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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