| |
Obese subjects
|
Non-obese subjects
|
|---|
| |
EZ/Simva 10/20 mg (N = 181)
|
Doubling statin dose (N = 93)
|
Rosuvastatin 10 mg (N = 192)
|
EZ/Simva 10/20 mg (N = 140)
|
Doubling statin dose (N = 69)
|
Rosuvastatin 10 mg (N = 131)
|
|---|
| |
n (%)
|
n (%)
|
n (%)
|
n (%)
|
n (%)
|
n (%)
|
|---|
|
≥1 AE
|
18 (9.9)
|
9 (9.7)
|
13 (6.8)
|
15 (10.7)
|
4 (5.8)
|
15 (11.5)
|
|
Drug-related AE
|
6 (3.3)
|
2 (2.2)
|
2 (1.0)
|
2 (1.4)
|
0 (0.0)
|
0 (0.0)
|
|
Serious AE
|
0 (0.0)
|
1 (1.1)
|
2 (1.0)
|
2 (1.4)
|
0 (0.0)
|
0 (0.0)
|
|
Serious drug-related AE
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
|
Death
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
|
Discontinued due to
| | | | | | |
|
AE
|
3 (1.7)
|
3 (3.2)
|
0 (0.0)
|
4 (2.9)
|
0 (0.0)
|
1 (0.8)
|
|
Drug-related AE
|
2 (1.1)
|
2 (2.2)
|
0 (0.0)
|
1 (0.7)
|
0 (0.0)
|
0 (0.0)
|
|
Serious AE
|
0 (0.0)
|
1 (1.1)
|
0 (0.0)
|
1 (0.7)
|
0 (0.0)
|
0 (0.0)
|
|
AEs of special interest
| | | | | | |
|
Allergic reaction or rash
|
1 (0.6)
|
0 (0.0)
|
1 (0.5)
|
0 (0.0)
|
0 (0.0)
|
1 (0.8)
|
|
Gastrointestinal-related
|
4 (2.2)
|
1 (1.1)
|
3 (1.6)
|
6 (4.3)
|
0 (0.0)
|
4 (3.1)
|
|
Hepatitis-related
|
0 (0.0)
|
0 (0.0)
|
2 (1.0)
|
0 (0.0)
|
0 (0.0)
|
2 (1.5)
|
|
Laboratory AEs of special interest
|
N = 177
|
N = 89
|
N = 188
|
N = 131
|
N = 69
|
N = 125
|
|
ALT ≥3xULN, consecutive*
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
0 (0.0
|
0 (0.0)
|
0 (0.0)
|
|
AST ≥3xULN, consecutive*
|
0 (0.0)
|
0 (0.0)
|
1 (0.5)
|
0 (0.0
|
0 (0.0)
|
0 (0.0)
|
|
ALT and/or AST ≥3xULN, consecutive*
|
0 (0.0)
|
0 (0.0)
|
1 (0.5)
|
0 (0.0
|
0 (0.0)
|
0 (0.0)
|
|
CK ≥10xULN, single
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
0 (0.0
|
0 (0.0)
|
0 (0.0)
|
- *Consecutive includes those patients with (a) measurement ≥3 x ULN observed at 2 or more consecutive visits (b) a single, last measurement ≥3 x ULN, or (c) a measurement ≥3 x ULN followed by a measurement < 3 x ULN that was taken more than 2 days after the last dose of study medication.
- AE adverse event, ALT alanine aminotransferase, AST aspartate aminotransferase, CK creatine kinase, EZ ezetimibe, Simva Simvastatin, ULN upper limit of normal.
