The American Academy of Neurology and the American Epilepsy Society have assembled the top experts in the field to evaluate the available data of 1,462 research articles in order to create a guideline for the treatment of epilepsy with the new antiepileptic drugs (AEDs).
"These guidelines are designed to provide evidence-based assessments on the use of the new anti-epileptic drugs to clinicians," said Jacqueline French, M.D., professor of neurology at the University of Pennsylvania and one of the authors of the guidelines. "The 'older' drugs for epilepsy are literally some of the oldest drugs we have--for example, phenobarbital has been used for nearly 100 years to prevent seizures."
"The guidelines offer a rigorous, comprehensive and unbiased analysis of the available data on the safety, efficacy and mode of use of these AEDs that the clinician can use in making treatment decisions," said Andres Kanner, M.D., professor of neurological sciences at Rush University Medical Center in Chicago and another of the guidelines' authors. "This thorough review of the current research on epilepsy can also have a major impact on deciding what our priorities for future research should be," he said.
Because of their long experience with the older anti-epileptic drugs, doctors are comfortable using them. They need guidance in how and when to use the newer drugs. "There has been an explosion in the field of epilepsy research in the last decade," said Dr. French.
"Eight new drugs have been added to the five previously approved drugs commonly used for the treatment of epilepsy. While the older drugs are all effective in preventing seizures, there are some concerns about side effects over the long term."
"Epilepsy often strikes when people are young and patients will be on medication for decades," said Dr. French. "The older drugs are all known to have significant impact on liver metabolism which can affect other drugs a patient takes as well as the body's own hormone metabolism. Other possible side effects include osteoporosis, sleepiness and confusion. These new drugs may offer a significantly better day-to-day quality of life for the patient who must take them for years." "Usually when we see a whole new set of drugs approved for treating a condition, they are similar," said Dr. French. "This is a different situation entirely. Each of these new anti-epileptic drugs has an absolutely unique mode of action, absolutely unique side effect profile, and an absolutely unique set of drug interactions. There is a lot information for the practicing physician to sift through to use these drugs safely and effectively."
There are actually two sets of guidelines, one to treat newly diagnosed epilepsy and one to treat epilepsy that has already proved difficult to manage with the older drugs. "The FDA drug approval process, which requires placebo (or near-placebo)-controlled trials, makes it very difficult to gather some of the kinds of information we need," said Dr. French. "With a life-threatening illness, it is not possible to take people off all medications. We have to use other evidence of effectiveness, as well as European trials where new drugs are compared to older medications, to do our analysis."
"Because clinical trials are so expensive, head-to-head trials of new drugs are also very rare," said Dr. Kanner. "The European equivalent of the FDA has years of studies that provide us with a lot of good data on safety and efficacy of these new AEDs. With so many new drugs and an absence of head-to-head comparison studies, we have to rely on this type of evidence-based assessment of all the available information to give the practicing physician a better way to make a treatment choice."
"For patients who may find themselves paying more for the newer drugs, it is important that they can feel comfortable that the safety and efficacy of these new drugs have been analyzed in an objective and rigorous manner and are being used in an appropriate way," said Dr. Kanner. "There is a real concern in the media today that too much of the information reaching doctors about new drugs may come only from the pharmaceutical industry. These guidelines provide the clinician with an assessment that is in no way driven by the marketplace."