Oxcarbazepine in Clinical Practice: Data from the PADS Group
Abstract number :
1.268
Submission category :
Year :
2001
Submission ID :
2125
Source :
www.aesnet.org
Presentation date :
12/1/2001 12:00:00 AM
Published date :
Dec 1, 2001, 06:00 AM
Authors :
B.G. Nikolov, MD, Neurology, Weill Medical Center at Cornell University, New York, NY; J.A. French, MD, Neurology, Hospital of University of Pennsylvania, Philadelphia, PA; A.F. Fix, Neurology, Hospital of University of Pennsylvania, Philadelphia, PA; G.D
RATIONALE: The use of a newly approved antiepileptic drug (AED) in a clinical practice setting as compared to a clinical trial setting may provide valuable information. Using the Postmarketing Antiepileptic Drug/Device Survey (PADS) database, we sought to evaluate the patient population selected, side effects and titration schedule used when initiating oxcarbazepine (OXC).
METHODS: The PADS database contains information from 20 epilepsy centers on all patients starting newly marketed AEDs and the VNS. The subjects are enrolled prospectively and clinical care is not altered by the study. Demographic information, past neurologic history and response to the new treatment is gathered for subsequent analysis.
RESULTS: Since the release of OXC, 161 patients started on OXC were enrolled in the PADS database, having a mean age of 39 years (range 8-77) and a mean age of onset of epilepsy of 16 years (range 0-76); 90 were female and 71 were male. The mean duration of epilepsy was 23 years (range 0-66 years). Forty-three (27%) were started on monotherapy (16 were directly switched), 61 were on 1 concurrent AED, 43 took 2 AEDs, 10 took 3 AEDS, 4 took 4 AEDs. Numbers of previous AEDs taken ranged from 0-10, with a median of 3; 27 patients took no previous AEDs (17%), and 19 patients had taken only 1 previous AED (12%).
Follow-up for at least 6 months was available for 47 patients. Three were seizure-free on daily doses of 1050 mg, 1200 mg and 1800 mg per day. Twenty-five out of the 47 patients discontinued OXC for the following reasons: lack of efficacy (LOE) for 4, LOE and adverse events for 3, fatigue for 7, dizziness for 2, headache for 2, behavioral changes for 2, rash for 1, psychomotor slowing for 1, diplopia for 1, pain for 1, and self discontinued for 1.
Three titration ranges were used: [lt]300 mg/week, 600 mg/week and [gt]600 mg/week. No difference was found in titration rates between those patients who discontinued and those who remained on OXC using chi-square analysis.
CONCLUSIONS: A high proportion of patients are being started on OXC as monotherapy, with many taking OXC as their initial AED. Adverse events accounted for most discontinuations, and rapid titration rate or high initial dose was not associated with discontinuation in this sample.
Support: PADS group consortium