Table 1 Patient characteristics (FAS)

From: Efficacy and safety of esaxerenone in hypertensive patients with chronic kidney disease, with or without type 2 diabetes mellitus: a pooled analysis of five clinical studies

 

Overall

With T2DM

Without T2DM

eGFRcreat 30 to < 60 mL/min/1.73 m2

eGFRcreat  ≥ 60 mL/min/1.73 m2

 

(N = 175)

(n = 125)

(n = 50)

(n = 108)

(n = 59)

Sex, male

105 (60.0)

81 (64.8)

24 (48.0)

68 (63.0)

34 (57.6)

Age, years

67.6 ± 11.3

68.1 ± 10.3

66.4 ± 13.5

71.7 ± 8.7

60.9 ± 12.14

 ≥65

116 (66.3)

88 (70.4)

28 (56.0)

90 (83.3)

24 (40.7)

Body mass index, kg/m2

26.2 ± 4.4

n = 174

26.6 ± 3.8

n = 124

25.3 ± 5.4

n = 50

26.1 ± 3.6

n = 107

26.9 ± 5.5

n = 59

 ≥25

103 (58.9)

80 (64.0)

23 (46.0)

66 (61.1)

36 (61.0)

Current smoker

40 (22.9)

27 (21.6)

13 (26.0)

21 (19.4)

18 (30.5)

Alcohol use

73 (41.7)

49 (39.2)

24 (48.0)

41 (38.0)

29 (49.2)

Comorbidities

 T2DM

125 (71.4)

125 (100.0)

0 (0.0)

91 (84.3)

33 (55.9)

 Dyslipidemia

123 (70.3)

90 (72.0)

33 (66.0)

77 (71.3)

39 (66.1)

 Hyperuricemia

70 (40.0)

44 (35.2)

26 (52.0)

43 (39.8)

20 (33.9)

 Heart failure

33 (18.9)

16 (12.8)

17 (34.0)

12 (11.1)

14 (23.7)

Initial dose of esaxerenone

 1.25 mg

119 (68.0)

101 (80.8)

18 (36.0)

104 (96.3)

13 (22.0)

 2.5 mg

56 (32.0)

24 (19.2)

32 (64.0)

4 (3.7)

46 (78.0)

Final dose of esaxerenone

 1.25 mg

51 (29.1)

43 (34.4)

8 (16.0)

46 (42.6)

3 (5.1)

 2.5 mg

78 (44.6)

52 (41.6)

26 (52.0)

40 (37.0)

34 (57.6)

 5 mg

46 (26.3)

30 (24.0)

16 (32.0)

22 (20.4)

22 (37.3)

Hypertension disease duration, years

10.1 ± 9.0

n = 127

10.9 ± 8.8

n = 90

8.1 ± 9.5

n = 37

11.1 ± 9.9

n = 76

8.7 ± 7.5

n = 47

Morning home SBP, mmHg

140.4 ± 12.7

n = 171

139.3 ± 12.7

n = 124

143.1 ± 12.4

n = 47

139.5 ± 12.2

n = 104

141.7 ± 14.1

n = 59

Morning home DBP, mmHg

82.1 ± 11.7

n = 171

80.1 ± 11.2

n = 124

87.5 ± 11.3

n = 47

78.4 ± 11.1

n = 104

88.6 ± 10.4

n = 59

Bedtime home SBP, mmHg

134.5 ± 14.0

n = 172

133.9 ± 14.5

n = 124

136.2 ± 12.5

n = 48

134.1 ± 14.2

n = 106

134.8 ± 14.0

n = 58

Bedtime home DBP, mmHg

77.2 ± 11.7

n = 172

75.7 ± 12.0

n = 124

81.0 ± 9.9

n = 48

74.0 ± 11.8

n = 106

82.9 ± 9.4

n = 58

Office SBP, mmHg

145.6 ± 15.3

143.4 ± 13.7

150.9 ± 17.7

145.7 ± 13.9

145.0 ± 17.7

Office DBP, mmHg

82.3 ± 11.6

79.9 ± 10.4

88.2 ± 12.6

79.0 ± 10.8

88.0 ± 11.5

Basal antihypertensive agents

 RAS inhibitor

60 (34.3)

39 (31.2)

21 (42.0)

30 (27.8)

26 (44.1)

 CCB

46 (26.3)

17 (13.6)

29 (58.0)

17 (15.7)

25 (42.4)

 Both RAS inhibitor and CCB

69 (39.4)

69 (55.2)

0 (0.0)

61 (56.5)

8 (13.6)

Diabetes medications

 SGLT2i

66 (37.7)

66 (52.8)

0 (0.0)

49 (45.4)

17 (28.8)

 Biguanide

61 (34.9)

61 (48.8)

0 (0.0)

41 (38.0)

20 (33.9)

 Thiazolidinedione

8 (4.6)

8 (6.4)

0 (0.0)

6 (5.6)

