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Table 2 Summary of safety data

From: Ezetimibe + simvastatin versus doubling the dose of simvastatin in high cardiovascular risk diabetics: a multicenter, randomized trial (the LEAD study)

 

EZ + simva 10/20 mg

Simva 40 mg

p-value

Number of patients (%)

N = 42

N = 51

 

With adverse events

5 (12.5)

10 (20.0)

0.40008

With treatment-related adverse events

3 (7.5)

3 (6.0)

0.9999

Discontinued due to adverse events

1 (2.5)

2 (4.0)

0.9999

Discontinued due to treatment-related adverse events

1 (2.5)

2 (4.0)

0.9999

Serious adverse events

1*

0

0.4518

ALT/AST ≥ 3 × upper limit of normal

0

0

--

CK ≥ 5-10 × upper limit of normal elevation

0

0

--

  1. ALT, Alanine aminotransferase; AST, Aspartate aminotransferase; CK, creatine kinase.
  2. *Bone fracture, non-drug-related.