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BIAL announced on 2nd September 2021 that it has entered into an agreement with Sunovion Pharmaceuticals Inc. (Sunovion) whereby BIAL received exclusive commercial license rights to commercialise apomorphine sublingual film in the European Union (EU), the European Economic Area (EEA) and the United Kingdom.
Apomorphine sublingual film (APL-130277) is a novel thin film formulation of apomorphine that dissolves under the tongue for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD).
APL-130277 is currently in Phase 3 clinical development in Europe. Under the terms of the agreement, BIAL will be responsible for regulatory approvals and submissions, including interactions with the European Medicines Agency (EMA). BIAL expects to submit a European marketing authorisation application for apomorphine sublingual film by the end of 2021.
As part of the agreement, Sunovion will receive an upfront payment and is entitled to receive certain milestone payments. Sunovion will supply apomorphine sublingual film in all approved dose strengths to BIAL.
António Portela, Chief Executive Officer of BIAL, said
We are pleased to be the partner of choice for Sunovion in Europe. BIAL has an ongoing commitment to Parkinson’s disease patients. This partnership reflects our commitment to the Parkinson’s community and is also an important step in our development strategy to expand BIAL’s footprint in Europe. We look forward to making this treatment option available and thus helping patients with Parkinson’s disease to cope with OFF episodes which are difficult and disabling to their lives.
Apomorphine sublingual film is approved as KYNMOBI® in the US and Canada. Sunovion continues to hold the exclusive commercial rights to KYNMOBI in North America and all other regions of the world outside of the EU, EEA and the United Kingdom. KYNMOBI is the first and only sublingual (under the tongue) therapy available for the on-demand treatment of PD OFF episodes in the US and Canada.
“As Parkinson’s disease progresses an individual’s response to levodopa/carbidopa becomes less consistent and as a result they may spend hours a day navigating debilitating OFF episodes,” said Antony Loebel, M.D., President and Chief Executive Officer at Sunovion.
Apomorphine sublingual film offers healthcare providers and patients a novel treatment option to reliably treat OFF episodes when they occur. We look forward to working with our partner BIAL to help expand access to this important on-demand treatment option for people with Parkinson’s disease across Europe.”
A new Special Interest Group (SIG) was launched on September 9, 2021 to provide support, advice and resources to families affected by acquired brain injury (ABI).
Anchor Point will raise awareness of the needs of families of people with a brain injury, identify their unmet needs and deliver research, information and education required to make a positive difference.
Charlie Whiffin, Adult Nurse and Senior Lecturer at the University of Derby, decided to create Anchor Point after seeing the gap in provision and understanding for the family of individuals with a brain injury.
Over the past ten years an increasing number of studies have looked at how family members are affected by the impact of acquired brain injury and their crucial role in neurorehabilitation and long-term support. It is now well recognised that the experience of family members can be complex and enduring.
“Brain injury has a far-reaching impact on the family. The injury can be a life-long condition and for family members to provide the best possible care and support, they need access to accurate information. It is apparent to me that as health and social care professionals, we need to work together to pool our knowledge and experiences and improve the support available to families.”
Chloe Hayward, Executive Director of UK Acquired Brain Injury Forum (UKABIF), said: “We are delighted to work with Anchor Point to provide a much-needed service to families affected by brain injury – we know just how vital a role families can play in the on-going support and care of individuals with an acquired brain injury.
“People can join Anchor Point via our website. Through active participation of family members and health care professionals it will create a space where people with different knowledge and experiences can connect to work together to research, contribute, inform and improve service provision.”
The BNA has announced the launch of Ratlas, a new – and freely available – resource that will increase the accuracy and efficiency of experiments and also help to reduce animal numbers used for neuroscience research across the UK.
Ratlas is an atlas of the rat brain that has been developed to revolutionise and support vital experiments on the health and disorders of brain function.
Just published in an article in the open access journal, Brain and Neuroscience Advances, Neuroscientists from the University of Nottingham, working with colleagues at the Leibniz Institute of Neurobiology in Magdeburg, Germany, have created the first atlas – Ratlas – to present a close likeness to the brains of the rats most commonly used in UK neuroscience research, the Lister hooded rat.
