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Table 1 Baseline patient characteristics

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
(N = 37)
Simva 40 mg
(N = 50)
Between treatment difference
Demographics    
Age, mean years (SD) 65 (6.5) 64 (6.1) p = 0.204
Females, n (%) 16 (43.2) 12 (24.0) p = 0.078
Body mass index, kg/m2, mean (SD) 28.9 (4.1) 28.4 (3.6) p = 0.584
Hypertension, n (%) 30 (81.1) 32 (62.0) p = 0.090
Baseline lab values, mean (SD)    
Low-density lipoprotein cholesterol, mmol/L 3.3 (0.5) 3.2 (0.5) p = 0.413
Total cholesterol, mmol/L 5.2 (0.6) 5.1 (0.6) p = 0.335
High-density lipoprotein cholesterol, mmol/L 1.2 (0.3) 1.1 (0.3) p = 0.202
Triglycerides, mmol/L 1.6 (0.7) 1.6 (0.7) p = 0.933
Fasting plasma glucose, mmol/L 10.2 (2.7) 10.0 (2.9) p = 0.717
Hemoglobin A1c 7.5 (0.7) 7.4 (0.8) p = 0.539
Aspartate aminotransferase, U/L 16.9 (3.4) 20.2 (5.1) p = 0.001
Alanine aminotransferase, U/L 20.8 (7.1) 27.6 (11.4) p = 0.002
Creatine kinase, U/L 80.4 (35.5) 107.5 (47.3) p = 0.002
Prevalence of cardiovascular diseases, n (%)    
Cerebrovascular disease 3 (8.1) 5 (10.0) p = 1.000
Peripheral vascular disease 7 (18.9) 11 (22.0) p = 0.999
Ischemic heart disease 22 (59.5) 27 (54.0) p = 0.666
Cerebrovascular disease + PAD 1 (2.7) 2 (4.0) p = 1.000
Cerebrovascular disease + ischemic heart disease 0 (0.0) 0 (0.0) --
PAD + ischemic heart disease 3 (8.1) 4 (8.0) p = 1.000
Cerebrovascular disease + PAD + ischemic heart disease 1 (2.7) 1 (2.0) p = 1.000
  1. N, number in full analysis set population; SD, standard deviation; n, number; PAD, peripheral arterial disease