11 results
Search Results
2. Bioequivalence and switchability of generic antiseizure medications (ASMs): A re‐appraisal based on analysis of generic ASM products approved in Europe.
- Author
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Odi, Reem, Franco, Valentina, Perucca, Emilio, and Bialer, Meir
- Subjects
GENERIC products ,DRUGS ,CONFIDENCE intervals ,GABAPENTIN ,ANTICONVULSANTS - Abstract
The safety of switching between generic products of antiseizure medications (ASMs) continues to be a hot topic in epilepsy management. The main reason for concern relates to the uncertainty on whether, and when, two generics found to be bioequivalent to the same brand (reference) product are bioequivalent to each other, and the risk of a switch between generics resulting in clinically significant changes in plasma ASM concentrations. This article addresses these concerns by discussing the distinction between bioequivalence and statistical testing for significant difference, the importance of intra‐subject variability in interpreting bioequivalence studies, the stricter regulatory bioequivalence requirements applicable to narrow‐therapeutic‐index (NTI) drugs, and the extent by which currently available generic products of ASMs comply with such criteria. Data for 117 oral generic products of second‐generation ASMs approved in Europe by the centralized, mutual recognition or decentralized procedure were analyzed based on a review of publicly accessible regulatory assessment reports. The analysis showed that for 99% of generic products assessed (after exclusion of gabapentin products), the 90% confidence intervals (90% CIs) of geometric mean ratios (test/reference) for AUC (area under the drug concentration vs time curve) were narrow and wholly contained within the acceptance interval (90%–111%) applied to NTI drugs. Intra‐subject variability for AUC was <10% for 53 (88%) of the 60 products for which this measure was reported. Many gabapentin generics showed broader, 90% CIs for bioequivalence estimates, and greater intra‐subject variability, compared with generics of other ASMs. When interpreted within the context of other available data, these results suggest that any risk of non‐bioequivalence between these individual generic products is small, and that switches across these products are not likely to result in clinically relevant changes in plasma drug exposure. The potential for variability in exposure when switching across generics is likely to be greatest for gabapentin. [ABSTRACT FROM AUTHOR]
- Published
- 2021
- Full Text
- View/download PDF
3. Advancing research toward faster diagnosis, better treatment, and end of stigma in epilepsy.
- Author
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Pitkänen, Asla, Henshall, David C., Cross, J. Helen, Guerrini, Renzo, Jozwiak, Sergiusz, Kokaia, Merab, Simonato, Michele, Sisodiya, Sanjay, and Mifsud, Janet
- Subjects
THERAPEUTICS ,SOCIAL stigma ,EPILEPSY ,GENETICS ,DIAGNOSIS - Abstract
Seven large European Union (EU)–funded epilepsy‐related research projects joined forces in May 2018 in Brussels, Belgium, in a unique community building event—the epiXchange conference. During this conference, 170 investigators from the projects DESIRE, EpimiRNA, EPISTOP, EpiTarget, EpiXchange, and EpiPGX as well as the European Reference Network EpiCARE, met up with key stakeholders including representatives of the European Commission, patient organizations, commercial partners, and other European and International groups. The epiXchange conference focused on sharing and reviewing the advances made by each project in the previous 5 years; describing the infrastructures generated; and discussing the innovations and commercial applications across five thematic areas: biomarkers, genetics, therapeutics, comorbidities, and biobanks and resources. These projects have, in fact, generated major breakthroughs including the discovery of biofluid‐based molecules for diagnosis, elucidating new genetic causes of epilepsy, creating advanced new models of epilepsy, and the pre‐clinical development of novel compounds. Workshop‐style discussions focused on how to overcome scientific and clinical challenges for accelerating translation of research outcomes and how to increase synergies between the projects and stakeholders at a European level. The resulting advances would lead toward a measurable impact of epilepsy research through better diagnostics, treatments, and quality‐of‐life for persons with epilepsy. In addition, epiXchange provided a unique forum for examining how the different projects could build momentum for future novel groundbreaking epilepsy research in Europe and beyond. This report includes the main recommendations that resulted from these discussions. [ABSTRACT FROM AUTHOR]
- Published
- 2019
- Full Text
- View/download PDF
4. Preface.
- Author
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Wolf, Peter
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EPILEPSY ,MEDICAL needs assessment ,DEVELOPED countries ,DEVELOPING countries - Abstract
In 1993, when the International League Against Epilepsy appointed a special Commission on European Affairs for the first time, it became clear that there was an urgent need for a detailed assessment of the situation in epilepsy across Europe. After the widening of the European agenda in the early 1990s, Europe was one continent that included some of the most developed nations of the world alongside others with developing country status. Some of the internationally leading epilepsy centres found themselves side-to-side with environments where epilepsy was still considered a psychiatric condition of doubtful prognosis, and where a regular supply of the necessary medicine was not available, or patients could not afford it.
- Published
- 2003
- Full Text
- View/download PDF
5. Announcements.
- Subjects
CALENDARS (Publications) ,CONFERENCES & conventions ,EPILEPSY - Abstract
A calendar of conferences related to epilepsy is presented which includes the 11th European Conference on Epilepsy and Society, Malformations of Cortical Development (MCD) and Epilepsy symposium, 2nd Biennial North American Regional Epilepsy Congress.
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- 2008
- Full Text
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6. ANNOUNCEMENTS.
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SPECIAL events ,NEUROLOGY ,AWARDS ,EPILEPSY - Abstract
The article offers developments related to neurology in Europe. Schedule for educational of European Epilepsy Academy Distance Education Programs 2007/2008 will include a course on "Genetics of Epilepsy". The opening of the Early Career Physician Scientists awards to investigators from around the world has been announced by the Milken Family/American Foundation and the American Epilepsy Society (APS). APS has announced the call for nominations for the 2007 Epilepsy Research Recognition Awards.