The new brain atlas – Ratlas – delivers more accurate coordinates, because it is more representative of the brains of rats used in UK Neuroscience research. As a direct result, this will minimise the requirement for laborious pilot experiments and help to reduce animal numbers used for research.
The new atlas was constructed based on the live magnetic resonance (MR) images of seven brains of Lister hooded rats, one of the main rat strains used in the UK for studies of the brain mechanisms of cognition and behaviour in health and disorder. These MR images were used to form an ‘average’ rat brain, which was then combined with an average of computer tomography (CT)-generated images of the surrounding skulls. Labels were added to the brain images to aid identification of different brain regions. The digital format of the atlas also makes it very user friendly and accessible, compared to traditional atlases.
In future work, the researchers in Nottingham and Magdeburg plan to generate additional atlases, based on other commonly used rat and mouse strains, including both sexes and different developmental stages.
Ratlas is freely available to everyone thanks to it being in BNA’s Gold Open Access journal. Open access for all is a critical part of the BNA’s credibility in neuroscience campaign, promoting credibility initiatives that support reproducibility, replicability and reliability in science.
The Mike Barnes Award for Innovation 2021 recognises and celebrates innovative projects and concepts in the management of Acquired Brain Injury (ABI).
It is open to people who may have a project to look at new ways of improving an aspect of neurorehabilitation in hospital, the community, school or prison. You may have an innovative concept focussing on sport-related concussion. Whatever the idea, the winner will be given support to take that concept forward.
Chloe Hayward, Executive Director of UKABIF, said:
We are looking for projects that have originality, viability, feasibility and desirability. We are encouraging entries from professionals from all disciplines involved in the management of Acquired Brain Injury, individuals with a brain injury and their families or carers, students, care providers, social care workers, voluntary organisations and personal injury lawyers. This award is open to both UKABIF members and non-members in the UK.
This award is sponsored by Elysium Neurological and is run in collaboration with the National Institute for Health Research (NIHR) Brain Injury MedTech Co-operative – one of 11 MedTech and In Vitro Diagnostic Co-operatives (MICs) run by NIHR across the UK.
The winner will have access to NIHR Brain Injury MIC’s network, which provides research design, business support, access to a patient advisory group and support with making bids for further funding. The winner will also be invited to attend UKABIF’s conference in 2022 free of charge.
The deadline for entries is 30 September 2021 and as well as receiving support from NIHR Brain MIC, the winner will also receive mentoring from Dr Penny Trayner – the first winner of the award in 2019 for her project ‘Goal Manager’. You can see her talking to last year’s winner Dr Ellis Parry below:
The pivotal Phase 3 OPTIMUM trial showed treatment with ponesimod (n=567) led to a 30.5 percent relative reduction in annual relapse rate (p=0.0003) vs. treatment with teriflunomide (n=566), an active comparator and established first-line oral treatment in adult patients with relapsing multiple sclerosis (RMS)1-4
The OPTIMUM trial is the first head-to-head comparison of two oral disease modifying treatments (DMT) for RMS1
Authorisation follows more than 10 years of cumulative data from Phase 2 and Phase 3 studies (plus their open label extensions) showing ponesimod’s efficacy and safety profile1,5,6
The Janssen Pharmaceutical Companies of Johnson & Johnson announced on August 10th 2021 that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Marketing Authorisation in Great Britain for PONVORY® (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features.2-4
“We are delighted to receive MHRA authorisation for ponesimod, Janssen’s first treatment for relapsing multiple sclerosis,” said Tito Roccia, Therapeutic Area Medical Affairs Director, Neuroscience and Immunology, Janssen-Cilag Ltd. “We are committed to helping people living with MS and this milestone is a positive step forward in providing a new therapeutic solution which can help to address some of the life-long and life-limiting symptoms of MS.”
“Unfortunately, there is no cure for multiple sclerosis and a high unmet medical need remains,” said Gavin Giovannoni, Professor of Neurology, Blizzard Institute, Barts and The London School of Medicine and Dentistry.* “Most people are diagnosed with multiple sclerosis in their younger years, between the ages of twenty to forty. As such, people living with multiple sclerosis are often looking for treatment solutions which help to minimise the burden and impact the condition has on their daily lives. Disease modifying treatments for relapsing multiple sclerosis are designed to reduce the number and severity of relapses, as well as slow disease and disability progression. Having a new oral therapy will provide patients with greater choice.”
