Trial Outcomes & Findings for Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease (NCT NCT00296374)
NCT ID: NCT00296374
Last Updated: 2011-09-01
Results Overview
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.
COMPLETED
PHASE2
353 participants
Assessed at Week 52, Last observation carried forward (LOCF)
2011-09-01
Participant Flow
353 patients entered the study with Type 1 or 2 diabetes and were receiving current treatment with angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blockers (ARBs). The study was conducted at 147 centers in 11 countries.
Patients requiring an adjustment of the ACE inhibitor and/or ARBs after Visit 1 were excluded. All 353 patients were randomized and 276 patients completed the study.
Participant milestones
| Measure |
Rosuvastatin 10mg
|
Rosuvastatin 40mg
|
Atorvastatin 80mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
118
|
124
|
111
|
|
Overall Study
COMPLETED
|
93
|
101
|
82
|
|
Overall Study
NOT COMPLETED
|
25
|
23
|
29
|
Reasons for withdrawal
| Measure |
Rosuvastatin 10mg
|
Rosuvastatin 40mg
|
Atorvastatin 80mg
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
14
|
10
|
7
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
11
|
|
Overall Study
Incorrect enrollment
|
3
|
3
|
4
|
|
Overall Study
Protocol Violation
|
1
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
1
|
|
Overall Study
Relocated to another state
|
1
|
0
|
0
|
|
Overall Study
Stopped drug before end of study visit
|
0
|
1
|
0
|
|
Overall Study
Nephrologist introduced ACE
|
0
|
1
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
2
|
|
Overall Study
Other
|
0
|
0
|
1
|
Baseline Characteristics
Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease
Baseline characteristics by cohort
| Measure |
Rosuvastatin 10mg
n=118 Participants
|
Rosuvastatin 40mg
n=124 Participants
|
Atorvastatin 80mg
n=111 Participants
|
Total
n=353 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18-49 years
|
22 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Age, Customized
50-64 years
|
59 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
|
Age, Customized
>=65 years
|
37 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
245 Participants
n=4 Participants
|
|
Estimated glomerular filtration rate [eGFR]
|
68.759 mL/min
STANDARD_DEVIATION 24.1080 • n=5 Participants
|
72.644 mL/min
STANDARD_DEVIATION 25.8018 • n=7 Participants
|
72.149 mL/min
STANDARD_DEVIATION 24.8721 • n=5 Participants
|
71.210 mL/min
STANDARD_DEVIATION 24.9455 • n=4 Participants
|
|
Urine albumin/creatinine ratio
|
1036.478 mg/g
STANDARD_DEVIATION 730.6185 • n=5 Participants
|
1079.802 mg/g
STANDARD_DEVIATION 725.7039 • n=7 Participants
|
1143.198 mg/g
STANDARD_DEVIATION 779.5282 • n=5 Participants
|
1085.435 mg/g
STANDARD_DEVIATION 743.5360 • n=4 Participants
|
|
Urine protein/creatinine ratio
|
1392.26 mg/g
STANDARD_DEVIATION 888.3215 • n=5 Participants
|
1493.574 mg/g
STANDARD_DEVIATION 996.0972 • n=7 Participants
|
1517.858 mg/g
STANDARD_DEVIATION 969.7020 • n=5 Participants
|
1467.843 mg/g
STANDARD_DEVIATION 952.0380 • n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=107 Participants
|
Rosuvastatin 40mg
n=116 Participants
|
Atorvastatin 80mg
n=102 Participants
|
|---|---|---|---|
|
Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.
|
1.016 mg/g
Interval 0.858 to 1.209
|
0.955 mg/g
Interval 0.869 to 1.185
|
0.874 mg/g
Interval 0.733 to 0.975
|
SECONDARY outcome
Timeframe: Assessed at Week 26Urinary 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.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=98 Participants
|
Rosuvastatin 40mg
n=108 Participants
|
Atorvastatin 80mg
n=92 Participants
|
|---|---|---|---|
|
Urinary Protein/Creatinine Ratio at Week 26.
