The aim of our study was to assess the efficacy and side effects of IV LEV as first-line AED together with IV LZP.
|
|
- Joel Watkins
- 7 years ago
- Views:
Transcription
1 1 Simultaneous administration of lorazepam and levetiracetam in non-convulsive status epilepticus (SALLISE), followed by IV valproate: a prospective, randomized, placebocontrolled, double-blind pilot trial. Introduction. Lorazepam (LZP) is an established first-line anti-epileptic drug (AED) in the treatment of status epilepticus (SE). In the VA trial (1), LZP controlled almost 65% of generalized convulsive SE and 18% of subtle SE. Side effects of IV LZP include hypoventilation in around 10% and hypotension in around 25%. Following IV LZP, a second IV AED is administered to control SE, or to prevent recurrent SE. Phenytoin (PHT) is chosen as secondline therapy by a majority of neurologists (2). A disadvantage of IV PHT administration is the cardiovascular side effects, necessitating 1.) a slow administration over at least 30 minutes, and 2.) monitoring ECG and blood pressure during infusion (3). It is, therefore, recommended to transfer the patient to an emergency room or intensive care facility, further delaying adequate treatment of SE, which becomes more difficult to control as its duration increases. IV valproate (VPA) is an alternative as a second-line AED, which can be administered fast, without sedation, respiratory depression or hypotension, and has been reported to be effective in the treatment of SE (4-10). It has been reported that IV VPA can control up to 78% of status epilepticus, regardless of order of treatment. Levetiracetam (LEV) (Keppra ) is a new effective AED with few side effects, and an IV formulation is available. LEV was effective in an animal model of SE, and enhanced the anticonvulsant effect of diazepam (11). IV LEV was administered in a randomized, placebo-controlled safety and pharmacokinetic study. Single ascending doses of LEV administered by IV infusion (2000, 3000, 4000 mg over 15 min and 1500, 2000 and 2500 mg over 5 min) were evaluated in 48 healthy subjects in a randomized, single-blind, placebo-controlled study. Adverse events were primarily related to the central nervous system (dizziness (53%), somnolence (33%), fatigue (11%), headache (8%)). Safety profiles were similar for each dose level of LEV and for both IV infusion rates (12). Preliminary results of IV LEV in the treatment of SE in humans appear favourably (13-19). The aim of our study was to assess the efficacy and side effects of IV LEV as first-line AED together with IV LZP. Methods. Inclusion criteria. We included adult male and female patients with non-convulsive SE (NCSE), and more particularly complex partial SE (CPSE) and SE in coma. NCSE was defined as a change in behaviour and/or mental status from baseline associated with EEG changes consistent with SE. We subdivided CPSE into CPSE in patients with epilepsy and CPSE de novo. We considered subtle SE as a subgroup of SE in coma. Subtle SE was defined as SE that evolved from convulsive seizures to seizures with minor motor manifestations, such as muscle twitches, tonic eye deviation and nystagmoid eye jerks, and ictal EEG changes. Exclusion criteria. We excluded simple partial SE (SPS), absence SE and. postanoxic myoclonus or myoclonic SE, organic or psychogenic pseudoseizures, and coma with the following EEG patterns: periodic lateralised epileptiform discharges (PLEDs), bilateral independent periodic lateralised epileptiform discharges (BiPLEDs), periodic
2 2 epileptiform discharges (PEDs), generalized periodic epileptiform discharges, stimulusinduced rhythmic periodic ictal-like discharges (SIRPIDs), and triphasic waves. Cases that were doubtful on electroclinical grounds, in whom a diagnosis of SE would only be made a posteriori after a therapeutic trial with anti-epileptic drugs, were also excluded. Prior treatment for seizures was not an exclusion criterion. Current treatment with levetiracetam was an exclusion criterion. Renal failure was not an exclusion criterion. Contraindications for administration of VPA, such as hepatitis, mitochondrial disease, pancreatitis, pregnancy and hepatic porphyria, were exclusion criteria. Objectives. Our objectives were to assess whether IV LEV could be administered safely in the treatment of NCSE, whether it was efficacous in termination SE fast when administered together with IV LZP, and whether is was efficacous in preventing relapse within 12 hours after treatment. Interventions. We recorded demographic data (age, gender and body weight), history of epilepsy or SE, age of first seizure and features of the SE (duration, etiology and seizure type). We used the criterion of seven days to differentiate between acute and remote symptomatic causes. The acute physiology and chronic health evaluation on day 1 of the treatment of SE was recorded (APACHE II classification) (20, 21). Prior use of AEDs was recorded. We assessed outcome at day 30 using the Glasgow Outcome Scale (22): 1. no or minor disability, 2. moderate disability, 3. severe disability, 4. vegetative state, and 5. death. After the diagnosis of SE, hypoglycaemia was excluded by fingerprick. An IV line was inserted in an arm vein, a blood sample was taken for haematology, biochemistry, toxicology and arterial blood gases. Respiration was assessed and oxygen 10 L/min was administered if required. Vital sign, including temperature, pulse, blood pressure and respiration were assessed every 5 minutes. An oxymeter was applied and cardiac monitoring was performed. The Glasgow coma scale was assessed. Thiamine was administered in case of alcohol withdrawal. Continuous videoeeg monitoring was recorded, and recurrent seizures were assessed within 12 hours after treatment. The APACHE score was determined on the day of SE. EEG technicians and neurology residents received training session to recognise the different SE types, and an EEG course in the recognition of EEG patterns. All patients received standard first-line treatment for SE during EEG recording. In our protocol, we gave IV LZP 0.05 mg/kg over 5 minutes followed by VPA 30 mg/kg IV over 5 minutes. Patients were randomly assigned to treatment with IV LEV 2500 mg (100 mg/ml in 5 ml ampoules) diluted in 100 ml 0.9% NaCl over 5 minutes or IV placebo (100 ml 0.9% NaCl without LEV) over 5 minutes given together with IV LZP. Vital signs, including blood pressure, pulse and respiratory rate were assessed before treatment, after administration of IV LZP plus IV placebo/lev, and after administration of IV VPA. In this protocol, we have reduced the dose of LZP from the standard 0.1 mg/kg in view of side efffects, including hypotension and hypoventilation in around 20% of cases. If SE was not controlled, other AEDs were given at the discretion of the treating neurologist. There was no repeated administration of Keppra IV after 12 hours. Outcomes.
