TY - JOUR
T1 - Non-interventional surveillance study of adverse events in patients with epilepsy
AU - Cramer, J. A.
AU - Steinborn, B.
AU - Striano, P.
AU - Hlinkova, L.
AU - Bergmann, A.
AU - Bacos, I.
AU - Baukens, C.
AU - Buyle, S.
PY - 2011/7
Y1 - 2011/7
N2 - Objectives- Compare adverse events (AEs) in patients with epilepsy taking different antiepileptic drugs (AEDs) using standardized physician-completed questionnaires. Materials and methods- Multicenter, observational, cross-sectional study in epilepsy patients aged ≥4, stable on 1-2 AED(s) for ≥3months. Results- One thousand and nineteen patients were evaluated: 28.7% took newer, 71.3% older (or older+newer) AED(s); 56.9% monotherapy; 43.1% polytherapy. Overall, 68.3% reported ≥1 AE (61.3% newer; 71.1% older AEDs), most commonly: cognitive function disturbances, sedation, psychological problems. Patients taking newer AEDs were significantly less likely to report ≥1 AE (OR [95% CI]: 0.64 [0.46-0.89], P=0.008). Treatment/dose changed at study visit: 22.8% (17.5% newer; 24.9% older AEDs) because of (newer/older); lack of efficacy (6.2%/7.8%); AEs (4.1/8.4%); absence of seizures (3.8/4.0%). Patients receiving levetiracetam or lamotrigine were significantly less likely to report AEs/modify treatment. Conclusion- Patients taking newer AEDs were significantly less likely to report AEs, although the non-randomized study design does not allow the lower rate of AEs to be attributed with certainty to the use of newer AEDs. A standardized AE questionnaire appeared useful for monitoring AEs/optimizing AED therapy.
AB - Objectives- Compare adverse events (AEs) in patients with epilepsy taking different antiepileptic drugs (AEDs) using standardized physician-completed questionnaires. Materials and methods- Multicenter, observational, cross-sectional study in epilepsy patients aged ≥4, stable on 1-2 AED(s) for ≥3months. Results- One thousand and nineteen patients were evaluated: 28.7% took newer, 71.3% older (or older+newer) AED(s); 56.9% monotherapy; 43.1% polytherapy. Overall, 68.3% reported ≥1 AE (61.3% newer; 71.1% older AEDs), most commonly: cognitive function disturbances, sedation, psychological problems. Patients taking newer AEDs were significantly less likely to report ≥1 AE (OR [95% CI]: 0.64 [0.46-0.89], P=0.008). Treatment/dose changed at study visit: 22.8% (17.5% newer; 24.9% older AEDs) because of (newer/older); lack of efficacy (6.2%/7.8%); AEs (4.1/8.4%); absence of seizures (3.8/4.0%). Patients receiving levetiracetam or lamotrigine were significantly less likely to report AEs/modify treatment. Conclusion- Patients taking newer AEDs were significantly less likely to report AEs, although the non-randomized study design does not allow the lower rate of AEs to be attributed with certainty to the use of newer AEDs. A standardized AE questionnaire appeared useful for monitoring AEs/optimizing AED therapy.
KW - Antiepileptic drugs
KW - Lamotrigine
KW - Levetiracetam
KW - Monotherapy
KW - Polytherapy
KW - Tolerability
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U2 - 10.1111/j.1600-0404.2010.01440.x
DO - 10.1111/j.1600-0404.2010.01440.x
M3 - Article
C2 - 21039365
AN - SCOPUS:79958291914
VL - 124
SP - 13
EP - 21
JO - Acta Neurologica Scandinavica
JF - Acta Neurologica Scandinavica
SN - 0001-6314
IS - 1
ER -