Posts Tagged Epileptic Seizure

[WEB SITE] Real-world data confirms clinical effectiveness of Zebinix®  

Real-world data confirms clinical effectiveness of Zebinix® (eslicarbazepine acetate) for the treatment of partial-onset epilepsy in adults

  • Eslicarbazepine acetate data shows seizure freedom in 41.3% of patients at 12 months, and retention rates of 73.4%.1
  • Results from the Euro-Esli study presented 5th September 2017 at the 32ndInternational Epilepsy Congress (IEC) in Barcelona, Spain.1

Bial and Eisai have announced data confirming the effectiveness and tolerability of Zebinix® (eslicarbazepine acetate) in routine clinical practice, thereby complementing evidence from clinical trials.[i] The Euro-Esli study is an exploratory pooled analysis of data from 14 European clinical practice studies, analysing data of 2,058 patients aged between 14-88 years old with partial-onset seizures (POS), with or without secondary generalisation.1 Full results were presented at the IEC in Barcelona, Spain.1

“It is most reassuring to see similar efficacy results with eslicarbazepine acetate in a routine clinical setting compared to that of clinical trials; we can be confident that this treatment is effective amongst the diversity of our ‘real’ epilepsy patients,” explains Dr Vicente Villanueva, Neurologist and Epileptologist, Hospital Universitario y Politécnico La Fe, Valencia, Spain. “Real-world studies like the Euro-Esli study are important because they provide significant insight into how a drug performs in a routine medical setting, allowing us to assess the drug, to ultimately improve patient outcomes.”

Epilepsy is one of the most common neurological conditions in the world, affecting approximately six million people in Europe.2 An epileptic seizure is a clinical manifestation of the condition, thought to result from an abnormal discharge of a set of neurons in the brain.[ii] Seizures can vary in manifestation, from brief lapses of attention to severe and prolonged convulsions.[iii] Depending on the type, seizures may involve one part of the body or the whole body, and may affect consciousness.3 Seizures can also vary in frequency from less than one per year, to several per day.3 Epilepsy has many possible causes but often the cause is unknown.3

The Euro-Esli study (in over 2,000 patients with epilepsy) showed that at 3, 6 and 12 months, seizure freedom rates in patients aged 14-88 years treated with eslicarbazepine acetate were 30.6%, 38.3% and 41.3% respectively. Retention rates were 95.4%, 86.6% and 73.4% and responder rates were 60.9%, 70.5% and 75.6%, respectively.1 There were significant reductions from baseline to final visit in monthly frequencies of total (mean reduction 44.1%), simple partial (78.8%), complex partial (53.1%) and secondarily generalised (80.0%) seizures (p<0.001 for all).1 Adverse events were reported for 34.0% of patients and led to discontinuation of 13.6% of patients.1 The most frequently reported adverse events were dizziness (6.7%), fatigue (5.4%) and somnolence (5.1%).1

These results improve our knowledge and understanding around the use of eslicarbazepine acetate in routine clinical practice and strengthen Bial’s commitment to developing and delivering beneficial treatment options for people living with epilepsy António Portela, CEO of Bial

These data underscore our commitment to our anti-epileptic drug product portfolio. We will continue to invest both in clinical trials and the generation of real-world evidence to improve the lives of patients living with epilepsy
Neil West, Vice President EMEA, Global Neurology Business Unit at Eisai

Eslicarbazepine acetate is indicated as monotherapy in the treatment of POS, with or without secondary generalisation, in adults with newly diagnosed epilepsy; and as adjunctive therapy in adults, adolescents, and children aged above six years, with POS with or without secondary generalisation.[iv]

About the Euro-Esli study1

The Euro-Esli study was a large, exploratory, pooled analysis of real-world data from 14 European clinical practice studies, including data from 2,058 patients (52.1% male; mean age 44 years; mean epilepsy duration 20.9 years). Retention and effectiveness were assessed after 3, 6 and 12 months of treatment with eslicarbazepine acetate. Effectiveness assessments comprised percentage reduction from baseline in monthly seizure frequency, responder rate (≥50% seizure frequency reduction) and seizure freedom rate (seizure freedom at least since prior visit). Safety and tolerability were assessed by evaluating adverse events (AEs).

REFERENCES

[i] Villanueva V, et al. (2017) A European audit of real-world use of eslicarbazepine acetate as a treatment for partial-onset seizures: the Euro-Esli study. International Epilepsy Congress (IEC) 2017; Barcelona, Spain, Poster p0918

[ii] World Health Organization. (2010) Epilepsy in The WHO European Region: Fostering Epilepsy Care in Europe. Cruquius, Paswerk Bedrijven. Available from: www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed August 2017].

[iii] World Health Organization. (2017) Epilepsy Fact Sheet. Available from: www.who.int/mediacentre/factsheets/fs999/en/ [Accessed August 2017].