3 3 During the study, there were three evaluations of seizure activity: 1.) immediately after IV administration of LZP and placebo/lev, 2.) immediately after IV administration of VPA, and 3.) 12 hours after treatment. Primary outcome. The primary outcome was responder rate immediately after IV administration of LZP and before administration of VPA comparing the group that received placebo versus the group that received LEV. Secondary outcomes. Secondary outcomes were responder rate 1.) immediately after IV administration of VPA and 2.) 12 hours after IV administration of LZP and VPA comparing the group that received placebo versus the group that received LEV. Further secondary outcomes were side effects and Glasgow Outcome Scale 30 days after treatment comparing the group that received IV placebo versus the group that received IV LEV. Sample size. This trial was conceived as a pilot-study, for which 80 patients were available. Based on this sample size, using a one-sided Fisher exact test with alpha=5%, the study had 80% power to detect a difference between 15% (placebo group) and 42% responder rate at the first evaluation. To detect a difference between 15% and 25%, 430 patients would be needed. In these power analyses, the stratified character of the study was not taken into account, due to lack of information on the prevalence of SE type and on homogeneity of the effect over the strata. Randomization. The clinician first stratified the patients according to SE type into CPSE or SE in coma. The patients were then randomized to receive IV LEV or IV placebo to achieve equal numbers of patients receiving LEV and placebo in each SE group. An independent pharmacist numbered placebo and LEV vials from 1 to 80 according to a computer generated randomization list with 4 subject per block ( The interventions were sealed in sequentially numbered identical containers according to the allocation sequence, and the lowest number available for the specified SE type was chosen to treat the patient. Blinding. IV LEV 500 mg and placebo were kept in identical vials that were not distinguishable from each other. The administration of LEV versus placebo was blinded for the treating physicians and patients till the end of the study. Statistical analysis. For the primary outcome, the responder rate at the first evaluation, an exact p-value was calculated testing that the common odds ratio (common to the two strata) equals 1. The test was one-sided with alpha=5%. When the exact test for the homogeneity of this odds ratio was significant, strata-specific odds ratios were reported. Similar analyses were performed for each of the secondary outcomes, i.e. responder rate at the second evaluation and success rate at the third evaluation. Ethical committee approval was obtained. Patients were informed that they had participated in a trial as soon as possible and were asked to sign an informed consent in which they consented that we could use the data for study purposes. Reference List
4 4 (1) Treiman DM, Meyers PD, Walton NY, et al. A comparison of four treatments for generalized convulsive status epilepticus. Veterans Affairs Status Epilepticus Cooperative Study Group. N Engl J Med 1998 Sep 17;339: (2) Claassen J, Hirsch LJ, Mayer SA. Treatment of status epilepticus: a survey of neurologists. J Neurol Sci 2003 Jul 15;211: (3) Treatment of convulsive status epilepticus. Recommendations of the Epilepsy Foundation of America's Working Group on Status Epilepticus. JAMA 1993 Aug 18;270: (4) Agarwal P, Kumar N, Chandra R, Gupta G, Antony AR, Garg N. Randomized study of intravenous valproate and phenytoin in status epilepticus. Seizure 2007 Sep;16: (5) Giroud M, Dumas R. [Treatment of status epilepticus by sodium valproate]. Neurophysiol Clin 1988 Feb;18: (6) Jha S, Jose M, Patel R. Intravenous sodium valproate in status epilepticus. Neurol India 2003 Sep;51: (7) Limdi NA, Shimpi AV, Faught E, Gomez CR, Burneo JG. Efficacy of rapid IV administration of valproic acid for status epilepticus. Neurology 2005 Jan 25;64: (8) Olsen KB, Tauboll E, Gjerstad L. Valproate is an effective, well-tolerated drug for treatment of status epilepticus/serial attacks in adults. Acta Neurol Scand Suppl 2007;187: (9) Peters CN, Pohlmann-Eden B. Intravenous valproate as an innovative therapy in seizure emergency situations including status epilepticus--experience in 102 adult patients. Seizure 2005 Apr;14: (10) Wheless JW, Vazquez BR, Kanner AM, Ramsay RE, Morton L, Pellock JM. Rapid infusion with valproate sodium is well tolerated in patients with epilepsy. Neurology 2004 Oct 26;63: (11) Mazarati AM, Baldwin R, Klitgaard H, Matagne A, Wasterlain CG. Anticonvulsant effects of levetiracetam and levetiracetam-diazepam combinations in experimental status epilepticus. Epilepsy Res 2004 Feb;58: (12) Ramael S, Daoust A, Otoul C, et al. Levetiracetam intravenous infusion: a randomized, placebo-controlled safety and pharmacokinetic study. Epilepsia 2006 Jul;47: (13) Abend NS, Florance N, Finkel RS, Licht DJ, Dlugos DJ. Intravenous Levetiracetam Terminates Refractory Focal Status Epilepticus. Neurocrit Care 2008 Jan 8. (14) Alehan F, Ozcay F, Haberal M. The Use of Levetiracetam in a Child with Nonconvulsive Status Epilepticus. J Child Neurol 2008 Jan 11.
