Table 1 Baseline characteristics of participants with LVEF ≥ 50% or 41–49%, overall and by treatment group

From: Efficacy of empagliflozin in heart failure with preserved versus mid-range ejection fraction: a pre-specified analysis of EMPEROR-Preserved

 

HFpEF (LVEF ≥ 50%)

HFmrEF (LVEF 41–49%)

PHFpEF versus HFmrEF

Empagliflozin (n = 2,002)

Placebo (n = 2,003)

Overall (n = 4,005)

Empagliflozin (n = 995)

Placebo (n = 988)

Overall (n = 1,983)

Age (years), mean (s.d.)

72.7 (9.2)

72.9 (9.2)

72.8 (9.2)

70.2 (9.3)

69.9 (10.0)

70.1 (9.7)

<0.001

Sex (self-reported), n (%)

 Female

1,016 (50.7)

1,003 (50.1)

2,019 (50.4)

322 (32.4)

335 (33.9)

657 (33.1)

<0.001

 Male

986 (49.3)

1,000 (49.9)

1,986 (49.6)

673 (67.6)

653 (66.1)

1326 (66.9)

BMI (kg m−2), mean (s.d.)

30.05 (5.97)

30.20 (6.00)

30.12 (5.98)

29.21 (5.44)

29.31 (5.73)

29.26 (5.58)

<0.001

Race, n (%)

 White

1,525 (76.2)

1,516 (75.7)

3,041 (75.9)

761 (76.5)

740 (74.9)

1501 (75.7)

0.003

 Black or African American

84 (4.2)

75 (3.7)

159 (4.0)

49 (4.9)

50 (5.1)

99 (5.0)

 Asian

288 (14.4)

294 (14.7)

582 (14.5)

125 (12.6)

117 (11.8)

242 (12.2)

 Other (including mixed) or missing

105 (5.2)

118 (5.9)

223 (5.6)

60 (6.0)

81 (8.2)

141 (7.1)

Region, n (%)

 North America

279 (13.9)

279 (13.9)

558 (13.9)

81 (8.1)

80 (8.1)

161 (8.1)

<0.001

 Latin America

457 (22.8)

459 (22.9)

916 (22.9)

301 (30.3)

298 (30.2)

599 (30.2)

 Europe

890 (44.5)

890 (44.4)

1,780 (44.4)

456 (45.8)

453 (45.9)

909 (45.8)

 Asia

249 (12.4)

250 (12.5)

499 (12.5)

94 (9.4)

93 (9.4)

187 (9.4)

 Other

127 (6.3)

125 (6.2)

252 (6.3)

63 (6.3)

64 (6.5)

127 (6.4)

Smoking status, n (%)

 Never smoked

1,108 (55.3)

1,073 (53.6)

2,181 (54.5)

470 (47.2)

494 (50.0)

964 (48.6)

<0.001

 Ex-smoker

779 (38.9)

795 (39.7)

1,574 (39.3)

427 (42.9)

402 (40.7)

829 (41.8)

 Current smoker

114 (5.7)

134 (6.7)

248 (6.2)

97 (9.7)

91 (9.2)

188 (9.5)

 Missing

1 (<0.1)

1 (<0.1)

2 (<0.1)

1 (0.1)

1 (0.1)

2 (0.1)

NYHA class, n (%)

 I

2 (0.1)

0

2 (<0.1)

1 (0.1)

1 (0.1)

2 (0.1)

0.58

 II

1,624 (81.1)

1,631 (81.4)

3,255 (81.3)

808 (81.2)

820 (83.0)

1,628 (82.1)

 III

369 (18.4)

365 (18.2)

734 (18.3)

183 (18.4)

166 (16.8)

349 (17.6)

 IV

7 (0.3)

7 (0.3)

14 (0.3)

3 (0.3)

1 (0.1)

4 (0.2)

Etiology of heart failure, n (%)

 Ischemic

587 (29.3)

547 (27.3)

1,134 (28.3)

492 (49.4)

491 (49.7)

983 (49.6)

<0.001

 Hypertensive

831 (41.5)

859 (42.9)

1,690 (42.2)

235 (23.6)

261 (26.4)

496 (25.0)

 Other or missing

584 (29.2)

597 (29.8)

1,181 (29.5)

268 (26.9)

236 (23.9)

504 (25.4)

NT-proBNP (pg ml−1), median (IQR)

981 (481–1,711)

909 (482–1,647)

946 (482–1,677)

1,013 (540–1,868)

1,037 (561–1,912)

1,025 (550–1,882)

<0.001

Heart rate (b.p.m.), mean (s.d.)

71 (12)

70 (12)

70 (12)

70 (12)

71 (12)

71 (12)

0.056

SBP (mmHg), mean (s.d.)

