Clinical Trial Issues

NCEs with anticonvulsant potential are typically tested as add-on therapy with existing AEDs to test the efficacy of the NCEs as AEDs.30 As efficacy is established in longer-term studies, monotherapy studies are initiated to establish the efficacy of the NCE on its own and the potential for side effects. Individuals with epilepsy require considerable data to switch AEDs as they are fearful of being exposed to agents that do not provided them coverage from episodes of epilepsy. For this reason, it takes 5 years or more for a new AED to achieve significant market share requiring a considerable investment on the part of the company advancing the new AED. Optimal treatment of epilepsy in adults requires a tailored approach that weighs the efficacy of individual AEDs in the specific epilepsy diagnosis against the risk for adverse events. Partial seizures can be effectively controlled by all the standard and newer AEDs. For the generalized epilepsies, valproate has been the drug of choice, but overall, many of the newer AEDs may offer a better tolerability than the standard agents because of more favorable pharmacokinetic (PK) characteristics and lack of interactions with drugs other than AEDs.31 Monotherapy is the goal when AED treatment is instituted for the adult with epilepsy. In monotherapy-resistant patients, polytherapy will generally be necessary. A combination of two AEDs may produce antagonistic, additive, or synergistic anticonvulsant effects. However, when the supra-additive anticonvulsant efficacy is also associated with a distinct increase in toxicity, the therapeutic index may be not affected or even lowered. There is evidence of a synergistic interaction between combinations of valproate/phenytoin/ ethosuximide, topiramate/carbamazepine/phenobarbital, and felbamate/all major conventional antiepileptics.32

Blood Pressure Health

Blood Pressure Health

Your heart pumps blood throughout your body using a network of tubing called arteries and capillaries which return the blood back to your heart via your veins. Blood pressure is the force of the blood pushing against the walls of your arteries as your heart beats.Learn more...

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