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

From: Imbalance in glycemic control between the treatment and placebo groups in cardiovascular outcome trials in type 2 diabetes

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 (0.680.90) 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)  
  1. 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