Summary of findings 6. SGLT2i compared to placebo in people with CVD: safety outcomes.
| SGLT2i compared to placebo in people with CVD | ||||||
| Patient or population: CVD (ASCVD, HF, or both) Setting: outpatient Intervention: SGLT2i (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, sotagliflozin ) Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with SGLT2i | |||||
| Worsening renal function Follow‐up duration: range 1.3 to 1.5 years |
23 per 1,000 | 14 per 1,000 (10 to 19) | OR 0.59 (0.43 to 0.82) | 8474 (2 RCTs) | ⊕⊕⊕⊝ MODERATE 2 | |
| Hypoglycaemia Follow‐up duration: range 0.8 to 3.5 years |
27 per 1,000 | 25 per 1,000 (21 to 29) |
OR 0.90 (0.75 to 1.07) | 21232 (4 RCTs) |
⊕⊕⊕⊝ MODERATE 1 | |
| Pancreatitis Follow‐up duration: median 3.5 years |
3 per 1,000 | 3 per 1,000 (1 to 6) |
OR 0.85 (0.39 to 1.86) | 8246 (1 RCT) |
⊕⊕⊝⊝ LOW 3 | |
| Fracture Follow‐up duration: range 0.8 to 3.5 years |
32 per 1,000 | 33 per 1,000 (29 to 38) |
OR 1.02 (0.88 to 1.18) | 24962 (5 RCTs) |
⊕⊕⊕⊕ HIGH | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1Graded down for imprecision: The 95% CI includes no effect and includes default values for appreciable harm (i.e. CI > 1.25), appreciable benefit (i.e. CI < 0.75), or both. (‐1)
2Graded down for imprecision: The number of accrued outcome events was small. (‐1)
3Graded down for imprecision: Only 1 RCT was included for this outcome, the 95% CI includes no effect and includes default values for appreciable harm (i.e. CI > 1.25) and appreciable benefit (i.e. CI < 0.75), and the number of accrued outcome events was small. (‐2)
ASCVD: atherosclerotic cardiovascular disease, CI: confidence interval, CVD; cardiovascular disease, HF: heart failure, OR: odds ratio, RCT: randomized controlled trial, SGLT2i: sodium‐glucose co‐transporter‐2 inhibitor