Assessing the Incidence of Ischemic Colitis in Treated Adult Hypertensive Patients in the United States – a Descriptive, Retrospective Cohort Study with Secondary Use of Data from a US Health Claims Database (NA)

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 data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  Rasilez
• Medical condition to be studied:
  Hypertension

Population studied

• Short description of the study population:
  Adult hypertensive subjects with a prescription for an antihypertensive medication between January 1, 2006 and March 31,2012.; Subjects were included who had evidence of a hypertension diagnosis (ICD-9-CM codes 401."M-405.yeO; the date of the first hypertension diagnosis will be considered the diagnosis date; At least I prescnption for an antihypertensive medication within 180 days of the diagnosis date OR with at least one days supply overlapping the diagnosis date; 18 years of age or older at the time of the index date; Continuous health plan enrollment for a minimum of 180 days prior to the index date (pre-index period) and a mimmum of 90 days of continuous enrollment following the index date (post-index period).
• 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:
  20000

Study design details

• Main study objective:
  To assess the incidence of probable ischemic colitis in treated hypertensive patients (with focus on aliskiren)
• Outcomes:
  Probable ischemic colitis (defined by ICD-9-CM and CPT-4 codes, using inpatient and outpatient claims as evidence of a recorded diagnosis of ischemic colitis (ICD-9-CM code 557.xx) within 3 months after a colonoscopy (CPT-4 codes 45378-45387), a rectosigmoidoscopy (CPT-4 codes 45330-45331, 45340-45342, 45300, 45303, 45305) or a colectomy (CPT-4 codes 44140-44160).
• Data analysis plan:
  Incidence of ischemic colitis will be calculated per 100,000 person-years (PYs) and presented as incidence rates (IRs) with 95% confidence intervals (CIs). These rates will be reported by age group and gender as well as by index antihypertensive drug cohort (stratified by age group and gender), antihypertensive drug cohort prior to the end of follow-up (stratified by age and gender), and by adherence (using medication possession ratio or MPR, defined later in this document) to the index antihypertensive therapy and to any antihypertensive therapy. Additional IRs that take into account patients’ varying exposure to antihypertensive medications will be calculated per person-time contributed to each drug classification.

Documents

Study results

SPP100A2416-Redacted-Final-Study-Report