ACEP News - June 2008 - (Page 12)

ACEP NEWS • J U N E 2 0 0 8 NEWS FROM THE COLLEGE This is an excellent venue for showcasing outstanding emergency medicine research from competing meetings or journals. Please submit your research abstract(s) to the academic affairs department by Sept. 12 at academicaffairs@acep.org, or by fax at 972-580-2816. For questions about Research Forum, please call 800-798-1822, ext. 3291. ■ Request for Abstracts for ACEP’s Research Forum CEP’s Research Forum offers emergency medicine researchers another opportunity this year to present scientific emergency medicine research at its 2008 conference, Oct. 27-28, in conjunction with ACEP’s Scientific Assembly in Chicago. Abstracts from emergency physicians who have presented or published in nonemergency medicine specialty meetings or journals within the past 12 months will be considered. Case reports or subject reviews are not considered original research. These abstracts will be accepted on a space available basis as non-moderated posters. Presenters are obligated to be available to discuss their poster(s) with Research Forum attendees. KEPPRA® (levetiracetam) injection 500 mg/5 mL (100 mg/mL) Brief summary (for full prescribing information, consult package insert) only INDICATIONS AND USAGE KEPPRA injection is an alternative for adult patients (16 years and older) when oral administration is temporarily not feasible. Partial Onset Seizures KEPPRA is indicated as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy KEPPRA is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults with juvenile myoclonic epilepsy. CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Neuropsychiatric Adverse Reactions Partial Onset Seizures In some adults experiencing partial onset seizures, KEPPRA causes the occurrence of central nervous system adverse reactions that can be classiﬁed into the following categories: 1) somnolence and fatigue, 2) coordination difﬁculties, and 3) behavioral abnormalities. In controlled trials of adult patients with epilepsy experiencing partial onset seizures, 14.8% of KEPPRA-treated patients reported somnolence, compared to 8.4% of placebo patients. There was no clear dose response up to 3000 mg/day. In a study where there was no titration, about 45% of patients receiving 4000 mg/day reported somnolence. The somnolence was considered serious in 0.3% of the treated patients, compared to 0% in the placebo group. About 3% of KEPPRA-treated patients discontinued treatment due to somnolence, compared to 0.7% of placebo patients. In 1.4% of treated patients and in 0.9% of placebo patients the dose was reduced, while 0.3% of the treated patients were hospitalized due to somnolence. In controlled trials of adult patients with epilepsy experiencing partial onset seizures, 14.7% of treated patients reported asthenia, compared to 9.1% of placebo patients. Treatment was discontinued in 0.8% of treated patients as compared to 0.5% of placebo patients. In 0.5% of treated patients and in 0.2% of placebo patients the dose was reduced. A total of 3.4% of KEPPRA-treated patients experienced coordination difﬁculties, (reported as either ataxia, abnormal gait, or incoordination) compared to 1.6% of placebo patients. A total of 0.4% of patients in controlled trials discontinued KEPPRA treatment due to ataxia, compared to 0% of placebo patients. In 0.7% of treated patients and in 0.2% of placebo patients the dose was reduced due to coordination difﬁculties, while one of the treated patients was hospitalized due to worsening of pre-existing ataxia. Somnolence, asthenia and coordination difﬁculties occurred most frequently within the ﬁrst 4 weeks of treatment. In controlled trials of patients with epilepsy experiencing partial onset seizures, 5 (0.7%) of KEPPRA-treated patients experienced psychotic symptoms compared to 1 (0.2%) placebo patient. Two (0.3%) KEPPRA-treated patients were hospitalized and their treatment was discontinued. Both events, reported as psychosis, developed within the ﬁrst week of treatment and resolved within 1 to 2 weeks following treatment discontinuation. Two other events, reported as hallucinations, occurred after 1-5 months and resolved within 2-7 days while the patients remained on treatment. In one patient experiencing psychotic depression occurring within a month, symptoms resolved within 45 days while the patient continued treatment. A total of 13.3% of KEPPRA patients experienced other behavioral symptoms (reported as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, etc.) compared to 6.2% of placebo patients. Approximately half of these patients reported these events within the ﬁrst 4 weeks. A total of 1.7% of treated patients discontinued treatment due to these