Aliskiren Prescription Event Monitoring Study (Aliskiren PEM)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prescription event monitoring

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ALISKIREN

Population studied

• Short description of the study population:
  Patients prescribed with aliskiren (Rasilez®) in general practice between February 2008 and November 2010 in England
• 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:
  6385

Study design details

• Main study objective:
  To examine the safety of aliskiren used in general medical practice in England which is licensed as a treatment for essential hypertension.
• Data analysis plan:
  PEM methodology provides a numerator (the number of reports of an event) and a denominator (the number of patient-months at risk), both collected within a known time frame. This allows for the calculation of risk (percent of total valid cohort exposed) and incidence densities (ID, person-time incidence rates) for each event. Such analyses will be performed using ‘Higher-level’ event terms from the DSRU drug dictionary.