TABLE 3.
Subgroup analysis of main safety outcomes of ertugliflozin vs. control.
| Subgroup | No. S | RR | 95% CI | I 2 | PI | |
|---|---|---|---|---|---|---|
| Different dosages | ||||||
| Any AEs | 5 mg | 8 | 0.994 | 0.950–1.041 | 0% | 0.586 |
| 15 mg | 8 | 0.976 | 0.931–1.023 | 0% | ||
| AEs related to study drug | 5 mg | 8 | 1.148 | 0.914–1.442 | 53.6% | 0.921 |
| 15 mg | 8 | 1.168 | 0.913–1.495 | 59.9% | ||
| Serious AEs | 5 mg | 8 | 1.219 | 0.952–1.559 | 0% | 0.489 |
| 15 mg | 8 | 1.069 | 0.812–1.407 | 8.2% | ||
| Deaths | 5 mg | 4 | 1.466 | 0.407–5.278 | 29.1% | 0.875 |
| 15 mg | 4 | 1.240 | 0.469–3.283 | 0% | ||
| AEs leading to discontinuation | 5 mg | 8 | 1.155 | 0.836–1.596 | 0% | 0.980 |
| 15 mg | 8 | 1.148 | 0.826–1.597 | 0% | ||
| Genital mycotic infection | 5 mg | 8 | 4.094 | 2.588–6.476 | 1.8% | 0.882 |
| 15 mg | 8 | 4.338 | 2.480–7.588 | 26.2% | ||
| Urinary tract infection | 5 mg | 8 | 0.845 | 0.601–1.189 | 39.5% | 0.490 |
| 15 mg | 8 | 0.982 | 0.760–1.269 | 10.2% | ||
| Symptomatic hypoglycaemia | 5 mg | 8 | 0.708 | 0.336–1.492 | 83.8% | 0.912 |
| 15 mg | 8 | 0.750 | 0.416–1.354 | 75.1% | ||
| Hypovolaemia | 5 mg | 8 | 1.466 | 0.714–3.010 | 19.1% | 0.934 |
| 15 mg | 8 | 1.403 | 0.739–2.663 | 1.5% | ||
| Different follow-ups | ||||||
| Any AEs | ≤26 weeks | 3 | 0.966 | 0.854–1.093 | 0% | 0.768 |
| >26 weeks | 6 | 0.985 | 0.944–1.027 | 0% | ||
| AEs related to study drug | ≤26 weeks | 3 | 1.229 | 0.869–1.738 | 0% | 0.761 |
| >26 weeks | 6 | 1.149 | 0.906–1.458 | 64.3% | ||
| Serious AEs | ≤26 weeks | 3 | 1.512 | 0.283–8.078 | 65.4% | 0.845 |
| >26 weeks | 6 | 1.122 | 0.895–1.406 | 0% | ||
| Deaths | >26 weeks | 5 | 1.174 | 0.504–2.739 | 0% | — |
| AEs leading to discontinuation | ≤26 weeks | 3 | 0.732 | 0.280–1.910 | 0% | 0.314 |
| >26 weeks | 6 | 1.190 | 0.883–1.602 | 0% | ||
| Genital mycotic infection | ≤26 weeks | 3 | 1.977 | 0.756–5.165 | 0% | 0.112 |
| >26 weeks | 6 | 4.962 | 2.826–8.712 | 23.4% | ||
| Urinary tract infection | ≤26 weeks | 3 | 0.820 | 0.398–1.687 | 0% | 0.810 |
| >26 weeks | 6 | 0.904 | 0.698–1.171 | 27.8% | ||
| Symptomatic hypoglycaemia | ≤26 weeks | 3 | 3.896 | 1.058–14.337 | 0% | 0.329 |
| >26 weeks | 6 | 0.580 | 0.305–1.102 | 87.2% | ||
| Hypovolaemia | ≤26 weeks | 2 | 1.170 | 0.211–6.474 | 0% | 0.898 |
| >26 weeks | 6 | 1.397 | 0.560–3.484 | 51.9% | ||
| Different controls | ||||||
| Any AEs | placebo | 5 | 0.966 | 0.903–1.033 | 0% | 0.533 |
| active | 4 | 0.992 | 0.944–1.043 | 0% | ||
| AEs related to study drug | placebo | 5 | 1.251 | 0.984–1.591 | 0% | 0.571 |
| active | 4 | 1.115 | 0.812–1.531 | 76.6% | ||
| Serious AEs | placebo | 5 | 1.159 | 0.682–1.971 | 30.8% | 0.930 |
| active | 4 | 1.127 | 0.853–1.489 | 0% | ||
| Deaths | active | 4 | 1.192 | 0.400–3.559 | 0% | — |
| AEs leading to discontinuation | placebo | 5 | 0.995 | 0.594–1.667 | 0% | 0.549 |
| active | 4 | 1.205 | 0.850–1.707 | 2.8% | ||
| Genital mycotic infection | placebo | 5 | 2.725 | 1.287–5.768 | 0% | 0.272 |
| active | 4 | 5.142 | 2.640–10.016 | 35.6% | ||
| Urinary tract infection | placebo | 5 | 0.710 | 0.490–1.030 | 0% | 0.156 |
| active | 4 | 1.004 | 0.745–1.353 | 27.9% | ||
| Symptomatic hypoglycaemia | placebo | 5 | 1.152 | 0.668–1.988 | 19.9% | 0.075 |
| active | 4 | 0.464 | 0.224–0.963 | 82.7% | ||
| Hypovolaemia | placebo | 4 | 1.237 | 0.299–5.119 | 33.4% | 0.917 |
| active | 4 | 1.392 | 0.519–3.737 | 53.8% | ||
No. S, numbers of studies; RR, risk ratio; PI, P for interaction; AEs, adverse events.