|
Trial
|
HbA1c imbalancea
|
Additional hypoglycemic agents
|
Primary endpoint
|
Cardiovascular death
|
Nonfatal MI
|
Nonfatal Stroke
|
Heart failure
|
Death from any cause
|
Increased adverse eventsb
|
|---|
|
EXAMINE
|
0.36 (mean)
|
NA
|
0.96 (0.8–1.16)
|
0.79 (0.60–1.04)
|
1.08 (0.88–1.33)
|
0.91 (0.55–1.50)
|
1.76
c
(1.07–2.90)
|
0.88 (0.71–1.13)
|
Heart failure
|
|
CARMELINA
|
0.36 (mean)
|
More in P group
|
1.02 (0.89–1.17)
|
0.96 (0.81–1.14)
|
1.15 (0.91–1.45)
|
0.88 (0.63–1.23)
|
0.90 (0.74–1.08)
|
0.98 (0.84–1.09)
| |
|
SAVOR-TIMI
|
0.3 (52d)
|
More in P group
|
1.00 (0.98–1.12)
|
1.03 (0.87–1.22)
|
0.95 (0.80–1.12)
|
1.11 (0.88–1.39)
|
1.27 (1.07–1.51)
|
1.11 (0.96–1.27)
|
Heart failure
|
|
TECOS
|
0.29 (mean)
|
More in P group
|
0.98 (0.89–1.08)
|
1.03 (0.89–1.19)
|
0.96 (0.81–1.13)e
|
0.93 (0.75–1.16) f
|
1.00 (0.83–1.20)
|
1.01 (0.90–1.14)
| |
|
HARMONY
|
0.63 (8d)
|
More in P group
|
0.78 (0.68–0.90)
|
0.93 (0.73–1.19)
|
0.75 (0.61–0.90)
e
|
0.86 (0.66–1.14) f
|
0.85 (0.70–1.04)
|
0.95 (0.79–1.16)
| |
|
EXSCEL
|
0.53 (mean)
|
More in P group
|
0.91 (0.83–1.00)
|
0.88 (0.73–1.05)
|
0.95 (0.84–1.09)
|
0.86 (0.70–1.07)
|
0.94 (0.78–1.13)
|
0.86 (0.77–0.97)
| |
|
LEADER
|
0.4 (36d)
|
More in P group
|
0.87 (0.78–0.97)
|
0.78 (0.66–0.93)
|
0.88 (0.75–1.03)
|
0.89 (0.72–1.11)
|
0.87 (0.73–1.05)
|
0.85 (0.74–0.97)
| |
|
ELIXA
|
0.27 (mean)
|
NA
|
1.02 (0.89–1.17)
|
0.98 (0.78–1.22)
|
1.03 (0.87–1.22)
|
1.12 (0.79–1.58)
|
0.96 (0.75–1.23)
|
0.94 (0.78–1.13)
| |
|
SUSTAIN-6
|
1.00 (104d)
|
More in P group
|
0.74 (0.58–0.95)
|
0.98 (0.65–1.48)
|
0.74 (0.51–1.08)
|
0.61 (0.38–0.99)
|
1.11 (0.77–1.61)
|
1.05 (0.74–1.50)
| |
|
CANVAS
|
0.58 (mean)
|
More in P group
|
0.86 (0.75–0.97)
|
0.87 (0.72–1.06)
|
0.85 (0.69–1.05)
|
0.90 (0.71–1.15)
|
0.67 (0.52–0.87)
|
0.87 (0.74–1.01)
|
Amputation
|
|
DECLARE–TIMI
|
0.42 (mean)
|
More in P group
|
0.93 (0.84–1.03)
|
0.98 (0.82–1.17)
|
0.89 (0.77–1.01)
|
1.01 (0.84–1.21)
|
0.73 (0.61–0.88)
|
0.93 (0.82–1.04)
|
Ketoacidosis Genital infection
|
|
EMPA-REG OUTCOME
|
0.47 (94d)
|
More in P group
|
0.86 (0.74–0.99)
|
0.62 (0.49–0.77)
|
0.87 (0.70–1.09)
|
1.24 (0.92–1.67)
|
0.65 (0.50–0.85)
|
0.68 (0.57–0.82)
| |
- aHbA1c concentrations were significantly higher in the placebo group than in the treatment group. bAdverse events that had a significant increase in frequency in the treatment group. cIn patients without a history of heart failure at baseline.dWeek at which the data were obtained. eFatal myocardial infarction included. fFatal stroke included. Data are presented as the hazard ratio (95% confidence interval). Bold type represents a significant increase of the event in the treatment group compared with that in the placebo group. Italic type represents a significant reduction. MI Myocardial infarction, NA Data not available, P Placebo