5 5 (15) Farooq MU, Naravetla B, Majid A, Gupta R, Pysh JJ, Kassab MY. IV levetiracetam in the management of non-convulsive status epilepticus. Neurocrit Care 2007;7: (16) Knake S, Gruener J, Hattemer K, et al. Intravenous levetiracetam in the treatment of benzodiazepine-refractory status epilepticus. J Neurol Neurosurg Psychiatry 2007 Sep 26. (17) Rossetti AO, Bromfield EB. Levetiracetam in the treatment of status epilepticus in adults: a study of 13 episodes. Eur Neurol 2005;54: (18) Rupprecht S, Franke K, Fitzek S, Witte OW, Hagemann G. Levetiracetam as a treatment option in non-convulsive status epilepticus. Epilepsy Res 2007 Mar;73: (19) Schulze-Bonhage A, Hefft S, Oehl B. Termination of complex partial status epilepticus by intravenous levetiracetam - a case report. J Neurol Neurosurg Psychiatry 2007 Mar 12. (20) Knaus WA, Zimmerman JE, Wagner DP, Draper EA, Lawrence DE. APACHE-acute physiology and chronic health evaluation: a physiologically based classification system. Crit Care Med 1981 Aug;9: (21) Wagner DP, Draper EA. Acute physiology and chronic health evaluation (APACHE II) and Medicare reimbursement. Health Care Financ Rev 1984;Suppl: (22) Jennett B, Snoek J, Bond MR, Brooks N. Disability after severe head injury: observations on the use of the Glasgow Outcome Scale. J Neurol Neurosurg Psychiatry 1981 Apr;44:
Drugs for MS.Drug fact box cannabis extract (Sativex) Version 1.0 Author
Version History Policy Title Drugs for MS.Drug fact box cannabis extract (Sativex) Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review Date Supersedes/New (Further
More informationDepartment of Clinical Pharmacy, University of Colorado, Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO 6
American Epilepsy Society Guideline Evidence-Based Guideline: Treatment of Convulsive Status Epilepticus in Children and Adults: Report of the Guideline Committee of the American Epilepsy Society Tracy
More informationOral Zinc Supplementation as an Adjunct Therapy in the Management of Hepatic Encephalopathy: A Randomized Controlled Trial
Oral Zinc Supplementation as an Adjunct Therapy in the Management of Hepatic Encephalopathy: A Randomized Controlled Trial Marcus R. Pereira A. Study Purpose Hepatic encephalopathy is a common complication
More informationEfficacy, safety and preference study of a insulin pen PDS290 vs. a Novo Nordisk marketed insulin pen in diabetics
Efficacy, safety and preference study of a insulin pen PDS290 vs. a Novo Nordisk marketed insulin pen in diabetics This trial is conducted in the United States of America (USA). The aim of this clinical
More informationSponsor Novartis. Generic Drug Name Secukinumab. Therapeutic Area of Trial Psoriasis. Approved Indication investigational
Clinical Trial Results Database Page 2 Sponsor Novartis Generic Drug Name Secukinumab Therapeutic Area of Trial Psoriasis Approved Indication investigational Clinical Trial Results Database Page 3 Study
More informationActive centers: 2. Number of patients/subjects: Planned: 20 Randomized: Treated: 20 Evaluated: Efficacy: 13 Safety: 20
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: sanofi-aventis ClinialTrials.gov
More informationLEVETIRACETAM MONOTHERAPY
LEVETIRACETAM MONOTHERAPY Beth Korby, RN C Patricia E. Penovich, MD John R. Gates, MD Deanna L. Dickens, MD Gerald L. Moriarty, MD This paper has been prepared specifically for: American Epilepsy Society
More informationEvaluation of a Morphine Weaning Protocol in Pediatric Intensive Care Patients
Evaluation of a Morphine Weaning Protocol in Pediatric Intensive Care Patients Jennifer Kuhns, Pharm.D. Pharmacy Practice Resident Children s Hospital of Michigan **The speaker has no actual or potential
More informationSponsor. Novartis Generic Drug Name. Vildagliptin. Therapeutic Area of Trial. Type 2 diabetes. Approved Indication. Investigational.
