A multi-database cohort study to assess the incidence rates of colorectal hyperplasia among hypertensive patients

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• 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:
  ALISKIREN HEMIFUMARATE
• Anatomical Therapeutic Chemical (ATC) code:
  (C09XA) Renin-inhibitors

  Renin-inhibitors
• Medical condition to be studied:
  Essential hypertension

  Accelerated hypertension

  Hypertension

  Blood pressure increased

  Blood pressure orthostatic increased

  Blood pressure measurement

  HELLP syndrome

  Blood pressure ambulatory increased

  Blood pressure diastolic increased

  Blood pressure systolic increased

Population studied

• Short description of the study population:
  Adult patients (aged 18-80 years) in the individual databases with an incident diagnosis of arterial hypertension between January 01, 2000 and December 31, 2012.; Patients with continuous enrollment in the database for at least 1 year prior to the start of follow-up, aged 18 years or older at the start of follow-up and diagnosis of arterial hypertension were included.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Arterial hypertension patients
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  This study will estimate the frequency of colorectal polyps, cysts and neoplasms among hypertensive patients. Age- and sex-specific incidence rates will be estimated as well as the time from hypertension diagnosis to colorectal polyps, colorectal cysts and colorectal neoplasms.
• Outcomes:
  Incidence of colorectal polyps, cysts and neoplasms among hypertensive patients.
• Data analysis plan:
  Incidence rates will be calculated by dividing the total number of incident cases over the total number of person-years at risk within the study population for each database separately.. Standardization of incidence rates will be performed using either a European reference population or by internal validation using one of the four databases as reference population to which the other three databases will be compared to.Kaplan Meier analyses will be performed to estimate the survival time from arterial hypertension diagnosis date until one of the primary safety endpoints (colorectal polyps, cysts or neoplasms) but also for each of the endpoints separately.

Documents

Study results

SPP100A2417-Redacted-Final-Study-Report