Table 2 HbA1c imbalance, additional hypoglycemic agents, and outcomes in the cardiovascular outcome trials
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) |  |