Trial Outcomes & Findings for 12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe (NCT NCT00525824)
NCT ID: NCT00525824
Last Updated: 2011-05-13
Results Overview
Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value\*100
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1743 participants
Primary outcome timeframe
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Results posted on
2011-05-13
Participant Flow
Eight hundred thirty-three patients (with hypercholesterolaemia and CHD or CHD risk equivalent, atherosclerosis or a 10-year CHD risk of \>20%) were randomized into the study, from 111 sites located in the United States (56), Peru (13), Netherlands (12), Colombia (8), Argentina (8), Brazil (6), Chile (4) and Lithuania (4).
Patients underwent screening procedures (Week -6; Visit 1), and entered a 6-week dietary lead-in period. Those who fulfilled all eligibility criteria (Week -6; Visit 1) and had qualifying lipid values at Visit 2 were randomly allocated (1:1:1:1) to 1 of 4 treatments for a period of 12 weeks.
Participant milestones
| Measure |
R10 to R10 + E10
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
|
R20 to R20 + E10
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
|
S40 to S40 + E10
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
|
S80 to S80 + E10
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
214
|
214
|
202
|
203
|
|
Overall Study
COMPLETED
|
195
|
186
|
183
|
188
|
|
Overall Study
NOT COMPLETED
|
19
|
28
|
19
|
15
|
Reasons for withdrawal
| Measure |
R10 to R10 + E10
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
|
R20 to R20 + E10
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
|
S40 to S40 + E10
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
|
S80 to S80 + E10
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
11
|
6
|
7
|
|
Overall Study
Withdrawal by Subject
|
5
|
9
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
4
|
0
|
|
Overall Study
Incorrect enrolment/mis-randomisation
|
1
|
2
|
1
|
2
|
|
Overall Study
Severe non-compliance
|
0
|
1
|
1
|
1
|
|
Overall Study
Safety reasons
|
1
|
0
|
1
|
0
|
|
Overall Study
Other
|
1
|
3
|
3
|
1
|
Baseline Characteristics
12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe
Baseline characteristics by cohort
| Measure |
R10 to R10 + E10
n=214 Participants
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
|
R20 to R20 + E10
n=214 Participants
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
|
S40 to S40 + E10
n=202 Participants
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
|
S80 to S80 + E10
n=203 Participants
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
|
Total
n=833 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
62.2 years
STANDARD_DEVIATION 10.14 • n=99 Participants
|
61.8 years
STANDARD_DEVIATION 9.93 • n=107 Participants
|
61.9 years
STANDARD_DEVIATION 9.37 • n=206 Participants
|
62.1 years
STANDARD_DEVIATION 9.17 • n=7 Participants
|
62.0 years
STANDARD_DEVIATION 9.66 • n=31 Participants
|
|
Sex: Female, Male
Female
|
91.0000 Participants
n=99 Participants
|
97.0000 Participants
n=107 Participants
|
97.0000 Participants
n=206 Participants
|
90.0000 Participants
n=7 Participants
|
375.0 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
123.0000 Participants
n=99 Participants
|
117.0000 Participants
n=107 Participants
|
105.0000 Participants
n=206 Participants
|
113.0000 Participants
n=7 Participants
|
458.0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value\*100
Outcome measures
| Measure |
S80 to S80 + E10
n=201 Participants
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
|
R10 to R10 + E10
n=210 Participants
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
|
R20 to R20 + E10
n=204 Participants
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
|
S40 to S40 + E10
n=199 Participants
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
|
|---|---|---|---|---|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment
|
-57.4200 Percentage
Standard Deviation 20.4660
|
-59.7200 Percentage
Standard Deviation 14.1660
|
-63.4800 Percentage
Standard Deviation 16.6970
|
-55.2200 Percentage
Standard Deviation 15.7500
|
SECONDARY outcome
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)Percent change in HDL-C = (Combination treatment value - Baseline value)/Baseline value\*100
