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• W2799749968 abstract "Objective: To assess erenumab safety by triptan/ergotamine use or cardiovascular (CV) risk. Background: Erenumab is the only fully human monoclonal antibody in development specifically targeting the CGRP receptor to prevent migraine. As CGRP can mediate vasodilation, inhibiting the CGRP pathway may carry a theoretical CV risk. Here we assess the safety of erenumab in patients with CV risk factors or in patients using triptans/ergotamines (which are known to have vasoconstrictive effects). Design/Methods: 12-week integrated safety analysis of patients in phase 2/3 clinical trials (NCT02066415, NCT01952574, NCT02456740, NCT02483585) who received ≥1 dose of placebo or erenumab (7-, 21-, 70-, 140 mg). We report treatment-emergent adverse events (AE) in 2 groups: triptan/ergotamine users and patients with preexisting CV risk factors (0, 1, ≥2). Results: Overall, 66.2% (n=690/1043) of placebo and 65.5% (n=1056/1613) of erenumab-treated patients used migraine medications (primarily triptans [>99%]). AE incidence was similar between treatment groups and triptan/ergotamine users (49.6% placebo, 47.4% erenumab) and non-users (47.9% placebo, 47.2% erenumab). Serious AE incidence for triptan/ergotamine users was 1.9% placebo, 1.7% erenumab, and for non-users, 0.8% placebo, 0.5% erenumab. At baseline, 29.7% and 28.2% of placebo and erenumab-treated patients had 0 CV risk factors, respectively, 40.6% and 41.7% had 1 CV risk factor, and 29.7% and 30.1% had ≥2 CV risk factors. AE incidence was similar between groups for 0 CV risk factors, (47.4% placebo, 44.8% erenumab), 1 CV risk factor (46.3% placebo, 46.4% erenumab), or ≥2 CV risk factors (54.2% placebo, 51.1% erenumab). Cardiac ( Conclusions: AEs, including CV AEs, were similar between erenumab and placebo in triptan/ergotamine users and in those with CV risk factors. Study Supported by: Amgen Inc. Disclosure: Dr. Winner has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consulting fees/honoraria from Allergan, Amgen, Supernus, has served on the speaker’s bureau for Allergan, Avanir, Supernus. Dr. Winner has received research support from Allergan, Amgen, NuPathe, AstraZeneca, Avanir, Eli Lilly, Novartis. Dr. Reuter has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Amgen, Autonomic Technologies, CoLucid, ElectroCore, Novartis, Pharm Allergan; EliLily, TEVA. Dr. Reuter has received research support from Allergan, Amgen, Autonomic Technologies, CoLucid, ElectroCore, Novartis,EliLilly and TEVA. Dr. Dodick has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acorda, Allergan, Amgen, Alder, Dr Reddy’s, Merck, Dr Reddy’s, Promius, eNeura, Eli Lilly & Company, Insys therapeutics, Autonomic Technologies, Teva, Xenon, Tonix, Trigemina, Boston Scientific, GBS, Colucid, Zosano, Laydenburg Thalmann, Biocentric, Biohaven, Magellan, Pfizer (Japan), Charleston Laboratories. Royalties: Oxford University Press and Cambridge University Press (Book Royalty). Uptodate — editorial/honoraria. CME companies honoraria/publishing honoraria/royalites: Chameleon Communications, Medscape, WebMD, Academy for Continued Healthcare Learning, Haymarket Medical Education, Miller Medical Communications, Global Scientific Communications, HealthLogix, Academy for Continued Healthcare Learning, Meeting LogiX, Health LogiX, . Dr. Kudrow has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly, Amgen, Alder. Dr. Kudrow has received research support from Amgen, Alder, Eli Lilly, Teva, Zosano, Allergan, Genentech, VM Biopharma, Co-Lucid. Dr. Rozniecki has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Participation in Chronic Migraine Global Advisory Board on September 13, 2016 in Glasgow, UK. Taking part in 3 clinical trials as PI. Dr. Xue has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Amgen. Dr. Xue has received compensation for serving on the Board of Directors of Amgen. Dr. Zhang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Amgen. Dr. Zhang has received compensation for serving on the Board of Directors of Amgen. Dr. Cheng has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Amgen. Dr. Cheng has received compensation for serving on the Board of Directors of Amgen. Dr. Picard has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Amgen. Dr. Picard has received compensation for serving on the Board of Directors of Amgen. Dr. Mikol has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Amgen. Dr. Mikol has received compensation for serving on the Board of Directors of Amgen." @default.
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• W2799749968 date "2018-04-10" @default.
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• W2799749968 title "Erenumab Safety Among Migraine Patients Using Triptans or With Cardiovascular (CV) Risk Factors (P4.100)" @default.
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