Alogliptin-5002: Association between therapy with Dipeptidyl peptidase-4 (DPP-4) inhibitors and risk of ileus: A cohort study

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:
  ALOGLIPTIN
• Medical condition to be studied:
  Ileus

  Diabetes mellitus

Population studied

• Short description of the study population:
  Patients with T2DM who were new users of alogliptin, another DPP-4 inhibitor, a GLP-1 receptor agonist, or voglibose between April 1, 2010 and April 30, 2014 were selected. New users were defined as adults 40 years of age or older at cohort entry date and having at least one year of enrollment in the MDV database without any previous prescriptions for alogliptin, other DPP-4 inhibitors, GLP-1 receptor agonists, or voglibose. Participants with a record of an ileus diagnosis in the year before or on the cohort entry date were excluded to avoid misclassification of prevalent ileus cases as incident cases.
• Age groups:
  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:
  Type 2 diabetes mellitus patients with ileus
• Estimated number of subjects:
  234089

Study design details

• Main study objective:
  We will use the MDV database in Japan to conduct a retrospective cohort study among T2DM patients who received a prescription for alogliptin, another DPP-4 inhibitor, a GLP-1 receptor agonist, or voglibose between April 1, 2010 and April 30, 2014 (study enrolment period).
• Outcomes:
  The primary outcome in our study will be an incident diagnosis of ileus (identified by the ICD-10 codes of K56.7 for Ileus, unspecified and K56.0 for paralytic ileus) occurring after the cohort entry date (CED).
• Data analysis plan:
  Descriptive statistics, including means (SD) and medians (10th to 90th percentiles) for continuous variables, and numbers and percentages for categorical variables will be used to examine patient baseline characteristics in the cohorts of interest, and the presence of ileus. Incidence rates of ileus per 1000 person-years with 95% confidence intervals (CIs) for the study and comparators cohort will be calculated. In addition, the incidence rates of ileus will be stratified by the following risk window time frames from the date of first prescription

Documents

Study results

Alogliptin-5002-RDS-2015-07-09