Headache
`© 2018 American Headache Society
`
`Letter to the Editor
`
`ISSN 0017-8748
`doi: 10.1111/head.13402
`Published by Wiley Periodicals, Inc.
`
`Is CGRP Receptor Blockade
`Cardiovascularly Safe? Appropriate
`Studies are Needed
`
`With great interest, we read the publication by
`Depre and colleagues1 describing that inhibition
`of the canonical CGRP receptor does not seem to
`worsen myocardial ischemia contrary to theoretical
`concerns.2 In a randomized, double-blind, place-
`bo-controlled study the authors did not find evidence
`for an adverse effect of the CGRP receptor antibody
`erenumab on exercise time during a treadmill test in
`patients with stable angina. Although we certainly
`appreciate the endeavor to address this important
`issue, we are concerned that the study population, the
`study design, and the interpretation of the results do
`not allow for such a reassuring conclusion.
`While the authors rightly indicate that it is
`currently not clear to which extent CGRP is relevant
`in maintaining blood flow in case of myocardial and
`cerebral ischemia, we do not agree with their argument
`stating that “the concentrations of exogenous CGRP
`required to increase total exercise time or protect
`against myocardial ischemia far exceed the endogenous
`physiological levels of CGRP that are released during
`a response to ischemia.” This is because it is not the
`systemic plasma concentration that is relevant in this
`perspective, but the actual concentration of CGRP at
`the neuro-vascular junction, where CGRP is released.
`Obviously, the plasma concentration is likely to be
`several log units lower than the junctional concentration
`due to dilution and hydrolysis. Further, we feel that the
`argument that erenumab does not contract the human
`isolated coronary artery per se3 does not add to the
`introduction, since the question that should be answered
`here is whether inhibition of the actions of CGRP is
`potentially harmful in myocardial ischemia.
`
`More importantly, the patients included in
`this study suffered from stable angina pectoris,
`which often is caused by a stenosis of the epicardial
`conducting portions of the coronary artery. As we
`pointed out earlier,2 the importance of CGRP in
`the proximal, epicardial portions of the coronary
`artery bed seems limited, while CGRP is a highly
`effective vasodilator in the intramyocardial, smaller
`(distal) sections of the coronary artery bed. Thus, it
`is unfortunate that a patient population with, most
`likely, mainly diseased proximal coronary arteries,
`was chosen for this study, despite the advantage of a
`clear-cut definition of these patients. Although stable
`angina pectoris due to epicardial stenosis may occur
`in both men and women, this is typically considered
`a “male” form of cardiac pathology,4 as illustrated by
`the fact that 78% of patients included in the current
`study were male. In contrast, in females, who are
`the majority of migraine sufferers and thus also the
`majority of the population likely to use erenumab
`or related drugs in future, coronary artery disease
`often presents as diffuse atherosclerosis, without
`an angiographically detectable stenosis.4–6 These
`observations indicate that coronary microvascular
`dysfunction plays a more important role in angina
`pectoris in female patients and that blocking the
`effects of CGRP in female patients may have different
`effects than in male patients.
`An essential concern of this study is based on
`pharmacokinetic and pharmacodynamic considerations.
`The authors rightly indicate that plasma concentrations
`obtained 30 min after intravenous infusion of 140
`mg erenumab (the time interval until the start of the
`
`Conflict of Interest: AMvdB received research grants and/or
`consultation fees from Amgen/Novartis, Lilly/CoLucid, Teva,
`and ATI.
`CMV received consultation fees from Lilly/CoLucid.
