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

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

Accelerated hypertension
Blood pressure ambulatory increased
Blood pressure diastolic increased
Blood pressure inadequately controlled
Blood pressure orthostatic increased
Blood pressure management
Blood pressure systolic increased
Diastolic hypertension
Eclampsia
Endocrine hypertension
Population studied

Short description of the study population

Using the index window from 1 January 2007 through 31 December 2012, patients (for the treatment groups) were selected into the study cohort if they (1) have at least 1 prescription for an antihypertensive medication (the first such prescription will be defined as a patient’s index date), (2) evidence of at least 1 hypertension diagnosis (ICD-9-CM codes 401.xx-405.xx) in 180-day pre-index, (3) are 18+ years of age at the time of the index date, and (4) have continuous health plan enrollment for a minimum of 180 days prior to the index date and a minimum of 180 days following the index date.
Individuals for the general population control group will be selected into the study cohort if they have (1) no prescriptions for an antihypertensive medication between 1 July 2006 and 30 June 2013 (2) no evidence of a hypertension diagnosis (ICD-9-CM codes 401.xx-405.xx) any time between 1 July 2006 and 30 June 2013), (3) are 18+ years of age at the time of the index date, and (4) have continuous health plan enrollment for a minimum of 180 days prior to the index date and a minimum of 180 days following the index date

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

10000
Study design details

Main study objective

To determine age- and sex-stratified incidence rates of colorectal hyperplasia and gastrointestinal (GI) cancer in adult hypertensive patients exposed to aliskiren and other antihypertensive drugs other than aliskiren, as well as in a sample of patients without a diagnosis of hypertension and without antihypertensive drug use.

Outcomes

Incidence of colorectal hyperplasia and GI cancer among treated hypertensive patients and a sample of patients without hypertension, Relative risk of colorectal hyperplasia and GI cancer among hypertensive patients (treated by aliskiren versus antihypertensive drugs other than aliskiren) and a sample of patients without hypertension

Data analysis plan

All data will be reported for the aggregate antihypertensive treatment population (treated by aliskiren and other antihypertensive drugs) as well as stratified by the incident vs. prevalent antihypertensive treatment cohorts, and the general population control cohort. For the primary analyses, incidence rates with 95% confidence intervals will be calculated per 100,000 person-years for colorectal hyperplasia and GI cancer. These rates will be reported by age group and gender, as well as by index antihypertensive drug cohort and antihypertensive drug cohort from index date to prior to the end of follow-up. For the secondary analyses, relative risks will be estimated using Cox proportional hazards models for colorectal hyperplasia and GI cancer among hypertensive patients exposed to aliskiren vs. hypertensive patients exposed to antihypertensive drugs other than aliskiren and vs. a general population sample without a diagnosis of hypertension and without antihypertensive drug use.