Ribeirão Preto Medical School University Hospital, University of São Paulo, Federal Technological University of Paraná, Cornélio Procópio, Brazil, Clinical Pharmacology Unit, University of Pavia and National Neurological Institute IRCCS C. Mondino Foundation, Pavia, Italy
Background. Patients with refractory epilepsy often have impaired quality of life (QOL) as a consequence of seizures and adverse effects of antiepileptic drugs. We assessed the impact of adverse effects on QOL and the utility of a structured instrument to help the physician manage adverse effects in patients with refractory epilepsy.
Methods. Clinical characteristics, drug treatment and adverse effects were evaluated in 102 patients with refractory epilepsy at a single tertiary referral centre. The Adverse Events Profile (AEP) and Quality of Life in Epilepsy-31 (QOLIE-31) questionnaires were completed at baseline and after six months. At baseline, patients with a high burden of adverse effects (AEP scores ≥45) were randomized to an intervention or control group. AEP scores in the intervention group were available to the physician as an instrument to help to reduce adverse effects.
Results. Ninety-five patients (93.1%) were on polytherapy. Sixty-six completed the questionnaires and, of these, 43 (65.1%) had a high AE burden and were randomized to the intervention and control group. QOLIE-31 scores were inversely correlated with AEP scores at both visits. Among randomized patients, AEP scores tended to decrease between the baseline and the final visit without significant differences between groups (intervention group: 54.1 ± 6.1
vs 51.1 ± 9.1; control group: 55.8 ± 5.8
vs 50.5 ± 12.2). QOLIE-31 scores did not change substantially between visits (intervention group: 45.9 ± 17.4
vs 48.4 ± 14; control group: 47.5 ± 15.7
vs 45.2 ± 18.9).
Conclusion. A significant proportion of patients had a high toxicity burden which had an impact on their QOL. Reduction of overtreatment is a difficult challenge which cannot be addressed solely by providing a structured assessment of adverse effects, but requires a more comprehensive approach aimed at optimizing the many components of the management strategy.