The MHRA authorisation of ponesimod is based on data from the Phase 3 OPTIMUM trial, a multicentre, randomised, double-blind, parallel-group, active-controlled superiority study of 1,133 adult patients (aged 18-55 years) with RMS in 28 countries. The trial was designed to evaluate the efficacy and safety of once-daily oral ponesimod (20 mg) vs. once-daily teriflunomide (14 mg), an approved and established first-line oral treatment, in adult patients with RMS.1
The Phase 3 study showed the mean annualised relapse rate (ARR) (defined as confirmed relapses per year up to end of study) for ponesimod 20 mg (n=567) and teriflunomide (n=566) were 0.202 and 0.290, respectively. The study showed superior efficacy of ponesimod (n=567) on the primary endpoint, ARR, with a relative rate reduction of 30.5 percent (p=0.0003) compared with teriflunomide (n=566). Ponesimod (n=539) showed statistically significant superiority on one of the secondary endpoints, combined unique active lesions (CUALs), with relative reduction of new or enlarging inflammatory lesions on brain MRI by 56 percent (p<0.0001) at week 108, in comparison to teriflunomide (n=536). Another secondary endpoint was time to 12-week and 24-week confirmed disability accumulation (CDA). The risk of 12-week and 24-week CDA was not different in the two groups of ponesimod (n=567) and teriflunomide (n=566) (10.8 percent and 13.2 percent; 8.7 percent and 10.5 percent, respectively). The relative rate reduction of 12-week CDA was 17 percent (p=0.2939) in comparison to teriflunomide (n=566), and the relative rate reduction of 24-week CDA between ponesimod (n=567) and teriflunomide (n=566) was 16 percent (p=0.3720).1—4
“The unpredictable and fluctuating nature of multiple sclerosis makes it a challenge to manage day-to-day. Disease modifying treatment options that can reduce the rate of relapse, mean that people living with the condition can minimise some of the life-limiting symptoms of multiple sclerosis,” said Dr Ruth Dobson, Clinical Senior Lecturer and Consultant Neurologist at Barts Health.* “This authorisation marks a significant step forward for people living with relapsing multiple sclerosis, providing them an additional treatment option to manage their condition.”
Within the OPTIMUM study, overall, the number of treatment-emergent adverse events reported was similar between the ponesimod and teriflunomide treated groups, and the majority were mild/moderate and did not result in treatment discontinuation.1 The most commonly reported adverse events in either the ponesimod 20 mg group versus the teriflunomide 14 mg group were Alanine Aminotransferase (ALT) enzyme elevations (19.5 vs. 9.4 percent), nasopharyngitis (19.3 vs. 16.8 percent), headache (11.5 vs. 12.7 percent), upper respiratory tract infection (10.6 vs. 10.4 percent) and alopecia (3.2 vs. 12.7 percent).1—4 The current/currently known safety profile of ponesimod is consistent with the known safety profile of other S1P receptor modulators, although no other head-to-head comparisons have been conducted to date.1 The ponesimod clinical development programme showed patients could take ponesimod with or without food.+2-4,7 The programme also showed rapid elimination and reversibility of lymphocyte levels within 7-15 days after discontinuation.2–4
1 Kappos L, Fox RJ, Burcklen M, et al. Ponesimod Compared With Teriflunomide in Patients With Relapsing Multiple Sclerosis in the Active-Comparator Phase 3 OPTIMUM Study: A Randomized Clinical Trial. JAMA Neurol. 2021;78(5):558–567.
2 PONVORY® (ponesimod). Summary of Product Characteristics – Initiation Pack. Great Britain. July 2021
3 PONVORY® (ponesimod). Summary of Product Characteristics – Maintenance Pack. Great Britain. July 2021.
4 PONVORY® (ponesimod). Summary of Product Characteristics. EU. May 2021.
5 Olsson T, Boster A, Fernández Ó, et al. Oral ponesimod in relapsing-remitting multiple sclerosis: a randomised phase ll trial. J Neurol Neurosurg Psych. 2014;85(11):1198208.
