PMID- 31852816
OWN - NLM
STAT- MEDLINE
DCOM- 20200518
LR  - 20200518
IS  - 1526-632X (Electronic)
IS  - 0028-3878 (Print)
IS  - 0028-3878 (Linking)
VI  - 94
IP  - 5
DP  - 2020 Feb 4
TI  - Vascular safety of erenumab for migraine prevention.
PG  - e497-e510
LID - 10.1212/WNL.0000000000008743 [doi]
AB  - OBJECTIVE: To examine the cardiovascular, cerebrovascular, and peripheral 
      vascular safety of erenumab across migraine prevention studies. METHODS: Vascular 
      adverse events (AEs) and blood pressure data were integrated across 4 
      double-blind, placebo-controlled studies of erenumab and their open-label 
      extensions in patients with chronic or episodic migraine. Subgroup analyses were 
      conducted by acute migraine-specific medication use and number of vascular risk 
      factors at baseline. Standardized search terms were used to identify vascular AEs 
      (cardiovascular, cerebrovascular, or peripheral). An independent committee 
      adjudicated whether targeted events were vascular in origin. RESULTS: In 
      placebo-controlled studies, 2,443 patients received placebo (n = 1,043), erenumab 
      70 mg (n = 893), or erenumab 140 mg (n = 507) subcutaneously once monthly. 
      Regardless of acute migraine-specific medication use or vascular risk factors at 
      baseline, AE incidence was similar across the placebo and erenumab treatment 
      groups. Hypertension AEs were reported for 0.9% (placebo), 0.8% (erenumab 70 mg), 
      and 0.2% (erenumab 140 mg) of patients. Vascular AEs, which were similar across 
      double-blind and open-label treatment, generally were confounded, with plausible 
      alternative etiologies. In 18 patients with events reviewed by the independent 
      committee, 4 events were positively adjudicated as cardiovascular in origin: 2 
      deaths and 2 vascular events. All 4 positively adjudicated cardiovascular events 
      occurred during open-label erenumab treatment. CONCLUSION: Selective blockade of 
      the canonical calcitonin gene-related peptide receptor with erenumab for migraine 
      prevention had a vascular safety profile comparable to that of placebo over 12 
      weeks, with no increased emergence of events over time. Further study of 
      long-term safety of erenumab in patients with migraine is needed. 
      CLINICALTRIALSGOV IDENTIFIERS: NCT02066415, NCT02456740, NCT01952574, 
      NCT02483585, NCT02174861, and NCT01723514. CLASSIFICATION OF EVIDENCE: This 
      analysis provides Class II evidence that for patients with migraine, erenumab 
      does not increase the risk of vascular AEs.
CI  - Copyright (c) 2019 The Author(s). Published by Wolters Kluwer Health, Inc. on 
      behalf of the American Academy of Neurology.
FAU - Kudrow, David
AU  - Kudrow D
AD  - From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department 
      of Neurology (J.P.), University Hospital Marques de Valdecilla and IDIVAL, 
      Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern 
      University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, 
      Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at 
      Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charite 
      Universitatsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and 
      Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), 
      Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA. 
      dbkudrow@earthlink.net.
FAU - Pascual, Julio
AU  - Pascual J
AD  - From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department 
      of Neurology (J.P.), University Hospital Marques de Valdecilla and IDIVAL, 
      Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern 
      University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, 
      Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at 
      Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charite 
      Universitatsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and 
      Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), 
      Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.
FAU - Winner, Paul K
AU  - Winner PK
AD  - From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department 
      of Neurology (J.P.), University Hospital Marques de Valdecilla and IDIVAL, 
      Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern 
      University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, 
      Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at 
      Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charite 
      Universitatsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and 
      Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), 
      Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.
FAU - Dodick, David W
AU  - Dodick DW
AD  - From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department 
      of Neurology (J.P.), University Hospital Marques de Valdecilla and IDIVAL, 
      Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern 
      University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, 
      Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at 
      Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charite 
      Universitatsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and 
      Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), 
      Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.
FAU - Tepper, Stewart J
AU  - Tepper SJ
AD  - From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department 
      of Neurology (J.P.), University Hospital Marques de Valdecilla and IDIVAL, 
      Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern 
      University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, 
      Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at 
      Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charite 
      Universitatsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and 
      Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), 
      Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.
FAU - Reuter, Uwe
AU  - Reuter U
AD  - From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department 
      of Neurology (J.P.), University Hospital Marques de Valdecilla and IDIVAL, 
      Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern 
      University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, 
      Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at 
      Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charite 
      Universitatsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and 
      Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), 
      Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.
FAU - Hong, Frank
AU  - Hong F
AD  - From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department 
      of Neurology (J.P.), University Hospital Marques de Valdecilla and IDIVAL, 
      Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern 
      University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, 
      Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at 
      Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charite 
      Universitatsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and 
      Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), 
      Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.