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- 2007
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7. Epilepsy Surgery: Historical Highlights 1909–2009.
- Author
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Feindel, William, Leblanc, Richard, and de Almeida, Antonio Nogueira
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AMYGDALOID body ,TEMPORAL lobe epilepsy ,HIPPOCAMPUS (Brain) ,SEIZURES (Medicine) - Abstract
This review focuses on some historical highlights of the surgery of epilepsy, beginning with the reports of Horsley, Krause, and Cushing to which appeared in 1909, the year that The International League Against Epilepsy (ILAE) was inaugurated. We then outline key contributions from Europe and North America, and examine particularly the evolution of our understanding of temporal lobe seizures, which have now become the most common form of epilepsy amenable to surgical cure. [ABSTRACT FROM AUTHOR]
- Published
- 2009
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8. Calender of Meetings.
- Subjects
MEDICAL conferences - Abstract
Presents information regarding various conferences to be held in Europe in the field of medicine as of 2003. Date for an international conference on epilepsy and surgery; Venue and date of the European Paediatric Neurology Society Congress for 2003.
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- 2003
- Full Text
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9. Estimating the Cost of Epilepsy in Europe: A Review with Economic Modeling.
- Author
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Pugliatti, Maura, Beghi, Ettore, Forsgren, Lars, Ekman, Mattias, and Sobocki, Patrik
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EPILEPSY ,EPIDEMIOLOGICAL research ,MEDICAL economics ,POPULATION statistics - Abstract
Based on available epidemiologic, health economic, and international population statistics literature, the cost of epilepsy in Europe was estimated. Europe was defined as the 25 European Union member countries, Iceland, Norway, and Switzerland. Guidelines for epidemiological studies on epilepsy were used for a case definition. A bottom-up prevalence-based cost-of-illness approach, the societal perspective for including the cost items, and the human capital approach as valuation principle for indirect costs were used. The cost estimates were based on selected studies with common methodology and valuation principles. The estimated prevalence of epilepsy in Europe in 2004 was 4.3–7.8 per 1,000. The estimated total cost of the disease in Europe was €15.5 billion in 2004, indirect cost being the single most dominant cost category (€8.6 billion). Direct health care costs were €2.8 billion, outpatient care comprising the largest part (€1.3 billion). Direct nonmedical cost was €4.2 billion. That of antiepileptic drugs was €400 million. The total cost per case was €2,000–11,500 and the estimated cost per European inhabitant was €33. Epilepsy is a relevant socioeconomic burden at individual, family, health services, and societal level in Europe. The greater proportion of such burden is outside the formal health care sector, antiepileptic drugs representing a smaller proportion. Lack of economic data from several European countries and other methodological limitations make this report an initial estimate of the cost of epilepsy in Europe. Prospective incidence cost-of-illness studies from well-defined populations and common methodology are encouraged. [ABSTRACT FROM AUTHOR]
- Published
- 2007
- Full Text
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10. The Provision of Epilepsy Care across Europe.
- Author
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Malmgren, Kristina, Flink, Roland, Guekht, Alla B., Michelucci, Roberto, Neville, Brian, Pedersen, Birthe, Pinto, Francisco, Stephani, Ulrich, and Özkara, Cigdem
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EPILEPSY ,DEVELOPMENTAL disabilities ,BRAIN diseases - Abstract
Summary: Purpose: To assess the needs and resources available in the provision of basic epilepsy care across Europe. Methods: A mailed questionnaire was used, the European Epilepsy Services inventory (EESI). The EESI was distributed to all 36 European chapters of the International League Against Epilepsy (ILAE), and answers were obtained from 32, a response rate of 89%. For the purpose of studying trends across Europe, the chapters were divided into a Western, an Eastern, a Central, and a Southern group. Results: The survey results showed that there was a wide range in the number of physicians and specialists involved in epilepsy care across Europe, with a trend toward higher numbers of neurologists, pediatricians, and pediatric neurologists in Eastern Europe. Many different specialities were involved in epilepsy care, and many chapters reported differences in the provision of care across their countries, with less possibility for patients to see a specialist in the least provided areas, where most epilepsy patients were cared for by general practitioners and internists. Problems with high costs of the newer antiepileptic drugs were most pronounced in Eastern Europe. Problems with lack of comprehensive care and of epilepsy specialists, with stigma and social problems, and with insufficient professional education and knowledge about epilepsy were reported all across Europe. Conclusions: Knowledge about differences in the pattern of provision of epilepsy care and about the main problems encountered by the European ILAE chapters is of importance in the continuing efforts to improve management of epilepsy all over Europe. [ABSTRACT FROM AUTHOR]
- Published
- 2003
- Full Text
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11. Minimum requirements for approval of a drug in status epilepticus.
- Author
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Baulac, Michel and Navarro, Vincent
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INTRAVENOUS therapy ,NEUROBEHAVIORAL disorders ,EPILEPSY ,DENTAL prophylaxis ,BRAIN diseases ,PATIENTS - Abstract
The article focuses on regulatory experience concerning intravenous (i.v.) formulations and their potential indication in status epilepticus (SE) in Europe. As reported, the European regulatory experience in general convulsive status epilepticus (GCSE) has been the only approval of fosphenytoin (fosPHT). As stated, the regulatory dossier of fosPHT includes several safety measures such as seizure prophylaxis in neurosurgery and substitution to oral PHT in chronic epilepsy patients for five days.
- Published
- 2009
- Full Text
- View/download PDF
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