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The prospective, observational, non-comparative trial in South Korea was designed to evaluate the efficacy and safety of pitavastatin (Livalo) in clinical practice in 28,343 patients.
This study was conducted in 893 facilities in Korea from 2 Apr 2012 to 1 Apr 2017. This study was designed to administer 1mg, 2mg, or 4mg pitavastatin to patients with hyperlipidemia at the age of 20 or older for at least 8 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin | Drug | 1mg, 2mg, or 4mg, Once a day, at least 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as assessed by CTCAE v4.0 | Incidence of musculoskeletal-related adverse events and rhabdomyolysis | At 8 weeks after administration of pitavastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Overall symptom satisfaction evaluation | The investigating physician selects one of the followings according to medical judgment: Improvement, constant, exacerbation | At 8 weeks after administration of pitavastatin |
| Change in serum lipid profile before and after administration of pitavastatin |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving Livalo tablets in clinical practice in South Korea
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| Name | Affiliation | Role |
|---|---|---|
| Sung-Rae Kim, MD,PhD | The Catholic University of Korea | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33261312 | Result | Jeong IK, Kim SR. Efficacy and Safety of Pitavastatin in a Real-World Setting: Observational Study Evaluating SaFety in Patient Treated with Pitavastatin in Korea (PROOF Study). Endocrinol Metab (Seoul). 2020 Dec;35(4):882-891. doi: 10.3803/EnM.2020.723. Epub 2020 Dec 2. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
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Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride |
| At screening and after 8 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |