New epilepsy treatment guidelines reflect significant changes in drug choices

November 26, 2001

Key changes geared to improve quality of care for millions with epilepsy, including women and older adults

RESEARCH TRIANGLE PARK, NC (November 27, 2001) - A notable shift is reflected in new guidelines for the treatment of adolescents and adults with epilepsy, compared to just 10 years ago.

The new recommendations contain two major changes: first, increased use of single antiepileptic drugs (AEDs) before turning to combination therapies; next, recognizing the need for special treatment strategies for groups such as women and older adults, who until recently have been overlooked in clinical studies. An estimated 2.3 million Americans have epilepsy, half of whom are female. In addition, more than 60,000 new cases are diagnosed each year among those aged 65 and older.

The "Expert Consensus Guidelines," based on clinical practice of leading epilepsy experts around the country, appear in the November/December issue of the journal Epilepsy and Behavior and will be distributed widely to physicians around the country.

"We are fortunate to have so many antiepileptic drugs today. But this also makes the selection and sequence of therapies more complex, especially for physicians who don't routinely see patients with epilepsy," said Martha Morrell, M.D., senior author of the "Expert Consensus Guidelines", director of the Columbia Comprehensive Epilepsy Center of New York-Presbyterian Hospital and professor of neurology at Columbia University College of Physicians & Surgeons in New York.

For the first time, the new Guidelines address how to integrate the full range of AEDs - including newer therapies - into optimal treatment strategies, based on seizure type and individual patient needs, noted Dr. Morrell.

According to Dr. Morrell, the use of single agents can help accomplish the goal of balancing the best degree of seizure control with the least likelihood of side effects that could impair a patient's ability to function and participate in routine activities.

The Guidelines also reflect the distinct needs of specific patient populations such as women of childbearing years and older adults. New research has demonstrated that many AEDs can either compromise reproductive health for women, or impair the cognitive ability of older patients, as well as causing dizziness and sedation in the latter group.

"Epilepsy cannot be treated with a 'one-size fits all' approach. The expert opinions reflected here underscore the need to tailor AED choices to individual patient needs," noted Steven Karceski, M.D., co-author and assistant professor of neurology of the Columbia Comprehensive Epilepsy Center of New York-Presbyterian Hospital and assistant professor of neurology at Columbia University College of Physicians & Surgeons in New York.

Sequential Monotherapy Overrides Early Use of Combination Therapy Regardless of the category or type of epilepsy, the "Expert Consensus Guidelines" recommend at least two, and possibly three trials with a single AED in a newly diagnosed patient before considering combinations.

Populations Who Warrant Special Consideration The Guidelines also address areas of clinical practice pertaining to populations for whom the current literature is evolving, specifically for women of childbearing years and older adults.

Women of Childbearing Age

Reproductive health problems in women with epilepsy can include difficulties becoming pregnant and an increased risk of having children with birth defects, menstrual irregularity, infertility and a condition called polycystic ovarian syndrome (PCOS), which itself causes infertility, irregular or absent menses, ovarian cysts, obesity, and unwelcome changes in facial and body hair. In addition, oral contraceptives are more likely to fail if a woman is taking AEDs known to be "liver-enzyme inducing drugs". Evolving research is also raising concern that some AEDs may affect bone health in women with epilepsy, potentially resulting in premature osteoporosis. Published studies link some AEDs to these problems.

Older Adults

According to the Epilepsy Foundation, at least 550,000 older Americans live with a seizure disorder, with 61,000 new cases each year; and as the American population ages, the incidence of epilepsy is likely to increase. Among those over 65, epilepsy may be caused by stroke, cardiovascular disease, Alzheimer's disease or brain tumors. As noted above, impairment of cognitive function, dizziness and sedation are common side effects associated with many AEDs. These side effects are often confused by patients and medical professionals as signs of other conditions, which may result in unnecessary treatment. The side effects may be attributed to the natural aging process. Ultimately, the result is that the patient's ability to participate in daily activities is diminished or compromised. Older adults are also more likely to require medications for a variety of conditions, increasing the risk for drug interactions.

Epilepsy Background

According to the Epilepsy Foundation, of the 2.3 million Americans with epilepsy, nearly half will get inadequate relief from their seizures. Epilepsy is a neurological condition that makes people susceptible to seizures. A seizure is a change in sensation, awareness, or behavior brought about by a brief electrical disturbance in the brain.

There are many different types of seizures. People may experience just one type or more than one. The kind of seizure and the severity of the seizure a person has depend on which part and how much of the brain is affected by the electrical disturbance that produces seizures. Experts broadly divide seizures into generalized seizures, which affect both sides of the brain, and localized -- or partial - seizures, which are restricted to one part of the brain. Partial seizures are the most common form of seizure in adults, affecting six out of every ten people with epilepsy.

Treatment Background

Today, there are 26 drugs indicated for the treatment of epilepsy in the United States, eight of which were introduced in the past decade, offering improved tolerability and efficacy. AEDs are used alone or in combination. Single AED use, known as monotherapy, often offers improved tolerability by diminishing the interaction of AEDs that typically increase side effects.

According to the literature and the experts, AED selection should be matched to the seizure syndrome and to the needs of individual patients. Formal classification systems were established in the 1980s to specifically define the various seizure categories and types, and it is known that the many different syndromes respond differently to available AEDs. The goal of treatment is to prevent or control seizures with a minimum amount of side effects.

A survey by the Epilepsy Foundation reports that the average general practitioner only treats five or six patients with epilepsy each year, with one or two new cases every two to three years. General neurologists play a key role in the diagnosis and management of people with this disorder, and in cases that are more difficult to manage, patients may be referred to epileptologists, who are neurologists specially trained to treat epilepsy.

Novel Methodology Applied to Development of "Expert Consensus Guidelines" A group of 45 epilepsy specialists participated in the development of the "Expert Consensus Guidelines", a new scientific process applying quantitative analysis of responses to a mail-in survey to obtain pooled opinions about the treatment of common patient scenarios. Selected participants were considered to be leaders in the field of epilepsy, had recent publications, and provided geographic diversity. Participants had an average of 20 years in practice and the majority worked in an academic clinical or research setting.

Each participant responded to 23 questions about more than 800 treatment options relating to four main clinical scenarios: idiopathic generalized epilepsy, symptomatic localization related epilepsy, symptomatic generalized epilepsy and status epilepticus. Questions focused first on overall treatment strategy and then asked about specific medications. This was followed by questions on special treatment issues for each syndrome, such as how to combine medications, what to do with a woman who is pregnant or breast-feeding, treatment of an elderly patient, treatment of a patient with clinical depression or one who is intellectually impaired.

The methodology used to develop the "Expert Consensus Guidelines" was designed to overcome some of the limitations in other systems of consensus development or guidelines development. Such limitations include lack of comparison between two or more active therapies in randomized clinical trials (RCTs); inclusion of treatment-resistant patients in most RCTs, who may not represent a general clinical population; difficulty in drawing direct comparisons in studies through the meta-analysis process, caused in part by the lack of uniformity in patient populations and study designs; expert opinions from small group settings may be influenced by a strong personality or may not reflect the opinions of larger physician groups.
The "Expert Consensus Guidelines" were sponsored by an unrestricted educational grant from Abbott Laboratories, GlaxoSmithKline, and Novartis Pharmaceuticals.

GlaxoSmithKline, one of the world's leading research-based pharmaceutical and health care companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

Cooney Waters Group, Inc.

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