6 Freedman M, Pozzilli C, Havrdova EK, et al. Long-term Efficacy and Safety of Ponesimod: Results from Randomized Phase II Core and Extension Studies in Relapsing-Remitting Multiple Sclerosis. Presented at Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum. 2020.
7 Hoch M, Darpo B, Brossard P et al. Effect of posenimod, a selective S1P1 receptor modulator on the QT interval in healthy individuals. Basic Clin Pharmacol Toxicol. 2015;116:429-437.
*Professor Gavin Giovannoni and Dr Ruth Dobson have received consultancy honoraria from Janssen. They have not been compensated for any media work.
+Ponesimod contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.2-4
About PONVORY® (ponesimod)
Ponesimod is an oral, highly selective S1P1 modulator that functionally inhibits S1P1 receptor activity and, in doing so, it is believed to reduce the number of circulating lymphocytes.12 In patients with multiple sclerosis (MS), inflammatory immune cells, including lymphocytes, can cross the blood brain barrier into the brain and damage myelin, the protective sheath that insulates nerve cells. Damage to myelin slows or halts nerve conduction, producing the neurologic signs and symptoms of MS.13
One of the Janssen Pharmaceutical Companies of Johnson & Johnson, Actelion Pharmaceuticals Ltd, is party to a revenue sharing agreement with Idorsia Pharmaceuticals Ltd, which provides for certain payments to Idorsia related to the sales of ponesimod.
Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Janssen-Cilag Ltd on 01494 567447.
On 23rd July, Kyowa Kirin Co., Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for istradefylline as an add-on treatment to levodopa (L-Dopa) based regimens in adults living with Parkinson’s, experiencing end-of-dose motor fluctuations. Kyowa Kirin International remain committed to istradefylline and people living with Parkinson’s and are currently reviewing the options available, which may include re-examination.
“We are disappointed by the CHMP opinion. However, we remain confident in the benefit-risk profile of istradefylline and are committed to making a difference to the lives of people living with Parkinson’s, an area which has had few innovative therapies for decades,” said Abdul Mullick, President of Kyowa Kirin International. “There are currently few new treatment options available to manage end-of-dose motor fluctuations in Parkinson’s, and we believe that istradefylline offers people living with the condition a chance to regain some control over the management of their ‘OFF’ time.”
We remain committed to pursuing the registration of istradefylline in the EU.
“Parkinson’s is a complex condition that affects every person living with it differently and is characterised by a broad range of symptoms that can significantly impact their quality of life,” said Professor Heinz Reichmann, Professor and Chair of the Neurology Department at the University of Dresden. “There is currently an urgent need for innovative treatments such as istradefylline for people living with Parkinson’s, to support them and their families in reducing their ‘OFF’ time. I hope that the CHMP will reconsider their position on istradefylline.”
“First of all, I would like to appreciate those who have contributed to the development of istradefylline.” Said Tomohiro Sudo, Executive Officer, Head of Global Product Strategy Department at Kyowa Kirin. “Although unfortunately it is a negative opinion from the CHMP this time, we will continue to think of how we can contribute to people living with Parkinson’s and their families as we do in the US and Japan.”
Istradefylline is a novel, first-in-class non-dopaminergic, adenosine A2A receptor antagonist that reduces ‘OFF’ time in people living with Parkinson’s through selective targeting of adenosine A2A receptors in the basal ganglia. Whilst dopaminergic treatment targets the dopamine receptors in the direct and indirect pathways to facilitate movement, istradefylline, as an add-on to L-Dopa, reduces the activity of the indirect pathway which suppresses movement. Therefore, it helps restore the balance within the basal ganglia.1,2
Istradefylline has been approved for use in Japan by the Ministry of Health, Labour and Welfare since 2013, under the brand name of NOURIAST®. In August 2019 it also received approval from the U.S. Food and Drug Administration (FDA) as adjunctive treatment to levodopa / carbidopa in adult patients with Parkinson’s experiencing “OFF” episodes and is marketed under the name of NOURIANZ®.3,4
About Kyowa Kirin International in neurology
Kyowa Kirin International is committed to building meaningful partnerships with the wider Parkinson’s community and is working with healthcare professionals, government agencies, policymakers and patient advocacy groups to improve care and support for people living with Parkinson’s.
