Safety of Eslicarbazepine Acetate in Elderly Versus Non-Elderly Patients with Focal Seizures: From Pooled Data of Clinical Studies to 8 Years of Post-Marketing Experience.

Abstract

INTRODUCTION:

The prevalence of epilepsy increases in elderly patients aged > 65 years, and treatment is challenging because clinical data are limited.

OBJECTIVE:

Our objective was to evaluate the safety of eslicarbazepine acetate (ESL) in patients aged ≥ 65 years versus non-elderly patients with focal seizures.

METHODS:

The safety data of seven phase II and III, double-blind, open-label, randomized clinical studies of ESL in adults were pooled. At least possibly related treatmentemergent adverse events (TEAEs) and ESL post-marketing adverse drug reactions (ADRs) were analyzed separately by age categories.

RESULTS:

The most frequently reported at least possibly related TEAEs in elderly (N = 120) versus non-elderly patients (N = 1863) were dizziness (10.8 vs. 20.3%), somnolence (9.2 vs. 12.6%), and hyponatremia (6.7 vs. 1.5%). Elderly patients presented a higher incidence of serious TEAEs (22.5 vs. 7.6%) and at least possibly related serious TEAEs (6.7 vs. 2.5%), probably because treatment was complicated by comorbidities and comedications. After an estimated cumulative exposure of over 2 million patient-months worldwide and 8 years of post-marketing surveillance, hyponatremia was the most frequently reported ADR (n = 232), accounting for 14.6% and 6.8% of the ADRs reported in elderly (n = 473) and non-elderly patients (n = 2406), respectively. This was followed by ADR/safety information such as drug-dose titration not performed (7.0 vs. 5.4%), product use in unapproved indication (4.9 vs. 1.9%), off-label use (3.4 vs. 2.2%), dizziness (3.4 vs. 3.5%), and seizure (2.1 vs. 5.8%).

CONCLUSION:

No specific safety issue was identified from the pooled studies for elderly compared with non-elderly patients. After 8 years of post-marketing surveillance, the qualitative safety of ESL remains similar to that observed in the clinical studies.

• Authors: Luís M Magalhães, Raquel Costa, Mariana Vieira, Joana Moreira, Helena Gama, Patrício Soares-da-Silva
• Journal: Drug safety (Drug Saf) Vol. 44 Issue 10 Pg. 1099-1107 (10 2021) ISSN: 1179-1942 [Electronic] New Zealand
• PMID: 34536187 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2021. The Author(s).

Chemical References

• Anticonvulsants
• Dibenzazepines
• eslicarbazepine acetate

Topics

• Adult
• Aged
• Anticonvulsants (adverse effects)
• Dibenzazepines
• Dizziness (chemically induced, epidemiology)
• Drug-Related Side Effects and Adverse Reactions (epidemiology, etiology)
• Humans
• Hyponatremia (chemically induced, drug therapy)
• Marketing
• Middle Aged
• Seizures (chemically induced, drug therapy, epidemiology)
• Treatment Outcome