Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163)

• Incidence rate of gastrointestinal ulcer, perforation or bleeding [ Time Frame: First incident event for a given patient through 31-December-2017 ] [ Designated as safety issue: Yes ]
• Incidence rate of fatal or non-fatal acute myocardial infarction or unstable angina pectoris [ Time Frame: First incident event for a given patient through 31-December-2017 ] [ Designated as safety issue: Yes ]
• Incidence rate of fatal or non-fatal ischemic stroke, or transient ischemic attack [ Time Frame: First incident event for a given patient through 31-December-2017 ] [ Designated as safety issue: Yes ]
• Incidence rate of fatal or non-fatal hemorrhagic stroke [ Time Frame: First incident event for a given patient through 31-December-2017 ] [ Designated as safety issue: Yes ]
• Incidence rate of deep venous thrombosis, pulmonary embolism, or peripheral arterial embolism or thrombosis [ Time Frame: First incident event for a given patient through 31-December-2017 ] [ Designated as safety issue: Yes ]
• Incidence rate of acute renal impairment or failure [ Time Frame: First incident event for a given patient through 31-December-2017 ] [ Designated as safety issue: Yes ]
• Incidence rate of hypertension [ Time Frame: First incident event for a given patient through 31-December-2017 ] [ Designated as safety issue: Yes ]
• Incidence rate of congestive heart failure or left ventricular dysfunction [ Time Frame: First incident event for a given patient through 31-December-2017 ] [ Designated as safety issue: Yes ]
• Incidence rate of sudden or unexplained death [ Time Frame: First incident event for a given patient through 31-December-2017 ] [ Designated as safety issue: Yes ]

• Incidence rate of gastrointestinal ulcer, perforation or bleeding [ Time Frame: First incident event for a given patient through 31-December-2008 ] [ Designated as safety issue: Yes ]
• Incidence rate of fatal and non-fatal acute myocardial infarction and unstable angina pectoris [ Time Frame: First incident event for a given patient through 31-December-2008 ] [ Designated as safety issue: Yes ]
• Incidence rate of fatal and non-fatal ischemic stroke, or transient ischemic attack [ Time Frame: First incident event for a given patient through 31-December-2008 ] [ Designated as safety issue: Yes ]
• Incidence rate of fatal and non-fatal hemorrhagic stroke [ Time Frame: First incident event for a given patient through 31-December-2008 ] [ Designated as safety issue: Yes ]
• Incidence rate of deep venous thrombosis or pulmonary embolism [ Time Frame: First incident event for a given patient through 31-December-2008 ] [ Designated as safety issue: Yes ]
• Incidence rate of acute renal impairment or failure [ Time Frame: First incident event for a given patient through 31-December-2008 ] [ Designated as safety issue: Yes ]
• Incidence rate of hypertension [ Time Frame: First incident event for a given patient through 31-December-2008 ] [ Designated as safety issue: Yes ]
• Incidence rate of congestive heart failure or left ventricular dysfunction [ Time Frame: First incident event for a given patient through 31-December-2008 ] [ Designated as safety issue: Yes ]
• Incidence rate of sudden or unexplained death [ Time Frame: First incident event for a given patient through 31-December-2008 ] [ Designated as safety issue: Yes ]

This is a descriptive study of a cohort of patients with ankylosing spondylitis and use of etoricoxib in this population. It also includes a nested case-control analysis (when greater than or equal to 700 events of a given type are available for analysis) that will estimate the odds of current exposure to etoricoxib, and to various other anti-inflammatory treatments, compared with non-exposure to any such treatments, for the clinical outcomes of interest in European patients with Ankylosing Spondylitis.

The study population and follow-up time will be refreshed / added to annually, and the analysis re-run annually on a cumulative basis until 2017.

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.

• Exposure
  Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments
• Non-exposure
  Ankylosing spondylitis patients not currently exposed to anti-inflammatory treatments

Inclusion Criteria:

• A recorded Ankylosing Spondylitis diagnosis in the database
• A recorded AS diagnosis following the applicable "acceptable data quality" date for the database that contains the patient's records
• At least 6 months of registered medical records in the database after the applicable "acceptable data quality" date as described above, and prior to the recorded AS diagnosis
• Complete information on gender and birth year