Outcome measures
| Measure |
S80 to S80 + E10
n=201 Participants
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
|
R10 to R10 + E10
n=210 Participants
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
|
R20 to R20 + E10
n=204 Participants
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
|
S40 to S40 + E10
n=199 Participants
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
|
|---|---|---|---|---|
|
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment
|
4.3400 Percentage
Standard Deviation 12.6430
|
6.4100 Percentage
Standard Deviation 13.9340
|
7.4600 Percentage
Standard Deviation 16.3510
|
3.9200 Percentage
Standard Deviation 12.6830
|
SECONDARY outcome
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)Percent change in TC = (Combination treatment value - Baseline value)/Baseline value\*100
Outcome measures
| Measure |
S80 to S80 + E10
n=201 Participants
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
|
R10 to R10 + E10
n=210 Participants
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
|
R20 to R20 + E10
n=204 Participants
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
|
S40 to S40 + E10
n=199 Participants
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
|
|---|---|---|---|---|
|
Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment
|
-41.7100 Percentage
Standard Deviation 15.1500
|
-43.0000 Percentage
Standard Deviation 11.2080
|
-46.6300 Percentage
Standard Deviation 12.8180
|
-39.5600 Percentage
Standard Deviation 12.6640
|
SECONDARY outcome
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)Percent change in TG = (Combination treatment value - Baseline value)/Baseline value\*100
Outcome measures
| Measure |
S80 to S80 + E10
n=201 Participants
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
|
R10 to R10 + E10
n=210 Participants
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
|
R20 to R20 + E10
n=204 Participants
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
|
S40 to S40 + E10
n=199 Participants
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
|
|---|---|---|---|---|
|
Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment
|
-25.8200 Percentage
Standard Deviation 26.6190
|
-28.8500 Percentage
Standard Deviation 23.7090
|
-35.0000 Percentage
Standard Deviation 23.9710
|
-22.9500 Percentage
Standard Deviation 28.1390
|
SECONDARY outcome
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)Percent change in nonHDL-C = (Combination treatment value - Baseline value)/Baseline value\*100
Outcome measures
| Measure |
S80 to S80 + E10
n=201 Participants
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
|
R10 to R10 + E10
n=210 Participants
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
|
R20 to R20 + E10
n=204 Participants
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
|
S40 to S40 + E10
n=199 Participants
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
|
|---|---|---|---|---|
|
Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment
|
-52.3700 Percentage
Standard Deviation 18.4290
|
-54.6500 Percentage
Standard Deviation 13.6770
|
-58.9100 Percentage
Standard Deviation 14.9320
|
-49.9300 Percentage
Standard Deviation 14.7380
|
SECONDARY outcome
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)Percent change in ApoB = (Combination treatment value - Baseline value)/Baseline value\*100
Outcome measures
| Measure |
S80 to S80 + E10
n=199 Participants
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
|
R10 to R10 + E10
n=206 Participants
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
|
R20 to R20 + E10
n=199 Participants
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
|
S40 to S40 + E10
n=194 Participants
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
|
|---|---|---|---|---|
|
Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment
|
-44.1700 Percentage
Standard Deviation 17.1790
|
-46.1100 Percentage
Standard Deviation 12.6280
|
-49.5000 Percentage
Standard Deviation 13.8210
|
-41.9500 Percentage
Standard Deviation 14.7500
|
SECONDARY outcome
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)Percent change in ApoA-1 = (Combination treatment value - Baseline value)/Baseline value\*100
Outcome measures
| Measure |
S80 to S80 + E10
n=199 Participants