Clinical Trial Results Database Page 1 Sponsor Novartis Generic Drug Name Vildagliptin Therapeutic Area of Trial Type 2 diabetes Approved Indication Investigational Study Number CLAF237A2386 Title A single-center,
More informationVersion History. Previous Versions. Drugs for MS.Drug facts box fampridine Version 1.0 Author
Version History Policy Title Drugs for MS.Drug facts box fampridine Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review Date Supersedes/New (Further fields as required
More informationEMS Branch / Office of the Medical Director. Active Seziures (d) Yes Yes Yes Yes. Yes Yes No No. Agitation (f) No Yes Yes No.
M07 Medications 2015-07-15 All ages EMS Branch / Office of the Medical Director Benzodiazepines Primary Intermediate Advanced Critical INDICATIONS Diazepam (c) Lorazepam (c) Midazolam (c) Intranasal Midazolam
More information2.0 Synopsis. Vicodin CR (ABT-712) M05-765 Clinical Study Report R&D/07/095. (For National Authority Use Only) to Part of Dossier: Volume:
2.0 Synopsis Abbott Laboratories Name of Study Drug: Vicodin CR Name of Active Ingredient: Hydrocodone/Acetaminophen Extended Release (ABT-712) Individual Study Table Referring to Part of Dossier: Volume:
More informationPHARMACOKINETICS (PK) AND PHARMACODYNAMICS (PD) STUDY IN THE ESTABLISHED STATUS EPILEPTICUS TREATMENT TRIAL. Lisa Coles, MS, PhD
PHARMACOKINETICS (PK) AND PHARMACODYNAMICS (PD) STUDY IN THE ESTABLISHED STATUS EPILEPTICUS TREATMENT TRIAL Lisa Coles, MS, PhD Key Personnel Personnel Institution Role James Cloyd, PharmD UMN Pharmacology
More informationElements for a Public Summary
VI.2 Elements for a Public Summary VI.2.1 Overview of Disease Epidemiology Hunter syndrome is a rare genetic disease which mainly affects males of all ethnicities. The incidence rate ranges from 0.6 to
More informationGloucestershire Hospitals
Gloucestershire Hospitals NHS Foundation Trust TRUST GUIDELINE EPILEPSY AND STATUS EPILEPTICUS MANAGEMENT 1. INTRODUCTION The aim of this guideline is to ensure safe management of Status Epilepticus in
More informationSummary 1. Comparative-effectiveness
Cost-effectiveness of Delta-9-tetrahydrocannabinol/cannabidiol (Sativex ) as add-on treatment, for symptom improvement in patients with moderate to severe spasticity due to MS who have not responded adequately
More informationMANAGEMENT OF STATUS EPILEPTICUS. Elizabeth Macri, MS, MD
MANAGEMENT OF STATUS EPILEPTICUS Elizabeth Macri, MS, MD Definition Continuous or repeat seizure activity persisting for at least 30 minutes without full recovery between attacks. Very few single seizures
More informationEpilepsy12 National Audit Round 2 Final Unit Report for: University Hospital of North Tees and Hartlepool
United Kingdom collaberative clinical audit of health care for children and young people with suspected epileptic seizures Epilepsy12 National Audit Round 2 Final Unit Report for: University Hospital of
More informationVersion History. Previous Versions. Policy Title. Drugs for MS.Drug facts box Glatiramer Acetate Version 1.0 Author
Version History Policy Title Drugs for MS.Drug facts box Glatiramer Acetate Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review Date Supersedes/New (Further fields
More informationSponsor Novartis Pharmaceuticals
Clinical Trial Results Database Page 1 Sponsor Novartis Pharmaceuticals Generic Drug Name Indacaterol Therapeutic Area of Trial Chronic Obstructive Pulmonary Disease (COPD) Indication studied: COPD Study
More informationThis clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.
abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical
More informationAdding IV Amiodarone to the EMS Algorithm for Cardiac Arrest Due to VF/Pulseless VT
Adding IV Amiodarone to the EMS Algorithm for Cardiac Arrest Due to VF/Pulseless VT Introduction Before the year 2000, the traditional antiarrhythmic agents (lidocaine, bretylium, magnesium sulfate, procainamide,
More informationSymptom-Triggered Alcohol Detoxification: A Guideline for use in the Clinical Decisions Unit of the Emergency Department.
Symptom-Triggered Alcohol Detoxification: A Guideline for use in the Clinical Decisions Unit of the Emergency Department. Dr Eugene Cassidy, Liaison Psychiatry; Dr Io har O Sulliva, E erge cy Department,
More informationMedical management of CHF: A New Class of Medication. Al Timothy, M.D. Cardiovascular Institute of the South
Medical management of CHF: A New Class of Medication Al Timothy, M.D. Cardiovascular Institute of the South Disclosures Speakers Bureau for Amgen Background Chronic systolic congestive heart failure remains
More informationFREEDOM C: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C
FREEDOM C: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C SR in Combination with an ERA and/or a PDE-5 Inhibitor
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationPROTOCOL SYNOPSIS Evaluation of long-term opioid efficacy for chronic pain
P a g e 1 PROTOCOL SYNOPSIS Evaluation of long-term opioid efficacy for chronic pain Clinical Phase 4 Study Centers Study Period 25 U.S. sites identified and reviewed by the Steering Committee and Contract
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationMOH CLINICAL PRACTICE GUIDELINES 2/2008 Prescribing of Benzodiazepines
MOH CLINICL PRCTICE GUIELINES 2/2008 Prescribing of Benzodiazepines College of Family Physicians, Singapore cademy of Medicine, Singapore Executive summary of recommendations etails of recommendations
More informationReducing Insulin Related Errors in Patients Treated for Hyperkalemia
Reducing Insulin Related Errors in Patients Treated for Hyperkalemia Tan Tock Seng Hospital is an acute care general hospital with a 1,200 bed capacity The hospital addressed the problem of insulinrelated
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationIf several different trials are mentioned in one publication, the data of each should be extracted in a separate data extraction form.