`
`1257
`
`1
`
`EX2178
`Eli Lilly & Co. v. Teva Pharms. Int'l GMBH
`IPR2018-01422
`
`

`

`1258
`
`treadmill test) will provide “a substantial margin over
`concentrations achieved by subcutaneous administration
`of 140 mg.” In contrast, their claim that “the use of 140 mg
`intravenous dose of erenumab ensured rapid and robust
`blockade of the CGRP receptor” is not substantiated
`by any evidence. It should be taken into account that,
`before a receptor blocking antibody can effectively
`occupy the receptor where it is binding to, the antibody
`should first have access to the receptor biophase. In
`this case, erenumab was infused intravenously and thus
`reached the blood vessel wall from the luminal side. The
`CGRP receptor is located in the smooth muscle wall,5
`thus it may take several hours before the receptor was
`reached by erenumab at sufficiently high concentrations
`to induce an effective blockade of the CGRP receptor,
`especially given the large molecular size (150 kDa) of
`erenumab. This is well beyond the time the treadmill test
`had finished. A way to verify whether blockade has been
`achieved (at least in skin blood vessels) is by assessing
`blockade of capsaicin-induced increases in dermal blood
`flow. The earliest time point for such measurements that
`has been published, to the best of our knowledge, for
`erenumab is 2 days after intravenous administration,6
`which is about 100-fold longer than the period applied
`in the current study. Thus, we feel that evidence for
`significant blockade of the canonical CGRP receptor
`should have been provided to substantiate the statement
`that CGRP receptor blockade was reached during the
`treadmill study, since otherwise the interpretation of the
`current study is questionable.
`Taken together, we would politely urge the au-
`thors to provide evidence for the fact that vascular
`CGRP receptor blockade has been achieved 30 min
`after intravenous infusion of erenumab, since this is
`a crucial part of the study. Further, we plead for car-
`diovascular safety studies on patients and/or experi-
`mental animals with microvascular disease, as such
`a group may better represent the patients at cardio-
`vascular risk after the use of erenumab. Even if the
`
`antibodies against CGRP or its receptor would not in-
`crease the risk for cardiovascular ischemia, there will
`be cases of patients with ischemic complaints, even
`without a causal relationship. Appropriate studies in
`relevant subjects may avoid sudden distress, such as
`happened with the triptans in the past.
`
`A. Maassen van den Brink, PhD; E. Rubio-Beltrán, MSc;
`D. Duncker, MD, PhD; C.M. Villalón, PhD
`Division of Pharmacology, Department of Internal Medicine,
`Erasmus MC, Rotterdam, The Netherlands (A. Maassen
`van den Brink and E. Rubio-Beltrán); Department of
`Experimental Cardiology, Erasmus MC, Rotterdam,
`The Netherlands (D. Duncker); Department Pharmacobiology,
`Cinvestav-Coapa, Tlalpan, Mexico City, Mexico (C. Villalón)
`e-mail: a.vanharen-maassenvandenbrink@erasmusmc.nl
`
`REFERENCES
`1. Depre C, Antalik L, Starling A, et al. A randomized, dou-
`ble-blind, placebo-controlled study to evaluate the effect of
`erenumab on exercise time during a treadmill test in patients
`with stable angina. Headache. 2018;58:715-723.
`2. MaassenVanDenBrink A, Meijer J, Villalón CM, Ferrari
`MD. Wiping out CGRP: Potential cardiovascular risks.
`Trends Pharmacol Sci. 2016;37:779-788.
`3. Rubio-Beltrán E, Labastida A, De Vries R, et al. Effects of
`AMG 334 on human isolated coronary artery. Cephalalgia.
`2016;36:S41.
`4. Humphries KH, Pu A, Gao M, Carere RG, Pilote L.
`Angina with “normal” coronary arteries: Sex differences
`in outcomes. Am Heart J. 2008;155:375-381.
`5. Maas AH, van der Schouw YT, Regitz-Zagrosek V, et al.
`Red alert for women’s heart: The urgent need for more
`research and knowledge on cardiovascular disease in
`women: Proceedings of the workshop held in Brussels on
`gender differences in cardiovascular disease, 29 September
`2010. Eur Heart J. 2011;32:1362-1368.
`6. Duncker DJ, Koller A, Merkus D, Canty JM Jr. Regulation
`of coronary blood flow in health and ischemic heart disease.
`Prog Cardiovasc Dis. 2015;2015:409-422.
`7. Chan KY, Edvinsson L, Eftekhari S, et al. Characterization
`of the calcitonin gene-related peptide receptor antagonist
`telcagepant (MK-0974) in human isolated coronary arter-
`ies. J Pharmacol Exp Ther. 2010;334:746-752.
