Cardiovascular Adverse Drug Reactions of Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies for Migraine Prevention: An Analysis from the European Spontaneous Adverse Event Reporting System

Stovner LJ, Nichols E, Steiner TJ, Abd-Allah F, Abdelalim A, Al-Raddadi RM, et al. Global, regional, and national burden of migraine and tension-type headache, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018;17:954–76.

Article  Google Scholar 

Louter MA, Bosker JE, van Oosterhout WPJ, van Zwet EW, Zitman FG, Ferrari MD, et al. Cutaneous allodynia as a predictor of migraine chronification. Brain. 2013;136:3489–96.

Article  PubMed  Google Scholar 

Zhang N, Robbins MS. Migraine. Ann Intern Med. 2023;176:ITC1-16.

Article  PubMed  Google Scholar 

Burch R, Rizzoli P, Loder E. The prevalence and impact of migraine and severe headache in the United States: figures and trends from government health studies. Headache. 2018;58:496–505.

Article  PubMed  Google Scholar 

Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z. Migraine remains second among the world’s causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020;21:137.

Article  PubMed  PubMed Central  CAS  Google Scholar 

Laurell K, Artto V, Bendtsen L, Hagen K, Häggström J, Linde M, et al. Premonitory symptoms in migraine: a cross-sectional study in 2714 persons. Cephalalgia. 2016;36:951–9.

Article  PubMed  Google Scholar 

Aguilar-Shea AL, Membrilla MDJA, Diaz-de-Teran J. Migraine review for general practice. Aten Primaria. 2022;54: 102208.

Article  PubMed  Google Scholar 

Jain S, Yuan H, Spare N, Silberstein SD. Erenumab in the treatment of migraine. Pain Manag. 2018;8:415–26.

Article  PubMed  Google Scholar 

European Medicines Agency. Aimovig®, summary of product characteristics [Internet]. 2018. Available from: https://www.ema.europa.eu/en/documents/product-information/aimovig-epar-product-information_en.pdf. Accessed 27 June 2023.

European Medicines Agency. Emgality®, summary of product characteristics [Internet]. 2018. Available from: https://www.ema.europa.eu/en/documents/product-information/emgality-epar-product-information_en.pdf. Accessed 27 June 2023.

European Medicines Agency. Ajovi®, summary of product characteristics [Internet]. 2019. Available from: https://www.ema.europa.eu/en/documents/product-information/ajovy-epar-product-information_en.pdf. Accessed 27 June 2023.

European Medicines Agency. Vyepti®, summary of product characteristics [Internet]. 2021. Available from: https://www.ema.europa.eu/en/documents/product-information/vyepti-epar-product-information_en.pdf. Accessed 27 June 2023.

Dodick DW. CGRP ligand and receptor monoclonal antibodies for migraine prevention: evidence review and clinical implications. Cephalalgia. 2019;39:445–58.

Article  PubMed  Google Scholar 

European Medicines Agency. Summary of risk management plan for VYEPTI® (eptinezumab) [Internet]. 2022. p. 1–5. Available from: https://www.ema.europa.eu/en/documents/rmp-summary/vyepti-epar-risk-management-plan-summary_en.pdf. Accessed 1 July 2023.

European Medicines Agency. Summary of risk management plan for AJOVY (fremanezumab) [Internet]. 2023. p. 1–4. Available from: https://www.ema.europa.eu/en/documents/rmp-summary/ajovy-epar-risk-management-plan-summary_en.pdf. Accessed 1 July 2023.

European Medicines Agency. Summary of the risk management plan for Aimovig (erenumab) [Internet]. 2023. p. 1–4. Available from: https://www.ema.europa.eu/en/documents/rmp-summary/aimovig-epar-risk-management-plan-summary_en.pdfv. Accessed 1 July 2023.

European Medicines Agency. Summary of risk management plan for Emgality (galcanezumab) [Internet]. 2021. p. 1–9. Available from: https://www.ema.europa.eu/en/documents/rmp-summary/emgality-epar-risk-management-plan-summary_en.pdf. Accessed 1 July 2023.

Kudrow D, Dafer R, Dodick DW, Starling A, Ailani J, Dougherty C, et al. 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. Headache. 2023;63:418–28.

Article  PubMed  Google Scholar 

Liang D, Sessa M. Post-marketing safety surveillance of erenumab: new insight from EudraVigilance. Expert Opin Drug Saf. 2022;21:1205–10.

Article  PubMed  CAS  Google Scholar 

Gérard AO, Merino D, Van Obberghen EK, Rocher F, Destere A, Lantéri-Minet M, et al. Calcitonin gene-related peptide-targeting drugs and Raynaud’s phenomenon: a real-world potential safety signal from the WHO pharmacovigilance database. J Headache Pain. 2022;23:53.