132 (16)

133 (16)

133 (16)

131 (16)

131 (15)

131 (15)

<0.001

DBP (mmHg), mean (s.d.)

76 (11)

75 (11)

75 (11)

76 (10)

77 (10)

76 (10)

<0.001

eGFR (ml min−1 1.73 m−2), mean (s.d.)

59.4 (19.5)

59.5 (19.5)

59.4 (19.5)

63.1 (20.1)

63.0 (20.6)

63.0 (20.3)

<0.001

KCCQ-CSS, mean (s.d.)

69.7 (21.3)

69.2 (21.2)

69.5 (21.2)

71.2 (21.7)

73.5 (19.7)

72.4 (20.7)

<0.001

Medical history, n (%)

 Hypertension

1,837 (91.8)

1,831 (91.4)

3,668 (91.6)

884 (88.8)

872 (88.3)

1,756 (88.6)

<0.001

 Diabetes

957 (47.8)

956 (47.7)

1,913 (47.8)

509 (51.2)

516 (52.2)

1,025 (51.7)

0.004

 CKD (eGFR < 60 ml min−1 1.73 m−2 or UACR > 300 mg g−1)

1,134 (56.6)

1,093 (54.6)

2,227 (55.6)

481 (48.2)

490 (49.6)

971 (49.0)

<0.001

 Baseline hematocrit < median

950 (47.5)

964 (48.1)

2,089 (52.2)

396 (39.8)

414 (41.9)

810 (40.8)

<0.001

 Atrial fibrillation or flutter

1,117 (55.8)

1,107 (55.3)

2,224 (55.5)

459 (46.1)

452 (45.7)

911 (45.9)

<0.001

 Invasive electrophysiological procedure

123 (6.1)

141 (7.0)

264 (6.6)

38 (3.8)

46 (4.7)

84 (4.2)

<0.001

 Valvular heart disease

341 (17.0)

313 (15.6)

654 (16.3)

141 (14.2)

124 (12.6)

265 (13.4)

0.003

 Myocardial infarction

484 (24.2)

467 (23.3)

951 (23.7)

408 (41.0)

421 (42.6)

829 (41.8)

<0.001

 PCI or CABG

575 (28.7)

554 (27.7)

1,129 (28.2)

399 (40.1)

386 (39.1)

785 (39.6)

<0.001

Heart failure medication, n (%)

 ACEIs/ARBs

1,561 (78.0)

1,537 (76.7)

3,098 (77.4)

806 (81.0)

801 (81.1)

1,607 (81)

0.001

 ARNI

20 (1.0)

31 (1.5)

51 (1.3)

45 (4.5)

38 (3.8)

83 (4.2)

<0.001

 Beta-blockers

1,688 (84.3)

1,687 (84.2)

3,375 (84.3)

910 (91.5)

882 (89.3)

1,792 (90.4)

<0.001

 Ivabradine

22 (1.1)

17 (0.8)

39 (1.0)

18 (1.8)

14 (1.4)

32 (1.6)

0.031

 MRAs

663 (33.1)

657 (32.8)

1,320 (33.0)

456 (45.8)

468 (47.4)

924 (46.6)

<0.001

 Diuretics other than MRA

1,620 (80.9)

1,626 (81.2)

3,246 (81.0)

787 (79.1)

776 (78.5)

1,563 (78.8)

0.041

 Triple therapya

443 (22.1)

440 (22.0)

883 (22.0)

372 (37.4)

371 (37.6)

743 (37.5)

<0.001

ICD or CRT-D, n (%)

58 (2.9)

70 (3.5)

128 (3.2)

55 (5.5)

49 (5.0)

104 (5.2)

0.002

  1. aDefined as: (ACEI or ARB or ARNI) + (beta-blocker or ivabradine) + MRA.
  2. P values are two-sided and are derived from t-tests for continuous variables and chi-squared tests for categorical variables. No adjustments for multiple testing were made. ACEI, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; ARNI, angiotensin receptor–neprilysin inhibitor; BMI, body mass index; CABG, coronary artery bypass graft; CKD, chronic kidney disease; CRT-D, cardiac resynchronization therapy defibrillator; DBP, diastolic blood pressure; eGFR, estimated glomerular filtration rate; ICD, implantable cardioverter defibrillator; KCCQ-CSS, Kansas City Cardiomyopathy Questionnaire–Clinical Summary Score; LVEF, left ventricular ejection fraction; MRA, mineralocorticoid receptor antagonist; NT-proBNP, N-terminal pro-brain natriuretic peptide; NYHA, New York Heart Association; PCI, percutaneous coronary intervention; SBP, systolic blood pressure; UACR, urinary albumin-to-creatine ratio.
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