Safety Data on Etoricoxib From Swedish Registries of Spondyloarthropathy/Ankylosing Spondylitis Patients (MK-0663-159; EP07013.013.11.082)

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

  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ETORICOXIB
• Anatomical Therapeutic Chemical (ATC) code:
  (M01AH05) etoricoxib

  etoricoxib
• Medical condition to be studied:
  Ankylosing spondylitis

  Spondyloarthropathy

Population studied

• Short description of the study population:
  A patient was eligible for inclusion on the first date who have met all of the following criteria:; - Attended an out-patient clinic 2001-2010; - Age >=16 years on the date attended the out-patient clinic; - Registered with an ICD-code corresponding to SPA/AS (i.e. ICD10: M46.1, M46.8, M46.9, and ICD9: 720B, 720C or 720X for the appropriate periods) and AS (i.e. ICD10: M459 and ICD9: 720A for the appropriate periods)
• Age groups:
  Adolescents (12 to < 18 years)

  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 and Spondyloarthropathy patients
• Estimated number of subjects:
  21108

Study design details

• Main study objective:
  Describe characteristics of Swedish participants with inflammatory SpA/AS, describe use of etoricoxib & other COX-2 inhibitors/nsNSAIDs in Swedish participants with SpA/AS, estimate & compare rates of clinical outcomes of special interest (GI, renovascular, CV, cerebrovascular) with use of etoricoxib & other COX-2 inhibitors/nsNSAIDs in Swedish participants with SpA/AS.
• Outcomes:
  Number of participants with characteristics of inflammatory SpA/AS, participants who used etoricoxib, participants who used other COX-2 inhibitors, participants who used nsNSAIDs, clinical outcomes of special interest. Outcomes included atherosclerotic CV events, atherosclerotic cerebrovascular events, congestive heart failure, severe hypertension, renovascular, and GI events.
• Data analysis plan:
  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.

Documents

Study results

MK-0663-159 Interim Results Summary

p159mk0663-final-report_Final Redaction