|
1.007 mg/g
Interval 0.895 to 1.133
|
0.994 mg/g
Interval 0.881 to 1.121
|
0.876 mg/g
Interval 0.784 to 0.979
|
SECONDARY outcome
Timeframe: Assessed at Week 26Urinary 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.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=98 Participants
|
Rosuvastatin 40mg
n=109 Participants
|
Atorvastatin 80mg
n=92 Participants
|
|---|---|---|---|
|
Urinary Albumin/Creatinine Ratio at Week 26
|
0.927 mg/g
Interval 0.792 to 1.085
|
0.913 mg/g
Interval 0.788 to 1.058
|
0.831 mg/g
Interval 0.726 to 0.951
|
SECONDARY outcome
Timeframe: Assessed at Week 52 LOCFUrinary 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.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=107 Participants
|
Rosuvastatin 40mg
n=116 Participants
|
Atorvastatin 80mg
n=102 Participants
|
|---|---|---|---|
|
Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]
|
1.016 mg/g
Interval 0.856 to 1.206
|
0.836 mg/g
Interval 0.704 to 0.993
|
0.823 mg/g
Interval 0.709 to 0.954
|
SECONDARY outcome
Timeframe: Assessed at Baseline and Week 26Outcome measures
| Measure |
Rosuvastatin 10mg
n=100 Participants
|
Rosuvastatin 40mg
n=111 Participants
|
Atorvastatin 80mg
n=92 Participants
|
|---|---|---|---|
|
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26
|
-2.73 mL/min
Standard Deviation 12.644
|
-5.46 mL/min
Standard Deviation 14.079
|
-1.78 mL/min
Standard Deviation 10.997
|
SECONDARY outcome
Timeframe: Assessed at Baseline and Week 52 [LOCF]Outcome measures
| Measure |
Rosuvastatin 10mg
n=107 Participants
|
Rosuvastatin 40mg
n=115 Participants
|
Atorvastatin 80mg
n=101 Participants
|
|---|---|---|---|
|
Change From Baseline in eGFR at Week 52 [LOCF]
|
-3.70 mL/min
Standard Deviation 14.551
|
-7.29 mL/min
Standard Deviation 20.040
|
-1.61 mL/min
Standard Deviation 12.769
|
SECONDARY outcome
Timeframe: 52 weeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (LOCF).
Outcome measures
| Measure |
Rosuvastatin 10mg
n=205 Participants
|
Rosuvastatin 40mg
n=91 Participants
|
Atorvastatin 80mg
n=296 Participants
|
|---|---|---|---|
|
Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes
|
-0.03507 Correlation coefficient
|
0.14258 Correlation coefficient
|
0.01600 Correlation coefficient
|
SECONDARY outcome
Timeframe: Assessed at 52 WeeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=190 Participants
|
Rosuvastatin 40mg
n=79 Participants
|
Atorvastatin 80mg
n=269 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC
|
0.07019 Correlation coefficient
|
0.26855 Correlation coefficient
|
0.12013 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=203 Participants
|
Rosuvastatin 40mg
n=90 Participants
|
Atorvastatin 80mg
n=293 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C]
|
-0.08588 Correlation coefficient
|
0.18570 Correlation coefficient
|
-0.02491 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=190 Participants
|
Rosuvastatin 40mg
n=78 Participants
|
Atorvastatin 80mg
n=268 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C
|
0.04510 Correlation coefficient
|
0.16280 Correlation coefficient
|
0.06739 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=203 Participants
|
Rosuvastatin 40mg
n=90 Participants
|
Atorvastatin 80mg
n=293 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C]
|
0.15614 Correlation coefficient
|
0.06987 Correlation coefficient
|
0.14226 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=190 Participants
|
Rosuvastatin 40mg
n=78 Participants
|
Atorvastatin 80mg
n=268 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C
|
0.16111 Correlation coefficient
|
0.26194 Correlation coefficient
|
0.18918 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=203 Participants
|
Rosuvastatin 40mg
n=90 Participants
|
Atorvastatin 80mg
n=293 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C]
|
-0.12068 Correlation coefficient
|
0.15929 Correlation coefficient
|
-0.05186 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=190 Participants
|
Rosuvastatin 40mg
n=78 Participants
|
Atorvastatin 80mg
n=268 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C
|
0.02594 Correlation coefficient
|
0.24018 Correlation coefficient
|
0.07381 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=205 Participants
|
Rosuvastatin 40mg
n=91 Participants
|
Atorvastatin 80mg
n=296 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG]
|
-0.14569 Correlation coefficient
|
