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Epilepsy Drug is Effective with Fewer Side Effects
ST. PAUL, MN (October 20, 1998) ñ A new study shows that the drug lamotrigine can be used alone to treat epilepsy with fewer side effects than many epilepsy drugs. The study was published in the October issue of Neurology, the scientific journal of the American Academy of Neurology.
The drug is currently approved by the Federal Drug Administration (FDA) for use only in addition to other epilepsy medications. The study shows that lamotrigine is effective by itself, said neurologist and study author Frank Gilliam, MD, of the University of Alabama at Birmingham.
"This is important for epilepsy patients because so few new drugs have been shown to be effective on their own," Gilliam said.
Taking only one drug is preferable to taking two or more drugs for several reasons, he said, including: less potential for interactions between the drugs, fewer side effects and lower medication costs. "ItÃs also much simpler for patients to remember to take only one drug instead of two or three," Gilliam said. "It can be very burdensome for patients to live their lives knowing that if they donÃt take all their medications at the right time, they could have a seizure and not be able to drive for a period of time."
Lamotrigine also has fewer side effects than many other epilepsy drugs, Gilliam said. None of the patients in the study reported feeling excessive sleepiness; most epilepsy drugs cause sleepiness in 15 to 40 percent of patients, he said.
The seven-month study involved 156 patients, ages 13 to 73, at 36 epilepsy centers in the United States. All of the patients experienced partial seizures, which are seizures that do not spread to involve the entire brain. The patientsà seizures were not fully controlled by other medications. All patients were taking one of two epilepsy drugs, and were monitored for eight weeks prior to the study to determine the frequency of their seizures. Then the patients were randomly assigned to receive either lamotrigine or another epilepsy drug which can be used on its own. The dosage was increased over four weeks while patients continued taking their original drug. Next the original drug was gradually withdrawn over four weeks. Finally, the patients took only lamotrigine or a suboptimal dosage of the other drug for 12 weeks.
(In many studies a drugÃs effectiveness is determined by comparing its use to the use of a placebo, or an inactive substance. However, placebo use is limited in epilepsy patients because a dangerous prolonged seizure, known as status epilepticus, could occur if patients receive no medication. Therefore, a low dose of an active drug is used as a comparison in studies.)
If patientsà seizures worsened according to study criteria, they were withdrawn from the study. Of the patients taking lamotrigine, 56 percent successfully completed the study, compared to 20 percent of those receiving the low-dose drug. And of those who were withdrawn from the study, the patients taking lamotrigine remained in the study for an average of 168 days, versus 57 days for those taking the low-dose drug.
Gilliam said patients whose seizures are not fully controlled or who are experiencing unacceptable side effects should talk with their doctors about the possibility of taking lamotrigine. "Even if the side effects are mild, if they are burdensome for the patient, there may be another option for treating the seizures without causing the side effects," he said.
Epilepsy is a family of more than 40 neurological conditions that share a common symptom ñ seizures. It affects about 2.5 million Americans.
This study was funded by Glaxo Wellcome Inc., which manufactures lamotrigine.
Improving care for patients with neurological disorders through education and research is the goal of the American Academy of Neurology, an association of more than 15,000 neurologists and neuroscience professionals.
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