ACEP News - June 2008 - (Page 13)

JUNE 2008 • ACEP NEWS NEWS FROM THE COLLEGE alcohol screening and brief intervention. The American College of Emergency Physicians encourages its members to leave comments and participate at the Joint Commission Web site, which is located at http://wikihealthcare.jointcommission.org/ twiki/bin/view/Standards/ ScreeningAndBriefIntervention. Joint Commission Seeks Input on Alcohol Screening T he Joint Commission is looking for emergency physicians to participate in a discussion about what role, if any, it might play in developing a potential alcohol screening and brief intervention standard. To generate discussion, an interactive Web site about the possible standard has been created by the Joint Commission. There is a general explanation of why the Joint Commission is considering adding a standard, as well as a place to leave comments. In addition, there is an area where emergency physicians and others can help draft or edit a potential requirement for ■ Table 1 lists treatment-emergent adverse reactions that occurred in at least 1% of adult epilepsy patients treated with KEPPRA tablets participating in placebocontrolled studies and were numerically more common than in patients treated with placebo. In these studies, either KEPPRA or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity. Table 1: Incidence (%) Of Treatment-Emergent Adverse Reactions In PlaceboControlled, Add-On Studies In Adults Experiencing Partial Onset Seizures By Body System (Adverse Reactions Occurred In At Least 1% Of KEPPRA-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients) Body System/ Adverse Reaction Body as a Whole Asthenia Headache Infection Pain Digestive System Anorexia Nervous System Somnolence Dizziness Depression Nervousness Ataxia Vertigo Amnesia Anxiety Hostility Paresthesia Emotional Lability Respiratory System Pharyngitis Rhinitis Cough Increased Sinusitis Special Senses Diplopia KEPPRA (N=769) % 15 14 13 7 3 15 9 4 4 3 3 2 2 2 2 2 6 4 2 2 2 Placebo (N=439) % 9 13 8 6 2 8 4 2 2 1 1 1 1 1 1 0 4 3 1 1 1 Discontinuation Or Dose Reduction In Well-Controlled Clinical Studies Partial Onset Seizures: In well-controlled adult clinical studies using KEPPRA tablets, 15.0% of patients receiving KEPPRA and 11.6% receiving placebo either discontinued or had a dose reduction as a result of an adverse event. Table 3 lists the most common (>1%) adverse reactions that resulted in discontinuation or dose reduction and that occurred more frequently in KEPPRA-treated patients than in placebo-treated patients. Table 3: Adverse Reactions That Most Commonly Resulted In Discontinuation Or Dose Reduction That Occurred More Frequently in KEPPRA-Treated Patients In Placebo-Controlled Studies In Adult Patients Experiencing Partial Onset Seizures Adverse Reaction Asthenia Dizziness Somnolence KEPPRA (N=769) n (%) 10 (1.3%) 11 (1.4%) 34 (4.4%) Placebo (N=439) n (%) 3 (0.7%) 0 7 (1.6%) Myoclonic Seizures: In the placebo-controlled study using KEPPRA tablets, 8.3% of patients receiving KEPPRA and 1.7% receiving placebo either discontinued or had a dose reduction as a result of an adverse event. The adverse reactions that led to discontinuation or dose reduction in the well-controlled study and that occurred more frequently in KEPPRA-treated patients than in placebotreated patients are presented in Table 4. Table 4: Adverse Reactions That Resulted In Discontinuation Or Dose Reduction That Occurred More Frequently in KEPPRA-Treated Patients In The PlaceboControlled Study In Patients With Juvenile Myoclonic Epilepsy Adverse Reaction Anxiety Depressed mood Depression Diplopia Hypersomnia Insomnia Irritability Nervousness Somnolence KEPPRA (N=60) n (%) 2 (3.3%) 1 (1.7%) 1 (1.7%) 1 (1.7%) 1 (1.7%) 1 (1.7%) 1 (1.7%) 1 (1.7%) 1 (1.7%) Placebo (N=60) n (%) 1 (1.7%) 0 0 0 0 0 0 0 0 Myoclonic Seizures Although the pattern of adverse reactions in this study seems somewhat different from that seen in patients with partial seizures, this is likely due to the much smaller number of patients in this study compared to partial seizure studies. The adverse reaction pattern