A randomized, double-blind, placebo-controlled 12 week trial of acetaminophen extended release for the treatment of signs and symptoms of osteoarthritis

Current Medical Research and Opinion

Volumn 30, Issue 11, 2014, Pages 2377-2387

  Prior, Mary Jane ^a   Harrison, Diane D ^b   Frustaci, Mary Ellen ^b  

^a McNeil Laboratories Inc   (United States)

^b JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

Acetaminophen; Efficacy; Osteoarthritis; Pain; Randomized controlled trial

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; DEXTROPROPOXYPHENE; PARACETAMOL; PLACEBO; ANALGESIC AGENT; DELAYED RELEASE FORMULATION;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AMINOTRANSFERASE BLOOD LEVEL; ANGINA PECTORIS; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CONGESTIVE HEART FAILURE; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; FEMALE; GASTRITIS; HEADACHE; HEART ATRIUM FIBRILLATION; HIP OSTEOARTHRITIS; HIP PAIN; HUMAN; HYPERTENSION; KIDNEY CYST; KIDNEY TUMOR; KNEE OSTEOARTHRITIS; KNEE PAIN; LEG FRACTURE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; NAUSEA; NOTTINGHAM HEALTH PROFILE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SUSTAINED DRUG RELEASE; THORAX PAIN; TREATMENT RESPONSE; UROSEPSIS; WOMAC PHYSICAL FUNCTION SUBSCALE SCORE; AGED; CLINICAL TRIAL; COMPLICATION; DELAYED RELEASE FORMULATION; DRUG ADMINISTRATION; MIDDLE AGED; OSTEOARTHRITIS, HIP; OSTEOARTHRITIS, KNEE; PAIN; PAIN MEASUREMENT; TREATMENT OUTCOME; YOUNG ADULT;

ACETAMINOPHEN; ADULT; AGED; ANALGESICS, NON-NARCOTIC; DELAYED-ACTION PREPARATIONS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MALE; MIDDLE AGED; OSTEOARTHRITIS, HIP; OSTEOARTHRITIS, KNEE; PAIN; PAIN MEASUREMENT; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84908617629     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007995.2014.949646     Document Type: Article

References (26)

1. Lawrence RC, Felson DT, Helmick CG, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States: part II. Arthritis Rheum 2008;58:26-35
2. Felson DT. Osteoarthritis. In: Longo DL, Fauci AS, Kasper DL, et al, eds. Harrisons Principles of Internal Medicine, 18th edn. New York, NY: McGraw-Hill, 2012:2828-36
3. Bradley JD, Brandt KD, Katz BP, et al. Comparison of an anti-inflammatory dose of ibuprofen, an analgesic dose of ibuprofen, and acetaminophen in the treatment of patients with osteoarthritis of the knee. N Engl J Med 1991;325:87-91
4. Dillon CF, Rasch EK, Gu Q, Hirsch R. Prevalence of knee osteoarthritis in the United States: arthritis data from the Third National Health and Nutrition Examination Survey 1991-94. J Rheumatol 2006;33:2271-9
5. Jordan JM, Helmick CG, Renner JB, et al. Prevalence of hip symptoms and radiographic and symptomatic hip osteoarthritis in African Americans and Caucasians: the Johnson County Osteoarthritis Project. J Rheumatol 2009;36:809-15
6. Losina E, Weinstein AM, Reichmann WM, et al. Lifetime risk and age at diagnosis of symptomatic knee osteoarthritis in the US. Arthritis Care Res 2013;65:703-11
7. Murphy L, Schwartz TA, Helmick CG, et al. Lifetime risk of symptomatic knee osteoarthritis. Arthritis Rheum 2008;59:1207-13
8. Murphy LB, Helmick CG, Schwartz TA, et al. One in four people may develop symptomatic hip osteoarthritis in his or her lifetime. Osteoarthritis Cartilage 2010;18:1372-9
9. Hochberg MC, Altman RD, April KT, et al. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res 2012;64:465-74
10. Zhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management of hip and knee osteoarthritis, part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage 2008;16:137-62
11. Zhang W, Nuki G, Moskowitz RW, et al. OARSI recommendations for the management of hip and knee osteoarthritis, part III: changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage 2010;18:476-99
12. Zhang W, Doherty M, Leeb BF, et al. EULAR evidence based recommendations for the management of hand osteoarthritis: report of a task force of the EULAR standing committee for international clinical studies including therapeutics (ESCISIT). Ann Rheum Dis 2007;66:377-88
13. Zhang W, Doherty M, Arden N, et al. EULAR evidence based recommendations for the management of hip osteoarthritis: report of a task force of the EULAR standing committee for international clinical studies including therapeutics (ESCISIT). Ann Rheum Dis 2005;64:669-81
14. Tylenol Arthritis Pain acetaminophen extended-release caplets. In: Physicians Desk Reference 67th edn. Montvale, NJ: PDR Network, 2013:1350-1
15. Altman R, Asch E, Bloch D, et al. Development of criteria for the classification and reporting of osteoarthritis: classification of osteoarthritis of the knee. Arthritis Rheum 1986;29:1039-49
16. Hochberg M, Altman R, Brandt K, et al. Guidelines for the medical management of osteoarthritis. Part I. Osteoarthritis of the hip. Arthritis Rheum 1995;38:1535-40
17. Altman R, Akarcón G, Appelrouth D, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum 1991;35:505-14
18. Kellgren JH, Lawrence JS. Radiological assessment of osteo-Arthrosis. Ann Rheum Dis 1957;16:494-501
19. Altman R, Brandt K, Hochberg M, et al. Design and conduct of clinical trials in patients with osteoarthritis: recommendations from a task force of the Osteoarthritis Research Society. Osteoarthritis Cartilage 1996;4: 217-43
20. Brandt KD, Doherty M, Lohmander LS, eds. Osteoarthritis. New York, NY: Oxford University Press, 1998
21. Hochberg MC, Chang RW, Dwosh I, et al. The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis. Arthritis Rheum 1992;35:498-502
22. Kuffner EK, Temple AR, Cooper KM, et al. Retrospective analysis of transient elevations in alanine aminotransferase during long-Term treatment with acetaminophen in osteoarthritis clinical trials. Curr Med Res Opin 2006;22:2137-48
23. Altman RD, Zinsenheim JR, Temple AR, Schweinle JE. Three-month efficacy and safety of acetaminophen extended-release for osteoarthritis pain of the hip or knee: a randomized, double-blind, placebo-controlled study. Osteoarthritis Cartilage 2007;15:454-61
24. Yelland MJ, Nikles CJ, McNairn N, et al. Celecoxib compared with sustainedrelease paracetamol for osteoarthritis: a series of n-of-1 trials. Rheumatology 2007;46:135-40
25. Schnitzer TJ, Tesser JRP, Cooper KM, Altman RD. A 4-week randomized study of acetaminophen extended-release vs rofecoxib in knee osteoarthritis. Osteoarthritis Cartilage 2009;17:1-7
26. Lee SH, Kim SI, Yoo WH, et al. The comparison of the efficacy and gastrointestinal side effects of Tylenol-ER (extended relief) and naproxen in the treatment of osteoarthritis of the knee: multicenter trial. J Korean Rheum Arthritis Soc 1998;5:211-20