0.04948 Correlation coefficient
|
-0.08471 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=190 Participants
|
Rosuvastatin 40mg
n=78 Participants
|
Atorvastatin 80mg
n=269 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG
|
-0.05251 Correlation coefficient
|
0.11755 Correlation coefficient
|
0.01345 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=203 Participants
|
Rosuvastatin 40mg
n=90 Participants
|
Atorvastatin 80mg
n=293 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio
|
-0.13572 Correlation coefficient
|
0.07339 Correlation coefficient
|
-0.08855 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=190 Participants
|
Rosuvastatin 40mg
n=78 Participants
|
Atorvastatin 80mg
n=268 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio
|
-0.05945 Correlation coefficient
|
0.12132 Correlation coefficient
|
-0.02666 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=203 Participants
|
Rosuvastatin 40mg
n=90 Participants
|
Atorvastatin 80mg
n=293 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio
|
-0.13689 Correlation coefficient
|
0.12931 Correlation coefficient
|
-0.08108 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=190 Participants
|
Rosuvastatin 40mg
n=78 Participants
|
Atorvastatin 80mg
n=268 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio
|
-0.02775 Correlation coefficient
|
0.06535 Correlation coefficient
|
-0.01569 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=203 Participants
|
Rosuvastatin 40mg
n=90 Participants
|
Atorvastatin 80mg
n=293 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio
|
-0.16755 Correlation coefficient
|
0.08891 Correlation coefficient
|
-0.11221 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=190 Participants
|
Rosuvastatin 40mg
n=78 Participants
|
Atorvastatin 80mg
n=268 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio
|
-0.06085 Correlation coefficient
|
0.12507 Correlation coefficient
|
-0.02841 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=191 Participants
|
Rosuvastatin 40mg
n=87 Participants
|
Atorvastatin 80mg
n=278 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1]
|
0.15859 Correlation coefficient
|
0.13133 Correlation coefficient
|
0.15516 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=183 Participants
|
Rosuvastatin 40mg
n=78 Participants
|
Atorvastatin 80mg
n=261 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1
|
0.16587 Correlation coefficient
|
0.18469 Correlation coefficient
|
0.18832 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=191 Participants
|
Rosuvastatin 40mg
n=87 Participants
|
Atorvastatin 80mg
n=278 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB]
|
-0.02276 Correlation coefficient
|
0.21405 Correlation coefficient
|
0.04578 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=183 Participants
|
Rosuvastatin 40mg
n=78 Participants
|
Atorvastatin 80mg
n=261 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB
|
0.05397 Correlation coefficient
|
0.29486 Correlation coefficient
|
0.11079 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=191 Participants
|
Rosuvastatin 40mg
n=87 Participants
|
Atorvastatin 80mg
n=278 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio
|
-0.07846 Correlation coefficient
|
0.13910 Correlation coefficient
|
-0.02825 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=183 Participants
|
Rosuvastatin 40mg
n=78 Participants
|
Atorvastatin 80mg
n=261 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio
|
0.00600 Correlation coefficient
|
0.22710 Correlation coefficient
|
0.03684 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=206 Participants
|
Rosuvastatin 40mg
n=91 Participants
|
Atorvastatin 80mg
n=297 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC
|
0.00642 Correlation coefficient
|
0.14331 Correlation coefficient
|
0.04311 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=191 Participants
|
Rosuvastatin 40mg
n=79 Participants
|
Atorvastatin 80mg
n=270 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC
|
0.13220 Correlation coefficient
|
0.35715 Correlation coefficient
|
0.18971 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=204 Participants
|
Rosuvastatin 40mg
n=90 Participants
|
Atorvastatin 80mg
n=294 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C
|
-0.05514 Correlation coefficient
|
0.19842 Correlation coefficient
|
0.00038 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=191 Participants