[iv] Eisai. (2017) Zebinix® (eslicarbazepine acetate) Summary of Product Characteristics. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000988/WC500047225.pdf  [Accessed August 2017].

[v] Hebeisen S, et al. (2015) Eslicarbazepine and the enhancement of slow inactivation of voltage-gated sodium channels: A comparison with carbamazepine, oxcarbazepine and lacosamide. Neuropharmacology. 89, 122-135

[vi] Elger C, et al. (2007) Eslicarbazepine acetate: A double-blind, add-on, placebo-controlled exploratory trial in adult patients with partial-onset seizures. Epilepsia. 48, 497-504.

[vii] Elger C, et al. (2009) Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial onset seizures: A randomised, double-blind, placebo-controlled, parallel-group phase III study.Epilepsia. 50, 454-63.

[viii] Ben-Menachem E, et al. (2010) Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy. Epilepsy Research. 89(2-3), 278-85.

[ix] Gil-Nagel A, et al. (2009) Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures. Acta Neurologica Scandinavica. 120, 281-87.

Source: Real-world data confirms clinical effectiveness of Zebinix® | ACNR | Online Neurology Journal

, ,

Leave a comment

[WEB SITE] UC study explores how low risk stress reduction treatments may benefit epilepsy patients

Patients with epilepsy face many challenges, but perhaps the most difficult of all is the unpredictability of seizure occurrence. One of the most commonly reported triggers for seizures is stress.

A recent review article in the European journal Seizure, by researchers at University of Cincinnati Epilepsy Center at the UC Gardner Neuroscience Institute, looks at the stress-seizure relationship and how adopting stress reduction techniques may provide benefit as a low risk form of treatment.

The relationship between stress and seizures has been well documented over the last 50 years. It has been noted that stress can not only increase seizure susceptibility and in rare cases a form of reflex epilepsy, but also increase the risk of the development of epilepsy, especially when stressors are severe, prolonged, or experienced early in life.

“Studies to date have looked at the relationship from many angles,” says Michael Privitera, MD, director of the UC Epilepsy Center and professor in the Department of Neurology and Rehabilitation Medicine at the UC College of Medicine. “The earliest studies from the 1980s were primarily diaries of patients who described experiencing more seizures on ‘high-stress days’ than on ‘low-stress days.'”

Privitera and Heather McKee, MD, an assistant professor in the Department of Neurology and Rehabilitation Medicine, looked at 21 studies from the 1980s to present–from patients who kept diaries of stress levels and correlation of seizure frequency, to tracking seizures after major life events, to fMRI studies that looked at responses to stressful verbal/auditory stimuli.

“Most all [of these studies] show increases in seizure frequency after high-stress events. Studies have also followed populations who have collectively experienced stressful events, such as the effects of war, trauma or natural disaster, or the death of a loved one,” says Privitera. All of which found increased seizure risk during such a time of stress.

For example, a 2002 study evaluated the occurrence of epileptic seizures during the war in Croatia in the early 1990s. Children from war-affected areas had epileptic seizures more often than children not affected by the war. Additionally, the 10-year follow up showed that patients who had their first epileptic seizure during a time of stress were more likely to have controlled epilepsy or even be off medication years later.

“Stress is a subjective and highly individualized state of mental or emotional strain. Although it’s quite clear that stress is an important and common seizure precipitant, it remains difficult to obtain objective conclusions about a direct causal factor for individual epilepsy patients,” says McKee.

Another aspect of the stress-seizure relationship is the finding by UC researchers that there were higher anxiety levels in patients with epilepsy who report stress as a seizure precipitant. The researchers suggest patients who believe stress is a seizure trigger may want to talk with their health care provider about screening for anxiety.

“Any patient reporting stress as a seizure trigger should be screened for a treatable mood disorder, especially considering that mood disorders are so common within this population,” adds McKee.

The researchers report that while some small prospective trials using general stress reduction methods have shown promise in improving outcomes in people with epilepsy, large-scale, randomized, controlled trials are needed to convince both patients and providers that stress reduction methods should be standard adjunctive treatments for people with epilepsy.

“What I think some of these studies point to is that efforts toward stress reduction techniques, though somewhat inconsistent, have shown promise in reducing seizure frequency. We need future research to establish evidence-based treatments and clarify biological mechanisms of the stress-seizure relationship,” says Privitera.

Overall, he says, recommending stress reduction methods to patients with epilepsy “could improve overall quality of life and reduce seizure frequency at little to no risk.”

Some low risk stress reduction techniques may include controlled deep breathing, relaxation or mindfulness therapy, as well as exercise, or establishing routines.

Source: UC study explores how low risk stress reduction treatments may benefit epilepsy patients

, , , , , , , , , , , ,

Leave a comment

%d bloggers like this: