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7 Antiepileptic Therapy in Dogs

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7 Antiepileptic Therapy in Dogs 8/13/19 Disclosures è FINANCIAL DISCLOSURE: • Grant/Research Support – Purina, Boehringer Ingelheim, BBSRC, Wellcome Trust, AKC Canine Health Foundation Department of Small Animal Diseases • Consulting and Speaker Engagement – Purina, Boehringer Ingelheim. è UNLABELED/ UNAPPROVED USES DISCLOSURE: Antiepileptic Therapy in Dogs - Fundamentals • I will discuss results of clinical trials in which antiepileptic drugs were used which are either not licensed for the specie or are only licensed in certain countries. Please and Cases check local authorities before use. Prof. Holger A. Volk DipECVN, PhD, PGCAP, FHEA, MRCVS Head of Department, Tierärztliche Hochschule Hannover RCVS & EBVS® European Specialist in Veterinary Neurology Past-President of the European College of Veterinary Neurology Treasurer of the European Board of Veterinary Specialisation Honorary Senior Lecturer -UCL Institute of Neurology Honorary Professor of Veterinary Neurology and Neurosurgery -Royal Veterinary College Outcome in individual patients: impact on seizures How does success look like? Therapeutic success Outcome in individual patients: impact on seizures Thank you Marios Charalambous Evaluate short-term & long-term success. Term drug-resistant combined witH drug information. (e.g. PHB resistant) 1 8/13/19 International Veterinary Epilepsy Task Force 1. International Veterinary Epilepsy Task Force consensus report on epilepsy definition, classification and terminology in companion animals (chaired by Prof. Mette Berendt) 2. International Veterinary Epilepsy Task Force Consensus Proposal: Diagnostic approach to epilepsy in dogs (Chaired by Drs. Luisa De Risio and Sofie Bhatti) 3. International Veterinary Epilepsy Task Force current understanding of idiopathic epilepsy of genetic or suspected genetic origin in purebred dogs (Chaired by Dr. Velia-Isabel Hülsmeyer) 4. International Veterinary Epilepsy Task Force consensus proposal: Medical treatment of canine epilepsy in Europe (Chaired by Drs. Sofie Bhatti and Luisa De Risio) 5. International Veterinary Epilepsy Task Force Consensus Proposal: Outcome of therapeutic interventions in canine and feline epilepsy (Chaired by Profs. Heidrun Potschka and Andrea Fischer) 6. International Veterinary Epilepsy Task Force recommendations for a veterinary epilepsy-specific MRI protocol (Chaired by Drs. Clare Rusbridge and Sam Long) 7. International Veterinary Epilepsy Task Force recommendations for systematic sampling and Berendt M; Bhatti SFM; De Risio L; Farquhar RG; Fernández-Flores F; Fischer processing of brains from epileptic dogs and cats (Chaired by Profs. Kaspar Matiasek and Martí Pumarola Batlle). A, Hasegawa D; Hülsmeyer VI; Jokinen-Pääkkönen T; Jovanovik E; Löscher W, www.ivetf.org Lohi H; Long S; Mandigers PJJ; Matiasek K; Milne M; Muñana K; Packer, RMA; – Pakozdy A; Patterson EE; Penderis J; Platt S; Podell M; Potschka H; Pumarola MB; Rosati M; Rusbridge C; Saito M; Stein VM; Tipold A; Volk H; Wagner E. IVETF ACVIM consensus statement - Panel Members Scenario Which drug would you use? A 5 years old 17 kg German Shepherd intact male dog manifested single generalized tonic- clonic seizures one year ago. The dog is normal in-between the episodes. You wonder what the best treatment would be. 1. Phenobarbitone 2. Imepitoin 3. Potassium bromide 4. Levetiracetam 5. Gabapentin 6. Zonisamide 2 8/13/19 Scenario A 5 years old 17 kg German Shepherd intact male dog manifested single generalized tonic- clonic seizures one year ago. In the last two months the dog manifested five episodes. The dog is normal in-between the episodes, idiopathic epilepsy is suspected. You wonder what the best treatment would be. Scenario Which drug would you use first line? A 5 years old 17 kg German Shepherd intact male dog manifested single generalized tonic- clonic seizures one year ago. In the last two months the dog manifested cluster seizures. 1. Phenobarbitone The dog is normal between the episodes, idiopathic epilepsy is suspected. You wonder 2. Imepitoin what the best treatment would be. 3. Potassium bromide 4. Levetiracetam 5. Gabapentin 6. Zonisamide How high is the placebo effect if you are a surgeon or a medic? Which drug would you use first line? 1. Phenobarbitone J Vet Intern Med 2010;24:166–170 2. Imepitoin Placebo Effect in Canine Epilepsy Trials 3. Potassium bromide K.R. Mun˜ ana, D. Zhang, and E.E. Patterson 4. Levetiracetam Background: The placebo effect is a well-recognized phenomenon in human medicine; in contrast, little information exists on the effect of placebo administration in veterinary patients. 