Table 3.
GRADE recommendation for diabetes ketoacidosis for use of SGLT-2 inhibitors in DM patients
| Certainty assessment | № of patients | Effect | Certainty | Importance | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
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| № of studies Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Adverse events comparison in SGLT2 | Placebo group | Relative (95% CI) | Absolute (95% CI) | ||
| Events of DKA in SGLT2 inhibitors vs. Placebo | |||||||||||
| 16 RCT | not serious | not seriousa | not serious | not seriousb | strong associationc | 233/18956 (1.2%) | 31/12300 (0.3%) | RR 3.70 (2.58-5.29) | 7 more per 1,000 (from 4 more to 11 more) | ⨁⨁⨁⨁ HIGH | Critical |
| Events of DKA in SGLT2 inhibitors vs. Placebo - Certain DKA | |||||||||||
| 16 RCT | not serious | not seriousa | not serious | not seriousb | strong associationc | 192/17194 (1.1%) | 22/11303 (0.2%) | RR 4.08 (2.70-6.17) | 6 more per 1,000 (from 3 more to 10 more) | ⨁⨁⨁⨁ HIGH | Critical |
| Events of DKA in SGLT2 inhibitors vs. Placebo - Possible or Potential DKA | |||||||||||
| 2 RCT | not serious | not seriousa | not serious | not seriousb | strong associationc | 41/1762 (2.3%) | 9/997 (0.9%) | RR 2.60 (1.27-5.33) | 14 more per 1,000 (from 2 more to 39 more) | ⨁⨁⨁⨁ HIGH | Critical |
CI: Confidence interval; RR: Risk ratio; RCT: Randomized Clinical Trials Explanations. aAs I2=0%, hence low heterogeneity. bAs CI does not include one and overall information size is adequate; therefore, the outcome is precise. cAs RR is greater than 2, it is regarded as large effect