An Observational Study Investigating the Effectiveness of Pravastatin on Renal Function in Korean Dyslipidemic Patients With Type 2 Diabetes
- Conditions
- Dyslipidemia Associated With Type II Diabetes Mellitus
- Interventions
- Registration Number
- NCT05107063
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
This study investigated the effectiveness of pravastatin on renal function in Korean dyslipidemic patients with Type 2 diabetes.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2972
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Dyslipidemic participants with Type 2 diabetes Pravastatin 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.
- Primary Outcome Measures
Name Time Method 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 Week 24 post-dose 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)
- Secondary Outcome Measures
Name Time Method 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 Week 12 and Week 48 post-dose 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)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 Week 24 post-dose 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)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 Week 12 and Week 48 post-dose 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)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 Week 12, Week 24, and Week 48 post-dose 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.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 Week 12, Week 24, and Week 48 post-dose 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 \[mg/dL\]).
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 Week 12, Week 24, and Week 48 post-dose 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.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 Week 12, Week 24, and Week 48 post-dose 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 \[mg/dL\]).
Percentage Change Rate from Baseline in Hemoglobin A1c (HbA1c) at Week 12, Week 24 and Week 48 After Routine Care of Pravastatin Administration Week 12, Week 24, and Week 48 post-dose Blood plasma samples will be collected to assess hemoglobin A1c (HbA1c) (%)levels.
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 12, Week 24 and Week 48 After Routine Care of Pravastatin Administration Week 12, Week 24, and Week 48 post-dose Blood plasma samples will be collected to assess hemoglobin A1c (HbA1c) (%)levels.
Number of Participants With Treatment-emergent Adverse Events After Routine Care of Prevastatin Administration Week 48 post-dose 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.
Trial Locations
- Locations (47)
Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of
The Catholic University of Korea, Bucheon St. Mary's Hospital
🇰🇷Bucheon, Korea, Republic of
Yeongnam University Medical Center
🇰🇷Busan, Korea, Republic of
Inje University Busan Paik Hospital - Site 23
🇰🇷Busan, Korea, Republic of
Inje University Busan Paik Hospital - Site 26
🇰🇷Busan, Korea, Republic of
Bong Seng Memorial Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital - Site 43
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital - Site 49
🇰🇷Busan, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Changwon Fatima Hospital
🇰🇷Changwon, Korea, Republic of
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