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| Name | Class |
|---|---|
| Daiichi Sankyo Korea Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pravastatin | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population included Korean dyslipidemic participants with Type 2 diabetes.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Ansan | 15355 | South Korea | |||
| The Catholic University of Korea, Bucheon St. Mary's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38880822 | Derived | Kim HJ, Hur KY, Lee YH, Kim JT, Lee YK, Baek KH, Choi EJ, Hwang WM, Bang KT, Lim JS, Chung YJ, Jo SR, Oh JS, Lee SH, Ko SH, Choi SH. Effect of Pravastatin on Kidney Function in Patients with Dyslipidemia and Type 2 Diabetes Mellitus: A Multicenter Prospective Observational Study. Adv Ther. 2024 Aug;41(8):3119-3137. doi: 10.1007/s12325-024-02862-5. Epub 2024 Jun 16. |
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| 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 |
| Bucheon-si |
| 14647 |
| South Korea |
| Yeongnam University Medical Center | Busan | 42415 | South Korea |
| Inje University Busan Paik Hospital - Site 23 | Busan | 47392 | South Korea |
| Inje University Busan Paik Hospital - Site 26 | Busan | 47392 | South Korea |
| Bong Seng Memorial Hospital | Busan | 48775 | South Korea |
| Pusan National University Hospital - Site 43 | Busan | 49241 | South Korea |
| Pusan National University Hospital - Site 49 | Busan | 49241 | South Korea |
| Kosin University Gospel Hospital | Busan | 49267 | South Korea |
| Changwon Fatima Hospital | Changwon | 51394 | South Korea |
| Soon Chun Hyang University Cheonan Hospital | Cheonan | 31151 | South Korea |
| Daegu Catholic University Medical Center | Daegu | 42472 | South Korea |
| Eulji University DaeJeon Medical Center | Daejeon | 35233 | South Korea |
| Konyang University Hospital | Daejeon | 35365 | South Korea |
| GangNeung Asan Hospital | Gangneung | 25440 | South Korea |
| Dongguk University Ilsan Hospital | Goyang | 10326 | South Korea |
| Inje University Ilsan Paik Hospital | Goyang | 10380 | South Korea |
| National Health Insurance Service Ilsan Hospital | Goyang | 10444 | South Korea |
| Myongji Hospital | Goyang | 10475 | South Korea |
| Chosun University Hospital | Gwangju | 61453 | South Korea |
| Gwangju Veterans Hospital | Gwangju | 62284 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Bundang CHA General Hospital | Seongnam | 13496 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | 13620 | South Korea |
| HANIL General Hospital | Seoul | 01450 | South Korea |
| Korea Cancer Center Hospital | Seoul | 01812 | South Korea |
| Eulji University Medical Center - Site 20 | Seoul | 01830 | South Korea |
| Eulji University Medical Center - Site 52 | Seoul | 01830 | South Korea |
| Seoul Medical Center | Seoul | 02053 | South Korea |
| The Catholic University of Korea, St. Paul's Hospital | Seoul | 02559 | South Korea |
| Yonsei University Health System, Severance Hospital | Seoul | 03722 | South Korea |
| Soon Chun Hyang University Seoul Hospital | Seoul | 04401 | South Korea |
| Kyung Hee University Hospital at Gangdong | Seoul | 05278 | South Korea |
| Kangdong Sacred Heart Hospital | Seoul | 05355 | South Korea |
| VHS Medical Center | Seoul | 05368 | South Korea |
| Yonsei University Health System, Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Chung-Ang Univerisity Hospital | Seoul | 06973 | South Korea |
| The Catholic University of Korea, Yeouido St. Mary's Hospital | Seoul | 07345 | South Korea |
| St. Carollo General Hospital | Suncheon | 57931 | South Korea |
| The Catholic University of Korea, St. Vincent's Hospital - Site 45 | Suwon | 16247 | South Korea |
| The Catholic University of Korea, St. Vincent's Hospital - Site 50 | Suwon | 16247 | South Korea |
| Ajou University Hospital - Site 04 | Suwon | 16499 | South Korea |
| Ajou University Hospital - Site 05 | Suwon | 16499 | South Korea |
| Dongkang Medical Center | Ulsan | 44455 | South Korea |
| Yonsei University, Wonju Severance Christian Hospital - Site 10 | Wŏnju | 26426 | South Korea |
| Yonsei University, Wonju Severance Christian Hospital - Site 15 | Wŏnju | 26426 | South Korea |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D017035 | Pravastatin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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