Effectiveness, tolerability and changes in quality of life in patients with epilepsy treated with topiramate – results from a 28 weeks naturalistic study

Objectives: To explore tolerability, effectiveness and quality of life outcomes of patients with epilepsy treated with topiramate (TPM).

Methods: Prospective, open label, single arm, non-interventional study (TOPMAT-EPY-0009) of 28 weeks duration (4 visits: day 0, approx. 4, 16 and 28 weeks) in patients ≥12 years with epilepsy. TPM was introduced after physician's decision was made if the baseline AED was regarded as in-effective/-tolerable and transition onto TPM monotherapy or TPM as initial monotherapy was planned. Measures included number of patients with continued TPM therapy, reason for initiation of TPM, seizure type and frequency, quality of life (QOLIE-10) and adverse events (AEs).

Results: 149 patients were included in the Safety Set (51% females; mean age 45.3 (SD19.6) years; 41% with primary generalized, 43% with focal seizures), 136 patients in the ITT Set. 114 patients (77%) completed the study. 46% patients obtained TPM as first medication after initial diagnosis of epilepsy; 37% switched to TPM due to ineffectiveness and 26% due to AEs during the previous therapy. The proportion of patients receiving TPM monotherapy increased from 56% at baseline to 69% at endpoint. Retention to treatment with TPM monotherapy was 77%. The median dose of TPM prescribed increased from 25mg/day (mean 46.0, SD 51.2) at visit 1 to 100mg/day (mean 152.2, SD 92.1) at visit 4. Compared to a 12 weeks retrospective baseline, more than 66% of the patients were seizure free of each type of seizure (simple partial and generalized seizures). As for complex partial seizures, 59% patients were seizure free of this type. At endpoint QOLIE-10 total scores had improved by 29% (p<0.001 compared to baseline) corresponding to improvements in all subscales (epilepsy effects 26%, role functioning 31%, mental health 26%).

21 AEs were reported in 10 patients. No serious AEs were documented. Most common AEs (>1%) reported were fatigue (n=4), headache (n=2), dizziness (n=2), and diarrhea (n=2). 16 AEs (76%) were at least 'possibly' related to TPM. Physicians rated the tolerability and efficacy as at least 'good' for 97% and 94% of patients, respectively.

Conclusions: Topiramate was well tolerated as 77% of patients continued it either as adjunctive or monotherapy for at least 6 months in this study. In addition it was associated with a substantial seizure reduction in a large proportion of patients and improved quality of life outcomes.