risk margin larger than 1.3.
Table 14. Patients with MACE in EXAMINE
Composite of first event of CV death, nonfatal MI or nonfatal stroke (MACE) Alogliptin Placebo Hazard Ratio
Number of Patients (%) Rate per 100 PY* Number of Patients (%) Rate per 100 PY* (98% CI)
* Patient Years (PY)
N=2701 N=2679
305 (11.3) 7.6 316 (11.8) 7.9 0.96 (0.80, 1.16)
CV Death 89 (3.3) 2.2 111 (4.1) 2.8
Non-fatal MI 187 (6.9) 4.6 173 (6.5) 4.3
Non-fatal stroke 29 (1.1) 0.7 32 (1.2) 0.8
The Kaplan-Meier based cumulative event probability is presented in Figure 4 for the time to first occurrence of the primary MACE composite endpoint by treatment arm. The curves for placebo and alogliptin overlap throughout the duration of the study. The observed incidence of MACE was highest within the first 60 days after randomization in both treatment arms (14.8 MACE per 100 PY), decreased from day 60 to the end of the first year (8.4 per 100 PY) and was lowest after one year of follow-up (5.2 per 100 PY).
Figure 4. Observed Cumulative Rate of MACE in EXAMINE
Figure 4
The rate of all cause death was similar between treatment arms with 153 (3.6 per 100 PY) recorded among patients randomized to alogliptin and 173 (4.1 per 100 PY) among patients randomized to placebo. A total of 112 deaths (2.9 per 100 PY) among patients on alogliptin and 130 among patients on placebo (3.5 per 100 PY) were adjudicated as cardiovascular deaths.
CLOSE
16 HOW SUPPLIED/STORAGE AND HANDLING
OSENI tablets are available in the following strengths and packages:
25 mg/15 mg tablet: yellow, round, biconvex and film-coated with both "A/P" and "25/15" printed on one side, available in:
NDC 64764-251-03
Bottles of 30 tablets
NDC 64764-251-04
Bottles of 90 tablets
NDC 64764-251-05
Bottles of 500 tablets
25 mg/30 mg tablet: peach, round, biconvex and film-coated with both "A/P" and "25/30" printed on one side, available in:
NDC 64764-253-03
Bottles of 30 tablets
NDC 64764-253-04
Bottles of 90 tablets
NDC 64764-253-05
Bottles of 500 tablets
25 mg/45 mg tablet: red, round, biconvex, film-coated and with both "A/P" and "25/45" printed on one side, available in:
NDC 64764-254-03
Bottles of 30 tablets
NDC 64764-254-04
Bottles of 90 tablets
NDC 64764-254-05
Bottles of 500 tablets
12.5 mg/15 mg tablet: pale yellow, round, biconvex and film-coated with both "A/P" and "12.5/15" printed on one side, available in:
NDC 64764-121-03
Bottles of 30 tablets
NDC 64764-121-04
Bottles of 90 tablets
NDC 64764-121-05
Bottles of 500 tablets
12.5 mg/30 mg tablet: pale peach, round, biconvex and film-coated with both "A/P" and "12.5/30" printed on one side, available in:
NDC 64764-123-03
Bottles of 30 tablets
NDC 64764-123-04
Bottles of 90 tablets
NDC 64764-123-05
Bottles of 500 tablets
12.5 mg/45 mg tablet: pale red, round, biconvex and film-coated with both "A/P" and "12.5/45" printed on one side, available in:
NDC 64764-124-03
Bottles of 30 tablets
NDC 6476
