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Randomized Controlled Trial
. 2016 Jun;44(3):483-95.
doi: 10.1177/0300060516628704. Epub 2016 Mar 15.

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

Chris Walker  1 , Margaret N Essex  2 , Chunming Li  2 , Peter W Park  2
Affiliations
Randomized Controlled Trial

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

Chris Walker et al. J Int Med Res. 2016 Jun.

Abstract

Objective: To compare the efficacy and safety of two different doses of celecoxib and diclofenac in the treatment of Norwegian patients with ankylosing spondylitis.

Methods: 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.

Results: 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.

Conclusions: Celecoxib and diclofenac both provided pain reduction, in addition to improvements in disease activity and functional capacity, in patients with ankylosing spondylitis.

Keywords: COX-2 inhibitors; ankylosing spondylitis; celecoxib; non-steroidal anti-inflammatory drugs.

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Figures

Figure 1.
Figure 1.
Overview of study design for a Norwegian trial comparing the efficacy and safety of celecoxib 200 and 400 mg once daily (qd) and diclofenac 50 mg three times daily (tid) in patients with ankylosing spondylitis.
Figure 2.
Figure 2.
Patient disposition in a Norwegian trial comparing the efficacy and safety of celecoxib 200 and 400 mg once daily (qd) and diclofenac 50 mg three times daily (tid) in treatment of ankylosing spondylitis.
Figure 3.
Figure 3.
Change from baseline in Global Pain Intensity at Week 12 in Norwegian patients with ankylosing spondylitis treated with celecoxib 200 or 400 mg daily (qd) or diclofenac 50 mg three times daily (tid): intention-to-treat population. LS mean, least squares mean.
See this image and copyright information in PMC

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