Table 1 Patient characteristics (full analysis set)

From: Efficacy and safety of esaxerenone with and without sodium–glucose cotransporter-2 inhibitor use in hypertensive patients with type 2 diabetes mellitus: a pooled analysis of five clinical studies

Characteristic

Overall N = 279

SGLT2i n = 145

Non-SGLT2i n = 134

Sex, male

166 (59.5)

100 (69.0)

66 (49.3)

Age, years

67.9 ± 10.2

66.5 ± 9.9

69.4 ± 10.4

 ≥65

193 (69.2)

90 (62.1)

103 (76.9)

BMI, kg/m2

26.4 ± 4.1 n = 278

27.4 ± 4.2 n = 144

25.3 ± 3.8 n = 134

 ≥25

168 (60.2)

100 (69.0)

68 (50.7)

Initial esaxerenone dose, mg/day

1.7 ± 0.6

1.8 ± 0.6

1.6 ± 0.6

 1.25

180 (64.5)

85 (58.6)

95 (70.9)

 2.5

99 (35.5)

60 (41.4)

39 (29.1)

Final esaxerenone dose, mg/day

2.6 ± 1.4

2.8 ± 1.4

2.4 ± 1.3

 1.25

96 (34.4)

38 (26.2)

58 (43.3)

 2.5

123 (44.1)

71 (49.0)

52 (38.8)

 5

60 (21.5)

36 (24.8)

24 (17.9)

Dose escalation from the first dose of esaxerenone to 12 weeks

121 (43.4)

66 (45.5)

55 (41.0)

Current smoker

45 (16.1)

29 (20.0)

16 (11.9)

Alcohol use

103 (36.9)

62 (42.8)

41 (30.6)

Complications

277 (99.3)

144 (99.3)

133 (99.3)

 Dyslipidemia

223 (79.9)

116 (80.0)

107 (79.9)

 Hyperuricemia

78 (28.0)

39 (26.9)

39 (29.1)

 Heart failure

31 (11.1)

20 (13.8)

11 (8.2)

Disease duration of hypertension, years

10.7 ± 8.3 n = 195

10.6 ± 8.1 n = 105

10.8 ± 8.6 n = 90

Basal antihypertensive agents

 RAS inhibitor

113 (40.5)

50 (34.5)

63 (47.0)

 CCB

49 (17.6)

27 (18.6)

22 (16.4)

 Both RAS inhibitor/CCB

117 (41.9)

68 (46.9)

49 (36.6)

Diabetes drug class

 SGLT2i

145 (52.0)

145 (100.0)

0 (0.0)

 Biguanide

118 (42.3)

55 (37.9)

63 (47.0)

 Thiazolidinedione

13 (4.7)

5 (3.4)

8 (6.0)

 Sulfonylurea

41 (14.7)

18 (12.4)

23 (17.2)

 Glinide

23 (8.2)

9 (6.2)

14 (10.4)

 DPP-4 inhibitor

162 (58.1)

85 (58.6)

77 (57.5)

 Alpha-glucosidase inhibitor

25 (9.0)

5 (3.4)

20 (14.9)

 Insulin

24 (8.6)

8 (5.5)

16 (11.9)

 GLP1 agonist

14 (5.0)

6 (4.1)

8 (6.0)

Number of oral diabetes medications

 1

72 (25.8)

35 (24.1)

37 (27.6)

 2

85 (30.5)

42 (29.0)

43 (32.1)

 ≥3

99 (35.5)

68 (46.9)

31 (23.1)

 None

23 (8.2)

0 (0.0)

23 (17.2)

Morning home SBP, mmHg

137.4 ± 11.7 n = 277

137.2 ± 11.2 n = 145

137.6 ± 12.2 n = 132

Morning home DBP, mmHg

81.1 ± 10.3 n = 277

82.0 ± 9.4 n = 145

80.1 ± 11.3 n = 132

Bedtime home SBP, mmHg

132.2 ± 13.3 n = 274

132.5 ± 12.6 n = 142

132.0 ± 14.1 n = 132

Bedtime home DBP, mmHg

76.5 ± 11.2 n = 274

77.8 ± 10.8 n = 142

75.1 ± 11.4 n = 132

Office SBP, mmHg

140.6 ± 14.0

138.5 ± 14.8

142.8 ± 12.7

Office DBP, mmHg

79.1 ± 10.5

79.9 ± 10.1

78.3 ± 10.9

Serum potassium, mEq/L

4.2 ± 0.4 n = 278

4.3 ± 0.4 n = 145

4.2 ± 0.4 n = 133

 <4.5

209 (74.9)

105 (72.4)

104 (77.6)

 ≥4.5

69 (24.7)

40 (27.6)

29 (21.6)

eGFRcreat, mL/min/1.73 m2

61.7 ± 18.2 n = 278

65.1 ± 19.8 n = 145

58.0 ± 15.4 n = 133

 30 to <60

168 (60.2)

79 (54.5)

89 (66.4)

 ≥60

110 (39.4)

66 (45.5)

44 (32.8)

UACR, mg/gCr

144.1 ± 413.4 n = 278

174.1 ± 542.3 n = 145

111.3 ± 189.1 n = 133

 <30

153 (54.8)

79 (54.5)

74 (55.2)

 ≥30

125 (44.8)

66 (45.5)

59 (44.0)

NT-proBNP, pg/mL

102.9 ± 156.8 n = 267

87.4 ± 117.1 n = 140

119.9 ± 190.4 n = 127

 <125

215 (77.1)

115 (79.3)

100 (74.6)

 ≥125

52 (18.6)

25 (17.2)

27 (20.1)

Plasma aldosterone concentration, pg/mL

57.3 ± 38.0 n = 258

51.4 ± 40.0 n = 138

64.1 ± 34.4 n = 120

 <120

246 (88.2)

131 (90.3)

115 (85.8)

 ≥120

12 (4.3)

7 (4.8)

5 (3.7)

Plasma renin activity, ng/mL/h

4.3 ± 9.6 n = 263

5.1 ± 11.7 n = 139

3.5 ± 6.3 n = 124

 <1.0

82 (29.4)

42 (29.0)

40 (29.9)

 ≥1.0

181 (64.9)

97 (66.9)

84 (62.7)

  1. Data are n (%) or mean ± standard deviation
  2. BMI body mass index, CCB calcium channel blocker, DBP diastolic blood pressure, DPP-4 dipeptidyl peptidase-4, eGFRcreat estimated glomerular filtration rate (creatinine-based), GLP1 glucagon-like peptide-1, NT-proBNP N-terminal prohormone of brain natriuretic peptide, RAS renin–angiotensin system, SBP systolic blood pressure, SGLT2i sodium–glucose cotransporter-2 inhibitor, UACR urine albumin-to-creatinine ratio