Table 3 Key information of the STEP-HFpEF trial [50]

Class &

Cardiovascular (CV) outcomes

Estimated difference or ratio (95% CI)

p-value

Dual primary endpoints

Change in KCCQ-CSS from baseline to week 52 (points)

7.8 (4.8 to 10.9)

< 0.001

Change in body weight from baseline to week 52 (%)

-10.7 (-11.9 to -9.4)

< 0.001

Confirmatory secondary endpoints

Change from baseline to week 52 in 6-minute

walk distance (m)

20.3 (8.6 to 32.1)

< 0.001

Change from baseline to week 52 in CRP level (%)

0.61 (0.51 to 0.72)

< 0.001

Hierarchical composite endpoint (crude % of wins)

1.72 (1.37 to 2.15)

< 0.001

Adverse events

Event rate (%) active vs. placebo group

p-value

Serious adverse events

13.3 vs. 26.7

< 0.001

Cardiac disorder

2.7 vs. 11.3

< 0.001

Gastrointestinal disorders

2.7 vs. 2.7

1.0

Adjudicated events

Death from any cause

1.1 vs. 1.5

n.a.

CV death

0 vs. 0.4

n.a.

HF event

0.4 vs. 4.5

n.a.