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
|
R10 to R10 + E10
n=206 Participants
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
|
R20 to R20 + E10
n=199 Participants
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
|
S40 to S40 + E10
n=194 Participants
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
|
|---|---|---|---|---|
|
Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment
|
2.1300 Percentage
Standard Deviation 10.7410
|
3.8100 Percentage
Standard Deviation 13.0420
|
2.6800 Percentage
Standard Deviation 11.5020
|
1.4900 Percentage
Standard Deviation 9.6830
|
SECONDARY outcome
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)Percent change in TC/HDL-C = (Combination treatment value - Baseline value)/Baseline value\*100
Outcome measures
| Measure |
S80 to S80 + E10
n=201 Participants
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
|
R10 to R10 + E10
n=210 Participants
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
|
R20 to R20 + E10
n=204 Participants
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
|
S40 to S40 + E10
n=199 Participants
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
|
|---|---|---|---|---|
|
Percent Change in TC/HDL-C After 6 Weeks Combination Treatment
|
-43.4500 Percentage
Standard Deviation 16.3430
|
-45.5200 Percentage
Standard Deviation 13.2280
|
-49.4600 Percentage
Standard Deviation 13.5750
|
-41.2700 Percentage
Standard Deviation 13.0210
|
SECONDARY outcome
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)Percent change in LDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value\*100
Outcome measures
| Measure |
S80 to S80 + E10
n=201 Participants
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
|
R10 to R10 + E10
n=210 Participants
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
|
R20 to R20 + E10
n=204 Participants
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
|
S40 to S40 + E10
n=199 Participants
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
|
|---|---|---|---|---|
|
Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment
|
-58.6600 Percentage
Standard Deviation 21.1300
|
-61.4700 Percentage
Standard Deviation 15.5470
|
-65.2500 Percentage
Standard Deviation 16.6800
|
-57.1300 Percentage
Standard Deviation 14.7770
|
SECONDARY outcome
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)Percent change in non-HDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value\*100
Outcome measures
| Measure |
S80 to S80 + E10
n=201 Participants
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
|
R10 to R10 + E10
n=210 Participants
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
|
R20 to R20 + E10
n=204 Participants
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
|
S40 to S40 + E10
n=199 Participants
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
|
|---|---|---|---|---|
|
Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment
|
-53.5100 Percentage
Standard Deviation 20.2230
|
-56.4200 Percentage
Standard Deviation 15.4150
|
-60.8900 Percentage
Standard Deviation 15.5030
|
-51.1100 Percentage
Standard Deviation 15.3800
|
SECONDARY outcome
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)Percent change in ApoB/ApoA-1 = (Combination treatment value - Baseline value)/Baseline value\*100
Outcome measures
| Measure |
S80 to S80 + E10
n=199 Participants
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
|
R10 to R10 + E10
n=206 Participants
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
|
R20 to R20 + E10
n=199 Participants
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
|
S40 to S40 + E10
n=194 Participants
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
|
|---|---|---|---|---|
|
Percent Change in ApoB/ApoA-1 After 6 Weeks Combination Treatment
|
-44.7600 Percentage
Standard Deviation 17.8420
|
-47.3900 Percentage
Standard Deviation 13.8690
|
-50.2400 Percentage
Standard Deviation 14.2570
|
-42.5400 Percentage
Standard Deviation 14.2480
|
SECONDARY outcome
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)Percent change in hs-CRP = (Combination treatment value - Baseline value)/Baseline value\*100
Outcome measures
| Measure |
S80 to S80 + E10
n=199 Participants
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
|
R10 to R10 + E10
n=207 Participants