|
Rosuvastatin 40mg
n=78 Participants
|
Atorvastatin 80mg
n=269 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C
|
0.10037 Correlation coefficient
|
0.21205 Correlation coefficient
|
0.12270 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=204 Participants
|
Rosuvastatin 40mg
n=90 Participants
|
Atorvastatin 80mg
n=294 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C
|
0.08593 Correlation coefficient
|
0.00032 Correlation coefficient
|
0.06930 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=191 Participants
|
Rosuvastatin 40mg
n=78 Participants
|
Atorvastatin 80mg
n=269 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C
|
0.14758 Correlation coefficient
|
0.26805 Correlation coefficient
|
0.17550 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=204 Participants
|
Rosuvastatin 40mg
n=90 Participants
|
Atorvastatin 80mg
n=294 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C
|
-0.06694 Correlation coefficient
|
0.17296 Correlation coefficient
|
-0.01144 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=191 Participants
|
Rosuvastatin 40mg
n=78 Participants
|
Atorvastatin 80mg
n=269 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C
|
0.09189 Correlation coefficient
|
0.33769 Correlation coefficient
|
0.14988 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=206 Participants
|
Rosuvastatin 40mg
n=91 Participants
|
Atorvastatin 80mg
n=297 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG
|
-0.07271 Correlation coefficient
|
0.08654 Correlation coefficient
|
-0.02876 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=191 Participants
|
Rosuvastatin 40mg
n=79 Participants
|
Atorvastatin 80mg
n=270 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG
|
-0.02947 Correlation coefficient
|
0.27198 Correlation coefficient
|
0.08787 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=204 Participants
|
Rosuvastatin 40mg
n=90 Participants
|
Atorvastatin 80mg
n=294 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio
|
-0.04785 Correlation coefficient
|
0.11256 Correlation coefficient
|
-0.01362 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=191 Participants
|
Rosuvastatin 40mg
n=78 Participants
|
Atorvastatin 80mg
n=269 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio
|
0.01798 Correlation coefficient
|
0.20127 Correlation coefficient
|
0.05369 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=204 Participants
|
Rosuvastatin 40mg
n=90 Participants
|
Atorvastatin 80mg
n=294 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio
|
-0.08211 Correlation coefficient
|
0.16654 Correlation coefficient
|
-0.03001 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=191 Participants
|
Rosuvastatin 40mg
n=78 Participants
|
Atorvastatin 80mg
n=269 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio
|
0.03476 Correlation coefficient
|
0.10902 Correlation coefficient
|
0.04508 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=204 Participants
|
Rosuvastatin 40mg
n=90 Participants
|
Atorvastatin 80mg
n=294 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio
|
-0.08468 Correlation coefficient
|
0.12805 Correlation coefficient
|
-0.04102 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=191 Participants
|
Rosuvastatin 40mg
n=78 Participants
|
Atorvastatin 80mg
n=269 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio
|
0.01528 Correlation coefficient
|
0.21198 Correlation coefficient
|
0.05251 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=192 Participants
|
Rosuvastatin 40mg
n=87 Participants
|
Atorvastatin 80mg
n=279 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1
|
0.14207 Correlation coefficient
|
0.11171 Correlation coefficient
|
0.13429 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=184 Participants
|
Rosuvastatin 40mg
n=78 Participants
|
Atorvastatin 80mg
n=262 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1
|
0.16085 Correlation coefficient
|
0.15933 Correlation coefficient
|
0.17306 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=192 Participants
|
Rosuvastatin 40mg
n=87 Participants
|
Atorvastatin 80mg
n=279 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB
|
-0.00569 Correlation coefficient
|
0.20008 Correlation coefficient
|
0.04833 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=184 Participants
|
Rosuvastatin 40mg
n=78 Participants
|
Atorvastatin 80mg
