Investor Presentaiton
First Occurrence of Adjudicated MACE
During the Time Period for Follow-up of CV Events - ITT Population
asceND
DIALYSIS
1.0
0.9
Daprodustat
ESA
NON-DIALYSIS
asceND ND
Daprodustat
Darbepoetin alfa
1.0-
HR (95% CI): 0.93 (0.81, 1.07)
0.9
HR (95% CI): 1.03 (0.89–1.19)
Cumulative incidence
0.8
L
Non-fatal stroke
Daprodustat
(N=1487)
ESA
(N=1477)
0.7
First occurrence of adjudicated MACE,
374 (25.2)
394 (26.7)
0.6
n (%)
All-cause mortality
244 (16.4)
233 (15.8)
0.5
Non-fatal myocardial infarction
101 (6.8)
126 (8.5)
0.4
29 (2.0)
35 (2.4)
0.3
0.2
0.1
0.0
0
4
8
Cumulative incidence
0.8-
Daprodustat Darbepoetin alfa
(N=1937)
(N=1935)
0.7-
First occurrence of adjudicated MACE,
378 (19.5)
371 (19.2)
0.6-
n (%)
All-cause mortality
252 (13.0)
259 (13.4)
0.5-
Non-fatal myocardial infarction
96 (5.0)
91 (4.7)
0.4-
Non-fatal stroke
30 (1.5)
21 (1.1)
0.3
0.2-
0.1-
0.0-
T
T
T
12 16 20
Months since randomization
T
24 28
32
-
32
36
0
4
8
12 16 20 24 28 32 36
Months since randomization
Patients at risk
Daprodustat 1487 1425 1352 1297 1240 1181 1129 861 559 250
ESA 1477 1427 1348 1271 1217 1170 1108 836 525 245
Patients at risk
Daprodustat
Darbepoetin alfa
1937 1834 1601 1414 1207 1024 840 647 468 288
1935 1825 1582 1412 1221 1038 843 660 474 291
Noninferiority was achieved because the upper boundary of the 95% CI of the HR was lower than the pre-specified NI margin of 1.25
HR estimated using a Cox proportional hazards regression model with treatment group, dialysis type (ASCEND-D) or baseline ESA use (ASCEND-ND) and region as covariates.
A HR <1 indicates a lower risk with daprodustat compared with ESA/darbepoetin alfa. Note: y-axis scale may differ from those in the primary publications.
Cl, confidence interval; CV, cardiovascular; ESA, erythropoiesis-stimulating agent; HR, hazard ratio; ITT, intent-to-treat; MACE, major adverse cardiovascular event.
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