About Kyowa Kirin
Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with a more than 70-year heritage, we apply cutting-edge science including an expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions – Japan, Asia Pacific, North America and EMEA/International – we focus on our purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity. You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com/.
Kyowa Kirin International is a subsidiary of Kyowa Kirin Co., Ltd.
1 Jenner P, Mori A, Aradi S.D, et al. Istradefylline – a first generation adenosine A2A antagonist for the treatment of Parkinson’s disease. Expert Review of Neurotherapeutics 2021, doi:10.1080/14737175.2021.1880896. 2 LeWitt P, Aradi S, Hauser R, et al. The challenge of developing adenosine A2A antagonists for Parkinson disease: Istradefylline, preladenant, and tozadenant. Parkinsonism Related Disord 2020;80(Supple 1):S54–S63. 3 Ministry of Health, Labour and Welfare. NOURIAST Prescribing Information. Available at http://docplayer.net/43410136-Nouriast-tablets-20-mg.html [Last accessed: July 2021]. 4 FDA. NOURIANZ Prescribing Information. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022075s000lbl.pdf [Last accessed: July 2021]. 5 European Parkinson’s Disease Association. About Parkinson’s. Available from: https://www.epda.eu.com/about-parkinsons/what-is-parkinsons/ [Last accessed: July 2021]. 6 GBD 2016 Parkinson’s Disease Collaborator Group. Global, regional, and national burden of Parkinson’s disease, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2018;17:939–953. 7 Ball N et al. Parkinson’s Disease and the Environment. Front Neurol 2019;10:1-8 [Last accessed: July 2021]. 8 Armstrong MJ, Rastgardani T, Gagliardi AR, et al. The impact of off periods on persons with Parkinson’s and care partners: a qualitative study. Neurol Clin Pract 2020;10.1212/CPJ.0000000000000921. 9 Freitas M, Hess C, Fox S. Motor complication of dopaminergic medications in Parkinson’s disease. Semin Neurol 2017;33(2):147-157.
13 July 2021: BIAL and Medis, d.o.o. have entered into an exclusive partnership on two of BIAL’s proprietary drugs: Zebinix® (eslicarbazepine acetate) and Ongentys® (opicapone).
The established partnership comprises an exclusive distribution agreement for Zebinix® (eslicarbazepine acetate) in the Czech Republic and Slovakia and an exclusive distribution agreement for Ongentys® (opicapone) in 12 CEE countries (Bosnia and Herzegovina, Bulgaria, Croatia, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, North Macedonia, Serbia, Slovakia, and Slovenia.)
“We are pleased to have Medis as our new partner. We believe this partnership is another important step for the extensive commercialisation of our innovative medicines. Medis shares our long-term vision and we look forward to bringing these important treatment options to patients in the CEE region,” said António Portela, Chief Executive Officer of BIAL.
“In Medis we are excited and proud to partner with BIAL and thus being able to provide two medicines which we firmly believe represent a much-needed relief to thousands of people in the region who suffer from Parkinson’s disease and epilepsy.” claimed Martina Perharic, Medis’ Chief Executive Officer.
Epilepsy has a high prevalence with 6 million people affected in Europe and 15 million Europeans estimated to experience a seizure at some time in their life.1
Parkinson’s disease is a chronic, progressive neurodegenerative disorder characterized by a strong reduction of the neurotransmitter dopamine, caused by the degeneration of certain neurons in the brain. The European Parkinson’s Disease Association (EPDA) estimates that approximately 1.2 million people in Europe suffer from this disease.
