Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease (PLANET 1)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00296374 |
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Recruitment Status :
Completed
First Posted : February 27, 2006
Results First Posted : December 30, 2010
Last Update Posted : September 1, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus | Drug: Rosuvastatin Drug: Atorvastatin | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 353 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Randomised, Double-blind, 52-wk, Parallel-grp, Multicentre, PIIb Study to Evaluate Effects of Rosuvastatin 10mg, Rosuvastatin 40mg and Atorvastatin 80mg on Urinary Protein Excretion in Hypercholesterolaemic Diabetic Patients With Moderate Proteinuria |
| Study Start Date : | February 2006 |
| Actual Primary Completion Date : | March 2009 |
| Actual Study Completion Date : | March 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Rosuvastatin 10 mg
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Drug: Rosuvastatin
10 mg oral dose administered once daily for 52 weeks
Other Name: Crestor |
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Experimental: 2
Rosuvastatin 40 mg
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Drug: Rosuvastatin
20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks
Other Name: Crestor |
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Active Comparator: 3
Atorvastatin 80 mg
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Drug: Atorvastatin
40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks
Other Name: Lipitor |
- Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes. [ Time Frame: Assessed at Week 52, Last observation carried forward (LOCF) ]Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine protein/creatinine ratio over baseline urine protein/creatinine ratio.
- Urinary Protein/Creatinine Ratio at Week 26. [ Time Frame: Assessed at Week 26 ]Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine protein/creatinine ratio over baseline urine protein/creatinine ratio.
- Urinary Albumin/Creatinine Ratio at Week 26 [ Time Frame: Assessed at Week 26 ]Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.
- Urinary Albumin/Creatinine Ratio at Week 52 [LOCF] [ Time Frame: Assessed at Week 52 LOCF ]Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 [ Time Frame: Assessed at Baseline and Week 26 ]
- Change From Baseline in eGFR at Week 52 [LOCF] [ Time Frame: Assessed at Baseline and Week 52 [LOCF] ]
- Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes [ Time Frame: 52 weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (LOCF).
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC [ Time Frame: Assessed at 52 Weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C] [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C] [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C] [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG] [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1] [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1 [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB] [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1 [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1 [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio [ Time Frame: 26 weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio [ Time Frame: 52 Weeks ]Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: eGFR and TC [ Time Frame: 26 weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: eGFR and TC [ Time Frame: 52 Weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C [ Time Frame: 26 weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C [ Time Frame: 52 Weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C [ Time Frame: 26 weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C [ Time Frame: 52 Weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C [ Time Frame: 26 weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C [ Time Frame: 52 weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: eGFR and TG [ Time Frame: 26 weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: eGFR and TG [ Time Frame: 52 weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio [ Time Frame: 26 weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio [ Time Frame: 52 weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio [ Time Frame: 26 weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio [ Time Frame: 52 weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio [ Time Frame: 26 weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio [ Time Frame: 52 weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1 [ Time Frame: 26 weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1 [ Time Frame: 52 weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB [ Time Frame: 26 weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB [ Time Frame: 52 weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
- Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio [ Time Frame: 26 weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
- Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio [ Time Frame: 52 weeks ]Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- hyperlipidemia
- urinary protein
- diabetes
Exclusion Criteria:
- previous rosuvastatin treatment < 6 months prior to Visit 1
- statin intolerance
- severe hypertension
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296374
Show 116 study locations
| Study Director: | AstraZeneca Crestor Medical Science Director, MD | AstraZeneca |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00296374 |
| Other Study ID Numbers: |
D3569C00007 PLANET 1 |
| First Posted: | February 27, 2006 Key Record Dates |
| Results First Posted: | December 30, 2010 |
| Last Update Posted: | September 1, 2011 |
| Last Verified: | August 2011 |
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Hyperlipidemia Proteinuria Diabetes Mellitus |
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Proteinuria Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Urination Disorders Urologic Diseases Urological Manifestations Atorvastatin |
Rosuvastatin Calcium Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |

