A Post-marketing Database Surveillance to Investigate the Risk of Hyperglycemia and Diabetes Mellitus in Hypercholesterolemic Patients Treated with ATOZET or Ezetimibe Atorvastatin coadministration in Japan (MK-0653C-855)

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

  Other
• Non-interventional study design, other:
  Post-marketing database surveillance

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (C10AA05) atorvastatin

  atorvastatin

  (C10AX09) ezetimibe

  ezetimibe

  (C10BA05) atorvastatin and ezetimibe

  atorvastatin and ezetimibe
• Medical condition to be studied:
  Hypercholesterolaemia

Population studied

• Short description of the study population:
  The surveillance population is hypercholesterolemic patients with no past history of diabetes mellitus who are prescribed with ATOZET or coadministration of ezetimibe and atorvastatin between 1-APR-2018 and 30-SEP-2020 (selection period).; Inclusion criteria; 1) Patients who have a hypercholesterolemia diagnosis (ICD code: E78.5) during the selection period, AND; 2) Patients who have received ATOZET (ATC code: C10BA05) or coadministration of ezetimibe and atorvastatin (ATC code: C10AX09 and C10AA05) during the selection period.; The exclusion criteria are as follows:; • For the ATZ-group; 1) Patients given ezetimibe monotherapy (C10AX09) as a pre-treatment drug, OR; 2) Patients given other lipid modifying agents (C10) as a pre-treatment drug except atorvastatin (C10AA05), OR; 3) Patients who were not given any pre-treatment drug, OR; 4) Patients who had ATOZET treatment before April 2018, OR; 5) Patients who do not have a 6-month lookback period prior to the index date, OR; 6) Patients who have any missing information on critical variables (e.g., gender, age), OR; 7) Patients who have severe liver dysfunction considered as the contraindication for the use of ATOZET, OR; 8) Patients who were diagnosed with diabetes mellitus (ICD-10 codes: E10-E14) or were using antidiabetic drugs (A10) during the lookback period, OR; 9) Patients whose blood glucose level was >200 mg/dL during the 6-month lookback period prior to the index date, OR; 10) Patients whose HbA1c level was >6.5% during the 6-month lookback period before the index date will be excluded.; • For the EZE-ATV-group; 1) Patients given ezetimibe (C10AX09) as a pre-treatment drug, OR; 2) Patients given other lipid modifying agents (C10) as a pre-treatment drug except atorvastatin (C10AX09), OR; 3) Patients who were not given any pre-treatment drug, OR; 4) Patients who had Ezetimibe/Atorvastatin coadministration treatment before April 2018, OR ; 5) Patients who do not have a 6-month lookback period prior to the index date, OR; 6) Patient
• 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:
  Hepatic impaired
• Estimated number of subjects:
  2000

Study design details

• Main study objective:
  To compare the incidence rates of HOI between those taking ATOZET and those taking the coadministration of ezetimibe and atorvastatin. The HOI for this study are hyperglycemia and diabetes mellitus.
• Outcomes:
  The primary outcomes for diabetes and hyperglycemia are defined as: diagnostic code for hyperglycemia or diabetes mellitus AND (blood glucose > 200 mg/dL AND HbA1c >6.5%) OR (blood glucose > 200 mg/dL two times on different days). The secondary outcomes for diabetes and hyperglycemia are defined as: 1) (blood glucose > 200 mg/dL AND HbA1c >6.5%) OR (blood glucose > 200 mg/dL two times on different days) . 2) diagnostic code for hyperglycemia or diabetes mellitus AND (blood glucose > 200 mg/dL once or more than once).
• Data analysis plan:
  - Calculation of number of diabetes or hyperglycemia HOI (based on various definitions) per 1,000 person years for the ATOZET and ezetimibe/atorvastatin coadministration groups - Calculation of incidence rate ratios (IRR) of various diabetes or hyperglycemiaHOI, adjusting for covariates, for the ATOZET and ezetimibe/atorvastatin coadministration groups

Documents

Study results

MK0653C-855-CSR_final redaction