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Table 1 Baseline characteristics by baseline clinical cutoffs (SUSTAIN 3 and PIONEER 1 and 2; PIONEER 5)

From: Impact of semaglutide on high-sensitivity C-reactive protein: exploratory patient-level analyses of SUSTAIN and PIONEER randomized clinical trials

 

SUSTAIN 3, PIONEER 1 and 2 (pooled)

PIONEER 5

 

Overall

Low cutoff (< 1.0 mg/L)

Medium cutoff (≥ 1.0 to ≤ 3.0 mg/L)

High cutoff (> 3.0 mg/L)

p-value

Overall

Low cutoff (< 1.0 mg/L)

Medium cutoff (≥ 1.0 to  ≤ 3.0 mg/L)

High cutoff (> 3.0 mg/L)

p-value

Full analysis set, N

2158

324

Randomized with hsCRP measured at baseline, n

2150

394

750

1006

 

321

45

118

158

 

Age, years

56.4 ± 10.5

59.0 ± 9.6

57.6 ± 10.0

54.6 ± 10.9

 < 0.0001

70.4 ± 7.9

72.4 ± 6.3

70.9 ± 8.1

69.4 ± 8.0

0.0422

Female sex, n (%)

1028 (47.6)

114 (28.9)

305 (40.7)

605 (60.1)

 < 0.0001

168 (51.9)

17 (37.8)

58 (49.2)

91 (57.6)

0.0498

HbA1c, %

8.2 ± 0.9

8.0 ± 0.8

8.1 ± 0.9

8.2 ± 0.9

0.0009

8.0 ± 0.7

7.9 ± 0.6

8.0 ± 0.6

8.0 ± 0.8

0.6179

Body weight, kg

92.4 ± 21.5

82.7 ± 17.2

90.0 ± 19.5

98.0 ± 22.6

 < 0.0001

90.8 ± 17.6

85.0 ± 13.5

89.9 ± 15.4

93.2 ± 19.7

0.0653

Body mass index, kg/m2

32.9 ± 6.5

28.7 ± 4.4

31.7 ± 5.4

35.5 ± 6.8

 < 0.0001

32.4 ± 5.4

29.5 ± 3.8

31.9 ± 4.9

33.5 ± 5.8

 < 0.0001

Diabetes duration, years

7.1 ± 6.3

8.5 ± 6.5

7.7 ± 6.8

6.1 ± 5.6

 < 0.0001

14.0 ± 8.0

13.6 ± 6.4

15.0 ± 8.4

13.4 ± 8.1

0.1453

Previous/current smoker, n (%)

933 (43.2)

184 (46.7)

310 (41.3)

437 (43.4)

0.2181

113 (34.9)

21 (46.7)

36 (30.5)

55 (34.8)

0.1537

eGFR (CKD-EPI), mL/min/1.73 m2

96.7 ± 15.3

95.1 ± 13.2

95.1 ± 15.0

98.4 ± 16.1

 < 0.0001

47.6 ± 9.7

50.6 ± 8.5

47.2 ± 9.8

47.1 ± 9.9

0.0485

eGFR, n (%)

         

0.0612

 ≥ 45 mL/min/1.73 m2

N/A*

N/A*

N/A*

N/A*

 

202 (62.3)

34 (75.6)

66 (55.9)

101 (63.9)

 

 < 45 mL/min/1.73 m2

N/A*

N/A*

N/A*

N/A*

 

122 (37.7)

11 (24.4)

52 (44.1)

57 (36.1)

 

Lipids, mmol/L

          

 Total cholesterol

4.8 ± 1.1

4.6 ± 1.0

4.8 ± 1.1

4.9 ± 1.1

 < 0.0001

4.6 ± 1.3

4.2 ± 1.0

4.3 ± 1.1

4.9 ± 1.4

0.0002

 HDL cholesterol

1.2 ± 0.3

1.2 ± 0.3

1.2 ± 0.3

1.2 ± 0.3

0.0019

1.1 ± 0.3

1.2 ± 0.4

1.1 ± 0.3

1.1 ± 0.2

0.7598

 LDL cholesterol

2.7 ± 0.9

2.5 ± 0.9

2.7 ± 0.9

2.8 ± 0.9

 < 0.0001

2.5 ± 1.0

2.3 ± 0.9

2.3 ± 0.9

2.7 ± 1.1

0.0008

 Triglycerides

2.1 ± 1.4

1.8 ± 1.1

2.1 ± 1.4

2.2 ± 1.4

 < 0.0001

2.3 ± 1.4

1.9 ± 1.0

2.1 ± 1.1

2.6 ± 1.6

0.0009

Diastolic BP, mmHg

80.1 ± 9.0

79.0 ± 9.3

80.2 ± 8.6

80.4 ± 9.1

0.0215

77.6 ± 9.1

76.0 ± 9.0

77.8 ± 8.7

77.8 ± 9.5

0.5244

Systolic BP, mmHg

132.2 ± 14.7

131.8 ± 14.9

132.8 ± 14.3

131.8 ± 14.8

0.2370

137.5 ± 15.1

138.4 ± 17.8

137.6 ± 13.4

137.4 ± 15.7

0.9382

Statin use at baseline, yes, n (%)

891 (41.3)

194 (49.2)

316 (42.1)

377 (37.5)

0.0003

234 (72.2)

39 (86.7)

87 (73.7)

107 (67.7)

0.0400

  1. *In SUSTAIN 3, PIONEER 1, and PIONEER 2, subjects with a baseline eGFR of < 60 mL/min/1.73 m2 were excluded. Data are means (standard deviation) for continuous parameters and n (%) for categorical parameters. Percentages are based on total number of subjects. P-values for tests of differences between subgroups regardless of treatment group have been taken from a chi-squared test for categorical parameters and from a Kruskal–Wallis test for continuous parameters. BP blood pressure; CKD-EPI Chronic Kidney Disease–Epidemiology Collaboration; eGFR estimated glomerular filtration rate; HbA1c glycated hemoglobin; HDL high-density lipoprotein; hsCRP high-sensitivity C-reactive protein; LDL low-density lipoprotein; n number of subjects with available hsCRP data; N full analysis set; N/A not applicable
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Cardiovascular Diabetology

ISSN: 1475-2840