`8. Vu T, Ma P, Chen JS, et al. Pharmacokinetic-
`pharmacodynamic relationship of erenumab (AMG 334) and
`capsaicin-induced dermal blood flow in healthy and migraine
`subjects. Pharm Res. 2017;34:1784-1795.
`
`September 2018
`
`2
`
`

`

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`HEADACHE
`
`The Journal of Head and Face Pain
`Official Publication of the American
`Headache Society
`“. . .to improve the lives of headache sufferers”
`www.AmericanHeadacheSociety.org
`
`ISSN 0017-8748
`
`American Headache Society
`Board of Directors
`2018-2020
`PRESIDENT
`Kathleen B. Digre, MD, FAHS
`PRESIDENT-ELECT
`Peter J. Goadsby, MD, PhD, FAHS
`TREASURER
`Andrew C. Charles, MD, FAHS
`SECRETARY
`Todd J. Schwedt, MD, MSCI, FAHS
`IMMEDIATE PAST PRESIDENT
`R. Allan Purdy, MD, FAHS
`BOARD MEMBERS-AT-LARGE
`Jessica Ailani, MD, FAHS
`Dawn C. Buse, PhD, FAHS
`Deborah I. Friedman, MD, MPH, FAHS
`Morris Levin, MD, FAHS
`Matthew S. Robbins, MD, FAHS
`Robert E. Shapiro, MD, PhD
`Stewart J. Tepper, MD, FAHS
`Bert B. Vargas, MD, FAHS
`AMERICAN MIGRAINE FOUNDATION CHAIR
`David W. Dodick, MD, FAHS
`EDITOR HEADACHE
`Thomas N. Ward, MD, FAHS
`EXECUTIVE EDITOR OF HEADACHE
`Jason Roberts, PhD
`CORPORATE LIAISON
`Barry S. Baumel, MD
`CHAIR, SPECIAL INTEREST SECTIONS
`Mia Minen, MD, FAHS
`CHAIR, AAN HEADACHE SPECIAL INTEREST
`Morris Levin, MD, FAHS
`IHS REPRESENTATIVE
`R. Allan Purdy, MD, FAHS
`PAN AMERICAN LIAISON
`Fabiola Dach, MD, PhD
`PAN ASIAN LIAISON
`Toshi Shimizu, MD, PhD
`PAST PRESIDENT ADVISORS
`Robert B. Daroff, MD, FAHS
`Elizabeth W. Loder, MD, MPH, FAHS
`Richard B. Lipton, MD, FAHS
`Lawrence C. Newman, MD, FAHS
`Joel R. Saper, MD, FAHS
`Stephen D. Silberstein, MD, FAHS
`Paul Winner, DO, FAHS
`CHIEF EXECUTIVE OFFICER
`Linda McGillicuddy
`EXECUTIVE DIRECTOR
`Howard Rosen
`
`3
`
`

`

`
`
`Editorial Board
`Editor-in-Chief
`Thomas N. Ward, MD Hanover, NH
`Senior Editorial Advisors
`Robert B. Daroff, MD Cleveland, OH, USA
`Anne Ducros Montpellier, France
`Michel Ferrari, MD Leiden, The Netherlands
`Peter J. Goadsby, MD, PhD, DSc London,
`United Kingdom
`Donald Penzien, PhD Winston-Salem,
`North Carolina
`John Rothrock, MD Washington, DC, USA
`Associate Editors
`Steven M. Baskin, PhD Stamford, CT, USA
`Rebecca Burch, MD Boston, MA, USA
`Gregory Dussor, PhD Dallas, Texas, USA
`Deborah Friedman, MD Dallas, TX, USA
`Amy Gelfand, MD, San Francisco,
`California, USA
`Christopher Gottschalk, MD New Haven, CT, USA
`Laine Greene Halifax, Nova Scotia, Canada
`Lyn Griffiths, PhD Gold Coast, Australia
`Andrew Hershey, MD, PhD, Cincinnati, OH, USA
`Robert Kaniecki, MD Pittsburgh, PA, USA
`Abouch Krymchantowski, MD, PhD Rio de
`Janeiro, Brazil
`Morris Levin, MD San Francisco, CA
`Dan Levy Boston, MA, USA
`Elizabeth Loder, MD Boston, MA, USA
`Vincent Martin, MD Cincinnati, OH, USA
`Brian E. McGeeney, MD Boston, MA, USA
`Mia Minen, MD New York, NY
`Julio Pascual, MD, PhD Oviedo, Spain
`B. Lee Peterlin, DO Baltimore, MD, USA
`Luiz P. Queiroz, MD Florianopolis, Brazil
