Table 2 Primary and secondary outcomes

From: The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial

 

Empagliflozin (n = 265)

Placebo (n = 265)

 

P value

Primary endpoint

  

Win ratio (95% CI)a

 

 Primary endpoint (% wins)b

53.89

39.71

1.36 (1.09–1.68)

0.0054

 Time to death (% wins)

7.15

4.01

  

 HFE frequency (% wins)c

10.59

7.65

  

 Time to first HFE (% wins)

0.24

0.57

  

 ≥5 point difference in the KCCQ-TSS change from baseline to day 90 (% wins)d

35.91

27.48

  

 Percentage of ties

6.41

6.41

  

Components described separately in the whole study population

 Deaths, n (%)

11 (4.2)

22 (8.3)

  

 Patients with HFE, n (%)

28 (10.6)

39 (14.7)

  

 Total HFEs, n

36

52

  

 Change from baseline in KCCQ-TSS at day 90d

See secondary endpoint

  

Secondary endpoints

  

Hazard ratio (95% CI)

 

 CVD or HFE until end-of-trial visit, n (%), events per 100 patient years (95% CI)

34 (12.8), 55.01 (38.10–74.99)

49 (18.5), 80.45 (59.52–104.49)

0.69 (0.45–1.08)

 
   

Odds ratio (95% CI)

 

 KCCQ-TSS improvement ≥10 points at day 90, n (%)

220.1 (83.1)

202.1 (76.3)

1.522 (0.927–2.501)

 
   

Adjusted mean difference (95% CI)

 

 KCCQ-TSS change from baseline to day 90, adjusted mean (95% CI)

36.19 (33.28–39.09)

31.73 (28.80–34.67)

4.45 (0.32–8.59)

 

 Diuretic response (kg weight loss per mean daily loop diuretic dose)e, adjusted mean (95% CI)

    

 At day 15

−3.33 (−4.38 to −2.29)

−1.02 (−2.04 to 0.00)

−2.31 (−3.77 to −0.85)

 

 At day 30

−3.80 (−5.39 to −2.20)

−1.01 (−2.59 to 0.57)

−2.79 (−5.03 to −0.54)

 
   

Adjusted geometric mean ratio (95% CI)

 

AUC of change from baseline in NT-proBNP at day 30, adjusted geometric mean (95% CI)d

24.07 (22.61–25.62)

26.77 (25.15–28.48)

0.90 (0.82–0.98)

 
   

Adjusted mean difference (95% CI)

 

Percentage of days alive and out of hospital from study drug initiation until 30 days after initial hospital discharge, mean (s.d.)

81.37 (18.62)

80.90 (21.25)

0.47 (−2.97 to 3.91)

 

Days alive and out of hospital from study drug initiation until 30 days after initial hospital discharge, mean (s.d.)

28.00 (6.15)

27.47 (6.63)

NA

 

Percentage of days alive and out of hospital from study drug initiation until 90 days after randomization, mean (s.d.)

87.55 (19.54)

85.79 (22.76)

1.76 (−1.91 to 5.43)

 

Days alive and out of hospital from study drug initiation until 90 days after randomization, mean (s.d.)

78.29 (20.17)

76.13 (22.85)

NA

 
   

Odds ratio (95% CI)

 

Hospitalizations for heart failure until 30 days after initial hospital discharge, n (%)

14 (5.3)

12 (4.5)

1.179 (0.534–2.601)

 

Occurrence of chronic dialysis or renal transplant or sustained reduction of ≥40% eGFRCKD-EPIcr, or sustained eGFRCKD-EPIcr <15 ml min−1 1.73 m−2 for patients with baseline eGFR ≥30 ml min−1 1.73 m−2, sustained eGFRCKD-EPIcr <10 ml min−1 1.73 m−2 for patients with baseline eGFR <30 ml min−1 1.73 m−2, n (%)

0

2 (0.8)

Not possible to fit a model

 
  1. AUC, area under the curve; CKD-EPIcr, Chronic Kidney Disease Epidemiology Collaboration equation using serum creatinine concentration; CVD, cardiovascular death; eGFR, estimated glomerular filtration rate; NA, not applicable.
  2. The stratified win ratio for the primary endpoint was calculated using a non-parametric generalized pairwise comparison within heart failure status strata. For the secondary endpoints, the hazard ratio was calculated using a Cox proportional hazards model, the odds ratios were calculated using logistic regression models, the adjusted geometric mean ratio was calculated with analysis of covariance (ANCOVA), and the adjusted mean differences were calculated with either ANCOVA or mixed effects models for repeated measures, as appropriate. No adjustments for multiple testing were made. Data are given as point estimates and 95% CI, with two-sided P values, where appropriate. Full details are provided in Supplementary Note 2.
  3. aVariance calculated using the asymptotic normal U statistics approach.
  4. bPairs are analyzed within strata for a stratified win ratio, applying weights that are analogous to a Mantel–Haenszel approach.
  5. cFrequency based on events up to the earlier of the two censoring times.
  6. dBased on multiple imputation with 100 iterations.
  7. eExcluding patients not taking diuretics for more than 1 day during the time period; the units are kg per 40 mg i.v. furosemide (or 80 mg oral furosemide). The equivalent loop diuretic dose to a single dose of 40 mg furosemide is defined as 20 mg torasemide or 1 mg bumetanide.
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