Table 3.
Summary of safety outcomes in clinical trials.
| EMPA-REG OUTCOME [40] | EMPEROR-reduced [41] | EMPEROR-preserved [42] | EMPA-RESPONSE-AHF [43] | EMPULSE [44] | |
|---|---|---|---|---|---|
| Serious adverse effects | 38.2% (EMPA) vs. 42.3% (placebo) | 41.4% (EMPA) vs. 48.1% (placebo) | 47.9% (EMPA) vs. 51.6% (placebo) | 20% (EMPA) vs. 28.2% (placebo) | 15.0% (EMPA) vs. 20.5% (placebo) |
| Acute renal failure | 5.2% (EMPA) vs. 6.64% (placebo) | 8.4% (EMPA) vs. 10.6% (placebo) | 12.1% (EMPA) vs. 12.8% (placebo) | 10% (EMPA) vs. 8% (placebo) | 7.7% (EMPA) vs. 12.1% (placebo) |
| Ketoacidosis | 0.1% (EMPA) vs. <0.1% (placebo) | 0% (EMPA) vs. 0% (placebo) | 0.1% (EMPA) vs. 0.2% (placebo) | 0% (EMPA) vs. 3% (placebo) | 0% (EMPA) vs. 0% (placebo) |
| Amputations | – | 0.7% (EMPA) vs. 0.5% (placebo) | 0.5% (EMPA) vs. 0.8% (placebo) | – | – |
| Hypoglycemia | 27.8% (EMPA) vs. 27.9% (placebo) | 1.4% (EMPA) vs. 1.5% (placebo) | 2.4% (EMPA) vs. 2.6% (placebo) | 0% (EMPA) vs. 3% (placebo) | 1.9% (EMPA) vs. 1.5% (placebo) |
| Bone fractures | 3.81% (EMPA) vs. 3.9% (placebo) | – | 4.5% (EMPA) vs. 4.2% (placebo) | – | – |
| Genital infections | 6.4% (EMPA) vs. 1.8% (placebo) | 4.9% (EMPA) vs. 4.5% (placebo) | 3% (EMPA) vs. 3% (placebo) | – | – |
| Urinary tract infections | 18% (EMPA) vs. 18.1% (placebo) | 4.9% (EMPA) vs. 4.5% (placebo) | 9.9% (EMPA) vs. 8.1% (placebo) | 3% (EMPA) vs. 3% (placebo) | 4.2% (EMPA) vs. 6.4% (placebo) |
EMPA: Empagliflozin.