News Release

Experts propose minimum standards of care for epilepsy

Goal is to improve consistency and quality of care across all treatment settings

Peer-Reviewed Publication

GolinHarris International

[Seattle] (December 8, 2008) – Leading epilepsy specialists met today at the American Epilepsy Society annual meeting in Seattle to unveil a recently published consensus report that proposes minimum standards of care for diagnosing, treating and monitoring epilepsy. Primary among these is the need for a detailed medical history, neurological examination, discussions with caregivers and diagnostic tests to make a diagnosis, as well as the need to weigh seizure control, side effects and long-term safety when making treatment decisions.

The number of specialized epilepsy centers in the United States is limited, so many of the 2.7 million Americans with epilepsy are managed in a community setting. "This sometimes poses problems with delayed recognition and inadequate treatment, which can result in subsequent seizures, and related complications," said Tracy Glauser, MD, lead author of the report and professor of Pediatrics and Neurology, Cincinnati Children's Hospital Medical Center.

To develop consensus (defined as ≥50%) on the core elements of epilepsy management, members of the Leadership in Epilepsy, Advocacy and Development (LEAD) group, a coalition of 28 nationally recognized neurologists, pediatric neurologists and epileptologists, completed a detailed survey on the areas of diagnosis, treatment decisions and lifetime monitoring of epilepsy patients. "In the absence of universally accepted standards for the diagnosis and management of patients with epilepsy, our goal was to set standards to be used to improve consistency and quality of epilepsy care across all settings," Dr. Glauser said.

Diagnosis

Consensus was reached regarding the need to obtain basic information about the patient and their seizures and to perform the diagnostic tests necessary to make a diagnosis. A core list of questions was established to assess seizures, which includes questions to determine if there were warnings prior to the seizure, seizure triggers, what happened during the seizure and timing of the seizure. Physicians should also explore personal seizure history, medical history, social history and risk factors. In addition, neurological signs and symptoms, including memory problems, headache, lethargy and tremors should be assessed. Discussion with a patient's family or caregivers was also considered essential for accurate diagnosis. Finally, physicians should employ electroencephalogram (EEG) and magnetic resonance imaging (MRI). If these minimum standards are followed, consensus was reached that the categories of seizure that would be most accurately diagnosed include: absence, partial-onset, generalized and myoclonic.

Treatment

The overriding objective of epilepsy treatment is to achieve complete control of seizures, allowing the patient to maintain a normal life, with minimal or limited adverse drug effects. Consensus is that antiepileptic drug (AED) treatment should be initiated after two seizures. Currently, AED therapy is the initial treatment of choice for most patients, and, in general, long-term seizure freedom can be achieved by approximately 50 percent of patients with initial monotherapy. Several areas should be considered when selecting the appropriate AED therapy, including seizure type, co-existing conditions, and drug-drug interactions. Adverse events and tolerability should be carefully monitored and changes made when appropriate.

When patients are considered refractory or when their treatment has failed (the failure of two or more AEDs), physicians should refer patients to an epilepsy specialist. Ketogenic diet should be considered as a treatment option in pediatric patients after the failure of two to three or more medications or in cases of intractable seizures, but only if the family is committed to following the plan and other appropriate treatments have failed.

Monitoring

Periodic evaluations to assess seizure frequency are necessary and monitoring for adverse events and tolerability should occur at each visit. Common adverse events to look for include: cognitive slowing or difficulty concentrating, skin and hair changes, emotional or mood changes, ataxia, diplopia, drowsiness, fatigue and weight change.

While undergoing AED therapy, clinicians should be prepared to counsel patients regarding adverse events, co-existing conditions, driving, medication adherence, plan for seizure emergencies, bone health, safety during recreational activities, seizure frequency, drug-drug interactions, cognition, sleep problems, occupational considerations, behavioral issues and effects and limits of physical activity.

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The publication of these consensus views is sponsored by Ortho-McNeil Neurologics®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. The members of the LEAD faculty have all received honoraria from Ortho-McNeil Neurologics®. The final questionnaire developed by the LEAD faculty review process was reviewed by the corporate sponsor. The consensus results were tabulated with assistance from Health Learning Systems and the data analysis was conducted independently by members of the LEAD faculty. Editorial support and preparation of an initial draft of these consensus findings was provided by Health Learning Systems, and Ortho-McNeil Neurologics® reviewed the final manuscript submitted by the LEAD authors. The report was published in Current Medical Research and Opinion Journal in November, 2008. To view the full report, visit www.informapharmascience.com.

Ortho-McNeil Neurologics®

Headquartered in Titusville, N.J., Ortho-McNeil Neurologics®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, focuses exclusively on providing solutions that improve neurological health. The company currently markets products for Alzheimer's disease, epilepsy, and acute and preventive migraine treatment. Ortho-McNeil Neurologics®, in conjunction with internal and external research partners, continues to explore new opportunities to develop solutions for unmet healthcare needs in neurology. For more information, visit www.OrthoMcNeilNeurologics.com.


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