BALTIMORE, Md. (Ivanhoe Newswire) - Every two minutes someone in the U.S. dies from a neurological emergency. In fact, seizures are one of the most common reasons for ambulance runs. Now a new simple device could help save time and lives.
Seizures come on suddenly affecting one in 100 people, or 2.5 million Americans. Delemetria Grant is one of them. She began having seizures more than a decade ago.
"It's frightening because you don't know what's going to happen, when it's going to happen," Delmetria Grant, told Ivanhoe.
While most don't last longer than a minute, those with prolonged seizures risk brain damage and death.
"We know that the faster we can administer some treatment for them, the more likely that person is to stop seizing and to recover from that," Tricia Ting, M.D., an assistant professor of neurology at the University Of Maryland School Of Medicine, told Ivanhoe.
Doctor Tricia Ting said the current standard of care for patients is through an IV, but it can be difficult trying to access an IV in someone that may be convulsing and moving their arm around. That's why the doctor and her team at the University Of Maryland School Of Medicine participated in a national trial to test a new auto-injector. It's similar to the EpiPen used to treat serious allergic reactions. Results from the National Institutes of Health study show 73 percent of patients who received injected seizure medicine were seizure free when they got to the hospital versus 63 percent of patients who received IV treatment.
"This is a proven therapy to work to stop seizures that are prolonged and dangerous," Dr. Ting said.
Now Doctor Ting said it's only a matter of time before the auto-injectors are in the hands of patients and their families to stop seizures even sooner. That's something Delmetria believes is priceless.
"My insurance would be happy if it could keep me from being admitted to the hospital," Delemetria said, laughing.
About 55,000 deaths are attributed to prolonged seizures. While it might take a while until an auto-injector EpiPen is approved for caregivers, paramedics can use the auto-injector now.
BACKGROUND: Status epilepticus is a prolonged seizure lasting longer than five minutes. Status epilepticus is a potentially life-threatening emergency that causes 55,000 deaths each year. Anticonvulsant drugs are typically delivered intravenously (IV) as a first line of treatment. This has challenges though. Placing an IV in a patient having seizures can be difficult for paramedics and waste valuable time. An intramuscular shot is easier, faster and more reliable. (SOURCE: www.epilepsyfoundation.org)
RAMPART STUDY: The Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) is the first randomized clinical trial to investigate whether intramuscular delivery of midazolam is as effective as IV lorazepam, the current standard of care therapy.
RAMPART was conducted through the NINDS' Neurological Emergencies Treatment Trials (NETT) network. Paramedics compared how well delivery by each method stopped patients' seizures by the time the ambulance arrived at the emergency department. The investigators compared two medicines known to be effective in controlling seizures, midazolam and lorazepam. Midazolam was a candidate for injection because it is rapidly absorbed from muscle. But lorazepam must be given by IV. The study found that 73 percent of patients in the group receiving midazolam were seizure-free upon arrival at the hospital, compared to 63 percent of patients who received IV treatment with lorazepam. Patients treated with midazolam were also less likely to require hospitalization than those receiving IV lorazepam. Among those admitted, both groups had similarly low rates of recurrent seizures.
The trial started in 2009 and completed enrollment in June, 2011. RAMPART involved more than 79 hospitals, 33 emergency medical services agencies, more than 4,000 paramedics and 893 patients ranging in age from several months old to 103. (SOURCE: New England Journal of Medicine)
THE FUTURE: While autoinjectors could someday be available for use by epilepsy patients and their families, more studies are required.
Dr. Tricia Ting, Assistant Professor of Neurology at University of Maryland School of Medicine, talks about stopping seizures with a pen!
Can you talk about the rampart national trial?
Dr. Ting: Rampart is a national trial funded by the NIH through the Neurological Emergencies Treatment Trials (NETT) network in order to find a faster way to treat seizures when they're prolonged and dangerous, something we call status epilepticus. Currently the standard of care for trained medical personnel when they receive a 911 call to someone who's having a prolonged seizure at home is infusion through an IV of something called lorazepam, which is a rescue medicine for seizures. You can imagine how difficult it is when they're trying to access an IV in someone who may be convulsing and moving their arm around. Every time they face that sort of challenge, it lengthens the time before they can get the medicine in [to the patient], which can be even more dangerous for that person. The idea was to develop a faster method of delivering seizure rescue therapy. This Rampart trial looked at using an auto injector, an EpiPen like shot, to deliver a similar kind of medicine to stop someone's seizure.
Right now this is just for healthcare professionals to use?