n=262 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB
|
0.10997 Correlation coefficient
|
0.30537 Correlation coefficient
|
0.15652 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=192 Participants
|
Rosuvastatin 40mg
n=87 Participants
|
Atorvastatin 80mg
n=279 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio
|
-0.05906 Correlation coefficient
|
0.13706 Correlation coefficient
|
-0.01775 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=184 Participants
|
Rosuvastatin 40mg
n=78 Participants
|
Atorvastatin 80mg
n=262 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio
|
0.04760 Correlation coefficient
|
0.25636 Correlation coefficient
|
0.07766 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=211 Participants
|
Rosuvastatin 40mg
n=91 Participants
|
Atorvastatin 80mg
n=302 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and TC
|
0.01586 Correlation coefficient
|
-0.03124 Correlation coefficient
|
0.00101 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=195 Participants
|
Rosuvastatin 40mg
n=82 Participants
|
Atorvastatin 80mg
n=277 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and TC
|
-0.13489 Correlation coefficient
|
-0.18105 Correlation coefficient
|
-0.14690 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=209 Participants
|
Rosuvastatin 40mg
n=90 Participants
|
Atorvastatin 80mg
n=299 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C
|
0.03010 Correlation coefficient
|
-0.00944 Correlation coefficient
|
0.02609 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=195 Participants
|
Rosuvastatin 40mg
n=81 Participants
|
Atorvastatin 80mg
n=276 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C
|
-0.11072 Correlation coefficient
|
-0.12835 Correlation coefficient
|
-0.11378 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=209 Participants
|
Rosuvastatin 40mg
n=90 Participants
|
Atorvastatin 80mg
n=299 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C
|
0.11373 Correlation coefficient
|
0.01123 Correlation coefficient
|
0.07576 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 WeeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=195 Participants
|
Rosuvastatin 40mg
n=81 Participants
|
Atorvastatin 80mg
n=276 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C
|
0.14457 Correlation coefficient
|
-0.15546 Correlation coefficient
|
0.08841 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=209 Participants
|
Rosuvastatin 40mg
n=90 Participants
|
Atorvastatin 80mg
n=299 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C
|
-0.01709 Correlation coefficient
|
-0.05610 Correlation coefficient
|
-0.02569 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 weeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=195 Participants
|
Rosuvastatin 40mg
n=81 Participants
|
Atorvastatin 80mg
n=276 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C
|
-0.17729 Correlation coefficient
|
-0.19501 Correlation coefficient
|
-0.17911 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=211 Participants
|
Rosuvastatin 40mg
n=91 Participants
|
Atorvastatin 80mg
n=302 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and TG
|
-0.10533 Correlation coefficient
|
-0.00604 Correlation coefficient
|
-0.09437 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 weeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=195 Participants
|
Rosuvastatin 40mg
n=82 Participants
|
Atorvastatin 80mg
n=277 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and TG
|
-0.24494 Correlation coefficient
|
-0.07059 Correlation coefficient
|
-0.15586 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=209 Participants
|
Rosuvastatin 40mg
n=90 Participants
|
Atorvastatin 80mg
n=299 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio
|
-0.05426 Correlation coefficient
|
-0.01643 Correlation coefficient
|
-0.04256 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 weeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=195 Participants
|
Rosuvastatin 40mg
n=81 Participants
|
Atorvastatin 80mg
n=276 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio
|
-0.26268 Correlation coefficient
|
-0.08593 Correlation coefficient
|
-0.23226 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=209 Participants
|
Rosuvastatin 40mg
n=90 Participants
|
Atorvastatin 80mg
n=299 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio
|
-0.01040 Correlation coefficient
|
