An Observational Study Investigating the Effectiveness of Pravastatin on Renal Function in Korean Dyslipidemic Patients With Type 2 Diabetes

Daiichi Sankyo

Status: Completed

Conditions: Dyslipidemia Associated With Type II Diabetes Mellitus

Treatments: Drug: Pravastatin

Study type: Observational

Funder types: Industry

Identifiers

NCT05107063

MVT-OS-15-01

Details and patient eligibility

About

This study investigated the effectiveness of pravastatin on renal function in Korean dyslipidemic patients with Type 2 diabetes.

Full description

This survey study investigated the effect of routine initiation single dose of pravastatin (10 mg, 20 mg, or 40 mg) on renal function in Korean dyslipidemic patients with Type 2 diabetes. The study also examined the effect of pravastatin on lipid profiles, glucose metabolism, and safety.

Enrollment: 2,972 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with Type 2 diabetes (currently using an antidiabetic drug or satisfying diagnostic criteria of diabetes as defined by American Diabetes Association)
• Participants with dyslipidemia (currently using an antidyslipidemic drug or satisfying the Health Insurance Review & Assessment Service insurance coverage treatment criteria*) for whom drug treatment with pravastatin is confirmed
• Participants determined to be eligible as subjects at the discretion of the investigator
• Participants who voluntarily provided written consent using the Informed Consent Form on Use of Information

Exclusion criteria

• Participants who had administered pravastatin prior to study participation
• Participants with hypersensitivity to the investigational product or its history
• Participants with an active liver disease or persistent elevation of transaminase with an unknown cause
• Pregnant woman or women with childbearing potential, breastfeeding mothers
• Children
• Participants with severe hepatic or renal insufficiency
• Participants with myopathy
• Participants with cholestasis
• Participants with hypercholesterolemia due to hyperalphalipoproteinemia accompanied by HDL cholesterol elevation
• Participants with a genetic problem such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

Trial design

2,972 participants in 1 patient group

Dyslipidemic participants with Type 2 diabetes

Description:

Dyslipidemic participants with Type 2 diabetes who received a routine initiation dose of pravastatin 10 mg, 20 mg or 40 mg single dose once daily and maintained a low cholesterol diet throughout the study period.

Treatment:

Drug: Pravastatin