This study investigated the effectiveness of pravastatin on renal function in Korean dyslipidemic patients with Type 2 diabetes.
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
2,972
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.
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)
Time frame: Week 24 post-dose
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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
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Korea University Ansan Hospital
Ansan, South Korea
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, South Korea
Yeongnam University Medical Center
Busan, South Korea
Inje University Busan Paik Hospital - Site 23
Busan, South Korea
Inje University Busan Paik Hospital - Site 26
Busan, South Korea
Bong Seng Memorial Hospital
Busan, South Korea
Pusan National University Hospital - Site 43
Busan, South Korea
Pusan National University Hospital - Site 49
Busan, South Korea
Kosin University Gospel Hospital
Busan, South Korea
Changwon Fatima Hospital
Changwon, South Korea
...and 37 more locations
Time frame: 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.
Time frame: 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 \[mg/dL\]).
Time frame: 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 \[mg/dL\]).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 48 post-dose