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
|
R20 to R20 + E10
n=202 Participants
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
|
S40 to S40 + E10
n=197 Participants
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
|
|---|---|---|---|---|
|
Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) After 6 Weeks Combination Treatment
|
0.4200 Percentage
Full Range -94.9000 • Interval -94.9 to 1270.4
|
107.1200 Percentage
Full Range -99.0000 • Interval -99.0 to 20295.0
|
-9.5300 Percentage
Full Range -97.9000 • Interval -97.9 to 2368.3
|
15.0300 Percentage
Full Range -91.5000 • Interval -91.5 to 1611.4
|
SECONDARY outcome
Timeframe: Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward)Percent change in LDL-C = (Monotherapy treatment value - Baseline value)/Baseline value\*100
Outcome measures
| Measure |
S80 to S80 + E10
n=200 Participants
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
|
R10 to R10 + E10
n=206 Participants
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
|
R20 to R20 + E10
n=199 Participants
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
|
S40 to S40 + E10
n=197 Participants
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
|
|---|---|---|---|---|
|
Percent Change in LDL-C After 6 Weeks Monotherapy
|
-46.3500 Percentage
Standard Deviation 16.1880
|
-46.4900 Percentage
Standard Deviation 13.1080
|
-53.5900 Percentage
Standard Deviation 10.5030
|
-40.8600 Percentage
Standard Deviation 12.4130
|
Adverse Events
Rosuvastatin 10 mg
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Rosuvastatin 20 mg
Serious events: 5 serious events
Other events: 31 other events
Deaths: 0 deaths
Simvastatin 40 mg
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Simvastatin 80 mg
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Rosu 10 mg + Eze 10 mg
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Rosu 20 mg + Eze 10 mg
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Simva 40 mg + Eze 10 mg
Serious events: 7 serious events
Other events: 24 other events
Deaths: 0 deaths
Simva 80 mg + Eze 10 mg
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rosuvastatin 10 mg
Rosuvastatin 10 mg Monotherapy arm
|
Rosuvastatin 20 mg
Rosuvastatin 20 mg Monotherapy arm
|
Simvastatin 40 mg
Simvastatin 40 mg Monotherapy arm
|
Simvastatin 80 mg
Simvastatin 80 mg Monotherapy arm
|
Rosu 10 mg + Eze 10 mg
Rosuvastatin 10 mg + Ezetimibe 10 mg
|
Rosu 20 mg + Eze 10 mg
Rosuvastatin 20 mg + Ezetimibe 10 mg
|
Simva 40 mg + Eze 10 mg
Simvastatin 40 mg + Ezetimibe 10 mg
|
Simva 80 mg + Eze 10 mg
Simvastatin 80 mg + Ezetimibe 10 mg
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/213
|
0.00%
0/212
|
0.00%
0/199
|
0.00%
0/203
|
0.00%
0/200
|
0.00%
0/191
|
0.00%
0/189
|
0.52%
1/192
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/213
|
0.47%
1/212
|
0.00%
0/199
|
0.00%
0/203
|
0.00%
0/200
|
0.00%
0/191
|
0.00%
0/189
|
0.00%
0/192
|
|
Cardiac disorders
Angina pectoris
|
0.47%
1/213
|
0.00%
0/212
|
0.00%
0/199
|
0.00%
0/203
|
0.50%
1/200
|
0.00%
0/191
|
0.00%
0/189
|
0.00%
0/192
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/213
|
0.00%
0/212
|
0.00%
0/199
|
0.00%
0/203
|
1.0%
2/200
|
0.00%
0/191
|
1.6%
3/189
|
0.00%
0/192
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/213
|
0.47%
1/212
|
0.00%
0/199
|
0.00%
0/203
|
0.00%
0/200
|
0.00%
0/191
|
0.00%
0/189
|
0.00%
0/192
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/213
|
0.00%
0/212
|
0.00%
0/199
|
0.00%
0/203
|
0.00%
0/200
|
0.00%
0/191
|
0.53%
1/189
|
0.00%
0/192
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/213
|
0.47%
1/212
|
0.00%
0/199
|
0.00%
0/203
|
0.00%
0/200
|
0.00%
0/191
|
0.00%
0/189
|
0.00%
0/192
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/213
|
0.00%
0/212
|
0.00%
0/199
|
0.49%
1/203
|
0.00%
0/200
|
0.00%
0/191
|
0.00%
0/189
|
0.00%
0/192
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/213
|
0.00%
0/212
|
0.00%
0/199
|
0.00%
0/203
|
0.00%
0/200
|
0.00%
0/191
|
0.00%
0/189
|
0.52%
1/192
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/213
|
0.00%
0/212
|
0.00%
0/199
|
0.00%
0/203
|
0.00%
0/200
|
0.00%
0/191
|
0.00%
0/189
|
0.52%
1/192
|
|
Infections and infestations
Pneumonia
|
0.47%
1/213
|
0.00%
0/212
|
0.00%
0/199
|
0.00%
0/203
|
0.00%
0/200
|
0.00%
0/191
|
0.00%
0/189
|
0.00%
