Uncle Google tells us EXAMINE trial
Table 39Cardiovascular and Efficacy Outcomes
| End Point |
ALO
(N = 2,701) |
PL
(N = 2,679) |
Hazard Ratio for ALO
(95% CI) |
| Primary and Secondary End Points |
| |
n (%) |
n (%) |
|
| Primary MACE compositea |
305 (11.3) |
316 (11.8) |
0.96 (≤ 1.16)b
|
| Cardiovascular death |
89 (3.3) |
111 (4.1) |
0.79 (0.60, 1.04) |
| Non-fatal MI |
187 (6.9) |
173 (6.5) |
1.08 (0.88, 1.33) |
| Non-fatal stroke |
29 (1.1) |
32 (1.2) |
0.91 (0.55, 1.50) |
| Secondary MACE compositec |
344 (12.7) |
359 (13.4) |
0.95 (≤ 1.14)b
|
| Exploratory End Points |
| A1C (%) |
Baseline, mean (SD) |
8.0 (1.1) |
8.0 (1.1) |
NA |
| Last visit, mean (SD) |
7.7 (1.5)
(n = 2,648) |
8.1 (1.6)
(n = 2,621) |
NA |
| Change from baseline, LSM (SE) |
−0.3 (0.03) |
0.03 (0.03) |
NA |
| Change from baseline, LSMD (95% CI) versus PL |
−0.4d (−0.4 to −0.3) |
NA |
NA |
| FPG (mmol/L) |
Baseline, mean (SD) |
8.8 (3.2)
(n = 2,680) |
8.8 (3.1)
(n = 2,655) |
NA |
| Last visit, mean (SD) |
8.9 (3.7) |
9.3 (3.5) |
NA |
| Change from baseline, LSM (SE) |
0.1 (0.1) |
0.5 (0.1) |
NA |
| Change from baseline, LSMD (95% CI) versus PL |
−0.3d (−0.5 to −0.1) |
NA |
NA |
A1C = glycated hemoglobin; ALO = alogliptin; CI = confidence interval; FPG = fasting plasma glucose; LSM = least squares mean; LSMD = least squares mean difference; MACE = major adverse cardiac event; MI = myocardial infarction; NA = not applicable; SD = standard deviation; SE = standard error.
a
Composite of death from cardiovascular causes, non-fatal MI, or non-fatal stroke.
b
The parenthetical value is the upper boundary of the one-sided repeated CI, at an alpha level of 0.01.
c
Composite of death from cardiovascular causes, non-fatal MI, non-fatal stroke, or urgent revascularization due to unstable angina within 24 hours of hospital admission.
d
Source: EXAMINE Clinical Study Report.41
