Re: DECLARE TIMI-58 w/ prior MI as BETonMACE proxy?
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Message: DECLARE TIMI-58 w/ prior MI as BETonMACE proxy?
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.
Composite of death from cardiovascular causes, non-fatal MI, or non-fatal stroke.
The parenthetical value is the upper boundary of the one-sided repeated CI, at an alpha level of 0.01.
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.
P < 0.001.
Source: EXAMINE Clinical Study Report.41
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