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Table 2 Key efficacy outcomes in SGLT2 inhibitor CVOTs

From: SGLT2 inhibitors in T2D and associated comorbidities — differentiating within the class

  EMPA-REG OUTCOME [16, 33] CANVAS Program [17, 34] DECLARE-TIMI 58 [18]
Placebo (N = 2333) Empagliflozin (N = 4687) Placebo (N = 4347) Canagliflozin (N = 5795) Placebo (N = 8578) Dapagliflozin (N = 8582)
3P-MACE (CV death, MI or stroke)
 Rate per 1000 pt-yrs 43.9 37.4 31.5 26.9 24.2 22.6
 HR (95% CI; p-value) 0.86 (0.74–0.99; p = 0.04) 0.86 (0.75–0.97; p = 0.02) 0.93 (0.84–1.03; p = 0.17)
 RRR (ARR) 14% (6.5 events/1000 pt-ys) 14% (4.6 events/1000 pt-yrs) N/A
CV death
 Rate per 1000 pt-yrs 20.2 12.4 12.8 11.6 7.1 7.0
 HR (95% CI; p-value) 0.62 (0.49–0.77; p < 0.001) 0.87 (0.72–1.06)† 0.98 (0.82–1.17)†
 RRR (ARR) 38% (7.8 events/1000 pt-yrs) N/A N/A
Death by any cause
 Rate per 1000 pt-yrs 28.6 19.4 19.5 17.3 16.4 15.1
 HR (95% CI; p-value) 0.68 (0.57–0.82; p < 0.001) 0.87 (0.74–1.01; p = 0.24) 0.93 (0.82–1.04)†
 RRR (ARR) 32% (9.2 events/1000 pt-yrs) N/A N/A
HHF
 Rate per 1000 pt-yrs 14.5 9.4 8.7 5.5 8.5 6.2
 HR (95% CI; p-value) 0.65 (0.50–0.85; p = 0.002) 0.67 (0.52–0.87)† 0.73 (0.61–0.88)†
 RRR (ARR) 35% (5.1 events/1000 pt-yrs) 33% (3.2 events/1000 pt-yrs) 27% (2.3 events/1000 pt-yrs)
Renal composite (renal function decline*, ESRD or renal death)
 Rate per 1000 pt-yrs 11.5 6.3 9.0 5.5 7.0 3.7
 HR (95% CI; p-value) 0.54 (0.40–0.75; p < 0.001)† 0.60 (0.47–0.77)† 0.53 (0.43–0.66)†
 RRR (ARR) 46% (5.2 events/1000 pt-yrs) 40% (3.5 events/1000 pt-yrs) 47% (3.3 events/1000 pt-yrs)
Alternative renal composite (progression to macroalbuminuria, dSCr, ESRD or renal death)
 Rate per 1000 pt-yrs 76.0 47.8 27.4 15.1 Not reported
 HR (95% CI; p-value) 0.61 (0.53–0.70; p < 0.001) 0.58 (0.50–0.67)†
 RRR (ARR) 39% (28.2 events/1000 pt-yrs) 42% (12.3 events/1000 pt-yrs)
  1. Please note that direct comparison of trials may not be accurate owing to differences in study design, populations and methodology. RRR and ARR are only shown where a significant reduction was reported, or a nominally significant reduction in the case of an exploratory analysis. *Defined as: dSCr accompanied by eGFR of < 45 ml/min/1.73 m2 in EMPA-REG OUTCOME; ≤40% decrease in eGFR in the CANVAS Program; and ≤ 40% decrease in eGFR to < 60 ml/min/1.73 m2 in DECLARE-TIMI 58. †Exploratory analysis, p-value is nominal or not available. 3P-MACE, 3-point major adverse CV event; ARR, absolute risk reduction; CI, confidence interval; CV, cardiovascular; dSCr, doubling of serum creatinine; HHF, hospitalisation for heart failure; HR, hazard ratio; MI, myocardial infarction; pt-yrs, patient-years; RRR, relative risk reduction