5. Gabapentin Hypothesis: Nonpharmacologic therapeutic effects play a role in response rates identified in canine epilepsy trials. Animals: Thirty-four dogs with epilepsy. Methods: Meta-analysis of the 3 known prospective, placebo-controlled canine epilepsy trials. The number of seizures per 6. Zonisamide week was compiled for each dog throughout their participation in the trial. Log-linear models were developed to evaluate seizure frequency during treatment and placebo relative to baseline. Results: Twenty-two of 28 (79%) dogs in the study that received placebo demonstrated a decrease in seizure frequency compared with baseline, and 8 (29%) could be considered responders, with a 50% or greater reduction in seizures. For the 3 trials evaluated, the average reduction in seizures during placebo administration relative to baseline was 26% (P 5 .0018), 29% (P 5 .17), and 46% (P 5 .01). Conclusions and Clinical Importance: A positive response to placebo administration, manifesting as a decrease in seizure frequency, can be observed in epileptic dogs. This is of importance when evaluating open label studies in dogs that aim to assess efficacy of antiepileptic drugs, as the reported results might be overstated. Findings from this study highlight the need for more placebo-controlled trials in veterinary medicine. Key words: Clinical trials; Dog; Epilepsy; Statistical modeling. he placebo effect is a well recognized, but poorly un- placebo-controlled studies are considered necessary to Tderstood phenomenon that involves a nonspecific gauge the true efficacy of a novel intervention, and are psychological or physiological therapeutic effect of a the basis for drug evaluation and approval in human medical intervention that lacks specific activity for the medicine. condition being treated.1 Early medical practices were In contrast, the placebo effect has been largely disre- based on the placebo effect, wherein placebos were ad- garded in veterinary medicine, with only 2 publications ministered with the purpose of producing a desired identified that address the issue of a placebo effect in an- therapeutic response. More recently, the use of placebos imals.1,5 However, with the recent emphasis placed on has focused primarily on its role as a control in random- evidence based medicine in veterinary practice, it seems 3 ized-clinical trials that allows for an unbiased estimate of appropriate to consider the effect of placebos in veteri- the treatment effects of the agent being evaluated. nary patients, particularly the extent to which animals Results from numerous human trials have demon- may demonstrate an improvement in disease manifesta- strated that placebos can improve subjective and tions that could be because of nonspecific effects of a objective outcomes in patients with a wide range of therapeutic intervention. clinical conditions. A beneficial effect of placebo admin- The hypothesis tested in this study is that nonpharma- istration has been reported in 60–90% of all human cologic therapeutic effects play a role in response rates diseases,2 including musculoskeletal, respiratory, car- identified in canine epilepsy trials. The specific aim is to diac, dermatologic, gastrointestinal, and nervous system determine the magnitude of the placebo response in ran- disorders. Furthermore, a placebo response rate of ap- domized-controlled trials evaluating new treatment proximately 35% is commonly cited in the medical modalities for refractory canine epilepsy. literature,3 although higher rates have been reported and are most frequently seen in diseases with clinical Materials and Methods signs that wax and wane, fluctuate, or spontaneously re- mit.4 Because of the potential magnitude of this effect, Study Design Data was compiled from 3 clinical trials evaluating the safety and efficacy of novel treatments for refractory canine epilepsy in which a From the Department of Clinical Sciences, College of Veterinary placebo arm was a component of the study protocol. The studies Medicine (Mun˜ana) and the Department of Statistics (Zhang), evaluated were performed by 2 of the authors (K.R.M., E.E.P.), en- North Carolina State University, Raleigh, NC and the Department abling easy access to the data necessary to undertake the present of Veterinary Clinical Science (Patterson), University of Minnesota, analysis. A database search was performed to identify any addi- St Paul, MN. Presented at the 26th Annual Forum of the American College of Veterinary Medicine, San Antonio, TX, June 2008. tional placebo-controlled canine epilepsy trials that might be Corresponding author: Karen R. Mun˜ana, Department of Clinical included in the analysis, but none were found. Inclusion criteria Sciences, College of Veterinary Medicine, North Carolina State Uni- were similar for all 3 studies and consisted of (1) an onset of seizures versity, 4700 Hillsborough Street, Raleigh, NC 27606; e-mail: between 1 and 5 years of age; (2) a normal diagnostic evaluation, [email protected]
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