A retrospective cohort study to evaluate the efficacy and safety of pravastatin in hyperlipidemia patients in Korea using a common data model of multi-institutional electronic medical records

Daiichi-Sankyo Korea0 sites8,464 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Observational Study

Sex

All

Sponsor

Daiichi-Sankyo Korea

•1\) Patients prescribed pravastatin 40 mg or atorvastatin 10 mg within the common data model data utilization period (we define the date of first prescription as the index date)
•2\) Patients with documented healthcare utilization for at least one year before the index date
•3\) Patients with a documented diagnosis of dyslipidemia before the index date
•4\) Patients with no other statin prescriptions for at least one year before the index date
•5\) Patients who have been prescribed a statin for more than 180 consecutive days as of the index date

•Exclusion criteria
•1\) Patients with unverified age and gender at the index date
•2\) Patients whose age is less than 19 years at the index date
•3\) Patients with a prescription record for a statin with a different component or different dose other than study drugs statin before the time at risk start date.
•(e.g., if a patient is prescribed pravastatin 40 mg on the index date, they will be excluded from the study if they have a prescription record for a statin with a different component other than pravastatin or a different dose of pravastatin other than pravastatin 40mg during the entire before to the time at risk start date).
•4\) Patients prescribed a fixed\-dose combination containing pravastatin 40 mg or atorvastatin 10 mg before the time at risk start date.
•5\) Patients with any of the following medical conditions (based on diagnosis codes) before the time at risk start date
•? Human immunodeficiency virus
•? Solid organ transplant
•Define exclusion criteria differently for primary and secondary outcome variables to build cohorts by outcome variable.