Remacemide has only a modest effect as an add-on treatment for drug-resistant localization related (partial) epilepsy.
Epilepsy is a disorder where recurrent seizures are caused by abnormal electrical discharges from the brain. Most seizures can be controlled by a single antiepileptic drug but sometimes they are resistant to those drugs. The review of trials found that the new drug, remacemide, has only a modest effect on seizures and was more likely to be withdrawn than placebo. It is unlikely that remacemide will be further developed as an antiepileptic drug.
阅读完整摘要
This is an updated version of the original Cochrane review published in issue 4, 2002.
Epilepsy is a common neurological condition, affecting 0.5% to 1% of the population. Nearly 30% of people with epilepsy have seizures that are refractory to currently available drugs. In response to this problem, potential new drugs are being developed. Remacemide is one of these.
研究目的
To evaluate the effects of add-on treatment with remacemide upon seizures, adverse effects, cognition and quality of life for people with drug-resistant localization related epilepsy.
检索策略
We searched the Cochrane Epilepsy Group Specialised Register (31 August 2011), the Cochrane Central Register of Controlled Trials (CENTRAL issue 3 of 4, The Cochrane Library 2011) and MEDLINE (1948 to August week 3, 2011). In addition, we contacted AstraZeneca (makers of remacemide) and colleagues in the field to see if they were aware of any trials that we had missed.
纳入排除标准
Randomized placebo controlled add-on trials of people of any age with localization related seizures, in which an adequate method of concealment of randomization was used. The studies could be blinded or unblinded and be of parallel or crossover design. They had to have a minimum treatment period of eight weeks.
资料收集与分析
Two review authors independently selected trials for inclusion and extracted data. Any disagreements were resolved by discussion. Outcomes investigated included 50% or greater reduction in seizure frequency, treatment withdrawal, adverse effects, effects on cognition and quality of life. The primary analyses were by intention-to-treat. Dose response was evaluated in regression models.
主要结果
Two parallel group trials were included representing 514 individuals. Daily doses of 300 mg, 600 mg, 800 mg and 1200 mg of remacemide were tested. The overall relative risk (RR) for remacemide versus placebo with 95% confidence intervals (CI) for a 50% or greater reduction in seizure frequency was 1.59 (95% CI 0.91 to 2.79). Due to differences in response rates among trials, regression models were unable to provide reliable estimates of responses to individual doses. Regression models did however suggest a significant effect for 800 mg to 1200 mg remacemide per day. Remacemide was more likely to be withdrawn than placebo, the RR for treatment withdrawal was 1.90 (95% CI 1.00 to 3.60). The RR for dizziness indicates that it is significantly associated with remacemide 3.08 (99% CI 1.37 to 6.95). Effects on cognition and quality of life were not reported.
作者结论
Given the modest effect on seizure frequency and significant withdrawal rate it is unlikely that remacemide will be further developed as an antiepileptic drug.
