Angioedema among patients with hypertension treated with aliskiren or other anti-hypertensive medications in the US – a cohort Study and a nested case-control analysis using health claims data

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
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Name of medicine:
  RASILAMLO

  RASILEZ HCT
• Medical condition to be studied:
  Hypertension

Population studied

• Short description of the study population:
  All adult hypertensive subjects with a prescription for an anti-hypertensive medication of interest between July l, 2007 and September 30, 2012 derieved from IMS PharMetrics PlusTM US claims database.
• Age groups:
  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:
  Hypertensive patients
• Estimated number of subjects:
  45000

Study design details

• Main study objective:
  To assess the annual prevalence and incidence rates of angioedema in treated hypertensive patients (with focus on aliskiren)
• Outcomes:
  A diagnosis of angioedema, based on the ICD-9 code (i.e. ICD-9code 995.1) from medical claims, The secondary objective is to explore the relative risk of experiencing angioedema among patients prescribed aliskiren compared with other anti-hypertensive medications
• Data analysis plan:
  Prevalence: A one-year period prevalence of angioedema will be calculated for the calendar years 2008-11. The denominator will consist of the aggregate person-time (expressed in years) of all patients who were continuously enrolled for at least one month in the calendar year of interest.Incidence: Similarly, the incidence of angioedema will be calculated for each of calendar years 2008-11. The denominator for incidence determination will consist of the aggregate person-time (expressed in years) of all patients who were continuously enrolled for at least one month in the calendar year of interest as well as the full preceding calendar year. The numerator of the incidence estimate will be determined by identifying all patients with a diagnosis of angioedema during the calendar year of interest. In order to be considered an incident patient, there must additionally be no evidence of angioedema diagnoses during the preceding calendar year(s). per 1,000 patient-years of follow-up

Documents

Study results

SPP100A2415-Redacted-Final-Study-Report