FOR INFORMATION, CONTACT:
Holly Gibson at Fleishman Hillard, Inc. 816/512-2349 [email protected]
NEW MEDICATIONS LEAD THE WAY, YIELD HIGH RESULTS TOWARD IMPROVEMENTS IN EPILEPSY
BOSTON, Mass. (Dec. 8, 1997) -- A number of new anti-epileptic drugs introduced in the last several years are providing millions of epilepsy patients with new hope for this often devastating disorder. Which drugs work when -- and for whom -- will be part of the discussion at the 1997 meeting of the American Epilepsy Society (AES) Dec. 5--10 at The Westin Copley Place in Boston.
Thanks to the continued efforts of scientists around the globe, potentially safer and more effective drugs are making their way into the hands of physicians who treat the condition. According to reports from the 22nd International Epilepsy Congress held in Dublin, Ireland, this past summer, there are currently as many as 15 agents in varying stages of regulatory approval worldwide or in the research process. In the last few years, six new drugs and two newly-revised products have been introduced. They include Neurontin (gabapentin), Lamictal (lamotrigine), Topamax (topiramate), Gabatril (tiagebine), Tegretol XR (sustained-release carbamazepine) and Felbatol (felbamate). Diastat (diazepam rectal gel) and Carbatrol (extended-release carbamazepine) have been reformulated. All, however, are under continuing evaluation to determine their full potential in treating epilepsy.
"Most of these drugs were approved initially as add-on therapy for specific seizure types in adults," says Marc Dichter, M.D., Ph.D., and current AES president. "Many of the research reports at the AES meeting will address the safety and efficacy of these new medications in pediatric patients, their value in treating a variety of seizure types and their potential as monotherapy."
Among medications widely studied in reports presented at this meeting are Lamictal and Topamax. The efficacy of Lamictal against severe epilepsy in clinical assessments confirmed by EEG (brain wave) analysis is reported by Dr. Augusto Grinspan and colleagues at the University of Strasbourg Hospital, France. The French study is based on 17 patients with Lennox-Gastaut syndrome, one of the most devastating and difficult-to-treat forms of epilepsy. In 14 patients completing the study, a greater than 50 percent reduction in drop attacks and atypical absence seizures was reflected in a similar decrease in the number and duration of epileptiform brain waves (slow spike-waves) (abstract 70205, platform 3.46).
Skin rash, a common side effect of many, but not all, anti-epileptic medications, can be serious enough to require hospitalization. An investigator reviewing 4,624 patient records at one clinical facility reports a significant difference in rash occurrence when Lamictal is administered alone (7.7 percent), compared to co-administration with another commonly prescribed epilepsy drug (12.3 percent). Of 203 patients identified as taking Lamictal with or without another epilepsy drug, one had a rash-related hospitalization. There were no deaths nor incidents of Stevens-Johnson syndrome, a potentially devastating rash that defies treatment (abstract 70608, platform 5.88). Other studies being reported here demonstrate that it may be possible to reduce the incidence of serious rash associated with Lamictal even after reintroducing the drug subsequent to an initial rash reaction (abstract 70812, platform 3.59 and abstract 70694, platform 5.86).
Among the reports involving Topamax is a study of the medication's potential for treating infantile spasms (West syndrome), a severe seizure disorder that can progress to Lennox-Gastaut syndrome. Current therapy of choice for infantile spasms carries significant risk and cannot be used over a long period. In a pilot study at Children's Hospital Medical Center in Cincinnati, 11 children were weaned off most other medications and given a rapid dosing schedule of Topamax. Five of the children became spasm-free (abstract 70240, platform 3.31).
In a national, multi-center clinical trial, doctors conducted a study involving 98 children with Lennox-Gastaut syndrome. Slightly less than half were given Topamax, while 50 patients were treated with a placebo. According to Dr. Tracy Glauser, director of the Comprehensive Epilepsy Program at Children's Hospital Medical Center, Topamax was significantly more effective than the placebo in reducing drop attacks. In addition, seizure control was further improved with higher doses of the drug (abstract 70151, platform I.8).
"The results of this study indicate that Topamax is an important addition for the treatment of this devastating form of pediatric epilepsy," says Glauser.
Finally, additional news about Topamax surfaced in two studies out of Bennington, Vermont, and St. Louis, Missouri. One of the key side effects associated with the drug has been weight loss. But both the Neurological Consultants facility in Bennington and The Comprehensive Epilepsy Care Center for Children and Adults in St. Louis indicate the loss is moderate.
In fact, the Bennington study concluded that "modest weight loss is sustained with TPM (Topamax) therapy up to 12 months" (abstract 70242, platform III-33). And results from St. Louis, covering up to the first 92 days of treatment, showed that 73 percent of the patients experienced a weight-loss range of one to 20 pounds, 13.5 percent experienced no change in weight and 13.5 percent gained one to 11 pounds. In the end, the study concluded that the weight-loss side effects of Topamax appear to be a positive "adverse" event (abstract 70740, platform 3.37).
All the above abstracts will be presented during the 1997 meeting of the AES. The American Epilepsy Society is the professional society for physicians and other health care professionals who treat or study the biological, clinical and/or psychological aspects of epilepsy. Among its members are neurologists, epileptologists, neurologic nurses, basic scientists and clinical investigators devoted to improving the quality of life for the 2.5 million Americans with seizure disorders.
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