LEVETIRACETAM EXPERIENCE POST FDA APPROVAL IN AN ACADEMIC CLINICAL PRACTICE; A RETROSPECTIVE ANALYSIS
Abstract number :
2.270
Submission category :
Year :
2005
Submission ID :
5576
Source :
www.aesnet.org
Presentation date :
12/3/2005 12:00:00 AM
Published date :
Dec 2, 2005, 06:00 AM
Authors :
Cormac A. O[apos]Donovan, William L. Bell, Maria C. Sam, Valerie M. Woodard, and Misty D. Brown
Levetiracetam (LEV) is licensed for add-on treatment of patients with partial seizures with or without secondary generalization. In several placebo-controlled clinical studies, its efficacy as well as tolerability has been demonstrated. We sought to evaluate efficacy and tolerability of LEV since FDA approval in an academic clinical paractice using a retrospective analysis. We retrospectively reviewed chart notes of 513 patients with epilepsy who were treated with Keppra since FDA approval. Patients were followed at an epilepsy referral center by 3 adult epileptologists. The majority of patients had refractory epilepsy and were on concomitant AED[apos]s. Measures of efficacy, tolerability and retention rates were examined. 381 patients (74.3%) responded favorably to LEV in terms of seizure control and did not experience side effects. 12.5% had no benefit in terms of seizure control leading to discontinuation of LEV. 11.3% of all patients experienced side effects. 9.4 % had side effects which led to discontinuation of LEV. Sedation and dizziness constituted the majority of side effects. 2.7 % had psychiatric side effects leading to drug withdrawal in most cases. Skin rash was seen in only one patient. 72.4% of those experiencing side effects were on concomitant AED[apos]s. Levetiracetam (LEV) is well tolerated and efficacious in this cohort of patients. These results confirm the reports of high responder rates in studies outside of clinical trials. The increased efficacy and decrease in rates of psychiatric side effects are probably due to many factors and may include increased experience of clinicians in using LEV. The rare occurrence of allergic type skin reactions confers additional safety profile compared to older AED[apos]s.