0.00241 Correlation coefficient
|
0.00189 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 weeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=195 Participants
|
Rosuvastatin 40mg
n=81 Participants
|
Atorvastatin 80mg
n=276 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio
|
-0.19850 Correlation coefficient
|
-0.06481 Correlation coefficient
|
-0.17579 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=209 Participants
|
Rosuvastatin 40mg
n=90 Participants
|
Atorvastatin 80mg
n=299 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio
|
-0.06356 Correlation coefficient
|
-0.04402 Correlation coefficient
|
-0.05499 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 weeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=195 Participants
|
Rosuvastatin 40mg
n=81 Participants
|
Atorvastatin 80mg
n=276 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio
|
-0.26802 Correlation coefficient
|
-0.11804 Correlation coefficient
|
-0.24204 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=197 Participants
|
Rosuvastatin 40mg
n=87 Participants
|
Atorvastatin 80mg
n=284 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1
|
0.08146 Correlation coefficient
|
0.05333 Correlation coefficient
|
0.05845 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 weeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=187 Participants
|
Rosuvastatin 40mg
n=81 Participants
|
Atorvastatin 80mg
n=268 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1
|
0.17909 Correlation coefficient
|
0.08090 Correlation coefficient
|
0.12787 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=197 Participants
|
Rosuvastatin 40mg
n=87 Participants
|
Atorvastatin 80mg
n=284 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB
|
-0.01427 Correlation coefficient
|
0.08821 Correlation coefficient
|
0.00737 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 weeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=187 Participants
|
Rosuvastatin 40mg
n=81 Participants
|
Atorvastatin 80mg
n=268 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB
|
-0.15146 Correlation coefficient
|
0.04886 Correlation coefficient
|
-0.12168 Correlation coefficient
|
SECONDARY outcome
Timeframe: 26 weeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Outcome measures
| Measure |
Rosuvastatin 10mg
n=197 Participants
|
Rosuvastatin 40mg
n=87 Participants
|
Atorvastatin 80mg
n=284 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio
|
-0.04088 Correlation coefficient
|
0.06598 Correlation coefficient
|
-0.01652 Correlation coefficient
|
SECONDARY outcome
Timeframe: 52 weeksCorrelation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Outcome measures
| Measure |
Rosuvastatin 10mg
n=187 Participants
|
Rosuvastatin 40mg
n=81 Participants
|
Atorvastatin 80mg
n=268 Participants
|
|---|---|---|---|
|
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio
|
-0.26146 Correlation coefficient
|
0.05248 Correlation coefficient
|
-0.22109 Correlation coefficient
|
Adverse Events
Rosuvastatin 10mg
Rosuvastatin 40mg
Atorvastatin 80mg
Serious adverse events
| Measure |
Rosuvastatin 10mg
n=116 participants at risk
|
Rosuvastatin 40mg
n=123 participants at risk
|
Atorvastatin 80mg
n=110 participants at risk
|
|---|---|---|---|
|
Cardiac disorders
Cardiac Failure
|
2.6%
3/116
|
0.81%
1/123
|
0.91%
1/110
|
|
Cardiac disorders
Angina Pectoris
|
1.7%
2/116
|
0.81%
1/123
|
1.8%
2/110
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.86%
1/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.00%
0/116
|
0.81%
1/123
|
0.00%
0/110
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Cardiac disorders
Left Ventricular Failure
|
0.00%
0/116
|
0.81%
1/123
|
0.00%
0/110
|
|
Eye disorders
Cataract
|
0.00%
0/116
|
0.81%
1/123
|
0.00%
0/110
|
|
Eye disorders
Diabetic Eye Disease
|
0.86%
1/116
|
0.00%
0/123
|
0.00%
0/110
|
|
Eye disorders
Vitreous Haemorrhage
|
0.86%
1/116
|
0.00%
0/123
|
0.00%
0/110
|
|
Eye disorders
Diabetic Retinopathy
|
0.00%
0/116
|
0.81%
1/123
|
0.00%
0/110
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Gastrointestinal disorders
Ileus Paralytic
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.86%
1/116
|
0.00%
0/123
|
0.00%
0/110
|
|
Gastrointestinal disorders
Intestinal Polyp
|
0.86%
1/116
|
0.00%
0/123
|
0.00%
0/110
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/116
|
0.81%
1/123
|
0.00%
0/110