events, compared to 0.2% of placebo patients. The treatment dose was reduced in 0.8% of treated patients and in 0.5% of placebo patients. A total of 0.8% of treated patients had a serious behavioral event (compared to 0.2% of placebo patients) and were hospitalized. In addition, 4 (0.5%) of treated patients attempted suicide compared to 0% of placebo patients. One of these patients completed suicide. In the other 3 patients, the events did not lead to discontinuation or dose reduction. The events occurred after patients had been treated for between 4 weeks and 6 months [see Patient Counseling Information in the full prescribing information]. Myoclonic Seizures During clinical development, the number of patients with myoclonic seizures exposed to KEPPRA was considerably smaller than the number with partial seizures. Therefore, under-reporting of certain adverse reactions was more likely to occur in the myoclonic seizure population. In some patients experiencing myoclonic seizures, KEPPRA causes somnolence and behavioral abnormalities. It is expected that the events seen in partial seizure patients would occur in patients with JME. In the double-blind, controlled trial in patients with juvenile myoclonic epilepsy experiencing myoclonic seizures, 11.7% of KEPPRA-treated patients experienced somnolence compared to 1.7% of placebo patients. No patient discontinued treatment as a result of somnolence. In 1.7% of KEPPRA-treated patients and in 0% of placebo patients the dose was reduced as a result of somnolence. Non-psychotic behavioral disorders (reported as aggression and irritability) occurred in 5% of the KEPPRA-treated patients compared to 0% of placebo patients. Non-psychotic mood disorders (reported as depressed mood, depression, and mood swings) occurred in 6.7% of KEPPRA-treated patients compared to 3.3% of placebo patients. A total of 5.0% of KEPPRA-treated patients had a reduction in dose or discontinued treatment due to behavioral or psychiatric events (reported as anxiety, depressed mood, depression, irritability, and nervousness), compared to 1.7% of placebo patients. Withdrawal Seizures Antiepileptic drugs, including KEPPRA, should be withdrawn gradually to minimize the potential of increased seizure frequency. Hematologic Abnormalities Partial Onset Seizures Minor, but statistically signiﬁcant, decreases compared to placebo in total mean RBC count (0.03 x 106/mm3), mean hemoglobin (0.09 g/dL), and mean hematocrit (0.38%), were seen in KEPPRA-treated patients in controlled trials. A total of 3.2% of treated and 1.8% of placebo patients had at least one possibly signiﬁcant (≤2.8 x 109/L) decreased WBC, and 2.4% of treated and 1.4% of placebo patients had at least one possibly signiﬁcant (≤1.0 x 109/L) decreased neutrophil count. Of the treated patients with a low neutrophil count, all but one rose towards or to baseline with continued treatment. No patient was discontinued secondary to low neutrophil counts. Juvenile Myoclonic Epilepsy Although there were no obvious hematologic abnormalities observed in patients with JME, the limited number of patients makes any conclusion tentative. The data from the partial seizure patients should be considered to be relevant for JME patients. Hepatic Abnormalities There were no meaningful changes in mean liver function tests (LFT) in controlled trials in adult patients; lesser LFT abnormalities were similar in drug and placebo treated patients in controlled trials (1.4%). No patients were discontinued from controlled trials for LFT abnormalities except for 1 (0.07%) adult epilepsy patient receiving open treatment. Laboratory Tests Although most laboratory tests are not systematically altered with KEPPRA treatment, there have been relatively infrequent abnormalities seen in hematologic parameters and liver function tests. ADVERSE REACTIONS Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reﬂect the rates observed in practice. The adverse reactions that result from KEPPRA injection use include all of those reported for KEPPRA tablets and oral solution. Equivalent doses of intravenous (IV) levetiracetam and oral levetiracetam result in equivalent Cmax, Cmin, and total systemic exposure to levetiracetam when the IV levetiracetam is administered as a 15 minute infusion. The prescriber should be aware that the adverse reaction incidence ﬁgures in the following tables, obtained when KEPPRA was added to concurrent AED therapy, cannot be used to predict the frequency of adverse experiences in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with ﬁgures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the pr

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ACEP News - June 2008

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