General Remarks This template of a data extraction form is intended to help you to start developing your own data extraction form, it certainly has to be adapted to your specific question. Delete unnecessary
More informationDEMENTIA EDUCATION & TRAINING PROGRAM
The pharmacological management of aggression in the nursing home requires careful assessment and methodical treatment to assure maximum safety for patients, nursing home residents and staff. Aggressive
More informationUsual total daily dosage *Indicates usual starting dose in mg/kg/day (mg of AED per kg of the child s weight per day) Drug (Generic Name)
Table of Anti Epileptic Drugs (AEDs) used in the treatment of Epilepsy in Children under 12. IMPORTANT All the tables below are guidelines only, giving average daily dose ranges. Treatment will generally
More informationTHE INTERNET STROKE CENTER PRESENTATIONS AND DISCUSSIONS ON STROKE MANAGEMENT
THE INTERNET STROKE CENTER PRESENTATIONS AND DISCUSSIONS ON STROKE MANAGEMENT Stroke Prevention in Atrial Fibrillation Gregory Albers, M.D. Director Stanford Stroke Center Professor of Neurology and Neurological
More informationEmergency and inpatient treatment of migraine: An American Headache Society
Emergency and inpatient treatment of migraine: An American Headache Society survey. The objective of this study was to determine the practice preferences of AHS members for acute migraine treatment in
More informationHumulin (LY041001) Page 1 of 1
(LY041001) These clinical study results are supplied for informational purposes only in the interests of scientific disclosure. They are not intended to substitute for the FDA-approved package insert or
More informationTHE BASICS. Community Based Medically Assisted Alcohol Withdrawal. World Health Organisation 2011. The Issues 5/18/2011. RCGP Conference May 2011
RCGP Conference May 2011 Community Based Medically Assisted Alcohol Withdrawal THE BASICS An option for consideration World Health Organisation 2011 Alcohol is the world s third largest risk factor for
More informationFit, (falls) and funny turns. Richard J Davenport Consultant Neurologist Edinburgh
Fit, (falls) and funny turns Richard J Davenport Consultant Neurologist Edinburgh The plan Epilepsy nuggets 10 things I would like GPs to know This week s FS clinic What is epilepsy? Characterised by two
More informationSPECIALIZED PHYSICAL HEALTH CARE SERVICES. RECTAL DIAZEPAM ADMINISTRATION (DIASTAT or DIASTAT AcuDial )
SAN DIEGO UNIFIED SCHOOL DISTRICT Nursing & Wellness Program SPECIALIZED PHYSICAL HEALTH CARE SERVICES RECTAL DIAZEPAM ADMINISTRATION (DIASTAT or DIASTAT AcuDial ) THIS PROCEDURE SHALL BE PERFORMED BY
More informationVersion 2 This guideline describes how to manage patients who are showing signs and symptoms of alcohol withdrawal and Wernicke s Encephalopathy.
Title of Guideline (must include the word Guideline (not protocol, policy, procedure etc) Contact Name and Job Title (author) Directorate & Speciality A Guideline for the Management of Acute Alcohol Withdrawal
More informationMaking Telehealth Sustainable in South Australia Dr Victoria Wade
Making Telehealth Sustainable in South Australia Dr Victoria Wade Clinical Director, Adelaide Unicare e-health and Telehealth Unit Research Fellow, Discipline of General Practice The University of Adelaide
More informationSYNOPSIS. Risperidone: Clinical Study Report CR003274
SYNOPSIS Protocol No: CR003274 Title of Study: An Open-Label, Long-Term Trial of Risperidone Long-Acting Microspheres in the Treatment of Subjects Diagnosed with Schizophrenia Coordinating Investigator:
More informationClinical guideline Published: 11 January 2012 nice.org.uk/guidance/cg137
Epilepsies: diagnosis and management Clinical guideline Published: 11 January 2012 nice.org.uk/guidance/cg137 NICE 2012. All rights reserved. Last updated February 2016 Your responsibility The recommendations
More informationClinical Study Synopsis for Public Disclosure
abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of the clinical
More informationVersion History. Previous Versions. Drugs for MS.Drug facts box fingolimod Version 1.0 Author
Version History Policy Title Drugs for MS.Drug facts box fingolimod Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review Date Supersedes/New (Further fields as required
More informationStarting antiepileptic drug treatment
Starting antiepileptic drug treatment Chapter 26 MARGARET J. JACKSON Department of Neurology, Royal Victoria Infirmary, Newcastle upon Tyne Antiepileptic medication should not be prescribed without a careful
More informationStatus epilepticus is an under-recognized
Management of Status Epilepticus JOSEPH I. SIRVEN, M.D., Mayo Clinic, Scottsdale, Arizona ELIZABETH WATERHOUSE, M.D., Virginia Commonwealth University School of Medicine, Richmond, Virginia Status epilepticus
More informationAntipsychotic drugs are the cornerstone of treatment
