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| ID | Type | Description | Link |
|---|---|---|---|
| EP07013.013.11.082 | Other Identifier | Merck |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with SpA/AS and etoricoxib treatment |
| ||
| Patients with SpA/AS and other COX-2 inhibitor treatment |
| ||
| Patients with SpA/AS and nsNSAIDs treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etoricoxib | Drug | Patients with SpA/AS who took etoricoxib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with Characteristics of inflammatory SPA/AS | Over a 12 year period (2001-2013) | |
| Number of patients who used etoricoxib | Up to 7 1/2 years (Q3 2005 - 2013) | |
| Number of patients who used other COX-2 inhibitors | Up to 7 1/2 years (Q3 2005 - 2013) | |
| Number of patients who used nsNSAIDs | Up to 7 1/2 years (Q3 2005 - 2013) | |
| Number of clinical outcomes of special interest | Up to 7 1/2 years (Q3 2005 - 2013) |
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Inclusion Criteria:
Exclusion Criteria:
Not applicable.
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Out-patients in Sweden with SpA/AS who took etoricoxib, other COX-2 inhibitors, or nsNSAIDs from 2001-2010.
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| Label | URL |
|---|---|
| EU PAS Register (EUPAS19202) | View source |
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| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D013166 | Spondylitis |
| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000077613 | Etoricoxib |
| ID | Term |
|---|---|
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
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| Other COX-2 inhibitor | Drug | Patients with SpA/AS who took other COX-2 inhibitors |
|
| nsNSAIDs | Drug | Patients with SpA/AS who took nsNSAIDs |
|
| D001168 |
| Arthritis |
| D007592 | Joint Diseases |
| D001850 | Bone Diseases, Infectious |
| D007239 | Infections |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |