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

A Multi-center, Prospective Observational Study to Investigate the Effectiveness of Pravastatin on Renal Function in Korean Dyslipidemic Patients With Type 2 Diabetes

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

Study Overview

• Status: Completed
• Conditions: Dyslipidemia Associated With Type II Diabetes Mellitus
• Intervention / Treatment: Drug: Pravastatin

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 2972

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ansan, Korea, Republic of, 15355
    • Korea University Ansan Hospital
  • Bucheon, Korea, Republic of, 14647
    • The Catholic University of Korea, Bucheon St. Mary's Hospital
  • Busan, Korea, Republic of, 49267
    • Kosin University Gospel Hospital
  • Busan, Korea, Republic of, 42415
    • Yeongnam University Medical Center
  • Busan, Korea, Republic of, 47392
    • Inje University Busan Paik Hospital - Site 23
  • Busan, Korea, Republic of, 47392
    • Inje University Busan Paik Hospital - Site 26
  • Busan, Korea, Republic of, 48775
    • Bong Seng Memorial Hospital
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital - Site 43
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital - Site 49
  • Changwon, Korea, Republic of, 51394
    • Changwon fatima hospital
  • Cheonan, Korea, Republic of, 31151
    • Soon Chun Hyang University Cheonan Hospital
  • Daegu, Korea, Republic of, 42472
    • Daegu Catholic University Medical Center
  • Daejeon, Korea, Republic of, 35233
    • Eulji University DaeJeon Medical Center
  • Daejeon, Korea, Republic of, 35365
    • Konyang University Hospital
  • Gangneung, Korea, Republic of, 25440
    • GangNeung Asan Hospital
  • Goyang, Korea, Republic of, 10475
    • Myongji Hospital
  • Goyang, Korea, Republic of, 10326
    • Dongguk University Ilsan Hospital
  • Goyang, Korea, Republic of, 10380
    • Inje University Ilsan Paik Hospital
  • Goyang, Korea, Republic of, 10444
    • National Health Insurance Service Ilsan Hospital
  • Gwangju, Korea, Republic of, 61453
    • Chosun University Hospital
  • Gwangju, Korea, Republic of, 62284
    • Gwangju Veterans Hospital
  • Incheon, Korea, Republic of, 21565
    • Gachon University Gil Medical Center
  • Seongnam, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seongnam, Korea, Republic of, 13496
    • Bundang CHA General Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 05355
    • Kangdong Sacred Heart Hospital
  • Seoul, Korea, Republic of, 05278
    • Kyung Hee University Hospital at Gangdong
  • Seoul, Korea, Republic of, 02053
    • Seoul Medical Center
  • Seoul, Korea, Republic of, 02559
    • The Catholic University of Korea, ST. Paul's Hospital
  • Seoul, Korea, Republic of, 03722
    • Yonsei University Health System, Severance Hospital
  • Seoul, Korea, Republic of, 01450
    • Hanil General Hospital
  • Seoul, Korea, Republic of, 01812
    • Korea Cancer Center Hospital
  • Seoul, Korea, Republic of, 01830
    • Eulji University Medical Center - Site 20
  • Seoul, Korea, Republic of, 01830
    • Eulji University Medical Center - Site 52
  • Seoul, Korea, Republic of, 04401
    • Soon Chun Hyang University Seoul Hospital
  • Seoul, Korea, Republic of, 05368
    • VHS Medical Center
  • Seoul, Korea, Republic of, 06273
    • Yonsei University Health System, Gangnam Severance Hospital
  • Seoul, Korea, Republic of, 06973
    • Chung-Ang Univerisity Hospital
  • Seoul, Korea, Republic of, 07345
    • The Catholic University of Korea, Yeouido St. Mary's Hospital
  • Suncheon, Korea, Republic of, 57931
    • St. Carollo General Hospital
  • Suwon, Korea, Republic of, 16247
    • The Catholic University of Korea, St. Vincent's Hospital - Site 45
  • Suwon, Korea, Republic of, 16247
    • The Catholic University of Korea, St. Vincent's Hospital - Site 50
  • Suwon, Korea, Republic of, 16499
    • Ajou University Hospital - Site 04
  • Suwon, Korea, Republic of, 16499
    • Ajou University Hospital - Site 05
  • Ulsan, Korea, Republic of, 44455
    • Dongkang Medical Center
  • Wŏnju, Korea, Republic of, 26426
    • Yonsei University, Wonju Severance Christian Hospital - Site 10
  • Wŏnju, Korea, Republic of, 26426
    • Yonsei University, Wonju Severance Christian Hospital - Site 15