for patients with JME is expected to be essentially the same as for patients with partial seizures. In the well-controlled clinical study using KEPPRA tablets in patients with myoclonic seizures, the most frequently reported adverse reactions in patients using KEPPRA in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, neck pain, and pharyngitis. Table 2 lists treatment-emergent adverse reactions that occurred in at least 5% of juvenile myoclonic epilepsy patients experiencing myoclonic seizures treated with KEPPRA tablets and were numerically more common than in patients treated with placebo. In this study, either KEPPRA or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity. Table 2: Incidence (%) Of Treatment-Emergent Adverse Reactions In A PlaceboControlled, Add-On Study In Patients With Myoclonic Seizures By Body System (Adverse Reactions Occurred In At Least 5% Of KEPPRA-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients) Body System/ Adverse Reaction Ear and labyrinth disorders Vertigo Infections and infestations Pharyngitis Influenza Musculoskeletal and connective tissue disorders Neck pain Nervous system disorders Somnolence Psychiatric disorders Depression KEPPRA (N=60) % 5 7 5 Placebo (N=60) % 3 0 2 8 12 5 2 2 2 Comparison Of Gender, Age And Race The overall adverse experience proﬁle of KEPPRA was similar between females and males. There are insufﬁcient data to support a statement regarding the distribution of adverse experience reports by age and race. Postmarketing Experience The following adverse events have been identiﬁed during postapproval use of KEPPRA. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In addition to the adverse reactions listed above [see Adverse Reactions, Clinical Studies Experience], the following adverse events have been reported in patients receiving marketed KEPPRA worldwide. The listing is alphabetized: abnormal liver function test, hepatic failure, hepatitis, leukopenia, neutropenia, pancreatitis, pancytopenia (with bone marrow suppression identiﬁed in some of these cases), thrombocytopenia and weight loss. Alopecia has been reported with KEPPRA use; recovery was observed in majority of cases where KEPPRA was discontinued. There have been reports of suicidal behavior (including completed suicide, suicide attempt, and suicidal ideation) with marketed KEPPRA. DRUG INTERACTIONS General Information In vitro data on metabolic interactions indicate that KEPPRA is unlikely to produce, or be subject to, pharmacokinetic interactions. Levetiracetam and its major metabolite, at concentrations well above Cmax levels achieved within the therapeutic dose range, are neither inhibitors of nor high afﬁnity substrates for human liver cytochrome P450 isoforms, epoxide hydrolase or UDPglucuronidation enzymes. In addition, levetiracetam does not affect the in vitro glucuronidation of valproic acid. Levetiracetam circulates largely unbound (<10% bound) to plasma proteins; clinically signiﬁcant interactions with other drugs through competition for protein binding sites are therefore unlikely. Potential pharmacokinetic interactions were assessed in clinical pharmacokinetic studies (phenytoin, valproate, oral contraceptive, digoxin, warfarin, probenecid) and through pharmacokinetic screening in the placebo-controlled clinical studies in epilepsy patients. Phenytoin KEPPRA (3000 mg daily) had no effect on the pharmacokinetic disposition of phenytoin in patients with refractory epilepsy. Pharmacokinetics of levetiracetam were also not affected by phenytoin. http://wikihealthcare.jointcommission.org/twiki/bin/view/Standards/ScreeningAndBriefIntervention http://wikihealthcare.jointcommission.org/twiki/bin/view/Standards/ScreeningAndBriefIntervention http://wikihealthcare.jointcommission.org/twiki/bin/view/Standards/ScreeningAndBriefIntervention

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ACEP News - June 2008 Contents News - Time to Move Tricks of the Trade - Revealing Tips Focus On - Dengue Fever Practice Trends - EMTALA Results

ACEP News - June 2008

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