3- Ferreira J., et al. Lancet Neurol. 2016 Feb;15(2):154-165
4- Ferreira J., et al. Neurology. 2018 May 22;90(21):e1849-e185
5- Lees A., et al. JAMA Neurol. 2017 Feb 1;74(2):197-206
6- Hebeisen S, et al. Eslicarbazepine and the enhancement of slow inactivation of voltage-gated sodium channels: a comparison with carbamazepine, oxcarbazepine and lacosamide. Neuropharmacology 2015; 89:122-35
7- Vilin YY; Ruben PC, Slow inactivation in voltage-gated sodium channels: molecular substrates and contributions to channelopathies. Cell Biochem Biophys 2001; 35:171–90
Opicapone is a once-daily, peripherally-acting, third-generation, highly-selective COMT inhibitor.2
Opicapone works by decreasing peripheral levodopa’s conversion rate into 3-O- methyldopa, thereby prolonging the duration of levodopa’s effect in reducing the OFF-time period of Parkinson’s disease and extending the ON-time period.2-5
In June 2016, the European Commission authorized Ongentys® (opicapone) as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCIs) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations.2
About Zebinix® (eslicarbazepine acetate)
Eslicarbazepine acetate is a voltage-gated sodium channel blocker. It selectively targets the slow inactivated state of the sodium ion channel (which has been implicated in the pathogenesis of epilepsy), preventing its return to the active state, and thereby reduces repetitive neuronal firing.6, 7
Zebinix® is a once-daily antiepileptic drug that is indicated as monotherapy in the treatment of partial-onset seizures, with or without secondary generalization, in adults with newly diagnosed epilepsy and also as adjunctive therapy in patients aged above 6 years, with partial-onset seizures with or without secondary generalisation.8
Founded in 1924, BIAL’s mission is to research, develop and provide therapeutic solutions within the area of health. Over the last decades, BIAL has focused strategically on quality, innovation and internationalization. BIAL is strongly committed to therapeutic innovation, investing more than 20% of its annual turnover into research and development within neurosciences and the cardiovascular system. The company expects to introduce new drugs on the market in the coming years, strengthening its international presence based on proprietary drugs and achieving its goal of supplying innovative products to patients worldwide. For more information on BIAL visit www.bial.com.
Medis Pharmaceutical Company is the leading independent medical marketing company focused on commercialization of innovative pharmaceutical products, with emphasis on specialty drugs, medical equipment and self-care brands. Medis aims at making the most advanced and effective medical treatments accessible to every patient in the Central and Eastern Europe (CEE). Its fully owned subsidiaries across the CEE region are leveraging its marketing know-how, scientific expertise and product knowledge. It is headquartered in Ljubljana, Slovenia, founded in 1989, and employs more than 350 people. For more information about Medis visit www.medis.com
In a new report published on 14th July 2021, STARS Healthcare Pioneers Report Showcasing Best Practice in Syncope 2021, the charity STARS highlights the innovative and inspiring work that is being done to improve care and quality of life for people experiencing an unexplained loss of consciousness (including syncope; aka fainting). People with syncope/fainting are often told it is a “simple faint” or are misdiagnosed, misunderstood, and mismanaged when in fact all too often there is an underlying potentially fatal heart rhythm disorder.
The six case studies in the report range from using novel technologies to diagnose people presenting with pre-syncope to the benefits of multidisciplinary team working. For example, Dr Nasrin Khan (New Cross Hospital, Wolverhampton, UK) and colleagues highlight how close collaboration between neurologists and cardiologists ensures the accurate diagnosis of people with unexplained loss of consciousness.
Trudie Lobban MBE, Founder and CEO of STARS, says: “The diagnosis and management of syncope and syncope-related conditions continue to be challenging — far too many people with syncope wait months, or even years, for an accurate diagnosis and do not receive the care they need. Many are misdiagnosed with epilepsy and prescribed antiseizure medication when in fact they have an underlying potentially fatal heart rhythm condition. Often the only symptom prior to sudden cardiac death is a history of fainting. Therefore, it is essential that anyone presenting with a history of unexplained loss of consciousness or fainting should be seen by an appropriate team and get a correct diagnosis — this will save misdiagnosis and, in some cases, may even save lives.”
Syncope, or fainting, is often caused by low blood pressure, dehydration, or underlying heart rhythm issues. A major issue is misdiagnosis, with studies suggesting people with syncope are often misdiagnosed as having epilepsy — this not only means that they are potentially receiving treatments, such as anticonvulsants, that they do not need, but also means that they are not receiving the treatments they do need.1 Specifically if the epilepsy masks cardiac syncope, a person could have a potentially life-threatening arrhythmia and, therefore, are not being protected against sudden cardiac death. For more information about syncope and syncope-related conditions, visit: http://www.stars-international.org
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