Safety of Etoricoxib (MK-0663) in Patients With Spondyloarthropathy (SpA)/Ankylosing Spondylitis (AS) in Sweden (EP07013.013.11.082)

Organon

Status

Completed

Conditions

Spondylarthropathies; Spondylitis, Ankylosing

Treatments

Drug: etoricoxib

Drug: Other COX-2 inhibitor

Drug: nsNSAIDs

Study type

Observational

Funder types

Industry

Identifiers

EP07013.013.11.082 (Other Identifier)

0663-159

Details and patient eligibility

About

The study is intended to provide additional post-marketing safety data regarding the use of etoricoxib for the indication of ankylosing spondylitis.

Full description

The specific project objectives are to:

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.

Enrollment

21,108 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participant attended an out-patient clinic 2001-2010.
Participant is registered with an International Classification of diseases (ICD, Version 10)-code corresponding to SpA/AS and AS.

Exclusion criteria

Not applicable.