A non-interventional, population-based register study on the prescription of etoricoxib (Arcoxia®) to dental surgery patients in the Nordic countries (MK-0663-170)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional, population-based study of dispensed etoricoxib prescriptions in dental practice in the Nordic countries

Study drug and medical condition

• Medicinal product name, other:
  Arcoxia
• Medical condition to be studied:
  Dental care

Population studied

• Short description of the study population:
  All individuals in the four Nordic countries in the period 2012-2013 with dispensed etoricoxib prescribed by dentists.
• Age groups:
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • 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:
  1000

Study design details

• Main study objective:
  The primary study objective is to characterize dispensed etoricoxib prescribed by dentists, including off-label use.
• Outcomes:
  To describe: 1) dental prescriptions includeing the associated procedures, patient demographics, dosing, year, and country. 2) Use by dentists not associated with dental procedures. 3) Off-label use in patients <16 years of age and with doses >90 mg/day. 4) Duration of dental prescriptions and number of tablets dispensed. 5) Patients with concurrent prescriptions for anticoagulans.
• Data analysis plan:
  Descriptive analyses: 1) Distribution of dental procedures in patients with etoricoxib prescribed by a dentist2) Distribution of the etoricoxib prescriptions overall and stratified by dose, patient demographics, year, and country. 3) Distribution of etoricoxib prescriptions, which are associated / not associated with one or more defined dental procedures 4) Distribution of off-label use (>90 mg, <16 years of age)5. Description of number of patients with concurrent prescriptions for anti-coagulants