FAU - Klatt, Jan
AU  - Klatt J
AD  - From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department 
      of Neurology (J.P.), University Hospital Marques de Valdecilla and IDIVAL, 
      Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern 
      University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, 
      Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at 
      Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charite 
      Universitatsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and 
      Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), 
      Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.
FAU - Zhang, Feng
AU  - Zhang F
AD  - From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department 
      of Neurology (J.P.), University Hospital Marques de Valdecilla and IDIVAL, 
      Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern 
      University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, 
      Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at 
      Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charite 
      Universitatsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and 
      Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), 
      Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.
FAU - Cheng, Sunfa
AU  - Cheng S
AD  - From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department 
      of Neurology (J.P.), University Hospital Marques de Valdecilla and IDIVAL, 
      Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern 
      University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, 
      Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at 
      Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charite 
      Universitatsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and 
      Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), 
      Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.
FAU - Picard, Hernan
AU  - Picard H
AD  - From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department 
      of Neurology (J.P.), University Hospital Marques de Valdecilla and IDIVAL, 
      Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern 
      University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, 
      Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at 
      Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charite 
      Universitatsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and 
      Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), 
      Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.
FAU - Eisele, Osa
AU  - Eisele O
AD  - From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department 
      of Neurology (J.P.), University Hospital Marques de Valdecilla and IDIVAL, 
      Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern 
      University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, 
      Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at 
      Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charite 
      Universitatsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and 
      Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), 
      Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.
FAU - Wang, Julie
AU  - Wang J
AD  - From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department 
      of Neurology (J.P.), University Hospital Marques de Valdecilla and IDIVAL, 
      Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern 
      University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, 
      Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at 
      Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charite 
      Universitatsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and 
      Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), 
      Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.
FAU - Latham, Jonathan N
AU  - Latham JN
AUID- ORCID: 0000-0002-2354-9114
AD  - From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department 
      of Neurology (J.P.), University Hospital Marques de Valdecilla and IDIVAL, 
      Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern 
      University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, 
      Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at 
      Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charite 
      Universitatsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and 
      Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), 
      Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.
FAU - Mikol, Daniel D
AU  - Mikol DD
AD  - From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department 
      of Neurology (J.P.), University Hospital Marques de Valdecilla and IDIVAL, 
      Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern 
      University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, 
      Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at 
      Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charite 
      Universitatsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and 
      Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), 
      Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02483585
SI  - ClinicalTrials.gov/NCT02174861
SI  - ClinicalTrials.gov/NCT01952574
SI  - ClinicalTrials.gov/NCT01723514
PT  - Journal Article
DEP - 20191218
PL  - United States
TA  - Neurology
JT  - Neurology
JID - 0401060
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Calcitonin Gene-Related Peptide Receptor Antagonists)
RN  - I5I8VB78VT (erenumab)
SB  - IM
EIN - Neurology. 2020 Jun 9;94(23):1052. PMID: 32381555
MH  - Adult
MH  - Angina, Unstable/chemically induced/epidemiology/surgery
MH  - Antibodies, Monoclonal, Humanized/*therapeutic use
MH  - Calcitonin Gene-Related Peptide Receptor Antagonists/*therapeutic use
MH  - Female
MH  - Hospitalization/statistics & numerical data
MH  - Humans
MH  - Hypertension/chemically induced/epidemiology
MH  - Ischemic Attack, Transient/chemically induced/epidemiology
MH  - Male
MH  - Middle Aged
MH  - Migraine Disorders/*prevention & control
MH  - Myocardial Infarction/chemically induced/epidemiology/surgery
MH  - Myocardial Revascularization/statistics & numerical data
MH  - Peripheral Arterial Disease/chemically induced/epidemiology/surgery
MH  - Randomized Controlled Trials as Topic
MH  - Stroke/chemically induced/epidemiology
MH  - Vascular Surgical Procedures/statistics & numerical data
PMC - PMC7080286
EDAT- 2019/12/20 06:00
MHDA- 2020/05/19 06:00
PMCR- 2020/02/04
CRDT- 2019/12/20 06:00
PHST- 2018/12/04 00:00 [received]
PHST- 2019/08/06 00:00 [accepted]
PHST- 2019/12/20 06:00 [pubmed]
PHST- 2020/05/19 06:00 [medline]
PHST- 2019/12/20 06:00 [entrez]
PHST- 2020/02/04 00:00 [pmc-release]
AID - WNL.0000000000008743 [pii]
AID - NEUROLOGY2018956185 [pii]
AID - 10.1212/WNL.0000000000008743 [doi]
PST - ppublish
SO  - Neurology. 2020 Feb 4;94(5):e497-e510. doi: 10.1212/WNL.0000000000008743. Epub 
      2019 Dec 18.