`Paul B. Rizzoli, MD Boston, MA, USA
`Matthew S. Robbins, MD Bronx, NY
`Noah Rosen, MD Great Neck, New York, USA
`Todd J. Schwedt, MD Phoenix, AZ, USA
`Jonathan Smith, MD Lexington, KY, USA
`Todd A. Smitherman, PhD Oxford, MS,USA
`Till Sprenger, MD Basel, Switzerland
`Jerry W. Swanson, MD, MHPE Rochester,
`MN, USA
`Deborah E. Tepper, MD Sandwich, MA, USA
`Stewart J. Tepper, MD Lebanon, NH, USA
`Gretchen E. Tietjen, MD Toledo, OH, USA
`Marcelo M. Valenc¸ a, MD, PhD Recife, Brazil
`Shuu-Jiun Wang, MD Taipei, Taiwan
`Randall E. Weeks, PhD Stamford, CT, USA
`Assistant Editors
`Jennifer Hranilovich, MD Boston, MA, USA
`Saad Kanaan, MD Boston, MA, USA
`Amanda Macone, MD Lebanon, NH, USA
`Headache Currents Editor-in-Chief
`Stewart J. Tepper, MD Lebanon, NH, USA
`Online Editor
`Todd Schwedt, MD Phoenix, AZ, USA
`Associate Provider Editor
`Lynda J Krasenbaum MSN, ANP-BC
`New York, NY, USA
`Supplement Editors
`R. Allan Purdy, MD Halifax, Nova Scotia,
`Canada
`Alan Rapoport, MD Los Angeles, California
`Abstracts and Citations Editors
`Wade Cooper, DO Ann Arbor, Michigan,USA
`Robert Kaniecki, MD Pittsburgh, PA, USA
`Frederick R. Taylor, MD Minneapolis, MN, USA
`Book/Media Review Editor
`R. Allan Purdy, MD Halifax, Nova Scotia, Canada
`Expert Opinion Section Editor
`Randolph W. Evans, MD Houston, TX, USA
`Residents and Fellows Section Editors
`Morris Levin, MD San Francisco, CA
`Matthew S. Robbins, MD Bronx, NY
`Statistical Consultant
`Timothy Houle, PhD Boston, MA, USA
`Design & Methods Advisor
`Dana Turner Boston, MA, USA
`Editorial Office
`Jason Roberts, PhD
`Executive Editor, Headache Ottawa,
`Ontario, Canada
`Email: journal@ahsnet.org
`AHS Executive Office
`Linda McGillicuddy
`American Headache Society CEO
`Mount Royal, NJ USA
`Copyright © 2018 by the
`American Headache Society
`
`HEADACHE
`
`The Journal of Head and Face Pain
`
`http://mc.manuscriptcentral.com/headache
`
`Official Publication of the American Headache Society
`www.headachejournal.org
`
`Volume 58, Number 8
`
`September 2018
`
`Page
`
`Guest Editorials
`The Importance of Statistical Power Calculations 1187
`Dana P. Turner, MSPH, PhD; Timothy T. Houle, PhD
`Have You Got the Power? Why Statistical Power Calculations Are Critical to Research Design 1192
`Serena L. Orr, MD, MSc, FRCPC; Andrew D. Hershey, MD, PhD, FAHS
`
`Research Submissions
`Predictors of First-Line Treatment Success in Children and Adolescents Visiting an Infusion Center for
`Acute Migraine 1194
`Serena L. Orr, MD, MSc, FRCPC; Marielle A. Kabbouche, MD; Paul S. Horn, PhD; Hope L. O’Brien,
`MD, FAHS, FAAN; Joanne Kacperski, MD; Susan LeCates, MSN, APRN, CNP; Shannon White,
`DNP, CNP; Jessica Weberding, MSN, CNP; Mimi N. Miller, MSN, APRN, CNP; Scott W. Powers,
`PhD, ABPP, FAHS; Andrew D. Hershey, MD, PhD, FAHS
`Aura in Cluster Headache: A Cross-Sectional Study 1203
`Ilse F. de Coo, MD; Leopoldine A. Wilbrink, MD; Gaby D. Ie, MD; Joost Haan, MD, PhD;
`Michel D. Ferrari, MD, PhD
