The study is intended to provide additional post-marketing safety data regarding the use of etoricoxib for the indication of ankylosing spondylitis.
The specific project objectives are to: 1\) Describe the characteristics of Swedish patients with inflammatory SpA/AS ; 2) Describe the use of etoricoxib and other cyclooxygenase-2 (COX-2 inhibitors)/non-selective nonsteroidal anti-inflammatory drugs (nsNSAIDs) in Swedish patients with SpA/AS; and 3) Estimate and compare the rates of clinical outcomes of special interest (gastrointestinal, renovascular, cardiovascular and cerebrovascular) with use of etoricoxib and other COX-2 inhibitors/nsNSAIDs in Swedish patients with SpA/AS. Comparisons of clinical outcomes among the drugs of interest will be made by descriptive comparison of the point estimates for the incidence rates and their associated 95% confidence intervals (CIs), using both clinical and epidemiological judgment and in light of the limitations of this observational study. No formal statistical significance testing will be performed for purposes of such comparisons.
Study Type
OBSERVATIONAL
Enrollment
21,108
Patients with SpA/AS who took etoricoxib
Patients with SpA/AS who took other COX-2 inhibitors
Patients with SpA/AS who took nsNSAIDs
Number of patients with Characteristics of inflammatory SPA/AS
Time frame: Over a 12 year period (2001-2013)
Number of patients who used etoricoxib
Time frame: Up to 7 1/2 years (Q3 2005 - 2013)
Number of patients who used other COX-2 inhibitors
Time frame: Up to 7 1/2 years (Q3 2005 - 2013)
Number of patients who used nsNSAIDs
Time frame: Up to 7 1/2 years (Q3 2005 - 2013)
Number of clinical outcomes of special interest
Time frame: Up to 7 1/2 years (Q3 2005 - 2013)
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