Article Effectiveness of Olanzapine, Quetiapine, Risperidone, and Ziprasidone in Patients With Chronic Schizophrenia Following Discontinuation of a Previous Atypical Antipsychotic T. Scott Stroup, M.D.,
More informationPresented by: Jean Yoo-Campbell, Matthew Konerman, Monica Konerman, Jean Yoo Campbell, Christian Gocke, Eunpi Cho Donald Lynch
Bass N.M., et. al. N Engl J Med 2010; 362:1071-1081 Presented by: Jean Yoo-Campbell, Matthew Konerman, Monica Konerman, Jean Yoo Campbell, Christian Gocke, Eunpi Cho Donald Lynch Faculty Advisor: Dr. Fred
More informationBeaumont Hospital Department of Nephrology and Renal Nursing. Guideline for administering Ferinject
Beaumont Hospital Department of Nephrology and Renal Nursing Guideline Name: Guideline for administering Ferinject Guideline Number: 18 Guideline Version: a Developed By: Louise Kelly CNM 1 Renal Day Care
More informationSubstance Abuse Treatment. Naltrexone for Extended-Release Injectable Suspension for Treatment of Alcohol Dependence
Spring 2007 Volume 6 Issue 1 ADVISORY News for the Treatment Field Naltrexone for Extended-Release Injectable Suspension for Treatment of Alcohol Dependence What is naltrexone for extendedrelease injectable
More informationPrior Authorization Guideline
Prior Authorization Guideline Guideline: PDP IBT Inj - Vivitrol Therapeutic Class: Central Nervous System Agents Therapeutic Sub-Class: Opiate Antagonist Client: 2007 PDP IBT Inj Approval Date: 2/20/2007
More informationNeuroStar TMS Therapy Patient Guide for Treating Depression
NeuroStar TMS Therapy Patient Guide for Treating Depression This NeuroStar TMS Therapy Patient Guide for Treating Depression provides important safety and use information for you to consider about treating
More informationThe Paediatric EEG: Value and Abuses. Associate Professor Annie Bye
The Paediatric EEG: Value and Abuses Associate Professor Annie Bye How can EEG help in epilepsy? Diagnosis of epilepsy First Seizure Distinction between focal and generalized seizure disorder Identification
More informationOutcome of Drug Counseling of Outpatients in Chronic Obstructive Pulmonary Disease Clinic at Thawangpha Hospital
Mahidol University Journal of Pharmaceutical Sciences 008; 35(14): 81. Original Article Outcome of Drug Counseling of Outpatients in Chronic Obstructive Pulmonary Disease Clinic at Thawangpha Hospital
More informationMedication Policy Manual. Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012
Medication Policy Manual Policy No: dru283 Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012 Committee Approval Date: December 12, 2014 Next Review Date: December 2015 Effective Date: January
More informationIBADAN STUDY OF AGEING (ISA): RATIONALE AND METHODS. Oye Gureje Professor of Psychiatry University of Ibadan Nigeria
IBADAN STUDY OF AGEING (ISA): RATIONALE AND METHODS Oye Gureje Professor of Psychiatry University of Ibadan Nigeria Introduction The Ibadan Study of Ageing consists of two components: Baseline cross sectional
More informationGuidelines for the Evaluation and Management of Status Epilepticus
DOI 10.1007/s12028-012-9695-z REVIEW Guidelines for the Evaluation and Management of Status Epilepticus Gretchen M. Brophy Rodney Bell Jan Claassen Brian Alldredge Thomas P. Bleck Tracy Glauser Suzette
More informationMedical marijuana for pain and anxiety: A primer for methadone physicians. Meldon Kahan MD CPSO Methadone Prescribers Conference November 6, 2015
Medical marijuana for pain and anxiety: A primer for methadone physicians Meldon Kahan MD CPSO Methadone Prescribers Conference November 6, 2015 Conflict of interest statement No conflict of interest to
More informationPain Management. Practical Applications in Electrotherapy
Pain Management Practical Applications in Electrotherapy The TENS Advantage Deliver Immediate Pain Relief using a unique waveform designed to help prevent nerve accommodation. Manage Dynamic Pain by adjusting
More informationCADTH CANADIAN DRUG EXPERT REVIEW COMMITTEE FINAL RECOMMENDATION
CADTH CANADIAN DRUG EXPERT REVIEW COMMITTEE FINAL RECOMMENDATION RIOCIGUAT (Adempas Bayer HealthCare Inc.) Indication: Pulmonary Arterial Hypertension Recommendation: The CADTH Canadian Drug Expert Review
More informationCardiac Arrest - Ventricular Fibrillation / Pulseless Ventricular Tachycardia Protocol revised October 2008
Cardiac Arrest - Ventricular Fibrillation / Pulseless Ventricular Tachycardia Protocol revised October 2008 Preamble Survival from cardiorespiratory arrest for patients who present with ventricular fibrillation
More informationDevelopmental Pediatrics Rehabilitation Learner Orientation Package
Spasticity Clinic Follow Up Assessment Template This letter should be directed to the family, and copied to the involved family physician, any specialists that are involved of the care and also the relevant
