A Nested Case-control Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in a Cohort of Patients With Ankylosing Spondylitis (AS) in the UK, France and Germany
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27,381
- 主要终点
- Incidence rate of fatal or non-fatal hemorrhagic stroke
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Exposure
Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments
干预措施: Other Cox-2 inhibitors (Drug)
Exposure
Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments
干预措施: Other Non-selective NSAIDs (Drug)
Non-exposure
Ankylosing spondylitis patients not currently exposed to anti-inflammatory treatments
干预措施: No anti-inflammatory treatment (Other)
Exposure
Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments
干预措施: Etoricoxib (Drug)
结局指标
主要结局
Incidence rate of fatal or non-fatal hemorrhagic stroke
时间窗: 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
时间窗: First incident event for a given patient through 31-December-2017
Incidence rate of fatal or non-fatal ischemic stroke, or transient ischemic attack
时间窗: 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
时间窗: First incident event for a given patient through 31-December-2017
Incidence rate of acute renal impairment or failure
时间窗: First incident event for a given patient through 31-December-2017
Incidence rate of sudden or unexplained death
时间窗: First incident event for a given patient through 31-December-2017
Incidence rate of gastrointestinal ulcer, perforation or bleeding
时间窗: First incident event for a given patient through 31-December-2017
Incidence rate of hypertension
时间窗: First incident event for a given patient through 31-December-2017
Incidence rate of congestive heart failure or left ventricular dysfunction
时间窗: First incident event for a given patient through 31-December-2017
次要结局
未报告次要终点