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Table 1 Baseline characteristics of the FIELD study cohort

From: Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study: baseline characteristics and short-term effects of fenofibrate [ISRCTN64783481]

Characteristic

Category

Screened, not randomized

(n= 4105)

Randomized

(n= 9795)

n

%        

n

%

Sex

Male

2424

59.0

6138

62.7

 

Female

1681

41.0

3657

37.3

Age at Visit 1 (years)

<55

682

16.6

1668

17.0

 

55–59

802

19.5

1976

20.2

 

60–64

856

20.8

2196

22.4

 

65–69

888

21.7

2202

22.5

 

70+

877

21.4

1753

17.9

Ethnicity*

Caucasian

3757

91.5

9093

92.8

 

Indigenous

161

3.9

258

2.6

 

Asian

93

2.3

141

1.4

 

Other

94

2.3

303

3.1

Body mass index (kg/m2) (BMI)

BMI < 25

805

19.6

1198

12.2

 

25 ≤ BMI < 30

1511

36.8

3855

39.4

 

30 ≤ BMI < 35

1099

26.8

2869

29.3

 

BMI ≥ 35

652

15.9

1866

19.1

Waist (cm)

Female (mean ± SD)

98 ± 15

 

101 ± 14

 
 

Male (mean ± SD)

103 ± 13

 

105 ± 12

 

Waist-hip ratio

ratio < 0.8

242

5.9

333

3.4

 

0.8 ≤ ratio < 0.9

1184

28.8

2531

25.8

 

0.9 ≤ ratio < 1.0

1931

47.0

4942

50.5

 

1.0 ≤ ratio < 1.1

645

15.7

1797

18.4

 

ratio ≥ 1.1

73

1.8

179

1.8

Smoking (cigarettes)

Nonsmoker

1735

42.3

4000

40.8

 

Ex-smoker

1933

47.1

4908

50.1

 

Current smoker

404

9.8

887

9.1

Clinical history

Prior cardiovascular disease †

1045

25.4

2131

21.8

 

Prior myocardial infarction

278

6.7

485

5.0

 

Stroke

194

4.7

346

3.5

 

Angina

588

14.3

1188

12.1

 

Hypertension

2247

54.7

5544

56.6

 

Claudication or peripheral vascular disease

351

8.6

711

7.2

 

Transient ischemic attack

155

3.8

307

3.1

Prior coronary revascularisation

No CABG or PTCA

3908

95.2

9432

96.3

 

CABG only

122

3.0

230

2.4

 

PTCA only

49

1.2

102

1.0

 

CABG and PTCA

26

0.6

31

0.3

Diabetes management

Diet only

1119

27.3

2542

26.0

 

Diet + OH only

2238

54.5

5874

60.0

 

Diet + insulin

429

10.5

569

5.8

 

Diet + OH + insulin

319

7.8

810

8.3

Diabetic complications ‡

Retinopathy

431

10.5

814

8.3

 

Neuropathy

636

15.5

1394

14.2

 

Nephropathy

161

3.9

279

2.9

 

Skin ulcers

139

3.4

299

3.1

 

Amputations

106

2.6

176

1.8

Diabetes diagnosis ‡

Age at diagnosis (mean ± SD)

54.8 ± 8.7

 

55.5 ± 8.3

 
 

Median duration of diabetes in years (quartile 1, quartile 3)

6 (2, 11)

 

5 2, 10

 
  1. * Patients are assumed to be Caucasian unless otherwise stated. Indigenous includes Aborigines, Torres Strait Islanders, Maori and Pacific Islanders. Other includes mixed races, African-American, Indian, African, etc.
  2. † Prior cardiovascular disease is defined as a reported history of myocardial infarction, angina (stable and unstable), coronary revascularization (CABG or PTCA), stroke, claudication or peripheral vascular disease or peripheral revascularization before randomization. The count includes 13 randomized patients and 10 nonrandomized patients who suffered or reported a cardiovascular event during the run-in period (visit 1 to visit 4 (randomization)).
  3. ‡ Diabetic complications and age at diabetes diagnosis are self-reported.
  4. CABG = coronary artery bypass grafting; PTCA = percutaneous transluminal coronary angioplasty; SD = standard deviation; OH = oral hypoglycemic agents