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/116
|
0.81%
1/123
|
0.00%
0/110
|
|
General disorders
Oedema Peripheral
|
1.7%
2/116
|
0.00%
0/123
|
0.00%
0/110
|
|
General disorders
Death
|
0.86%
1/116
|
0.81%
1/123
|
0.00%
0/110
|
|
General disorders
Soft Tissue Inflammation
|
0.86%
1/116
|
0.00%
0/123
|
0.00%
0/110
|
|
General disorders
Sudden Death
|
0.86%
1/116
|
0.00%
0/123
|
0.00%
0/110
|
|
General disorders
Chest Pain
|
0.00%
0/116
|
0.81%
1/123
|
0.00%
0/110
|
|
General disorders
Pyrexia
|
0.00%
0/116
|
0.81%
1/123
|
0.00%
0/110
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.86%
1/116
|
0.00%
0/123
|
0.00%
0/110
|
|
Infections and infestations
Cellulitis
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Infections and infestations
Gangrene
|
0.00%
0/116
|
0.81%
1/123
|
0.91%
1/110
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Infections and infestations
Pneumonia
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Infections and infestations
Skin Infection
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Infections and infestations
Pyelonephritis Chronic
|
0.86%
1/116
|
0.00%
0/123
|
0.00%
0/110
|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/116
|
0.81%
1/123
|
0.00%
0/110
|
|
Infections and infestations
Abscess Limb
|
0.00%
0/116
|
0.81%
1/123
|
0.00%
0/110
|
|
Infections and infestations
Influenza
|
0.00%
0/116
|
0.81%
1/123
|
0.00%
0/110
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Injury, poisoning and procedural complications
Vascular Graft Occlusion
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.00%
0/116
|
0.00%
0/123
|
1.8%
2/110
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.86%
1/116
|
0.81%
1/123
|
0.00%
0/110
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/116
|
0.81%
1/123
|
0.91%
1/110
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/116
|
0.81%
1/123
|
0.00%
0/110
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/116
|
0.81%
1/123
|
0.00%
0/110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Central Nervous System
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Nervous system disorders
Aphasia
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Nervous system disorders
Presyncope
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Nervous system disorders
Headache
|
0.86%
1/116
|
0.00%
0/123
|
0.00%
0/110
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/116
|
0.81%
1/123
|
0.00%
0/110
|
|
Nervous system disorders
Syncope
|
0.00%
0/116
|
0.81%
1/123
|
0.00%
0/110
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/116
|
0.00%
0/123
|
1.8%
2/110
|
|
Psychiatric disorders
Factitious Disorder
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/116
|
1.6%
2/123
|
0.00%
0/110
|
|
Renal and urinary disorders
Diabetic Nephropathy
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Renal and urinary disorders
Haematuria
|
0.86%
1/116
|
0.00%
0/123
|
0.00%
0/110
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/116
|
0.81%
1/123
|
0.00%
0/110
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/116
|
0.81%
1/123
|
0.00%
0/110
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.86%
1/116
|
0.81%
1/123
|
0.00%
0/110
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.86%
1/116
|
0.00%
0/123
|
0.00%
0/110
|
|
Respiratory, thoracic and mediastinal disorders
Pickwickian Syndrome
|
0.86%
1/116
|
0.00%
0/123
|
0.00%
0/110
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.86%
1/116
|
0.00%
0/123
|
0.00%
0/110
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.86%
1/116
|
0.00%
0/123
|
0.00%
0/110
|
|
Vascular disorders
Femoral Arterial Stenosis
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Vascular disorders
Hypotension
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
|
Vascular disorders
Poor Peripheral Circulation
|
0.00%
0/116
|
0.00%
0/123
|
0.91%
1/110
|
Other adverse events
| Measure |
Rosuvastatin 10mg
n=116 participants at risk
|
Rosuvastatin 40mg
n=123 participants at risk
|
Atorvastatin 80mg
n=110 participants at risk
|
|---|---|---|---|
|
General disorders
Oedema Peripheral
|
7.8%
9/116
|
4.1%
5/123
|
2.7%
3/110
|
|
Infections and infestations
Influenza
|
2.6%
3/116
|
5.7%
7/123
|
0.00%
0/110
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.6%
3/116
|
4.9%
6/123
|
6.4%
7/110
|
|
Vascular disorders
Hypertension
|
1.7%
2/116
|
6.5%
8/123
|
1.8%
2/110
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60