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Table 1 Baseline characteristics (randomized population)

From: Alirocumab therapy in individuals with type 2 diabetes mellitus and atherosclerotic cardiovascular disease: analysis of the ODYSSEY DM-DYSLIPIDEMIA and DM-INSULIN studies

 

DM-DYSLIPIDEMIA

DM-INSULIN

Alirocumab (n = 95)

UC (n = 47)

Alirocumab (n = 119)

Placebo (n = 58)

Age, years, mean (SD)

64.9 (9.1)

65.4 (8.1)

66.2 (8.7)

64.9 (8.9)

Gender, male, n (%)

65 (68.4)

31 (66.0)

79 (66.4)

32 (55.2)

BMI, kg/m2, mean (SD)

33.0 (5.4)

32.7 (4.9)

32.6 (4.5)

33.4 (5.8)

CHD, n (%)

90 (94.7)

45 (95.7)

102 (85.7)

51 (87.9)

 Acute MI

43 (45.3)

20 (42.6)

59 (49.6)

18 (31.0)

 Silent MI

5 (5.3)

1 (2.1)

4 (3.4)

4 (6.9)

 Unstable angina

15 (15.8)

9 (19.1)

15 (12.6)

4 (6.9)

 Coronary revascularization

77 (81.1)

35 (74.5)

80 (67.2)

37 (63.8)

 Other clinically significant CHDa

20 (21.1)

14 (29.8)

31 (26.1)

15 (25.9)

Ischemic stroke, n (%)

14 (14.7)

5 (10.6)

27 (22.7)

9 (15.5)

PAD, n (%)

6 (6.3)

4 (8.5)

13 (10.9)

6 (10.3)

HTNb, n (%)

89 (93.7)

44 (93.6)

105 (88.2)

53 (91.4)

CKDc, n (%)

15 (15.8)

11 (23.4)

37 (31.1)

13 (22.4)

Diabetes target organ damaged, n (%)

31 (32.6)

15 (31.9)

60 (50.4)

28 (48.3)

Statin, n (%)

80 (84.2)

41 (87.2)

92 (77.3)

42 (72.4)

 Low intensity

6 (7.5)

0

3 (3.3)

1 (2.4)

 Moderate intensity

21 (26.3)

20 (48.8)

46 (50.0)

24 (57.1)

 High intensity

53 (66.3)

21 (51.2)

43 (46.7)

16 (38.1)

LLT other than statine, n (%)

0

2 (4.3)

34 (28.6)

11 (19.0)

HbA1c, %, mean (SD)

7.0 (0.8)

7.2 (0.8)

7.5 (0.9)

7.4 (1.0)

FPG, mg/dL [mmol/L], mean (SD)

144.1 (39.3) [8.0 (2.2)]

152.6 (41.7) [8.5 (2.3)]

162.6 (52.5) [9.0 (2.9)]

146.7 (45.2) [8.1 (2.5)]

Insulin, n (%)

40 (42.1)

19 (40.4)

119 (100)

57 (98.3)f

Non-insulin GLT, n (%)

 Biguanides

72 (75.8)

34 (72.3)

57 (47.9)

33 (56.9)

 Sulfonylureas

29 (30.5)

18 (38.3)

11 (9.2)

7 (12.1)

 DPP-4 inhibitor

12 (12.6)

8 (17.0)

21 (17.6)

7 (12.1)

 GLP-1 receptor agonist

16 (16.8)

6 (12.8)

11 (9.2)

8 (13.8)

 SGLT2 inhibitor

10 (10.5)

5 (10.6)

10 (8.4)

11 (19.0)

Lipids, mg/dL [mmol/L], mean (SD)

 Non-HDL-C

156.5 (48.4) [4.05 (1.26)]

156.8 (43.3) [4.06 (1.12)]

142.8 (41.5) [3.70 (1.08)]

147.0 (54.9) [3.81 (1.42)]

 LDL-C

108.3 (46.3) [2.81 (1.20)]

109.4 (44.0) [2.83 (1.14)]

107.2 (35.1) [2.78 (0.91)]

111.9 (46.4) [2.90 (1.20)]

 ApoB

103.0 (26.7)

104.3 (27.8)

96.4 (25.1)

98.7 (32.0)

 LDL-PN, nmol/L, mean (SD)

1400.2 (489.8)

1437.4 (479.4)

1339.5 (408.5)

1425.0 (467.9)

  1. Apo apolipoprotein, BMI body mass index, CHD coronary heart disease, CKD chronic kidney disease, DPP-4 dipeptidyl peptidase-4, GLP-1 glucagon-like peptide-1, GLT glucose-lowering treatment, FPG fasting plasma glucose, HbA1c glycated hemoglobin, HDL-C high-density lipoprotein cholesterol, HTN hypertension, LDL-C low-density lipoprotein cholesterol, LDL-PN low-density lipoprotein particle number, LLT lipid-lowering therapy, MI myocardial infarction, PAD peripheral artery disease, SD standard deviation, SGLT2 sodium glucose cotransporter 2
  2. aDiagnosis by invasive/non-invasive testing
  3. bIncludes patients with established HTN on anti-HTN medication
  4. cDefined as estimated glomerular filtration rate 15–60 mL/min/1.73 m2
  5. dDefined as microalbuminuria, macroalbuminuria, retinopathy, and/or CKD
  6. eLLT other than statins were not allowed per protocol in DM DYSLIPIDEMIA
  7. fOne individual in the placebo group was not receiving insulin at the time of randomization and remained without insulin treatment for the duration of the study