For 81-year-old Richfield, Minn., resident Martha Mason, taking care of her epileptic son, John, for the past 40 years was often a terrifying and exhausting experience. He often experienced a cluster of epileptic seizures for which there was no relief.
“We’d run him to Children’s Hospital so many times with the repetitive seizures and they would just put him under,” Mason said. “The last several years, we just let him go through it at home. Sometimes it lasted for hours.”
But now University researchers have developed a new method for the delivery of medicine which quickly stops epileptic seizures and provides relief to families like the Masons.
Though not a cure, the treatment allows epileptics and their families to stop seizures without relying on trips to the hospital. The New England Journal of Medicine recently documented the importance of the new treatment.
Approved by the Food and Drug Administration last summer, the treatment uses a drug called Diastat. Similar to Valium, it was previously employed as a tranquilizer. As some researchers quipped, they “taught an old drug new tricks.”
“It provides them a means to treat severe seizures or seizure emergencies at home as they occur, rather than having to take a family member to the emergency room or call 911,” said James Cloyd, professor of pharmacy and one of the treatment’s designers.
Epilepsy effects approximately 1 percent of all Americans. Based on this figure, Cloyd said epilepsy may effect as many as 500 University students.
Based in the brain, epileptic seizures are caused by “electrical outbursts,” Cloyd said.
Administered rectally, Diastat serves to suppress the outburst. Once in the rectal cavity, the medication passes quickly into the bloodstream and to the brain. There it excites a section called the gaba receptor. Once the gaba receptor increases activity, the seizures subside.
The treatment is designed to be used either during a seizure or immediately after, when the person is unconscious or semiconscious. During those times, the drug can’t be given by mouth or intravenously.
Cloyd and University researchers won FDA approval for the treatment after the conclusion of a study of the drug’s effectiveness.
Beginning in 1991, the nationwide clinical trial lasted until 1995. Researchers provided affected families with samples of Diastat. The researchers also taught the families how and when to administer the drug. The family members would then report their results back in a booklet.
Study subjects were chosen based on whether the family member suffered from a type of epilepsy that would cause a series of seizures in succession.
The idea for the treatment began in 1987 when Cloyd approached local drug manufacturer Upsher-Smith Laboratories about creating a commercial product designed to be administered rectally.
Previously, only hospitals offered the drug which doctors administered with a needle. Family members could be trained to mix the drug, draw a portion of the medication into a syringe, and inject it.
Andrea Bue of Lakeville, Minn., used Diastat with the ordinary syringe to treat her 18-year-old daughter, Allison.
“It made me nervous,” Bue said. “There are a lot of steps in the process and it always made me uncomfortable.”
Now, Cloyd and his group have designed a new, soft plastic syringe which is pre-measured and has a modified tip for easy rectal use.
Bue said that although her daughter takes other medications to suppress seizures, they do break through at times. She said the Diastat is useful in stopping the seizures, despite the fact that her daughter was sometimes wary of it.
“At first she wasn’t too wild about it,” Bue said. “Who wants to get medicine rectally? But now it’s pretty routine.”
Cloyd said the main value of the new treatment is that it empowers families and permits them to lead normal lives.
“Many patients tell me that the worst aspect of epilepsy is the unpredictability,” Cloyd said. “You have to plan your life around the fact that you may have a seizure. This allows families to say, ‘it may happen but we have something to do about it’.”
Bue said that the treatment has done just that.
“It’s so much less disruptive to our lives than riding the ambulance,” Bue said.
In the future, Cloyd says he hopes to further improve the uses of other anti-epileptic drugs. In addition, Cloyd and his group in the College of Pharmacy are about to begin a five-year study on how better to treat epilepsy in elderly people.