Page 62 - 51 the significance--29.2_opt

Table 3. Summary of saxagliptin phase III clinical data.

Monotherapy/ Total Duration Saxagliptin dose Mean baseline Change in
Combination number of HbA HbA
1c
1c
patients (weeks) (%) (%)
Monotherapy 47 401 24 2.5 mg, 5 mg or 10 mg QD 7.9 -0.46
Metformin 48
(initial combination study) 1306 24 5 mg or 10 mg QD 9.5 -2.5
Metformin 49 743 24 2.5 mg, 5 mg or 10 mg QD 8.1 -0.69
Metformin a 50 743 102 2.5 mg, 5 mg or 10 mg QD 8.1 -0.40
Metformin 51 858 52 5 mg QD 7.7 -0.74
Metformin 52 801 18 5 mg QD 6.5–10 -0.52*
Metformin 53
(initial combination study) 1306 76 5 mg or 10 mg QD 8.0–12.0 -1.55 to -2.33*
SU 54 768 24 2.5 mg or 5 mg QD 8.5 -0.64*
TZD 55 565 24 2.5 mg or 5 mg QD 8.4 -0.94*
*Change in HbA 1c = Adjusted mean change from baseline at end of study. a = long term extension of previous study. Efficacy
data refers to saxagliptin 5mg. Note that the studies are different and therefore not comparable. QD = once daily dosing.

Table 4. Summary of alogliptin phase III clinical data.
Monotherapy/ Total Duration Alogliptin dose Mean baseline Change in
Combination number of HbA 1c HbA 1c
therapy patients (weeks) (%) (%)
Monotherapy 56 329 26 12.5 mg or 25 mg QD 7.0-10.0 -0.56−0.59
Metformin 57 527 26 12.5 mg or 25 mg QD 7.9 -0.6
SU 58 500 26 12.5 mg or 25 mg QD 8.1 -0.38−0.52
TZD 59 493 26 12.5 mg or 25 mg QD 8.0 -0.66−0.80
TZD 60 - 12 12.5 mg or 25 mg QD 6.9-10.4 -0.91-0.97
TZD 61 655 26 12.5 mg or 25 mg QD 8.8 -1.7
(initial combination study)
Metformin + TZD 62 803 52 25 mg QD 7.0-10.0 -0.70
*Placebo-adjusted change. Note that the studies are different and therefore not comparable; doses may vary in different
studies. Change in HbA 1c shows change from baseline except when asterisk is shown. QD = once daily dosing.

Cardiovascular protection

Long-term safety data for DPP-4 inhibitors are not yet available. How-
ever, there is evidence to suggest these agents may confer some de-
gree of cardiovascular protection. 63 64 Further data to support or refute
this hypothesis is currently being collected in large, prospective studies.
63
A number of meta-analyses have recently been published that inves-
tigate, in detail, the cardiovascular safety of OADs. Sitagliptin was not
associated with an increased risk of major adverse cardiovascular
events. Likewise, vildagliptin was not associated with an increased risk
65
of adjudicated cardiovascular and cerebrovascular events, even in
a patient population that included subjects at increased risk of these
events. 66

62