2 (3.4)

 Sulfonylurea

21 (12.0)

21 (16.8)

0 (0.0)

20 (18.5)

1 (1.7)

 Glinide

8 (4.6)

8 (6.4)

0 (0.0)

7 (6.5)

1 (1.7)

 DPP-4 inhibitor

70 (40.0)

70 (56.0)

0 (0.0)

52 (48.1)

18 (30.5)

 Alpha glucosidase inhibitor

15 (8.6)

15 (12.0)

0 (0.0)

14 (13.0)

1 (1.7)

 Insulin

12 (6.9)

12 (9.6)

0 (0.0)

10 (9.3)

2 (3.4)

 GLP1 agonist

5 (2.9)

5 (4.0)

0 (0.0)

4 (3.7)

1 (1.7)

Number of diabetes medications

 1

28 (16.0)

28 (22.4)

0 (0.0)

22 (20.4)

6 (10.2)

 2

35 (20.0)

35 (28.0)

0 (0.0)

26 (24.1)

9 (15.3)

 3

50 (28.6)

50 (40.0)

0 (0.0)

37 (34.3)

13 (22.0)

 None

62 (35.4)

12 (9.6)

50 (100.0)

23 (21.3)

31 (52.5)

NT-proBNP, pg/mL

133.3 ± 199.3

80.0 (37.0, 130.0)

n = 170

123.2 ± 184.0

80.0 (37.5, 129.5)

n = 120

157.5 ± 232.0

75.7 (37.0, 162.0)

n = 50

159.2 ± 228.8

92.0 (50.0, 154.5)

n = 104

85.3 ± 111.7

43.0 (31.0, 82.0)

n = 58

 <125

123 (70.3)

88 (70.4)

35 (70.0)

69 (63.9)

48 (81.4)

 ≥125

47 (26.9)

32 (25.6)

15 (30.0)

35 (32.4)

10 (16.9)

UACR, mg/gCr

280.3 ± 536.0

113.6 (47.9, 304.0)

303.9 ± 578.7

150.2 (60.4, 332.9)

221.5 ± 409.4

69.9 (39.9, 173.2)

369.7 ± 652.1

177.1 (71.0, 472.2)

127.1 ± 174.9

57.9 (37.9, 139.0)

 ≥30

175 (100.0)

125 (100.0)

50 (100.0)

108 (100.0)

59 (100.0)

Serum potassium, mEq/L

4.2 ± 0.4

n = 167

4.2 ± 0.4

n = 124

4.1 ± 0.5

n = 43

4.3 ± 0.4

n = 108

4.1 ± 0.5

n = 59

 <4.5

125 (71.4)

93 (74.4)

32 (64.0)

77 (71.3)

48 (81.4)

 ≥4.5

42 (24.0)

31 (24.8)

11 (22.0)

31 (28.7)

11 (18.6)

eGFRcreat, mL/min/1.73 m2

60.4 ± 18.3

n = 167

57.3 ± 16.4

n = 124

69.3 ± 20.6

n = 43

49.7 ± 7.7

n = 108

80.0 ± 15.5

n = 59

 30 to <60

108 (61.7)

91 (72.8)

17 (34.0)

108 (100.0)

0 (0.0)

 ≥60

59 (33.7)

33 (26.4)

26 (52.0)

0 (0.0)

59 (100.0)

Plasma aldosterone, pg/mL

54.1 ± 37.9

n = 157

59.9 ± 39.9

n = 117

36.9 ± 24.5

n = 40

58.9 ± 33.7

n = 103

47.4 ± 46.8

n = 46

 <120

151 (86.3)

112 (89.6)

39 (78.0)

99 (91.7)

44 (74.6)

 ≥120

6 (3.4)

5 (4.0)

1 (2.0)

4 (3.7)

2 (3.4)

Plasma renin activity, ng/mL/h

3.0 ± 4.4

n = 164

3.5 ± 4.9

n = 118

1.7 ± 1.9

n = 46

2.9 ± 3.2

n = 104

3.4 ± 6.3

n = 52

 <1.0

56 (32.0)

33 (26.4)

23 (46.0)

31 (28.7)

22 (37.3)

 ≥1.0

108 (61.7)

85 (68.0)

23 (46.0)

73 (67.6)

30 (50.8)

  1. Data are n (%), mean ± standard deviation, or median (Q1, Q3)
  2. CCB calcium channel blocker, DBP diastolic blood pressure, DPP-4 dipeptidyl peptidase-4, eGFRcreat creatinine-based estimated glomerular filtration rate, FAS full analysis set, GLP1 glucagon-like peptide-1, NT-proBNP N-terminal prohormone of brain natriuretic peptide, Q quartile, RAS renin–angiotensin system, SBP systolic blood pressure, SGLT2i sodium–glucose cotransporter 2 inhibitor, T2DM type 2 diabetes mellitus, UACR urine albumin-to-creatinine ratio