Dataset Information

Celecoxib versus diclofenac for the treatment of ankylosing spondylitis: 12-week randomized study in Norwegian patients.

ABSTRACT: To compare the efficacy and safety of two different doses of celecoxib and diclofenac in the treatment of Norwegian patients with ankylosing spondylitis.In this 12-week, double-blind, non-inferiority trial patients were randomized to 200?mg once daily (qd) celecoxib, 400?mg qd celecoxib, or 50?mg three times daily (tid) diclofenac. The primary objective compared patients' assessments of Global Pain Intensity, measured on a visual analogue scale.A total of 330 patients were randomized (200?mg celecoxib, n?=?107; 400?mg celecoxib, n?=?108; diclofenac, n?=?115). Least squares mean changes in Global Pain Intensity at 12 weeks were -25.8?mm, -30.6?mm and -28.2?mm, respectively. Both celecoxib treatment groups were non-inferior to diclofenac. More patients in the 400?mg celecoxib group met the Assessments in Ankylosing Spondylitis 20 responder criteria at Week 12 (60.2%) than in the celecoxib 200?mg (51.4%) and the diclofenac 50?mg (57.4%) groups. Adverse events were mild-to-moderate in severity, with dyspepsia and diarrhoea the most commonly reported.Celecoxib and diclofenac both provided pain reduction, in addition to improvements in disease activity and functional capacity, in patients with ankylosing spondylitis.

SUBMITTER: Walker C

PROVIDER: S-EPMC5536700 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Celecoxib versus diclofenac for the treatment of ankylosing spondylitis: 12-week randomized study in Norwegian patients.

Walker Chris C Essex Margaret N MN Li Chunming C Park Peter W PW

The Journal of international medical research 20160315 3

<h4>Objective</h4>To compare the efficacy and safety of two different doses of celecoxib and diclofenac in the treatment of Norwegian patients with ankylosing spondylitis.<h4>Methods</h4>In this 12-week, double-blind, non-inferiority trial patients were randomized to 200 mg once daily (qd) celecoxib, 400 mg qd celecoxib, or 50 mg three times daily (tid) diclofenac. The primary objective compared patients' assessments of Global Pain Intensity, measured on a visual analogue scale.<h4>Results</h4>A ...[more]

PMID: 26980340

Similar Datasets

Project description:BackgroundAnkylosing spondylitis (AS) is a chronic inflammatory autoimmune disease. Kunxian capsule, a Chinese patent medicine which has been used in the treatment of immunologic diseases for many years in China, has anti-inflammatory and immunoregulatory effects. This study investigates the efficacy and safety of Kunxian capsules in the treatment of AS.MethodThis was a randomized, double-blind, parallel control clinical trial involving 80 patients with AS who fulfilled the modified New York criteria (1984) and had active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥40 mm under background stable nonsteroidal anti-inflammatory drugs (NSAIDs) for more than 4 weeks. Patients were randomly divided into two groups, the Kunxian group and the placebo group, and Kunxian (0.6 g, three times per day) and the placebo were provided for 12 weeks. The primary endpoint was the Assessment of SpondyloArthritis international Society (ASAS) 20 response rate at week 12. The secondary endpoints were ASAS 40, BASDAI 50, the Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), and Ankylosing Spondylitis Disease Activity Score on the basis of C-reactive protein level (ASDAS-CRP) at weeks 2, 6, and 12.ResultsThe primary endpoint of ASAS 20 at week 12 was achieved in 13 of 35 patients (37.1 %) among the Kunxian group, compared with 4 of 33 (12.1 %) in the placebo group (p < 0.05). Significant improvement (BASDAI 50) was also observed between the Kunxian group and the placebo group at week 6 (14 (40 %) and 5 (15.5 %), respectively, p < 0.05). At weeks 2, 6, and 12, the ASDAS-CRP level of the Kunxian group was significantly lower than that of the placebo group, especially at week 6 (p < 0.01). Kunxian obviously reduced CRP levels compared to placebo at weeks 2, 6, and 12 (p < 0.05). Compared with the placebo, Kunxian was associated with greater improvements in signs and symptoms of patients with AS from the baseline to week 12, and significant intergroup differences of additional composite indices of disease activity (i.e., erythrocyte sedimentation rate, patient global assessment of disease activity, total back pain, level of morning stiffness, tender joints, and BASFI scores) were also observed.ConclusionKunxian capsule significantly decreased the disease activity of patients with AS.Trial registrationNCT00953979 . Registered on 5 August 2009.

Project description:We have compared synovial biopsies from ankylosing spondylitis and undifferentiated spondylitis patients with healthy controls and osteoarthritis patients Objective: In spondylarthropies, whole-genome gene expression profiling studies have been limited to peripheral blood to date. By undertaking a study in knee synovial biopsies from spondylarthropy (SpA) and ankylosing spondylitis (AS) patients we aimed to identified joint-specific candidate genes and pathways. These pathways may mediate systemic inflammation driven joint damaging processes and more specifically, the osteoproliferation that is characteristic of these conditions. Methods: RNA was extracted from six seronegative SpA, two AS, three osteoarthritis (OA) and four normal control knee synovial biopsies. Whole genome expression profiling was undertaken using the Illumina DASL system, which assays 24000 cDNA probes. Differentially expressed candidate genes were then validated using quantitative PCR and immunohistochemistry. Results: 416 differentially expressed genes were identified that clearly delineated between AS/SpA and control groups. Pathway analysis showed altered gene-expression in oxidoreductase activity, osteoblast activity, B-cell associated, matrix catabolic, and metabolic pathways. The inflammatory mediator, MMP3, was strongly upregulated in AS/SpA samples and the Wnt pathway inhibitors DKK3 and Kremen1 were downregulated. Conclusion: Pathways mediating both systemic inflammation as well as local tissue changes were identified. This suggests initial systemic inflammation in spondylarthropies transfers to and persists in the local joint environment, subsequently mediating changes in genes directly involved in the destructive tissue remodelling. Fifteen knee synovial biopsy tissue samples consisting of six seronegative spondyloarthropy (SpA), two ankylosing spondylitis (AS), three osteoarthritis (OA) and four normal control biopsies were obtained from the Synovial Tissue Bank at the Repatriation General Hospital in Adelaide, South Australia with the appropriate ethical approval (Supplementary Table 1). All patients provided informed written consent.

Dataset Information

Celecoxib versus diclofenac for the treatment of ankylosing spondylitis: 12-week randomized study in Norwegian patients.

Publications

Celecoxib versus diclofenac for the treatment of ankylosing spondylitis: 12-week randomized study in Norwegian patients.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets