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) |