دورية أكاديمية
Risk of hypertension in erenumab-treated patients with migraine: Analyses of clinical trial and postmarketing data.
| العنوان: | Risk of hypertension in erenumab-treated patients with migraine: Analyses of clinical trial and postmarketing data. |
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| المؤلفون: | Dodick DW; Department of Neurology, Mayo Clinic, Scottsdale, Arizona, USA., Tepper SJ; Department of Neurology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, USA., Ailani J; Georgetown Headache Center, Medstar Georgetown University, Washington, DC, USA., Pannacciulli N; Global Medical Amgen Inc., Thousand Oaks, California, USA., Navetta MS; Global Medical Amgen Inc., Thousand Oaks, California, USA., Loop B; Global Patient Safety, Amgen Inc., Cambridge, Massachusetts, USA., Zhang F; Global Medical Amgen Inc., Thousand Oaks, California, USA., Khodavirdi AC; Global Medical Amgen Inc., Thousand Oaks, California, USA., Mann A; Medical Safety, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA., Abdrabboh A; Medical Safety, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA., Kalim J; Medical Safety, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA. |
| المصدر: | Headache [Headache] 2021 Oct; Vol. 61 (9), pp. 1411-1420. Date of Electronic Publication: 2021 Sep 30. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Wiley Country of Publication: United States NLM ID: 2985091R Publication Model: Print-Electronic 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: | Drug-Related Side Effects and Adverse Reactions*, Antibodies, Monoclonal, Humanized/*adverse effects , Calcitonin Gene-Related Peptide Receptor Antagonists/*adverse effects , Clinical Trials, Phase II as Topic/*statistics & numerical data , Clinical Trials, Phase III as Topic/*statistics & numerical data , Hypertension/*chemically induced , Migraine Disorders/*drug therapy , Product Surveillance, Postmarketing/*statistics & numerical data, Adult ; Antibodies, Monoclonal, Humanized/administration & dosage ; Calcitonin Gene-Related Peptide Receptor Antagonists/administration & dosage ; Female ; Humans ; Male ; Middle Aged |
| مستخلص: | Objective: To assess the risk of hypertension in patients with migraine who received erenumab in clinical trials and in the postmarketing setting. Background: Erenumab is a monoclonal antibody for migraine prevention that targets the calcitonin gene-related peptide (CGRP) receptor. Hypertension is a theoretical risk for inhibitors of the CGRP pathway. Although no evidence of an association between erenumab treatment and hypertension was observed during the clinical development program, adverse events (AEs) of hypertension have been identified in the postmarketing setting. Methods: Safety data from four phase 2 and phase 3 clinical trials were used to perform a pooled analysis of hypertension AEs in patients with migraine receiving erenumab. Postmarketing AEs of hypertension were identified from the Amgen Global Safety database from May 17, 2018, through January 31, 2020. Results: In the pooled analysis of clinical trials, hypertension AEs (placebo, 9/1043 [0.9%]; erenumab 70 mg, 7/893 [0.8%]; erenumab 140 mg, 1/507 [0.2%]) and percentage of patients initiating medication to treat hypertension (12/1043 [1.2%], 7/893 [0.8%], 1/507 [0.2%], respectively) were similar across treatment groups. A total of 362 AEs of hypertension were identified from the postmarketing setting, 26.2% (95/362) of which were serious, >245,000 patient-years of exposure. The exposure-adjusted incidence of hypertension was 0.144 per 100 patient-years. Conclusions: Clinical trials did not demonstrate an increased risk of hypertension with erenumab compared with placebo, and AE rates of hypertension reported with erenumab in the postmarketing setting were generally low. Additional data are needed to fully characterize the extent to which hypertension is a risk associated with erenumab. (© 2021 The Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.) |
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| فهرسة مساهمة: | Keywords: blood pressure; calcitonin gene-related peptide; drug safety; hypertension; individual case safety report; postmarketing surveillance |
| المشرفين على المادة: | 0 (Antibodies, Monoclonal, Humanized) 0 (Calcitonin Gene-Related Peptide Receptor Antagonists) I5I8VB78VT (erenumab) |
| تواريخ الأحداث: | Date Created: 20210930 Date Completed: 20220214 Latest Revision: 20220721 |
| رمز التحديث: | 20240829 |
| مُعرف محوري في PubMed: | PMC9293040 |
| DOI: | 10.1111/head.14208 |
| PMID: | 34591982 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1526-4610 |
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| DOI: | 10.1111/head.14208 |