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This study is a population-based cohort of patients with ankylosing spondylitis (AS) from general medical practices in the UK, France, and Germany with a nested case control component to assess associations between drug exposures of interest and clinical outcomes relevant to patients using cyclooxygenase-2 (COX-2) inhibitors / nonsteroidal anti-inflammatory drugs (NSAIDS).
The main objective of the study is to describe in European participants with AS: 1) the use of etoricoxib 2) characteristics of those who use etoricoxib. 3) the safety profile of etoricoxib and other anti-inflammatory therapies with respect to specific clinical outcomes of interest relative to non-use of these medications and relative to each other.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposure | Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments |
| |
| Non-exposure | Ankylosing spondylitis patients not currently exposed to anti-inflammatory treatments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoricoxib | Drug | Cox-2 inhibitor |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of gastrointestinal ulcer, perforation or bleeding | First incident event for a given patient through 31-December-2017 | |
| Incidence rate of fatal or non-fatal acute myocardial infarction or unstable angina pectoris | First incident event for a given patient through 31-December-2017 | |
| Incidence rate of fatal or non-fatal ischemic stroke, or transient ischemic attack | First incident event for a given patient through 31-December-2017 | |
| Incidence rate of fatal or non-fatal hemorrhagic stroke | First incident event for a given patient through 31-December-2017 | |
| Incidence rate of deep venous thrombosis, pulmonary embolism, or peripheral arterial embolism or thrombosis | First incident event for a given patient through 31-December-2017 | |
| Incidence rate of acute renal impairment or failure | First incident event for a given patient through 31-December-2017 | |
| Incidence rate of hypertension | First incident event for a given patient through 31-December-2017 | |
| Incidence rate of congestive heart failure or left ventricular dysfunction | First incident event for a given patient through 31-December-2017 | |
| Incidence rate of sudden or unexplained death |
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Inclusion Criteria:
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This study will use the combination of the General Practice Research Database (GPRD) in the UK, The Health Improvement Network (THIN) database in the UK, and the IMS Disease Analyzer Database (Disease Analyzer) in the UK, France and Germany.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| Label | URL |
|---|---|
| EU PAS Register (EUPAS19094) | View source |
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| Other Cox-2 inhibitors |
| Drug |
Cox-2 inhibitor |
|
| Other Non-selective NSAIDs | Drug | Non-selective NSAID |
|
| No anti-inflammatory treatment | Other | No anti-inflammatory prescription |
|
| First incident event for a given patient through 31-December-2017 |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
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| ID | Term |
|---|---|
| D000077613 | Etoricoxib |
| ID | Term |
|---|---|
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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