NIH Study Results: Autoinjectors Found to be Safe and Effective for Treating Prolonged Seizures
For immediate release: February 27, 2012
University of Maryland School of Medicine is One of 17 Leading Centers in National Trial
National researchers, including a team from University of Maryland School of Medicine, have determined that giving seizure medication into a muscle using an autoinjector, similar to the EpiPen used to treat serious allergic reaction, is a faster and more effective way to stop status epilepticus, a prolonged seizure lasting more than five minutes. Status epilepticus is a potentially life-threatening emergency that causes 55,000 deaths each year, according to federal researchers. Results from the National Institutes of Health study will be published in the February 16, 2012, edition of the New England Journal of Medicine.
“The first-line treatment for these dangerous seizures has been for paramedics to give anticonvulsant drugs intravenously (IV), but that can be hard to do when someone is having a seizure. The longer someone is having a seizure, the more likelihood there will be for brain damage or other complications. This research shows that giving an intramuscular shot is fast, reliable and effective especially in patients having convulsions,” says study investigator Tricia Ting, M.D, an assistant professor of neurology at the University of Maryland School of Medicine.
The study, called the Rapid Anticonvulsant Medications Prior to Arrival Trial (RAMPART), 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 the injected midazolam were seizure-free upon arrival to the hospital, compared to 63 percent of patients who received IV treatment with lorazepam. Patients treated with the injected drug were also less likely to require hospitalization than those receiving the IV medication. Both groups had similarly low rates of recurrent seizures.
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. 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 years old.
“The results from the RAMPART study may have a significant impact on how emergency personnel treat patients with status epilepticus in the future. The University of Maryland School of Medicine is proud to be part of such a distinguished group of national neurology and emergency medicine researchers working together to find better treatment options for patients,” says E. Albert Reece, M.D., Ph.D., M.B.A, vice president for medical affairs, University of Maryland, and dean, University of Maryland School of Medicine.
The network of investigators that designed and carried out the trial was established by the National Institute of Neurological Disorders and Stroke (NINDS) to conduct clinical trials on a variety of acute conditions affecting the brain such as stroke and traumatic brain injury. These investigators are organized into a system of 17 major research hospitals, such as the University of Maryland, each of which is linked to several community hospitals and other medical centers.
“The University of Maryland serves as a hub center for the Neurological Emergencies Treatment Trials (NETT) network. With the positive results of the RAMPART study, we are eager see how the combined resources of this network can advance research in other neurological conditions, such as stroke,” says Barney Stern, M.D., professor of neurology at the University of Maryland School of Medicine and a neurologist at the University of Maryland Medical Center.
About the University of Maryland School of Medicine
Established in 1807, the University of Maryland School of Medicine is the first public medical school in the United States, and the first to institute a residency training program. The School of Medicine was the founding school of the University of Maryland and today is an integral part of the 11-campus University System of Maryland. On the University of Maryland's Baltimore campus, the School of Medicine serves as the anchor for a large academic health center which aims to provide the best medical education, conduct the most innovative biomedical research and provide the best patient care and community service to Maryland and beyond. For more information, go to www.medschool.umaryland.edu
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