FDA approves bovistam as an adjunct to partial seizures in patients aged 16 years or older
October 11, 2016 Source: Drug Information Network
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Bovastatin has a high affinity for the selective binding of synaptophysin 2A (SV2A) and is the site of action of AED levetiracetam (Keppra®). Located in the presynaptic membrane, SV2A is involved in mediating the release of neurotransmitters and vesicle circulation to maintain the normal function of synaptic vesicles. [2] AED combined with SV2A can reduce the release of excitatory neurotransmitters and achieve the effect of controlling seizures by regulating the balance of excitatory transmitters and inhibitory transmitters in the brain. The affinity of bovistamine is 15-30 times that of levetiracetam, which reduces its dose by about 10 times.
In a meta-analysis involving 6 randomized, placebo-controlled, single- or double-blind trials, 1715 of 2399 participants received bovistam. [3] The proportion of 50% of responders (both seizures at least 50% lower than baseline) was approximately 2 times that of placebo (relative risk [RR], 1.79), in patients without seizures The ratio was nearly five times that of placebo (RR, 4.74). The most common adverse reactions are irritability, fatigue, lethargy, and dizziness. Among patients who had taken levetiracetam (RR, 0.8) and other AEDs (RR, 1.99), the effect of bovistam on seizures was diminished. The reduced efficacy may be related to the similar mechanism of action of bovistam and levetiracetam.
Buvaxitan and levetiracetam have similar chemical structures and mechanisms of action, but their efficacy has not been compared in head-to-head trials. A meta-analysis comparing two drugs indirectly and involving 13 trials showed that bovistam may not be superior to older drugs; the difference in efficacy between the two drugs was not significantly different, and Boisy The incidence of vertigo is higher than that of levetiracetam.
However, a small (n=29), open-label, prospective study showed improved quality of life and epileptic control in patients who had transitioned from levetiracetam to bovistam due to behavioral adverse events. Not reduced. Since bovistam is a new type of AED, its long-term efficacy and safety are still unknown.
New drugs that control seizures are always popular. Bovisitan is a second-generation SV2A ligand and is an analogue of the anti-epileptic drug levetiracetam. As with other new AEDs, it is unclear whether bovasistat can represent treatment progress or whether it can be a simple and viable alternative to patients who are unable to achieve epilepsy control or who are unable to tolerate other medications. A double-blind, randomized controlled trial comparing bovistam and levetiracetam is not necessarily possible for the foreseeable future. Given that the two drugs have a similar mechanism of action, the combination of the two may be unfavorable. With the increasing experience of using bovistam, close observation of the efficacy, tolerability and safety of the drug may reveal which patients may be more likely to respond to bovistam and which patients are more suitable to use left B La Sitan.
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