0/192
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/213
|
0.00%
0/212
|
0.00%
0/199
|
0.00%
0/203
|
0.00%
0/200
|
0.52%
1/191
|
0.00%
0/189
|
0.00%
0/192
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.00%
0/213
|
0.00%
0/212
|
0.00%
0/199
|
0.00%
0/203
|
0.00%
0/200
|
0.00%
0/191
|
0.53%
1/189
|
0.00%
0/192
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/213
|
0.00%
0/212
|
0.00%
0/199
|
0.00%
0/203
|
0.00%
0/200
|
0.00%
0/191
|
0.00%
0/189
|
0.52%
1/192
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/213
|
0.00%
0/212
|
0.00%
0/199
|
0.49%
1/203
|
0.00%
0/200
|
0.00%
0/191
|
0.00%
0/189
|
0.00%
0/192
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/213
|
0.00%
0/212
|
0.00%
0/199
|
0.00%
0/203
|
0.50%
1/200
|
0.00%
0/191
|
0.00%
0/189
|
0.00%
0/192
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/213
|
0.00%
0/212
|
0.00%
0/199
|
0.00%
0/203
|
0.00%
0/200
|
0.00%
0/191
|
0.53%
1/189
|
0.00%
0/192
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/213
|
0.00%
0/212
|
0.00%
0/199
|
0.00%
0/203
|
0.00%
0/200
|
0.00%
0/191
|
0.53%
1/189
|
0.00%
0/192
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/213
|
0.00%
0/212
|
0.00%
0/199
|
0.49%
1/203
|
0.00%
0/200
|
0.00%
0/191
|
0.00%
0/189
|
0.00%
0/192
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/213
|
0.94%
2/212
|
0.00%
0/199
|
0.00%
0/203
|
0.00%
0/200
|
0.00%
0/191
|
0.00%
0/189
|
0.00%
0/192
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/213
|
0.00%
0/212
|
0.50%
1/199
|
0.00%
0/203
|
0.50%
1/200
|
0.00%
0/191
|
0.00%
0/189
|
0.00%
0/192
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/213
|
0.00%
0/212
|
0.00%
0/199
|
0.49%
1/203
|
0.00%
0/200
|
0.00%
0/191
|
0.00%
0/189
|
0.00%
0/192
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.47%
1/213
|
0.00%
0/212
|
0.00%
0/199
|
0.00%
0/203
|
0.00%
0/200
|
0.00%
0/191
|
0.00%
0/189
|
0.00%
0/192
|
|
Vascular disorders
Arterial thrombosis limb
|
0.47%
1/213
|
0.00%
0/212
|
0.00%
0/199
|
0.00%
0/203
|
0.00%
0/200
|
0.00%
0/191
|
0.00%
0/189
|
0.00%
0/192
|
Other adverse events
| Measure |
Rosuvastatin 10 mg
Rosuvastatin 10 mg Monotherapy arm
|
Rosuvastatin 20 mg
Rosuvastatin 20 mg Monotherapy arm
|
Simvastatin 40 mg
Simvastatin 40 mg Monotherapy arm
|
Simvastatin 80 mg
Simvastatin 80 mg Monotherapy arm
|
Rosu 10 mg + Eze 10 mg
Rosuvastatin 10 mg + Ezetimibe 10 mg
|
Rosu 20 mg + Eze 10 mg
Rosuvastatin 20 mg + Ezetimibe 10 mg
|
Simva 40 mg + Eze 10 mg
Simvastatin 40 mg + Ezetimibe 10 mg
|
Simva 80 mg + Eze 10 mg
Simvastatin 80 mg + Ezetimibe 10 mg
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
1.9%
4/213
|
2.4%
5/212
|
0.50%
1/199
|
0.49%
1/203
|
0.50%
1/200
|
1.6%
3/191
|
1.1%
2/189
|
0.52%
1/192
|
|
General disorders
Oedema peripheral
|
0.00%
0/213
|
0.00%
0/212
|
0.00%
0/199
|
0.00%
0/203
|
0.50%
1/200
|
0.00%
0/191
|
1.1%
2/189
|
2.1%
4/192
|
|
Infections and infestations
Bronchitis
|
0.47%
1/213
|
0.47%
1/212
|
2.0%
4/199
|
0.99%
2/203
|
1.5%
3/200
|
1.0%
2/191
|
1.1%
2/189
|
0.52%
1/192
|
|
Infections and infestations
Influenza
|
0.94%
2/213
|
0.47%
1/212
|
2.0%
4/199
|
0.49%
1/203
|
0.00%
0/200
|
2.1%
4/191
|
1.6%
3/189
|
0.00%
0/192
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
3/213
|
1.4%
3/212
|
2.0%
4/199
|
1.5%
3/203
|
1.0%
2/200
|
2.6%
5/191
|
1.1%
2/189
|
1.6%
3/192
|
|
Infections and infestations
Upper respiratory tract infection
|
0.47%
1/213
|
0.47%
1/212
|
2.0%
4/199
|
1.5%
3/203
|
1.0%
2/200
|
0.52%
1/191
|
1.6%
3/189
|
1.0%
2/192
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.3%
5/213
|
1.9%
4/212
|
0.50%
1/199
|
2.0%
4/203
|
1.0%
2/200
|
0.00%
0/191
|
0.53%
1/189
|
1.0%
2/192
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.47%
1/213
|
0.94%
2/212
|
2.0%
4/199
|
0.49%
1/203
|
1.0%
2/200
|
0.52%
1/191
|
1.6%
3/189
|
1.6%
3/192
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.3%
5/213
|
4.7%
10/212
|
1.5%
3/199
|
3.4%
7/203
|
2.0%
4/200
|
2.6%
5/191
|
2.1%
4/189
|
1.6%
3/192
|
|
Nervous system disorders
Dizziness
|
0.47%
1/213
|
2.4%
5/212
|
0.50%
1/199
|
0.99%
2/203
|
0.50%
1/200
|
1.0%
2/191
|
1.6%
3/189
|
1.0%
2/192
|
|
Nervous system disorders
Headache
|
1.9%
4/213
|
1.9%
4/212
|
2.5%
5/199
|
2.0%
4/203
|
1.5%
3/200
|
0.52%
1/191
|
0.53%
1/189
|
1.0%
2/192
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place