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Table 1 Patient demographic and disease characteristics at baseline

From: Effects of evolocumab in individuals with type 2 diabetes with and without atherogenic dyslipidemia: An analysis from BANTING and BERSON

Characteristic

High TGs and normal HDL-C

High TGs and low HDL-C

Normal TGs and normal HDL-C

Placebo N = 64

Evolocumab N = 132

Placebo N = 125

Evolocumab N = 264

Placebo N = 178

Evolocumab N = 341

Sex, female, n (%)

28 (43.8)

58 (43.9)

72 (57.6)

143 (54.2)

95 (53.4)

161 (47.2)

Age, years, mean (SD)

63.0 (8.6)

61.9 (8.6)

60.2 (8.2)

60.9 (8.5)

62.6 (8.8)

62.2 (8.1)

Ethnicity Hispanic/Latino, n (%)

12 (18.8)

28 (21.2)

29 (23.2)

60 (22.7)

23 (12.9)

55 (16.1)

Race, n (%)

 White

40 (62.5)

82 (62.1)

79 (63.2)

165 (62.5)

83 (46.6)

157 (46.0)

 Asian

15 (23.4)

40 (30.3)

32 (25.6)

73 (27.7)

72 (40.4)

144 (42.2)

 Black or African American

7 (10.9)

8 (6.1)

6 (4.8)

11 (4.2)

20 (11.2)

31 (9.1)

 American Indian or Alaska native

1 (1.6)

1 (0.8)

6 (4.8)

6 (2.3)

0 (0.0)

2 (0.6)

 Native Hawaiian or other Pacific Islander

0 (0.0)

0 (0.0)

0 (0.0)

1 (0.4)

0 (0.0)

0 (0.0)

 Multiple

1 (1.6)

1 (0.8)

2 (1.6)

7 (2.7)

3 (1.7)

6 (1.8)

 Other

0 (0.0)

0 (0.0)

0 (0.0)

1 (0.4)

0 (0.0)

1 (0.3)

BMI, kg/m2, mean (SD)

31.2 (7.4)

30.2 (6.0)

31.2 (6.6)

31.6 (6.3)

28.8 (6.2)

28.4 (5.2)

Waist circumference, cm, mean (SD)

103.9 (17.2)

103.2 (14.4)

104.1 (16.6)

104.2 (15.7)

96.8 (14.4)

97.3 (12.8)

Duration of diabetes, years, mean (SD)

9.6 (7.51)

10.6 (7.80)

9.9 (7.52)

10.5 (7.18)

10.1 (7.75)

10.2 (7.60)

Fasting serum glucose, mmol/L, median (Q1, Q3)

7.25 (6.00, 8.85)

7.30 (6.20, 9.50)

7.50 (6.20, 9.70)

8.15 (6.35, 10.50)

6.80 (5.80, 8.30)

7.00 (5.80, 8.70)

HbA1c (fraction of 1), median (Q1, Q3)

0.0690

(0.0640,

0.0755)

0.0700 (0.0645, 0.0815)

0.0740 (0.0640, 0.0860)

0.0740 (0.0655, 0.0840)

0.0670 (0.0620, 0.0760)

0.0700 (0.0630, 0.0800)

Cardiovascular risk category per 2019 ESC/EAS [5] guidelines, n (%)

 Very high risk

58 (90.6)

124 (93.9)

116 (92.8)

243 (92.0)

154 (86.5)

303 (88.9)

 High risk

6 (9.4)

8 (6.1)

9 (7.2)

21 (8.0)

24 (13.5)

38 (11.1)

Statin use per 2018 ACC/AHA guidelines [21], n (%)

 Any statin usea

48 (75.0)

104 (78.8)

95 (76.0)

213 (80.7)

120 (67.4)

216 (63.3)

 High-intensity statin

12 (18.8)

29 (22.0)

35 (28.0)

67 (25.4)

23 (12.9)

45 (13.2)

 Moderate-intensity statin

35 (54.7)

71 (53.8)

56 (44.8)

134 (50.8)

93 (52.2)

162 (47.5)

 Ezetimibe

1 (1.6)

4 (3.0)

4 (3.2)

7 (2.7)

5 (2.8)

9 (2.6)

Lipid concentration

 LDL-C, mmol/L, mean (SD)

2.811 (0.901)

2.737 (0.971)

2.508 (0.817)

2.599 (0.895)

2.539 (0.884)

2.511 (0.818)

 Non-HDL-C, mmol/L, mean (SD)

3.819 (0.977)

3.752 (1.004)

3.720 (0.933)

3.793 (0.985)

3.052 (0.926)

3.033 (0.849)

 Total ApoB, g/L, mean (SD)

0.986 (0.225)

0.974 (0.229)

0.983 (0.238)

0.996 (0.239)

0.825 (0.217)

0.827 (0.205)

 Lp(a), nmol/L, median (Q1, Q3)

21.0

7.0, 58.0

37.0

9.0, 128.8

29.0

8.0, 136.0

22.0

8.0, 76.0

47.0

12.0, 128.0

33.0

11.5, 121.0

 VLDL-C, mmol/L, median (Q1, Q3)

0.970

(0.830, 1.140)

0.953

(0.840, 1.110)

1.040

(0.880, 1.335)

1.090

(0.910, 1.370)

0.520

(0.410, 0.600)

0.520

(0.410, 0.645)

 Remnant cholesterol, mmol/L, median (Q1, Q3)

0.965

(0.830, 1.125)

0.953

(0.840, 1.120)

1.060

(0.875, 1.400)

1.100

(0.900, 1.370)

0.520

(0.420, 0.600)

0.520

(0.420, 0.640)

 TG, mmol/L, median (Q1, Q3)

2.133

1.815, 2.475

2.078

1.830, 2.445

2.300

1.940, 3.065

2.440

1.975, 3.038

1.115

0.915, 1.300

1.140

0.900, 1.390

 HDL-C, mmol/L, mean (SD)

1.353 (0.245)

1.343 (0.206)

0.947 (0.163)

0.935 (0.185)

1.488 (0.338)

1.440 (0.286)

  1. When the calculated LDL-C was < 1.0 mmol/L or TGs were > 4.5 mmol/L, calculated LDL-C was replaced with ultracentrifugation to inform LDL-C and VLDL-C from the same blood sample, if available
  2. ACC American College of Cardiology, AHA American Heart Association, ApoB apolipoprotein B, BMI body mass index, EAS European Atherosclerosis Society, ESC European Society of Cardiology, HbA1c hemoglobin A1c, HDL-C high-density lipoprotein cholesterol, LDL-C low-density lipoprotein cholesterol, Lp(a) lipoprotein(a), non-HDL-C non-high-density lipoprotein cholesterol, Q quartile, TG triglycerides, VLDL-C very low-density lipoprotein cholesterol
  3. aRepresents use of statin therapy before initiating any treatment intervention (including atorvastatin and/or study drug); in BANTING, 99.3% of patients were on moderate- or high-intensity statin at randomization; in BERSON, all patients initiated moderate-intensity atorvastatin at enrollment
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Cardiovascular Diabetology

ISSN: 1475-2840