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population included Korean dyslipidemic participants with Type 2 diabetes.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dyslipidemic participants with Type 2 diabetes; 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.	Drug: Pravastatin; Routine initiation dose was 10 mg, 20 mg or 40 mg single dose once daily. Depending on patient response, dose could have been increased up to 40 mg. Maintenance dose was 10-40 mg once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change Rate From Baseline in the Modification of Diet in Renal Disease(MDRD) Estimated Glomerular Filtration Rate (eGFR) at Week 24 After Routine Care of Pravastatin Administration	The following formula was used to calculate MDRD eGFR: MDRD eGFR (mL/min/1.73 m^2) = 186 x (serum creatinine) -1.154 x (age)-0.203 x (0.742 if female)	Week 24 post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR) at Week 24 After Routine Care of Pravastatin Administration	The following formula was used to calculate MDRD eGFR: MDRD eGFR (mL/min/1.73 m^2) = 186 x (serum creatinine)^-1.154 x (age)^-0.203 x (0.742 if female)	Week 24 post-dose
Percentage Change Rate from Baseline in Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 48 After Routine Care of Pravastatin Administration	The following formula was used to calculate MDRD eGFR: MDRD eGFR (mL/min/1.73 m^2) = 186 x (serum creatinine)^-1.154 x (age)^-0.203 x (0.742 if female)	Week 12 and Week 48 post-dose
Change from Baseline in Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 48 after Routine Care of Pravastatin Administration	The following formula was used to calculate MDRD eGFR: MDRD eGFR (mL/min/1.73 m^2) = 186 x (serum creatinine)^-1.154 x (age)^-0.203 x (0.742 if female)	Week 12 and Week 48 post-dose
Percentage Change Rate from Baseline in Estimated Glomerular Filtration Rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI) Formula at Week 12, Week 24, and Week 48 After Routine Care of Pravastatin Administration	The following formula was used to calculate CKD-EPI eGFR: CKD-EPI eGFR (mL/min/1.73 m^2) = 141 × min (serum creatinine/k, 1)^α × max (serum creatinine/k, 1)^-1.209 × 0.993^(age) × 1.018 (if female), where k is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates minimum serum creatinine/k or 1, and max indicates maximum serum creatinine/k or 1.	Week 12, Week 24, and Week 48 post-dose
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI) Formula at Week 12, Week 24, and Week 48 After Routine Care of Pravastatin Administration	The following formula was used to calculate CKD-EPI eGFR: CKD-EPI eGFR (mL/min/1.73 m^2) = 141 × min (serum creatinine/k, 1)^α × max (serum creatinine/k, 1)^-1.209 × 0.993^(age) × 1.018 (if female), where k is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates minimum serum creatinine/k or 1, and max indicates maximum serum creatinine/k or 1.	Week 12, Week 24, and Week 48 post-dose
Percentage Change Rate from Baseline in Total Cholesterol, Low Density Lipoprotein Cholesterol, High Density Lipoprotein-Cholesterol, Triglycerides, Fasting Plasma Glucose at Week 12, Week 24, and Week 48 After Routine Care of Pravastatin Administration	Blood plasma samples will be collected to assess lipids (total cholesterol [mg/dL], low density lipoprotein cholesterol (LDL-C) [mg/dL], high density lipoprotein-cholesterol (HDL-C) [mg/dL], triglyceride [mg/dL], and fasting plasma glucose [mg/dL]).	Week 12, Week 24, and Week 48 post-dose
Change from Baseline in Total Cholesterol, Low Density Lipoprotein Cholesterol, High Density Lipoprotein-Cholesterol, Triglycerides, Fasting Plasma Glucose at Week 12, Week 24, and Week 48 After Routine Care of Pravastatin Administration	Blood plasma samples will be collected to assess lipids (total cholesterol [mg/dL], low density lipoprotein cholesterol (LDL-C) [mg/dL], high density lipoprotein-cholesterol (HDL-C) [mg/dL], triglyceride [mg/dL], and fasting plasma glucose [mg/dL]).	Week 12, Week 24, and Week 48 post-dose
Percentage Change Rate from Baseline in Hemoglobin A1c (HbA1c) at Week 12, Week 24 and Week 48 After Routine Care of Pravastatin Administration	Blood plasma samples will be collected to assess hemoglobin A1c (HbA1c) (%)levels.	Week 12, Week 24, and Week 48 post-dose
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 12, Week 24 and Week 48 After Routine Care of Pravastatin Administration	Blood plasma samples will be collected to assess hemoglobin A1c (HbA1c) (%)levels.	Week 12, Week 24, and Week 48 post-dose
Number of Participants With Treatment-emergent Adverse Events After Routine Care of Prevastatin Administration	Treatment-emergent adverse event (TEAE) is defined as an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state.	Week 48 post-dose

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.
• Collaborators: Daiichi Sankyo Korea Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2016
• Primary Completion (Actual): April 19, 2018
• Study Completion (Actual): April 19, 2018

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Dyslipidemia; Type II Diabetes Mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Pravastatin
• Other Study ID Numbers: MVT-OS-15-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No