical Practice Guideline (1999), AMDA, Columbia, Md
10. Muth-Selbach U.S., Tegeder I., Brune K., and Geisslinger G. Acetaminophen inhibits spinal prostaglandin E2 release after peripheral noxious stimulation. Anesthesiology 91 (1999) 231-239
11. Bjorkman R., Hallman K.M., Hedner J., et al. Acetaminophen blocks spinal hyperalgesia induced by NMDA and substance P. Pain 57 (1994) 259-264
12. Seideman P. Additive effect of combined naproxen and paracetamol in rheumatoid arthritis. Br J Rheumatol. 32 (1993) 1077-1082
13. Raffa R.B., Friderichs E., Reimann W., et al. Opioid and nonopioid components independently contribute to the mechanism of action of tramadol, an 'atypical' opioid analgesic. J Pharmacol Exp Ther. 260 (1992) 275-285
14. Medve R.A., Wang J., and Karim R. Tramadol and acetaminophen tablets for dental pain. Anesth Prog. 48 (2001) 79-81
15. Mullican W.S., Lacy J.R., and TRAMAP-ANAG-006 Study Group. Tramadol/acetaminophen combina tion tablets and codeine/acetaminophen combination capsules for the management of chronic pain: A comparative trial. Clin Ther. 23 (2001) 1429-1445
16. Emkey R., Rosenthal N., Wu S.C., et al., CAPSS-114 Study Group. 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,doubleblind,placebo-control led trial. J Rheumatol. 31 (2004) 150-156
17. Rosenthal N.R., Silverfield J.C., Wu S.C., et al., CAPSS-105 Study Group. Tramadol/acetaminophen combination tablets for the treatment of pain associated with osteoarthritis flare in an elderly patient population. J Am Geriatr Soc. 52 (2004) 374-380
18. Arnett F.C., Edworthy S.M., Bloch D.A., et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 31 (1988) 315-324
19. Bae S.C., Cook E.F., and Kim S.Y. Psychometric evaluation of a Korean Health Assessment Questionnaire for clinical research. J Rheumatol. 25 (1998) 1975-1979
20. Silverfield J.C., Kamin M., Wu S.C., Rosenthal N., and CAPSS-105 Study Group. Tramadol/acetamino phen combination tablets for the treatment of osteoarthritis flare pain: A multicenter, outpatient, randomized, double-blind, placebocontrolled, parallel-group, add-on study. Clin Ther. 24 (2002) 282-297
21. Krug H., Broadwell L.K., Berry M., et al. Tolerability and efficacy of nabumetone and naproxen in the treatment of rheumatoid arthritis. Clin Ther. 22 (2000) 40-52
22. Silverstein F.E., Faich G., Goldstein J.L., et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal antiinflammatory drugs for osteoarthritis and rheumatoid arthritis: The CLASS study: A randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. JAMA 284 (2000) 1247-1255
23. Fricke Jr. J.R., Karim R., Jordan D., and Rosenthal N. A double-blind, singledose comparison of the analgesic efficacy of tramadol/acetaminophen combination tablets, hydrocodone/ acetaminophen combination tablets, and placebo after oral surgery. Clin Ther. 24 (2002) 953-968
24. Petrone D., Kamin M., and Olson W. Slowing the titration rate of tramadol HCl reduces the incidence of discontinuation due to nausea and/ or vomiting: A double-blind randomized trial. J Clin Pharm Ther. 24 (1999) 115-123
25. Ruoff G.E. Slowing the initial titration rate of tramadol improves tolerability. Pharmacotherapy 19 (1999) 88-93