Dyslipidemias
Conditions
Keywords
Statin, Rosuvastatin, New onset DM, LDL-C
Brief summary
A Cohort Study for Comparison of Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration and Statin Prescription Patterns in Patients With Dyslipidemia in Korea.
Detailed description
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
Interventions
OTHERObservational
Statin therapy group and Rosuzet tablet group
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lipid profiles | 12 months | LDL-C percentage of change in Statin therapy group and Rosuzet group from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid profiles | 6 months | LDL-C percentage of change in Statin therapy group and Rosuzet group from baseline |
| Occurrence and aspect of new onset diabetes and adverse events | 12 months | Occurrence and aspect of new onset diabetes and adverse events in Statin therapy group and Rosuzet group during the study period |
| Prescription rate | 12 months | Prescription rate of Statin therapy group and Rosuzet group during the study period |
| Reason for medication change | 12 months | Evaluation of Rate on reason for medication change in Statin therapy group and Rosuzet group during the study period |
| Medication compliance | 12 months | MPR(medication possession ratio) of Statin therapy group and Rosuzet group during the study period |
Countries
South Korea
Outcome results
None listed