Table 13.
Outcomes | Anticipated absolute effects*(95% CI) | Relative effect(95% CI) | № of participants (studies) | Certainty of the evidence(GRADE) | Comments | |
---|---|---|---|---|---|---|
Risk with placebo | Risk with erenumab | |||||
Reduction of monthly migraine days follow up: 3 months | The mean reduction of monthly migraine days was − 4.2 days | The mean reduction of monthly migraine days in the intervention group was 2.5 days fewer (3.5 lower to 1.4 fewer) | – | 469(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with Erenumab 70 mg reduces monthly migraine days slightly compared to placebo. |
Reduction of monthly acute treatment daysfollow up: 3 months | The mean reduction of monthly acute treatment days was −1.6 days | The mean reduction of monthly acute treatment days in the intervention group was 1.9 days fewer (2.6 fewer to 1.1 fewer) | – | 469(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with Erenumab 70 mg reduces monthly acute treatment days slightly compared to placebo. |
At least 50% reduction of monthly migraine days follow up: 3 months | 235 per 1000 | 399 per 1000(303 to 525) | RR 1.6985 (1.2908 to 2.2349) | 469(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with Erenumab 70 mg results in at least 50% reduction of monthly migraine days compared to placebo. |
Serious adverse events follow up: 3 months | 25 per 1000 | 31 per 1000(11 to 92) | RR 1.2722(0.4340 to 3.7268) | 471(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with Erenumab 70 mg results in a small unimportant increase of serious adverse event occurrence compared to placebo. |
Mortalityfollow up: 3 months | 0 per 1000 | 0 per 1000(0 to 0) | not estimable | 471(1 RCT) | No deaths were observed with treatment with Erenumab 70 mg or placebo |
CI: Confidence interval; RR: Risk ratio; RCT: randomized controlled trial; aDowngraded once due to imprecision: phase II study
GRADE Working Group grades of evidenceHigh 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