Methods | Randomised, multicentre, double‐blind, parallel‐group trial conducted in the UK 2 treatment arms: LTG and CBZ randomised in a 2:1 ratio |
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Participants | Adults > 65 years with newly diagnosed epilepsy with ≥ 2 seizures in the previous year with at least 1 seizure in the last 6 months. None had received previous AED treatment. Number randomised: LTG = 102, CBZ = 48 83 male participants (55%) 105 participants with partial epilepsy (70%) Mean age (range): 77 (65‐94) years |
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Interventions | Monotherapy with LTG or CBZ 4‐week escalation phase leading to LTG = 100 mg/d, CBZ = 400 mg/d Range of follow‐up = 0‐13.5 months |
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Outcomes | Time to first seizure after 6 weeks of treatment Time to withdrawal Percentage of participants reporting an adverse event Proportion of participants who were both seizure‐free in the last 16 weeks of the trial and did not discontinue treatment |
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Notes | IPD provided by trial sponsor Glaxo Smith Kline for time to treatment withdrawal and time to first seizure (plus seizure‐freedom rates at 24 weeks) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random sequence (information provided by drug manufacturer). Participants randomised in a 2:1 ratio (LTG:CBZ) |
Allocation concealment (selection bias) | Low risk | Allocation concealed by individual sealed, opaque envelopes (information provided by drug manufacturer) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind achieved using LTG tablets formulated to be identical in appearance to CBZ tablets |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Trial investigator blinded, not stated if other outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rates reported, all randomised participants analysed from IPD provided (see footnote 2) |
Selective reporting (reporting bias) | Low risk | Protocol provided. All outcomes reported or calculated with IPD provided (see footnote 2) |
Other bias | Low risk | None identified |