Prasugrel Treatment Patterns in Outpatient Settings in Germany, the United Kingdom, and France (H7T-MC-B011)

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:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Effient
• Medical condition to be studied:
  Acute coronary syndrome

Population studied

• Short description of the study population:
  Patients who had the first prescription records of prasugrel, also referred to as prasugrel initiators, in the IMS Disease Analyzer and CPRD after prasugrel launch in France, the UK, and Germany. All prasugrel initiators in the IMS Disease Analyzer (France, the UK, and Germany) and CPRD were included.
• Age groups:
  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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with acute coronary syndrome
• Estimated number of subjects:
  4106

Study design details

• Main study objective:
  The objectives of the study were to provide descriptive statistics for the contraindication of TIA/stroke, maintenance dose, indication, patient characteristics, co-morbidities, co-prescriptions, and patterns of drug usage in outpatient practices in France, the UK, and Germany
• Data analysis plan:
  The study population consisted of patients who had at least 1 prescription record of prasugrel in France and Germany using the IMS Disease Analyzer and in the UK using the IMS Disease Analyzer and the CPRD. The date of the first prasugrel prescription recorded in the databases was defined as the index date. The patients were followed from the index date until death, transfer out of the practice, or the end of the study, whichever came first. Descriptive statistics (that is, mean SD, median, and quartile ranges for quantitative variables, and frequencies and percentages for qualitative variables) were provided for the contraindication of TIA/stroke, maintenance doses, body weight, patient demographic characteristics, co-morbidities, co-prescriptions, and patterns of drug usage in outpatient practices in respective countries.

Documents

Study results

B011 03 Synopsis_Part1