More informationNonconvulsive status epilepticus during childhood: clinical and electroencephalographic features
The Turkish Journal of Pediatrics 2008; 50: 449-455 Original Nonconvulsive status epilepticus during childhood: clinical and electroencephalographic features Yüksel Yılmaz, Oğuzhan Onultan, Mustafa Berber
More informationApplication Type NDA Submission Number 21-035 (S-040) and 21-505(S-007) Submission Code Supplement
CLINICAL REVIEW Application Type NDA Submission Number Submission Code Supplement Letter Date December 20, 2004 Stamp Date December 20, 2004 PDUFA Goal Date June 21, 2005 Reviewer Name Review Completion
More informationAlcohol Withdrawal. Introduction. Blood Alcohol Concentration. DSM-IV Criteria/Alcohol Abuse. Pharmacologic Effects of Alcohol
Pharmacologic Effects of Alcohol Alcohol Withdrawal Kristi Theobald, Pharm.D., BCPS Therapeutics III Fall 2003 Inhibits glutamate receptor function (NMDA receptor) Inhibits excitatory neurotransmission
More informationUniversity of Hawai i Human Studies Program. Guidelines for Developing a Clinical Research Protocol
University of Hawai i Human Studies Program Guidelines for Developing a Clinical Research Protocol Following are guidelines for writing a clinical research protocol for submission to the University of
More informationESCMID Online Lecture Library. by author
Do statins improve outcomes of patients with sepsis and pneumonia? Jordi Carratalà Department of Infectious Diseases Statins for sepsis & community-acquired pneumonia Sepsis and CAP are major healthcare
More informationANNE ARUNDEL MEDICAL CENTER CRITICAL CARE MEDICATION MANUAL DEPARTMENT OF NURSING AND PHARMACY. Guidelines for Use of Intravenous Isoproterenol
ANNE ARUNDEL MEDICAL CENTER CRITICAL CARE MEDICATION MANUAL DEPARTMENT OF NURSING AND PHARMACY Guidelines for Use of Intravenous Isoproterenol Major Indications Status Asthmaticus As a last resort for
More informationAdjunctive psychosocial intervention. Conditions requiring dose reduction. Immediate, peak plasma concentration is reached within 1 hour.
Shared Care Guideline for Prescription and monitoring of Naltrexone Hydrochloride in alcohol dependence Author(s)/Originator(s): (please state author name and department) Dr Daly - Consultant Psychiatrist,
More informationEffect of liraglutide on body weight in overweight or obese subjects with type 2 diabetes: SCALE - Diabetes
Effect of liraglutide on body weight in overweight or obese subjects with type 2 diabetes: SCALE - Diabetes This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim
More informationGuidance for Industry Migraine: Developing Drugs for Acute Treatment
Guidance for Industry Migraine: Developing Drugs for Acute Treatment DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft
More informationGENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8 Current
More informationS9 Administer thrombolytic treatment in acute ischaemic stroke
S9 Administer thrombolytic treatment in acute ischaemic Screening and initiating treatment, overseeing competency of treatment About this workforce competence This competence is about the emergency administration
More informationJournal Club: Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy by the AIM-HIGH Investigators
Journal Club: Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy by the AIM-HIGH Investigators Shaikha Al Naimi Doctor of Pharmacy Student College of Pharmacy Qatar University
More informationEmergency Room Treatment of Psychosis
OVERVIEW The term Lewy body dementias (LBD) represents two clinical entities dementia with Lewy bodies (DLB) and Parkinson s disease dementia (PDD). While the temporal sequence of symptoms is different
More informationPosition Statement from the Irish Thoracic Society on the treatment of Idiopathic Pulmonary Fibrosis
BACKGROUND Position Statement from the Irish Thoracic Society on the treatment of Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis (IPF) is a rare, chronic and fatal disease characterised by
More informationRATE VERSUS RHYTHM CONTROL OF ATRIAL FIBRILLATION: SPECIAL CONSIDERATION IN ELDERLY. Charles Jazra
RATE VERSUS RHYTHM CONTROL OF ATRIAL FIBRILLATION: SPECIAL CONSIDERATION IN ELDERLY Charles Jazra NO CONFLICT OF INTEREST TO DECLARE Relationship Between Atrial Fibrillation and Age Prevalence, percent
More informationMaintenance of abstinence in alcohol dependence
Shared Care Guideline for Prescription and monitoring of Acamprosate Calcium Author(s)/Originator(s): (please state author name and department) Dr Daly - Consultant Psychiatrist, Alcohol Services Dr Donnelly
More informationWhat s new, and why, in Neurology 4?
What s new, and why, in Neurology 4? All topics in Neurology 4 have been extensively reviewed and updated by the expert writing group, to provide concise evidence-based advice for the busy practitioner.
