Etoricoxib Prescribing Patterns and Adverse Events of Interest during Etoricoxib Treatment in UK Primary Care (MK-0663-162)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Etoricoxib Prescribing Patterns and Adverse Events of Interest
• 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
• Medical condition to be studied:
  Osteoarthritis

  Rheumatoid arthritis

  Ankylosing spondylitis

  Gout

Population studied

• Short description of the study population:
  All patients in the Medicines and Health Care Products Regulatory Agency's (MHRA’s) CPRD GOLD who have at least one electronic outpatient prescription record for etoricoxib issued during the period (1 April 2002 to 31 December 2011) at the date of query execution against the data warehouse.
• 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)
• Estimated number of subjects:
  79189

Study design details

• Main study objective:
  To evaluate characteristics of patients prescribed etoricoxib, patterns in the prescribing of etoricoxib by general practitioners, and to estimate the absolute incidence rate of adverse events among new users of etoricoxib.
• Outcomes:
  1. Dose of Initial Etoricoxib Prescription2. Duration of Initial Etoricoxib Prescription 3. Participants Baseline Characteristics (Demographics and Medical) 4. Incidence of Adverse Events of Special Interest Among Etoricoxib Users, 1. "Off-label" use of Etoricoxib
• Data analysis plan:
  All data analyses were purely descriptive and no statistical hypothesis testing was conducted in this observational study.

Documents

Study results

0663-162 Final Study Report_final-redaction