title: A 13-week, multicenter, randomized, double-blind study of lumiracoxib in hip osteoarthritis.
abstract: The aim of this 13-week, multicenter, randomized, double-blind, double-dummy, placebo- and positive-internal (celecoxib)-controlled, parallel-group study was to demonstrate the efficacy, safety, and tolerability of lumiracoxib in primary hip osteoarthritis (OA) patients. Eligible patients (n = 1,262; ACR criteria) were randomized (1:1:1) to receive lumiracoxib 100 mg once daily (o.d.) (n = 427), celecoxib 200 mg o.d. (n = 419), or matching placebo o.d. (n = 416) administered orally. The primary objective was to compare lumiracoxib 100 mg o.d. and placebo with respect to three co-primary efficacy variables: the pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index Likert version 3.1 (WOMAC™ LK 3.1) questionnaire, the function subscale of the WOMAC™ LK 3.1 questionnaire, and patient's global assessment of disease activity (100-mm visual analog scale (VAS)) after 13 weeks of treatment. Of the 1,262 randomized patients, 951 completed the study. All randomized patients were included in the intention-to-treat and safety populations. Lumiracoxib was superior to the placebo (p < 0.001) after 13 weeks for all three co-primary endpoints. By week 13, the patient's global assessment of disease activity (100-mm VAS) improved by 23.3 mm (±SD, 27.83 mm) with lumiracoxib and 13.3 mm (±26.71 mm) with placebo. The WOMAC™ function score decreased by 10.4 (±13.56) with lumiracoxib and 6.8 (±12.55) with placebo. The WOMAC™ pain scores decreased by 3.4 (±4.16) with lumiracoxib and 2.2 (±3.94) with placebo at week 13. Similar results were observed for secondary endpoints: OA pain intensity and WOMAC™ total score. Lumiracoxib was similar to celecoxib for all three co-primary endpoints. All treatments were well tolerated. In conclusion, lumiracoxib is effective in reducing pain and improving function in hip OA patients.
authors: Northwestern University Feinberg School of Medicine, 710 N. Lake Shore Drive, Chicago, IL 60611, USA. tjs@northwestern.edu
authors: Thomas J
authors: TJ
authors: Schnitzer
authors: I Dan
authors: ID
authors: Dattani
authors: Bruno
authors: B
authors: Seriolo
authors: Hartmut
authors: H
authors: Schneider
authors: Alan
authors: A
authors: Moore
authors: Lillian
authors: L
authors: Tseng
authors: Peter
authors: P
authors: Sallstig
authors: Rosemary
authors: R
authors: Rebuli
authors: Thomas
authors: T
authors: Maxwell
references: Osteoarthritis Cartilage. 2008 Feb;16(2):137-62
references: 18279766
references: Osteoarthritis Cartilage. 2010 Apr;18(4):476-99
references: 20170770
references: Arthritis Rheum. 1998 May;41(5):778-99
references: 9588729
references: Clin Ther. 2005 Jan;27(1):64-77
references: 15763607
references: Arthritis Res Ther. 2007;9(1):R11
references: 17266764
references: Lancet. 2004 Aug 21-27;364(9435):665-74
references: 15325831
references: Curr Med Res Opin. 2005 Apr;21(4):517-26
references: 15899100
references: Ann Rheum Dis. 2006 Jun;65(6):781-4
references: 16269428
references: Clin Rheumatol. 2006 Feb;25(1):42-53
references: 16132165
references: Osteoarthritis Cartilage. 2002 Apr;10(4):290-6
references: 11950252
references: Ann Rheum Dis. 2005 Apr;64(4):655-6; author reply 656
references: 15769931
references: J Int Med Res. 2001 Nov-Dec;29(6):467-79
references: 11803730
references: Osteoarthritis Cartilage. 2007 Sep;15(9):981-1000
references: 17719803
references: Ann Rheum Dis. 2005 May;64(5):669-81
references: 15471891
references: Arthritis Rheum. 2000 Sep;43(9):1905-15
references: 11014340
references: Ann Rheum Dis. 2005 Jan;64(1):29-33
references: 15208174
references: Lancet. 2004 Aug 21-27;364(9435):675-84
references: 15325832
references: Nat Genet. 2010 Aug;42(8):711-4
references: 20639878