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TOLERABILITY AND SAFETY OF ZONISAMIDE IN ELDERLY PATIENTS WITH PARTIAL EPILEPSY: RESULTS OF A POOLED ANALYSIS
  1. E Trinka,
  2. J Segieth,
  3. L Giorgi
  1. Paracelsus Medical University, Christian Doppler Klinik, Salzburg; Eisai Ltd, Hatfield

    Abstract

    Purpose To assess the tolerability/safety of zonisamide in elderly patients with partial epilepsy.

    Method A pooled analysis of data from elderly (≥65 years) patients receiving zonisamide for partial seizures in clinical studies was conducted (N=95) and compared to pooled adult (18−65 years) patient data (N=1389). Assessments included treatment-emergent adverse events (TEAEs), clinical laboratory parameters and weight.

    Results Overall incidence of TEAEs was similar in elderly versus adult patients (82.1% vs. 83.9%). Incidence was lower in elderly versus adult patients for treatment-related TEAEs (55.8% vs. 72.7%), severe TEAEs (11.6% vs. 20.4%), serious TEAEs (12.6% vs. 16.6%), and TEAEs leading to withdrawal (17.9% vs. 22.1%). TEAEs reported by ≥5% of patients in either cohort and more frequently by elderly versus adult patients were fatigue (11.6% vs. 9.7%), nasopharyngitis (8.4% vs. 7.2%), constipation (7.4% vs. 4.8%) and pruritus (6.3% vs. 2.1%). Serious TEAEs reported by >2% elderly patients were convulsion (2.1%) and grand mal convulsion (2.1%). Three elderly patients died but only one death was considered treatment-related (circulatory collapse following pancreatitis). No severe TEAEs were reported by >2% elderly patients. For elderly patients, there were few clinically significant changes in clinical laboratory parameters, no reports of respiratory alkalosis or metabolic acidosis, and no significant weight changes.

    Conclusion Zonisamide was well tolerated by elderly patients with partial epilepsy when compared to adult patients. Most TEAEs were of mild-to-moderate intensity and the overall incidence was similar to adult patients. No new or unexpected safety findings were identified.

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