Summary of findings 1. Rufinamide versus placebo for drug‐resistant focal epilepsy.
| Rufinamide versus placebo for drug‐resistant focal epilepsy | ||||||
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Patient or population: people with drug‐resistant focal epilepsy Settings: outpatients Intervention: rufinamide Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | Rufinamide | |||||
| 50% or greater reduction in seizure frequency ‐ ITT analysis | Study population |
RR 1.79 (1.44 to 2.22) |
1759 (6 studies) | ⊕⊕⊕⊝ Moderatea |
RR > 1 indicates outcome is more likely in rufinamide group | |
| 143 per 1000 | 256 per 1000 (206 to 317) | |||||
| Seizure freedom | 103 per 1000 |
136 per 1000 (37 to 500) |
RR 1.32 (0.36 to 4.86) |
73 (1 study) |
⊕⊕⊕⊝ Moderatea |
RR > 1 indicates outcome is more likely in rufinamide group |
| Treatment withdrawal | Study population |
RR 1.83 (1.45 to 2.31) |
1759 (6 studies) | ⊕⊕⊕⊝ Moderatea |
RR > 1 indicates outcome is more likely in rufinamide group | |
| 112 per 1000 | 205 per 1000 (162 to 259) | |||||
| Adverse effects: dizziness | Study population |
RR 2.52 (1.90 to 3.34) |
1295 (3 studies) | ⊕⊕⊕⊝ Moderatea |
RR > 1 indicates outcome is more likely in rufinamide group | |
| 108 per 1000 | 272 per 1000 (205 to 361) | |||||
| Adverse effects: fatigue | Study population |
RR 1.46 (1.08 to 1.97) |
1295 (3 studies) | ⊕⊕⊕⊝ Moderatea |
RR > 1 indicates outcome is more likely in rufinamide group | |
| 112 per 1000 | 164 per 1000 (121 to 221) | |||||
| Adverse effects: headache | Study population |
RR 1.36 (1.08 to 1.69) |
1228 (3 studies) | ⊕⊕⊕⊝ Moderatea |
RR > 1 indicates outcome is more likely in rufinamide group | |
| 196 per 1000 | 267 per 1000 (212 to 331) | |||||
| Adverse effects: somnolence | Study population |
RR 1.94 (1.44 to 2.61) |
1759 (6 studies) | ⊕⊕⊕⊝ Moderatea |
RR > 1 indicates outcome is more likely in rufinamide group | |
| 82 per 1000 | 159 per 1000 (118 to 214) | |||||
| Adverse effects: nausea | Study population |
RR 1.87 (1.33 to 2.64) |
1295 (3 studies) | ⊕⊕⊕⊝ Moderatea |
RR > 1 indicates outcome is more likely in rufinamide group | |
| 82 per 1000 | 153 per 1000 (109 to 216) | |||||
| Adverse effects: vomiting | Study population |
RR 2.95 (1.80 to 4.82) |
777 (4 studies) |
⊕⊕⊝⊝ Lowb |
RR > 1 indicates outcome is more likely in rufinamide group | |
| 49 per 1000 | 145 per 1000 (88 to 236) | |||||
| Adverse effects: diplopia | Study population |
RR 4.60 (2.53 to 8.38) |
1295 (3 studies) |
⊕⊕⊝⊝ Lowb |
RR > 1 indicates outcome is more likely in rufinamide group | |
| 24 per 1000 | 110 per 1000 (61 to 201) | |||||
| *The basis for the assumed riskc (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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). CI: confidence interval; ITT: intention‐to‐treat; RR: risk ratio. | ||||||
| GRADE Working Group grades of evidence. High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: we are very uncertain about the estimate. | ||||||
aDowngraded once due to risk of bias: unclear methodological information provided for some included studies and all included studies pharmaceutical sponsored.
bDowngraded once due to imprecision: wide confidence intervals.
cAssumed risk is calculated as the event rate in the control group per 1000 people (number of events divided by the number of participants receiving control treatment).