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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.