A Nested Case-control Post-authorization Safety Study of Etoricoxib and Other Non-steroidal Anti-inflammatory Therapies in a Cohort of Patients with Ankylosing Spondylitis (AS) in the UK, France and Germany (MK-0663-163)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (M01AH05) etoricoxib

  etoricoxib
• Medical condition to be studied:
  Ankylosing spondylitis

Population studied

• Short description of the study population:
  Patients with ankylosing spondylitis (AS) from general medical practices in the UK, France, and Germany.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Ankylosing spondylitis patients
• Estimated number of subjects:
  27381

Study design details

• Main study objective:
  To describe in European participants with AS: 1) use of etoricoxib 2) characteristics of those who use etoricoxib 3) to assess the safety profile of etoricoxib and other anti-inflammatory therapies with respect to specific clinical outcomes of interest (including upper GI, cardiovascular, cerebrovascular, and renovascular events) relative to non-use of these medications and relative to each other.
• Outcomes:
  Outcomes included gastrointestinal events, ischemic/thrombotic cardiac, cerebrovascular, and peripheral vascular events, haemorrhagic cerebrovascular events, congestive heart failure, hypertension, acute renal impairment or failure, and sudden/ unexplained death.
• Data analysis plan:
  Descriptive analyses of the AS cohort: A number of descriptive analyses will be done to characterize the patients who qualify for the AS cohort, their follow-up during the study period, their use of anti-inflammatory treatments during follow-up, and the crude incidence of the clinical outcomes of interest during follow-up.A nested case-control analysis will be performed on outcomes where at least 700 events are available for analysis. The case control analysis will estimate the odds of current exposure to etoricoxib and various other anti-inflammatory treatments, compared with non-exposure in European patients with AS.

Documents

Study results

MK-0663-163 Final Results Summary