Table 2.
Predicted absolute benefits and harms of SGLT-2 inhibitors per 1000 patient-years of treatment, by patient group
| Absolute rates and effects per 1000 patient years |
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|---|---|---|---|---|---|---|---|---|---|---|
| STABLE HEART FAILURE |
RECENTLY HOSPITALIZED FOR WORSENING HEART FAILURE |
TYPE 2 DIABETES MELLITUS AT HIGH ATHEROSCLEROTIC CARDIOVASCULAR RISK |
ALBUMINURIC CHRONIC KIDNEY DISEASE |
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| REDUCED EJECTION FRACTION |
PRESERVED EJECTION FRACTION |
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| Event rate | Events avoided/ caused (SE) in SGLT-2i arms | Event rate | Events avoided/ caused (SE) in SGLT-2i arms | Event rate | Events avoided/ caused (SE) in SGLT-2i arms | Event rate | Events avoided/ caused (SE) in SGLT-2i arms | Event rate | Events avoided/ caused (SE) in SGLT-2i arms | |
| Efficacy Outcomes | ||||||||||
| Hospitalization for heart failure | 123 | -39 (3) | 60 | -19 (1) | 639 | -204 (14) | 10 | -3 (0.2) | 20 | -6 (0.4) |
| Myocardial infarction | - | - | - | - | - | 15 | -2 (0.5) | 9 | -1 (0.3) | |
| Cardiovascular death | 80 | -11 (2) | 38 | -5 (1) | 125 | -17 (3) | 13 | -2 (0.4) | 21 | -3 (0.6) |
| Kidney disease progression | 20 | -7 (0.6) | 22 | -8 (0.6) | - | - | 9 | -3 (0.3) | 49 | -18 (1) |
| Acute kidney injury | 19 | -6 (0.9) | - | - | 59 | -18 (3) | 4 | -1 (0.2) | 15 | -5 (0.7) |
| Safety Outcomes | ||||||||||
| Ketoacidosis | - | - | - | - | - | - | 0.2 | 0.3 (0.1) | 0.3 | 0.3 (0.1) |
| Amputation | 4 | 0.6 (0.3) | 4 | 0.5 (0.3) | 2 | 0.3 (0.2) | 4 | 0.7 (0.3) | 9 | 1 (0.7) |
Patient group specific absolute effects estimated by applying the overall relative risk to the average event rate in the placebo arms (first event only). For the heart failure patient groups the placebo event rates were estimated separately for trials of stable heart failure with reduced ejection fraction (i.e. EMPEROR-REDUCED & DAPA-HF) versus stable heart failure with preserved ejection fraction (i.e. EMPEROR-PRESERVED) versus recent hospitalization for heart failure (i.e. SOLOIST-WHF). Standard errors (SE) in the numbers of events avoided or caused estimated from uncertainty in the relative risks. Kidney disease progression definitions were as reported by trials (i.e. not uniformly adjusted to a ≥40% eGFR decline). Data on acute kidney injury not available in trials of heart failure with preserved ejection fraction. There were too few ketoacidosis events to estimate absolute effects in heart failure patient groups.