`Structured Clinical Documentation to Improve Quality and Support Practice-Based Research in Headache 1211
`Steven Meyers, MD; Kelly Claire Simon, ScD; Stuart Bergman-Bock, MD; Franco Campanella,
`DO; Revital Marcus, MD; Angela Mark, MD; Thomas Freedom, MD; Susan Rubin, MD;
`Irene Semenov, DO; Rebekah Lai, BS; Laura Hillman, BBA; Samuel Tideman, MS; Anna Pham,
`BS; Roberta Frigerio, MD; Demetrius M. Maraganore, MD
`Migraine and Non-Migraine Headaches Following Diagnostic Catheter-Based Cerebral Angiography 1219
`Adnan I. Qureshi, MD; Nishath Naseem, MD; Muhammad A. Saleem, MD; Anvita Potluri, MD;
`Faisal Raja, MD; Shawn S. Wallery, MD
`Measures of Functioning in Patients With Episodic Migraine: Findings From a Double-Blind,
`Randomized, Placebo-Controlled Phase 2b Trial With Galcanezumab 1225
`David W. Ayer, PhD; Vladimir Skljarevski, MD; Janet H. Ford, PhD; Allen W. Nyhuis, MS;
`Richard B. Lipton, MD; Sheena K. Aurora, MD
`
`Images From Headache
`Central Skull Base Osteomyelitis Presenting Only With a Severe Headache 1236
`Pahn K. Choi, MD; Ji Y. Chung, MD; Hyun G. Kang, MD, PhD
`
`Brief Communications
`Orthostatic Headache After Suboccipital Craniectomy Without CSF Leak: Two Case Reports 1238
`Monique M. Montenegro, MD; Jeremy K. Cutsforth-Gregory, MD
`Cerebral Venous Thrombosis in Spontaneous Intracranial Hypotension: A Report on 4 Cases and a
`Review of the Literature 1244
`Dan Zhang, MD; Jin Wang, MD; Qiaowei Zhang, MD; Feifang He, PhD; Xingyue Hu, MD, PhD
`
`Scan this QR code with your smartphone to listen to the most recent Headache Journal podcast.
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`4
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`

`

`HEADACHE
`
`The Journal of Head and Face Pain
`
`Offi cial Publication of the American Headache Society
`www.headachejournal.org
`
`Volume 58, Number 8
`
`September 2018
`
`GUEST EDITORIALS
`1187 The Importance of Statistical Power Calculations
`Dana P. Turner, MSPH, PhD; Timothy T. Houle, PhD
`1192 Have You Got the Power? Why Statistical Power Calculations
`Are Critical to Research Design
`Serena L. Orr, MD, MSc, FRCPC; Andrew D. Hershey, MD, PhD, FAHS
`
`RESEARCH SUBMISSIONS
`1194 Predictors of First-Line Treatment Success in Children and
`Adolescents Visiting an Infusion Center for Acute Migraine
`Serena L. Orr, MD, MSc, FRCPC; Marielle A. Kabbouche, MD;
`Paul S. Horn, PhD; Hope L. O’Brien, MD, FAHS, FAAN; Joanne
`Kacperski, MD; Susan LeCates, MSN, APRN, CNP; Shannon
`White, DNP, CNP; Jessica Weberding, MSN, CNP; Mimi N. Miller,
`MSN, APRN, CNP; Scott W. Powers, PhD, ABPP, FAHS;
`Andrew D. Hershey, MD, PhD, FAHS
`1203 Aura in Cluster Headache: A Cross-Sectional Study
`Ilse F. de Coo, MD; Leopoldine A. Wilbrink, MD; Gaby D. Ie, MD;
`Joost Haan, MD, PhD; Michel D. Ferrari, MD, PhD
`1211 Structured Clinical Documentation to Improve Quality and
`Support Practice-Based Research in Headache
`Steven Meyers, MD; Kelly Claire Simon, ScD; Stuart Bergman-Bock,
