|
|
|
|
Cough |
25% |
17% |
69% |
|
|
|
|
Cough |
35% |
29% |
62% |
|
||||||
|
|
|||||
|
|
|
|
|||
AUC0-24 (ng•hr/mL) |
442 |
1685 |
368 |
1866 |
||
CMAX (ng/mL) |
224 |
212 |
141 |
222 |
||
T1/2 (h) |
2.1 |
7.4 |
2.3 |
5.6 |
||
TPEAK (h) |
0.9 |
3.5 |
2.0 |
4.1 |
||
CLREN (mL/min) |
56 |
20 |
53 |
17 |
|
|
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
|
||||||
Primary Composite Endpoint |
508 (11) |
23.8 |
588 (13) |
27.9 |
13% |
2% to 23% |
0.021 |
||||||
Components of Primary Composite Endpoint (as a first event) |
|||||||||||||
Stroke (nonfatal) |
209 (5) |
|
286 (6) |
|
|
|
|
||||||
Myocardial infarction (nonfatal) |
174 (4) |
|
168 (4) |
|
|
|
|
||||||
Cardiovascular mortality |
125 (3) |
|
134 (3) |
|
|
|
|
||||||
Secondary Endpoints (any time in study) |
|
|
|
|
|
|
|
||||||
Stroke (fatal/nonfatal) |
232 (5) |
10.8 |
309 (7) |
14.5 |
25% |
11% to 37% |
0.001 |
||||||
Myocardial infarction (fatal/nonfatal) |
198 (4) |
9.2 |
188 (4) |
8.7 |
-7% |
-13% to 12% |
0.491 |
||||||
Cardiovascular mortality |
204 (4) |
9.2 |
234 (5) |
10.6 |
11% |
-7% to 27% |
0.206 |
||||||
Due to CHD |
125 (3) |
5.6 |
124 (3) |
5.6 |
-3% |
-32% to 20% |
0.839 |
||||||
Due to Stroke |
40 (1) |
1.8 |
62 (1) |
2.8 |
35% |
4% to 67% |
0.032 |
||||||
Other |
39 (1) |
1.8 |
48 (1) |
2.2 |
16% |
-28% to 45% |
0.411 |
|
|
|
|
|
|
||||||||||
|
|
|
|
|
|
||||||||||
Primary Composite Endpoint |
43.5% |
47.1% |
16.1% |
2.3% to 27.9% |
0.022 |
||||||||||
Doubling of Serum Creatinine, ESRD and Death Occurring as a First Event |
|
|
|
|
|
||||||||||
Doubling of Serum Creatinine |
21.6% |
26.0% |
|
|
|
||||||||||
ESRD |
8.5% |
8.5% |
|
|
|
||||||||||
Death |
13.4% |
12.6% |
|
|
|
||||||||||
Overall Incidence of Doubling of Serum Creatinine, ESRD and Death |
|
|
|
|
|
||||||||||
Doubling of Serum Creatinine |
21.6% |
26.0% |
25.3% |
7.8% to 39.4% |
0.006 |
||||||||||
ESRD |
19.6% |
25.5% |
28.6% |
11.5% to 42.4% |
0.002 |
||||||||||
Death |
21.0% |
20.3% |
-1.7% |
-26.9% to 18.6% |
0.884 |
|
|
|
|||||||||
|
|
|
|
|
|
||||||
Overall Results |
1513 |
43.5 |
47.1 |
0.84 (0.72, 0.98) |
19.6 |
25.5 |
0.71 (0.58, 0.89) |
||||
Age |
|||||||||||
<65 years |
1005 |
44.1 |
49.0 |
0.78 (0.65, 0.94) |
21.1 |
28.5 |
0.67 (0.52, 0.86) |
||||
≥65 years |
508 |
42.3 |
43.5 |
0.98 (0.75, 1.28) |
16.5 |
19.6 |
0.85 (0.56, 1.28) |
||||
Gender |
|||||||||||
Female |
557 |
47.8 |
54.1 |
0.76 (0.60, 0.96) |
22.8 |
32.8 |
0.60 (0.44, 0.83) |
||||
Male |
956 |
40.9 |
43.3 |
0.89 (0.73, 1.09) |
17.5 |
21.5 |
0.81 (0.60, 1.08) |
||||
Race |
|||||||||||
Asian |
252 |
41.9 |
54.8 |
0.66 (0.45, 0.95) |
18.8 |
27.4 |
0.63 (0.37, 1.07) |
||||
Black |
230 |
40.0 |
39.0 |
0.98 (0.65, 1.50) |
17.6 |
21.0 |
0.83 (0.46, 1.52) |
||||
Hispanic |
277 |
55.0 |
54.0 |
1.00 (0.73, 1.38) |
30.0 |
28.5 |
1.02 (0.66, 1.59) |
||||
White |
735 |
40.5 |
43.2 |
0.81 (0.65, 1.01) |
16.2 |
23.9 |
0.60 (0.43, 0.83) |