Dr. Ting: That's right. It's in the hands of trained medical professionals. The idea is once it's proven to be safe and effectiveto stop seizures by personnel like paramedics, then we can advance that therapy perhaps to patients' families to be given at home.
What kind of problems prolonged seizures cause?
Dr. Ting: The reason that prolonged seizures can be so dangerous, something we call status epilepticus, is that the longer a seizure goes the more possibility there is for that person to suffer brain damage or even death. We know that the faster we can administer treatment the more likely that a person is to stop seizing and to recover from that. The longer that it goes it's even harder to get that seizure under control -- more medicines are needed and there's a greater likelihood that person will have a poor outcome.
Will patients be able to take the pen home one day?
Dr. Ting: The first step was just to show that something like an auto injector pen was working and would be safe and effective to stop seizures in the hands of trained personnel. It will take some more studies where patients and their family members are given these same auto-injectors to use at home. Again, similar to Rampart [in which patients would be] randomized to different therapies to make sure that it's as effective and safe for home use. Right now it [rescue benzodiazepine, midazolam] has been proven to be as safe and effective in the form of an auto injector intramuscular shot to stop seizures as the current standard of care, which has been this intravenous [benzodiazepine, lorazepam] therapy.
What does the future hold?
Dr. Ting: After the Rampart trial was completed in more than 890 patients, we saw that, indeed, this auto injector pen for seizures was as effective and safe as the intravenous medication. Now, it's only a matter of time for them to do a few more clinical trials giving this auto injector to patients' families to try to prove that it's as effective and safe in the hands of people who are not medically trained.
You can just imagine the lives that can be saved by that.
Dr. Ting: Absolutely, because in some places it takes much longer for emergency services to reach someone. Even if we consider on a wider scale, such as chemical warfare or on the battle field, when there really is no easy access to medical care, how much better it would be to have something so quick and simple as an auto injector in your bag. In this trial, patients were randomized to treatments. They either got the intramuscular shot with the benzodiazepine midazolam or the intravenous infusion of the standard of care benzodiazepine, lorazepam. When the patients were enrolled in these trials, they would have both an IM shot given to them and an IV infusion. Only one of those would have the active drug. Nobody knew what they got, not the patient, not the paramedic and not the doctor back at the hospital. It was only at the end of study when everyone had been treated did we find out the final results. People who got the shot for the seizures had a slightly higher percentage of no longer seizing when they got to the hospital versus those who received standard of care intravenous therapy. In addition, people who got the shot were less likely to need hospitalization than those people who got the standard of care intravenous. Finally, what's important is that both groups were equally less likely to have seizure recurrence after treatment. They didn't have to get more therapy to control their seizures after they were treated the first time.
Is that because of the drug type?
Dr. Ting: That just means that in the case of the IM [intramuscular] midazolam or the IV lorazepam, they were just as equally effective in controlling those seizures the first time around. That is the basis for us saying that this is a proven therapy to work.
How common are these prolonged seizures?
Dr. Ting: Not very commonly, but it's not that rare either. It happens in a fair number of patients who are at risk for having epilepsy.
Can you tell me a little more about the trial?
Dr. Ting: Another special feature of this national trial was that patients were given the research therapy without their consent ahead of time. You can imagine with these types of neurological emergencies, often patients are not able to give consent. Particularly in this case where time is of essence they did not feel that it was safe to wait to get consent first from family members to give the treatment, so they embarked on something called Exemption form informed consent, where ahead of time, the centers that were involved with this trial, including University of Maryland School of Medicine, went out in to the community and did many community consultations and were able to through these consultations to let the public know that this trial was about to happen and also to get their feedback about how they felt about possibly being randomized to some investigational therapies. In the end, we really overwhelmingly had very positive feedback from the community that allowed us to go forward with this type of clinical trial.
Could that be the standard of care one day?
Dr. Ting: The numbers show that there was a greater percentage of patients who had a very positive effect from the intramuscular shot. That being said, the study was not designed to show superiority, it's more of a statistical issue. It was designed to show non-inferiority, which is a technical way to say it's as safe and as effective [as the current standard of care]. We know, though, that there are lots of advantages to this kind of shot. Certainly this is something that will very likely be in widespread use once the FDA approves it for this condition.
What would you say would be some of the other advantages?
Dr. Ting: The advantages primarily are ease of use, how quickly it can be administered and the fact that the drug itself that's in the auto injector has a longer shelf life unrefrigerated. That implicates a lot more practicality in using it, again, in, say, the warfare situation where you don't have refrigeration readily at hand. Also, it may ultimately be translated in to more cost effectiveness because you don't have to replace the drug as often in its unrefrigerated state.
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