Summary of findings 5. Nanofiltered C1 esterase inhibitor compared with placebo or active control for preventing hereditary angioedema attacks.
| C1‐INH‐nf compared with placebo or active control for preventing HAE attacks | ||||||
|
Patient or population: children or adults with Types I or II HAE Settings: outpatient setting Intervention: C1‐INH‐nf Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with C1‐INH‐nf | |||||
|
Risk of HAE attacks (during follow‐up) |
Study population | N/A | N/A | N/A | Outcome not reported. | |
| N/A | N/A | |||||
|
Change in number of HAE attacks (per week) |
Study population | — | 22 (1) |
⊕⊝⊝⊝ Very lowa |
— | |
| The mean number of HAE attacks per week in the control group was 1.06 | The mean number of HAE attacks per week in the intervention group was 0.53 lower (0.78 lower to 0.28 attacks per week lower) | |||||
|
Mortality (during follow‐up) |
Study population | N/A | N/A | N/A | No deaths reported. | |
| N/A | N/A | |||||
|
Serious adverse events (during follow‐up) |
Study population | N/A | N/A | N/A | Outcome not reported. | |
| N/A | N/A | |||||
|
Quality of life
standardised mean difference (lower is better) (during follow‐up) |
Study population | — | 16 (1) |
⊕⊝⊝⊝ Very lowa | — | |
| The mean change in quality of life in the control group was 4.85 units | The mean change in quality of life in the intervention group was 0.91 units lower (1.64 lower to 0.18 lower) | |||||
|
Disability standardised mean difference (lower is better) (during follow‐up) |
Study population | — | 16 (1) |
⊕⊝⊝⊝ Very lowa | — | |
| The mean change in disability in the control group was −0.71 | The mean change in disability in the intervention group was 0.84 units lower (1.57 lower to 0.12 lower) | |||||
|
Adverse events (during follow‐up) |
Study population | N/A | N/A | N/A | Outcome not reported. | |
| N/A | N/A | |||||
| *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). C1‐INH‐nf: nanofiltered C1 esterase inhibitor; CI: confidence interval; HAE: hereditary angioedema; N/A: not applicable; RR: risk ratio. | ||||||
| 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. | ||||||
aDowngraded three levels for imprecision.