Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration in Patients With Dyslipidemia in Korea

Hanmi Pharmaceutical Company Limited5,717 enrolled

Overview

A Cohort Study for Comparison of Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration and Statin Prescription Patterns in Patients With Dyslipidemia in Korea.

The main objective of this study is to evaluate the effect of reducing LDL-C levels after 12 months of administration of Statin Monotherapy or Rosuzet Tab.(Rosuvastatin/Ezetimibe) in patients with dyslipidemia in Korea

Study Type

OBSERVATIONAL

Enrollment

5,717

Conditions

Dyslipidemias

Interventions

ObservationalOTHER

Statin therapy group and Rosuzet tablet group

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age≥19 2. Subject who is taking or is scheduled to take Statins therapy or Rosuzet Tab. 3. Not diagnosed with diabetes 4. Subject who can written informed consent voluntarily 5. Subject can continue to participate for 12 months on Study Exclusion Criteria: 1. Patients for whom use of Rosuzet Tab. and Statin therapy is prohibited (e.g. patient who are hypersensitive to the main or compositional component of this drug, patient with active liver disease, patient with severe renal failure, patient using combinations with cyclosporin) 2. A pregnant or nursing woman

Locations (1)

Hanmi Pharmaceutical Company Limited

Seoul, South Korea

Outcomes

Primary Outcomes

Lipid profiles

LDL-C percentage of change in Statin therapy group and Rosuzet group from baseline

Time frame: 12 months

Secondary Outcomes

Lipid profiles

LDL-C percentage of change in Statin therapy group and Rosuzet group from baseline

Time frame: 6 months

Lipid profiles

Triglyceride, HDL-C, Total Cholesterol percentage of change in Statin therapy group and Rosuzet group from baseline

Time frame: 6, 12 months

Occurrence and aspect of new onset diabetes and adverse events

Occurrence and aspect of new onset diabetes and adverse events in Statin therapy group and Rosuzet group during the study period

Time frame: 12 months

Prescription rate

Prescription rate of Statin therapy group and Rosuzet group during the study period

Time frame: 12 months

Reason for medication change

Evaluation of Rate on reason for medication change in Statin therapy group and Rosuzet group during the study period

Time frame: 12 months

Medication compliance

MPR(medication possession ratio) of Statin therapy group and Rosuzet group during the study period

Time frame: 12 months

Data from ClinicalTrials.gov

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