دورية أكاديمية
Evaluation of vascular risk in patients with migraine with and without aura treated with erenumab: Post hoc analysis of pooled long-term clinical trial data.
| العنوان: | Evaluation of vascular risk in patients with migraine with and without aura treated with erenumab: Post hoc analysis of pooled long-term clinical trial data. |
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| المؤلفون: | Kudrow D; California Medical Clinic for Headache, Santa Monica, California, USA., Dafer R; Rush University Medical Center, Chicago, Illinois, USA., Dodick DW; Mayo Clinic, Scottsdale, Arizona, USA., Starling A; Mayo Clinic, Scottsdale, Arizona, USA., Ailani J; Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA., Dougherty C; Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA., Kalidas K; University of South Florida, Tampa, Florida, USA., Zhang F; Amgen Inc., Thousand Oaks, California, USA., Jeswani R; Amgen Inc., Thousand Oaks, California, USA., Patel N; Amgen Inc., Thousand Oaks, California, USA., Khodavirdi AC; Amgen Inc., Thousand Oaks, California, USA. |
| المصدر: | Headache [Headache] 2023 Mar; Vol. 63 (3), pp. 418-428. |
| نوع المنشور: | Randomized Controlled Trial; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Wiley Country of Publication: United States NLM ID: 2985091R Publication Model: Print Cited Medium: Internet ISSN: 1526-4610 (Electronic) Linking ISSN: 00178748 NLM ISO Abbreviation: Headache Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: <2008- > : Hoboken, NJ : Wiley Original Publication: St. Louis : American Association for the Study of Headache |
| مواضيع طبية MeSH: | Migraine Disorders*/drug therapy , Migraine Disorders*/chemically induced , Epilepsy*/drug therapy, Humans ; Calcitonin Gene-Related Peptide Receptor Antagonists/adverse effects ; Antibodies, Monoclonal, Humanized/adverse effects ; Double-Blind Method ; Treatment Outcome |
| مستخلص: | Objective: To assess cardiovascular (CV) safety of erenumab in clinical trial patients associated with degree of CV risk. Background: Hypertension has been considered a theoretical risk associated with the inhibition of the calcitonin gene-related peptide pathway in migraine management, particularly in a patient population with pre-existing CV risk factors. Methods: Data pooled from four double-blind, randomized trials were used to assess blood pressure (BP) changes and CV safety in patients grouped based on 10-year risk of cardiac, cerebrovascular, and peripheral artery disease as no-risk-factors, low-risk (>0% to ≤10%), moderate-risk (>10% to ≤20%), and high-risk (>20%) categories. CV safety was assessed as ischemic cardiovascular and cerebrovascular adverse events (ICCAE). Results: There was no apparent difference between placebo- (N = 1032) and erenumab-treatment groups (70 mg, N = 885; 140 mg, N = 504) in clinical worsening of BP category from baseline to Months 1-3 (14% [143/1032] placebo vs. 13% [114/885] and 14% [71/504] for erenumab 70 and 140 mg, respectively) regardless of baseline BP category. The adverse event (AE) profile of erenumab was similar across CV risk categories throughout the long-term analysis. Erenumab-treated patients with high and moderate 10-year CV risk (N = 107) did not experience any ICCAEs during the double-blind treatment period; there was a single ICCAE (a cerebral dural venous sinus thrombosis) observed in the low-risk erenumab group (N = 273). There were no increases in AEs during the long-term extensions of up to 5 years (N = 2499; 3482 patient-years of exposure to erenumab) with exposure-adjusted incidence rates of cardio/cerebrovascular disorder AEs of 0.4, 0.5, 0.0, and 1.1 (per 100 patient-years) for no risk factor (N = 1805), low (N = 492), moderate (N = 121), and high (N = 81) 10-year CV risk groups, respectively. Conclusions: Ischemic CV and cerebrovascular AEs were uncommon and the incidence rates were similar across the 10-year CV risk categories. This analysis helps provide more detail on the CV safety of erenumab. (© 2023 Amgen Inc. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.) |
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| معلومات مُعتمدة: | Amgen Inc; Novartis |
| فهرسة مساهمة: | Keywords: calcitonin gene-related peptide receptor; cardiovascular; erenumab; migraine; safety |
| المشرفين على المادة: | I5I8VB78VT (erenumab) 0 (Calcitonin Gene-Related Peptide Receptor Antagonists) 0 (Antibodies, Monoclonal, Humanized) |
| تواريخ الأحداث: | Date Created: 20230321 Date Completed: 20230322 Latest Revision: 20230601 |
| رمز التحديث: | 20230601 |
| DOI: | 10.1111/head.14485 |
| PMID: | 36942409 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1526-4610 |
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| DOI: | 10.1111/head.14485 |