Study to Evaluate the Effectiveness and Safety of Pravastati

Not Applicable

Active, not recruiting

• Conditions: Endocrine, nutritional and metabolic diseases

• Registration Number: KCT0009248
• Lead Sponsor: Daiichi-Sankyo Korea

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 April 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 8464

Inclusion Criteria

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

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
? Cancer
? Human immunodeficiency virus
? Solid organ transplant

Define exclusion criteria differently for primary and secondary outcome variables to build cohorts by outcome variable.
Cohort for evaluation of primary prevention effect on major adverse cardiac events
1) Patients with a history of the following before the time at risk start date
? Acute myocardial infarction
? Ischemic stroke
? Heart failure for hospitalization
? Coronary revascularization

Relevant cohorts for evaluation of secondary prevention of major adverse cardiac events
*Build a cohort that includes patients with a history of major cardiovascular events before the time at risk start date.

Cohort for safety assessment of type II diabetes mellitus development
1) Patients with a medical history of diabetes mellitus before the time at risk start date

Cohort for safety assessment of dementia development
1) Patients with a medical history of dementia before the time at risk start date

Cohort for safety assessment of myalgia or rhabdomyolysis
1) Patients with a medical history of myalgia or rhabdomyolysis before the the time at risk start date

Cohort for safety assessment of liver toxicity
1) Patients with a medical history of liver-relatemyalgia or rhabdomyolysis before the the time at risk start date

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of composite of major adverse cardiac events

Secondary Outcome Measures

Name	Time	Method
Recurrence of composite of major adverse cardiac events;Incidence of type II diabetes mellitus;Incidence of type dementia;Incidence of myalgia and/or rhabdomyolysis