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Table 3 Summary of safety data (APaT population)

From: Consistency of effect of ezetimibe/simvastatin compared with intensified lipid-lowering treatment strategies in obese and non-obese diabetic subjects

 

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)

  1. *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.
  2. AE adverse event, ALT alanine aminotransferase, AST aspartate aminotransferase, CK creatine kinase, EZ ezetimibe, Simva Simvastatin, ULN upper limit of normal.