`MD; Franco Campanella, DO; Revital Marcus, MD; Angela Mark,
`MD; Thomas Freedom, MD; Susan Rubin, MD; Irene Semenov, DO;
`Rebekah Lai, BS; Laura Hillman, BBA; Samuel Tideman, MS;
`Anna Pham, BS; Roberta Frigerio, MD; Demetrius M. Maraganore, MD
`1219 Migraine and Non-Migraine Headaches Following Diagnostic
`Catheter-Based Cerebral Angiography
`Adnan I. Qureshi, MD; Nishath Naseem, MD; Muhammad A. Saleem,
`MD; Anvita Potluri, MD; Faisal Raja, MD; Shawn S. Wallery, MD
`1225 Measures of Functioning in Patients With Episodic Migraine:
`Findings From a Double-Blind, Randomized, Placebo-Controlled
`Phase 2b Trial With Galcanezumab
`David W. Ayer, PhD; Vladimir Skljarevski, MD; Janet H. Ford, PhD;
`Allen W. Nyhuis, MS; Richard B. Lipton, MD; Sheena K. Aurora, MD
`
`IMAGES FROM HEADACHE
`1236 Central Skull Base Osteomyelitis Presenting Only With a Severe
`Headache
`Pahn K. Choi, MD; Ji Y. Chung, MD; Hyun G. Kang, MD, PhD
`
`BRIEF COMMUNICATIONS
`1238 Orthostatic Headache After Suboccipital Craniectomy Without
`CSF Leak: Two Case Reports
`Monique M. Montenegro, MD; Jeremy K. Cutsforth-Gregory, MD
`
`1244 Cerebral Venous Thrombosis in Spontaneous Intracranial
`Hypotension: A Report on 4 Cases and a Review of the Literature
`Dan Zhang, MD; Jin Wang, MD; Qiaowei Zhang, MD;
`Feifang He, PhD; Xingyue Hu, MD, PhD
`
`LETTERS TO THE EDITOR
`1256 Choose Wisely: Adapt the Classification Characteristics for
`“Migraine Trigger Points”
`J. Alexander de Ru, MD, PhD
`1257 Is CGRP Receptor Blockade Cardiovascularly Safe? Appropriate
`Studies Are Needed
`A. Maassen van den Brink, PhD; E. Rubio-Beltrán,
`MSc; D. Duncker, MD, PhD; C.M. Villalón, PhD
`
`CLINICAL CORRESPONDENCE
`1259 Decreased Pulmonary Function During Botulinum Toxin
`A Therapy for Chronic Migraines in a 17-Year-Old Female
`Jeremie D. Oliver, BS, BA; R. Paul Boesch, DO;
`Kenneth J. Mack, MD, PhD
`
`ABSTRACTS AND CITATIONS
`1262 Abstracts and Citations
`Frederick R. Taylor, MD FAAN FAHS; Wade M. Cooper, DO;
`Robert G. Kaniecki, MD
`
`BOOKS RECEIVED
`1273 Books Received in 2018
`R. Allan Purdy, MD, FRCPC
`
`1274 HEADACHE CURRENTS
`
`1277 Migraine and cerebrovascular diseases: Epidemiology,
`pathophysiological, and clinical considerations
`João Eudes Magalhães, MD, PhD;
`Pedro Augusto Sampaio Rocha-Filho, MD, PhD
`
`VOLUME 58, NUMBER 8
`
`HEADACHE
`
`SEPTEMBER 2018 PAGES 1187–1337
`
`
`
`Eliminating barriers
`with Qudexy® XR
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`With the Platinum Pass, it has never been easier to
`prescribe Qudexy® XR. Help patients start, stay and
`save on therapy today!
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`Visit hcp.QudexyXR.com or call Access Pathways® at 1-855-282-4887.
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`Qudexy and Access Pathways are registered trademarks of Upsher-Smith Laboratories, LLC.
`© 2018 Upsher-Smith Laboratories, LLC, 6701 Evenstad Drive, Maple Grove, MN 55369 113236.02
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