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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.