More informationNovartis Gilenya FDO Program Clinical Protocol and Highlights from Prescribing Information (PI)
Novartis Gilenya FDO Program Clinical Protocol and Highlights from Prescribing Information (PI) Highlights from Prescribing Information - the link to the full text PI is as follows: http://www.pharma.us.novartis.com/product/pi/pdf/gilenya.pdf
More informationSYNOPSIS. 2-Year (0.5 DB + 1.5 OL) Addendum to Clinical Study Report
Name of Sponsor/Company: Bristol-Myers Squibb Name of Finished Product: Abatacept () Name of Active Ingredient: Abatacept () Individual Study Table Referring to the Dossier (For National Authority Use
More informationSystolic Blood Pressure Intervention Trial (SPRINT) Principal Results
Systolic Blood Pressure Intervention Trial (SPRINT) Principal Results Paul K. Whelton, MB, MD, MSc Chair, SPRINT Steering Committee Tulane University School of Public Health and Tropical Medicine, and
More informationStarting antiepileptic drug treatment
Starting antiepileptic drug treatment Chapter 26 KHALID HAMANDI Welsh Epilepsy Centre, University Hospital of Wales, Cardiff The single most important consideration before starting antiepileptic medication
More informationPOAC CLINICAL GUIDELINE
POAC CLINICAL GUIDELINE Acute Pylonephritis DIAGNOSIS COMPLICATED PYELONEPHRITIS EXCLUSION CRITERIA: Male Known or suspected renal impairment (egfr < 60) Abnormality of renal tract Known or suspected renal
More informationSeizures explained. Helpline: 0808 800 2200 Text: 07786 209 501 www.epilepsyscotland.org.uk. Epilepsy Scotland Guides
Epilepsy Scotland Guides Seizures explained Helpline: 0808 800 2200 Text: 07786 209 501 www.epilepsyscotland.org.uk Epilepsy Scotland, 48 Govan Rd, Glasgow G51 1JL General: 0141 427 4911 Fax: 0141 419
More informationHuman Clinical Study for Free Testosterone & Muscle Mass Boosting
Human Clinical Study for Free Testosterone & Muscle Mass Boosting GE Nutrients, Inc. 920 E. Orangethorpe Avenue, Suite B Anaheim, California 92801, USA Phone: +1-714-870-8723 Fax: +1-732-875-0306 Contact
More informationRivaroxaban: Prescribing Guidance for the treatment of provoked venous thromboembolism (VTE)
Rivaroxaban: Prescribing Guidance for the treatment of provoked venous thromboembolism (VTE) Amber Drug Level 2 Leeds We have started your patient on rivaroxaban for the treatment of provoked VTE (deep
More informationPhenobarbital in Severe Alcohol Withdrawal Syndrome. Jordan Rowe Pharm.D. Candidate UAMS College of Pharmacy
Phenobarbital in Severe Alcohol Withdrawal Syndrome Jordan Rowe Pharm.D. Candidate UAMS College of Pharmacy Disclosure: No relevant financial relationship exists. Objectives 1. Describe the pathophysiology
More informationGeneral PROVIDER INITIALS: PHYSICIAN ORDERS
Height Weight Allergies If appropriate for patient condition, please consider the following order sets: Initiate Electrolyte Replcement: Med/Surg, Med/Surg Tele Physician Order #842 General Vital Signs
More informationDiabetic Ketoacidosis: When Sugar Isn t Sweet!!!
Diabetic Ketoacidosis: When Sugar Isn t Sweet!!! W Ricks Hanna Jr MD Assistant Professor of Pediatrics University of Tennessee Health Science Center LeBonheur Children s Hospital Introduction Diabetes
More information嘉 義 長 庚 醫 院 藥 劑 科 Speaker : 翁 玟 雯
The Clinical Efficacy and Safety of Sodium Glucose Cotransporter-2 (SGLT2) Inhibitors in Adults with Type 2 Diabetes Mellitus 嘉 義 長 庚 醫 院 藥 劑 科 Speaker : 翁 玟 雯 Diabetes Mellitus : A group of diseases characterized
More informationAssessment, diagnosis and specialist referral of adults (>16 years) with an episode of transient loss of consciousness (TLoC) or a blackout.
Assessment, diagnosis and specialist referral of adults (>16 years) with an episode of transient loss of consciousness (TLoC) or a blackout. TLoC is common huge variation in management range of clinicians
More informationDeveloping Innovative Therapeutics for People with Orphan Liver Disease
Developing Innovative Therapeutics for People with Orphan Liver Disease PIPELINE PROGRESS AND FIRST QUARTER 2015 EARNINGS UPDATE NASDAQ: OCRX Forward-Looking Statements Certain statements in this presentation
More informationNaltrexone Shared Care Guideline for the treatment of alcohol dependence and opioid dependance
Naltrexone Shared Care Guideline for the treatment of alcohol dependence and opioid dependance Introduction Indication/Licensing information: Naltrexone is licensed for use as an additional therapy, within
More informationGlasgow Assessment and Management of Alcohol
Glasgow Assessment and Management of Alcohol If you would like further information or advice on the alcohol screening and withdrawal management guideline(gmaws) please contact your local acute addiction
More informationPrior Authorization Guideline
Prior Authorization Guideline Guideline: CSD - Suboxone Therapeutic Class: Central Nervous System Agents Therapeutic Sub-Class: Analgesics and Antipyretics (Opiate Partial Agonists) Client: County of San
More informationClinical Study Synopsis
Clinical Study Synopsis This file is posted on the Bayer HealthCare Clinical Trials Registry and Results website. It is provided for patients and healthcare professionals to increase the transparency of
More informationImmunex Corporation Novantrone (Mitoxantrone HCL) P&CNS Advisory Committee Briefing Document. Page 020
Page 020 4.0 Efficacy of Mitoxantrone in Multiple Sclerosis The efficacy of mitoxantrone in MS was demonstrated in two well-designed, randomized trials: Studies 901 and 902. The study design and efficacy
More information