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• W2592118257 abstract "HomeStrokeVol. 48, No. 4Response by Hänggi and Macdonald to Letter Regarding Article, “Randomized, Open-Label, Phase 1/2a Study to Determine the Maximum Tolerated Dose of Intraventricular Sustained Release Nimodipine for Subarachnoid Hemorrhage (NEWTON [Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage])” Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBResponse by Hänggi and Macdonald to Letter Regarding Article, “Randomized, Open-Label, Phase 1/2a Study to Determine the Maximum Tolerated Dose of Intraventricular Sustained Release Nimodipine for Subarachnoid Hemorrhage (NEWTON [Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage])” Daniel Hänggi, MD R. Loch Macdonald, MD, PhD Daniel HänggiDaniel Hänggi Department of Neurosurgery, University Hospital Mannheim, Medical Faculty Mannheim, University of Heidelberg, Germany Search for more papers by this author R. Loch MacdonaldR. Loch Macdonald Division of Neurosurgery, St. Michael’s Hospital, Labatt Family Centre of Excellence in Brain Injury and Trauma Research, Keenan Research Centre for Biomedical Research and Li Ka Shing Knowledge Institute, Department of Surgery, University of Toronto, Canada Search for more papers by this author Originally published10 Mar 2017https://doi.org/10.1161/STROKEAHA.117.016603Stroke. 2017;48:e114Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2017: Previous Version 1 In Response:We thank Professor Rustemi for his insightful comments on the NEWTON study (Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage).1 This study included standard-of-care control subjects who received enteral nimodipine. Intravenous nimodipine was not used because it is not available in the United States and Canada, whereas enteral nimodipine is available in most countries worldwide. Meta-analysis of nimodipine randomized trials reported that the efficacy of nimodipine was based on the enteral formulation and that there was insufficient evidence to support the efficacy of intravenous nimodipine.2 Therefore, standard-of-care control subjects in NEWTON received enteral nimodipine.1,3We support the theory that the earlier after aneurysmal subarachnoid hemorrhage that one can start administering nimodipine, the better.We agree that NEWTON included a limited number of subjects. It was designed as a phase 1/2 dose-finding, safety, tolerability, and pharmacokinetic study with clinical outcomes as exploratory end points. We were not anticipating significant effects on exploratory end points, but we were intrigued by the observed reductions in angiographic vasospasm, delayed cerebral ischemia, use of rescue therapy, and the increase in favorable outcome with intraventricular sustained-release nimodipine (EG-1962). The results of NEWTON supported initiation of the ongoing NEWTON-2 pivotal phase 3 clinical study, which compares the efficacy and safety of intraventricular EG-1962 with oral nimodipine. In addition, a study to determine safety, pharmacokinetics, and clinical end points of intracisternal administration of EG-1962 also is underway. Although ventriculitis/meningitis are obviously of concern and to be avoided, adherence to guidelines for insertion and care of external ventricular drains can reduce the risk of infection.4 Fortunately, many of these infections resolve with treatment. In NEWTON, there were 5 cases of culture-positive ventriculitis/meningitis in subjects treated with EG-1962. All infections were associated with prolonged ventricular drainage, a known risk factor for external ventricular drain infection. The clinical outcome, which at the end of the day is what matters most, was favorable in 4 of 5 subjects (80%) with positive cultures.Daniel Hänggi, MDDepartment of NeurosurgeryUniversity Hospital Mannheim, Medical Faculty MannheimUniversity of HeidelbergGermanyR. Loch Macdonald, MD, PhDDivision of Neurosurgery, St. Michael’s HospitalLabatt Family Centre of Excellence in Brain Injury and TraumaResearch, Keenan Research Centre for Biomedical Research andLi Ka Shing Knowledge InstituteDepartment of SurgeryUniversity of Toronto, CanadaDisclosuresDr Macdonald receives grant support from the Physicians Services Incorporated Foundation, Brain Aneurysm Foundation, Canadian Institutes for Health Research, and the Heart and Stroke Foundation of Canada and is an employee and Chief Scientific Officer of Edge Therapeutics, Inc. Dr Hänggi receives consulting fees from Edge Therapeutics, Inc. for serving on the steering committee for this trial and for advising Edge Therapeutics, Inc.FootnotesStroke welcomes Letters to the Editor and will publish them, if suitable, as space permits. Letters must reference a Stroke published-ahead-of-print article or an article printed within the past 4 weeks. The maximum length is 750 words including no more than 5 references and 3 authors. Please submit letters typed double-spaced. Letters may be shortened or edited.References1. Hänggi D, Etminan N, Aldrich F, Steiger HJ, Mayer SA, Diringer MN, et al; NEWTON Investigators. Randomized, open-label, phase 1/2a study to determine the maximum tolerated dose of intraventricular sustained release nimodipine for subarachnoid hemorrhage (NEWTON [Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage]).Stroke. 2017; 48:145–151. doi: 10.1161/STROKEAHA.116.014250.LinkGoogle Scholar2. Dorhout Mees SM, Rinkel GJ, Feigin VL, Algra A, van den Bergh WM, Vermeulen M, et al. Calcium antagonists for aneurysmal subarachnoid haemorrhage.Cochrane Database Syst Rev2007; 3:CD000277.Google Scholar3. Hänggi D, Etminan N, Macdonald RL, Steiger HJ, Mayer SA, Aldrich F, et al. NEWTON: Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage.Neurocrit Care. 2015; 23:274–284. doi: 10.1007/s12028-015-0112-2.CrossrefMedlineGoogle Scholar4. Flint AC, Rao VA, Renda NC, Faigeles BS, Lasman TE, Sheridan W. A simple protocol to prevent external ventricular drain infections.Neurosurgery. 2013; 72:993–999, discussion 999. doi: 10.1227/NEU.0b013e31828e8dfd.CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Baranoski J and Ducruet A (2019)(2019) Nanoparticle-Facilitated Delivery of Antioxidant Therapy following Aneurysmal Subarachnoid Hemorrhage, Neurosurgery, 10.1093/neuros/nyz031, 85:2, (E174-E175), Online publication date: 1-Aug-2019. Christensen S, Johansson S, Radziwon-Balicka A, Warfvinge K, Haanes K, Edvinsson L and Holda M (2019) MEK1/2 inhibitor U0126, but not nimodipine, reduces upregulation of cerebrovascular contractile receptors after subarachnoid haemorrhage in rats, PLOS ONE, 10.1371/journal.pone.0215398, 14:4, (e0215398) April 2017Vol 48, Issue 4 Advertisement Article InformationMetrics © 2017 American Heart Association, Inc.https://doi.org/10.1161/STROKEAHA.117.016603PMID: 28283608 Originally publishedMarch 10, 2017 PDF download Advertisement SubjectsCerebral AneurysmIntracranial Hemorrhage" @default.
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