Efficacy and Safety of Pitavastatin in a Real-world Setting

Efficacy and Safety of Pitavastatin in a Real-wOrld Setting: Observational Study Evaluating saFety in Patient With Pitavastatin for Lipid Lowering Therapy in Korea

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04402112

Acronym

PROOF

Enrollment

28343

Registered

2020-05-26

Start date

2012-04-02

Completion date

2017-08-01

Last updated

2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

Pitavastatin, LIVALO, Safety data, South Korea, Large-scale prospective trial

Brief summary

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.

Detailed description

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.

Interventions

DRUGPitavastatin

1mg, 2mg, or 4mg, Once a day, at least 8 weeks

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients in need of statin treatment who are taking or are planning to take Livalo tablets, or who are taking other statins or are planning to change to Livalo tablets.

Exclusion criteria

* Patients with hypersensitivity to pitavastatin * Patients with active liver disease or untranslated transaminase levels Patients with a constant rise in * Patients with severe liver failure or biliary obstruction and patients with cholestasis * Patients who are receiving cyclosporine * Myopathy patients * Pregnant women or women of childbearing age and lactating women * Children * Patients with genetic problems, such as galactose intolerance, Lapp lactose deficiency or glucose-galactose * Patients deemed inappropriate by the investigator

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with adverse events as assessed by CTCAE v4.0	At 8 weeks after administration of pitavastatin	Incidence of musculoskeletal-related adverse events and rhabdomyolysis

Secondary

Measure	Time frame	Description
Overall symptom satisfaction evaluation	At 8 weeks after administration of pitavastatin	The investigating physician selects one of the followings according to medical judgment: Improvement, constant, exacerbation
Change in serum lipid profile before and after administration of pitavastatin	At screening and after 8 weeks	Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026