Efficacy and Safety of Pitavastatin in a Real-world Setting (PROOF)

JW Pharmaceutical

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Drug: Pitavastatin

Study type: Observational

Funder types: Industry

Identifiers

NCT04402112

JWP-PTV-712

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28,343 patients

Sex: All

Volunteers: No 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