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Subject: AUTOINJECTORS OFFER WAY TO TREAT PROLONGED SEIZURES

U.S. Department of Health and Human Services NATIONAL INSTITUTES OF HEALTH
NIH News National Institute of Neurological Disorders and Stroke (NINDS)
<http://www.ninds.nih.gov/> Embargoed for Release: Wednesday, February 15,
2012, 5 p.m. EST

CONTACT: Marian Emr/Margo Warren, NINDS,301-496-5924,
<e-mail:[log in to unmask]>    

AUTOINJECTORS OFFER WAY TO TREAT PROLONGED SEIZURES NIH study finds method
safe and effective for paramedics

Drug delivery into muscle using an autoinjector, akin to the EpiPen used to
treat serious allergic reactions, is faster and may be a more effective way
to stop status epilepticus, a prolonged seizure lasting longer than five
minutes, according to a study sponsored by the National Institutes of
Health. 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 treatment.  

Starting an IV in a patient experiencing seizures can pose a challenge for
paramedics and waste precious time.  Giving an intramuscular shot is easier,
faster, and more reliable, especially in patients having convulsions. The
researchers sought to determine whether an intramuscular injection, which
quickly delivers anticonvulsant medicine into a patient's thigh muscle, is
as safe and effective as giving medicine directly into a vein. The study,
which was carried out by 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.  Both are benzodiazapines, a
class of sedating anticonvulsant drugs.  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 study
appears in the Feb. 16, 2012 issue of The New England Journal of Medicine. 

"Patients with status epilepticus can suffer severe consequences if seizures
are not stopped quickly. This study establishes that rapid intramuscular
injection of an anticonvulsant drug is safe and effective," said Walter
Koroshetz, M.D., deputy director of the National Institute of Neurological
Disorders and Stroke (NINDS), part of the NIH, which funded the study. 

The investigators said that while autoinjectors might someday be available
for use by epilepsy patients and their family members, more research is
required.  Because of the strong sedative effect of midazolam, on-site
medical supervision is now required for the safety of the patient.  

The Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) study
was conducted through the NINDS' Neurological Emergencies Treatment Trials
(NETT) network.  Additional funding was provided by the NIH Countermeasures
Against Chemical Threats (NIH CounterACT) program and the Biomedical
Advanced Research and Development Authority (BARDA).  The Department of
Defense's Chemical Biological Medical Systems (CBMS) Joint Project
Management Office provided the autoinjectors for the trial under a
Memorandum of Agreement with NINDS.

NIH CounterACT, BARDA and CBMS are responsible for enhancing the U.S.
government's development of medical countermeasures to natural and
intentional public health threats (please see full statement below on CBMS).
The chemical defense community has a longstanding interest in research on
the rapid treatment of nerve agent-induced seizures.  As the RAMPART study
was being planned, investigators learned that the departments of Defense and
Health and Human Services were already working with a midazolam autoinjector
and the study was an opportunity to confirm its effectiveness in patients
with seizures.   

"There was great synergy when we realized that RAMPART was studying a
similar problem that was of concern to the chemical defense community.  This
led to a perfect collaboration between HHS and DoD," said David Jett, Ph.D.,
program director for NIH CounterACT and NINDS.  "The broader implication of
RAMPART is that we now have critical information from studies in humans that
a safe and effective tool may one day be available to enhance our public
health preparedness.  Autoinjectors provide a highly practical way to treat
hundreds of people quickly during an emergency."

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.  The network of
investigators that designed and carried out the trial was established by
NINDS to conduct clinical trials on a variety of acute conditions affecting
the brain such as stroke and traumatic brain injury.  NETT investigators are
organized into a system of 17 major research
hospitals(http://www.ninds.nih.gov/research/clinical_research/RAMPART-PI-con
tacts.htm) each of which is linked to several community hospitals and other
medical centers.  

Another special aspect of the study was that it was conducted under
exception from informed consent for emergency research. This is a federal
regulation to protect patients who are involved in research when consent is
not possible because of their medical condition.  Community consultation is
held in advance of the study to raise awareness, ensure transparency, and
get input from local residents.  

Paramedics in RAMPART used study boxes with a time-stamped voice recorder,
designed by the NETT team.  This tool allowed paramedics to make quick
decisions, indicate the time treatment began and the time the patient's
convulsions stopped, all without having to interrupt patient care to record
data.  The goal of the study was to control the seizures within 10 minutes
without having to deliver a second dose of medicine.  Prolonged status
epilepticus can last for hours and sometimes is controlled only with general
anesthesia.

"Few other areas of medicine are as time-dependent as injury to the brain.
In epilepsy, even a few minutes can be important. With every minute the
seizure continues, it becomes harder to stop.  RAMPART offers first
responders an important treatment tool that will have a meaningful impact on
the lives of many people with epilepsy," said Robert Silbergleit, M.D., of
the University of Michigan in Ann Arbor, first author of the NEJM paper. 

Reference: Silbergleit, R et al.  Intramuscular versus Intravenous Therapy
for Prehospital Status Epilepticus.  New England Journal of Medicine,
February 16, 2012.

Media outlets interested in downloading embargoed high-definition sound
bites and b-roll package, a pre-edited web video or additional images should
e-mail <[log in to unmask]>.

For more information about epilepsy, please visit
<http://www.ninds.nih.gov/disorders/epilepsy/epilepsy.htm>.

NINDS (www.ninds.nih.gov) is the nation's leading funder of research on the
brain and nervous system.  The NINDS mission is to reduce the burden of
neurological disease -- a burden borne by every age group, by every segment
of society, by people all over the world.

CounterACT (www.ninds.nih.gov/counteract) is supported by the NIH Office of
the Director and the program funds research on developing therapeutics and
diagnostic technologies that will reduce mortality and morbidity during and
after chemical emergency events. 

About CBMS: JPM-CBMS, one of eight joint project management offices within
the Joint Program Executive Office for Chemical and Biological Defense, is
responsible for research, development, acquisition, fielding, and life cycle
management of U.S. Food and Drug Administration (FDA) approved/cleared
medical systems for protection, treatment, and diagnostic capabilities
against chemical, biological, radiological, and nuclear (CBRN) warfare
threat agents. All CBRN medical countermeasures are approved by and
regulated through the FDA. CBMS is composed of a headquarters and three
Joint Product Management Offices: The Joint Vaccine Acquisition Program, the
Medical Identification and Treatment Systems, and Biosurveillance
(provisional). For more information, visit <www.jpeocbd.osd.mil>.

About the National Institutes of Health (NIH): NIH, the nation's medical
research agency, includes 27 Institutes and Centers and is a component of
the U.S. Department of Health and Human Services. NIH is the primary federal
agency conducting and supporting basic, clinical, and translational medical
research, and is investigating the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and its programs,
visit <www.nih.gov>.

 NIH...Turning Discovery into Health
---------------------------
REFERENCE: Silbergleit, R et al. Intramuscular versus Intravenous Therapy
for Prehospital Status Epilepticus. New England Journal of Medicine,
February 16, 2012.

##

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