Article  PubMed  PubMed Central  Google Scholar 

Woods RH. Alopecia signals associated with calcitonin gene-related peptide inhibitors in the treatment or prophylaxis of migraine: a pharmacovigilance study. Pharmacotherapy. 2022;42:758–67.

Article  PubMed  CAS  Google Scholar 

Sacco S, Amin FM, Ashina M, Bendtsen L, Deligianni CI, Gil-Gouveia R, et al. European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention—2022 update. J Headache Pain. 2022;23:67.

Article  PubMed  PubMed Central  Google Scholar 

Eigenbrodt AK, Ashina H, Khan S, Diener H-C, Mitsikostas DD, Sinclair AJ, et al. Diagnosis and management of migraine in ten steps. Nat Rev Neurol. 2021;17:501–14.

Article  PubMed  PubMed Central  Google Scholar 

Xu SY, Li HJ, Huang J, Li XP, Li CX. Migraine with brainstem aura accompanied by disorders of consciousness. J Pain Res. 2021;14:1119–27.

Article  PubMed  PubMed Central  Google Scholar 

Noghani TM, Rezaeizadeh H, Fazljoo SMB, Keshavarz M. Gastrointestinal headache: a narrative review. Emerg (Tehran). 2016;4:171–83.

Google Scholar 

Ailani J, Kaiser EA, Mathew PG, McAllister P, Russo AF, Vélez C, et al. Role of calcitonin gene-related peptide on the gastrointestinal symptoms of migraine-clinical considerations: a narrative review. Neurology. 2022;99:841–53.

Article  PubMed  PubMed Central  CAS  Google Scholar 

Pi L-Q, Jin X-H, Hwang ST, Lee W-S. Effects of calcitonin gene-related peptide on the immune privilege of human hair follicles. Neuropeptides. 2013;47:51–7.

Article  PubMed  CAS  Google Scholar 

Barbieri MA, Sorbara EE, Russo G, Cicala G, Franchina T, Santarpia M, et al. Neuropsychiatric adverse drug reactions with tyrosine kinase inhibitors in gastrointestinal stromal tumors: an analysis from the European Spontaneous Adverse Event Reporting System. Cancers (Basel). 2023;15:1851.

Article  PubMed  PubMed Central  CAS  Google Scholar 

Güner MD, Ekmekci PE. Healthcare professionals’ pharmacovigilance knowledge and adverse drug reaction reporting behavior and factors determining the reporting rates. J Drug Assess. 2019;8:13–20.

Article  PubMed  PubMed Central  Google Scholar 

Santoro A, Genov G, Spooner A, Raine J, Arlett P. Promoting and protecting public health: how the European Union Pharmacovigilance System works. Drug Saf. 2017;40:855–69.

Article  PubMed  PubMed Central  Google Scholar 

Arora A, Jalali R, Vohora D. Relevance of the Weber effect in contemporary pharmacovigilance of oncology drugs. Ther Clin Risk Manag. 2017;13:1195–203.

Article  PubMed  PubMed Central  Google Scholar 

Rhee TM, Choi EK, Do HK, Ahn HJ, Lee SR, Oh S, et al. Type and severity of migraine determines risk of atrial fibrillation in women. Front Cardiovasc Med. 2022;9:910225.

Article  PubMed  PubMed Central  Google Scholar 

Rambarat CA, Elgendy IY, Johnson BD, Reis SE, Thompson DV, Sharaf BL, et al. Migraine headache and long-term cardiovascular outcomes: an extended follow-up of the Women’s Ischemia Syndrome Evaluation. Am J Med. 2017;130:738–43.

Article  PubMed  PubMed Central  Google Scholar 

Schillaci G, Verdecchia P, Borgioni C, Ciucci A, Porcellati C. Early cardiac changes after menopause. Hypertension. 1998;32:764–9.

Article  PubMed  CAS  Google Scholar 

Costa S, Saguner AM, Gasperetti A, Akdis D, Brunckhorst C, Duru F. the link between sex hormones and susceptibility to cardiac arrhythmias: from molecular basis to clinical implications. Front Cardiovasc Med. 2021;8.

Favoni V, Giani L, Al-Hassany L, Asioli GM, Butera C, de Boer I, et al. CGRP and migraine from a cardiovascular point of view: what do we expect from blocking CGRP? J Headache Pain. 2019;20:27.

Article  PubMed  PubMed Central  Google Scholar 

Smith TR, Spierings ELH, Cady R, Hirman J, Ettrup A, Shen V. Cardiovascular outcomes in adults with migraine treated with eptinezumab for migraine prevention: pooled data from four randomized, double-blind, placebo-controlled studies. J Headache Pain. 2021;22:143.

Article  PubMed  PubMed Central  CAS  Google Scholar 

Mitsikostas DD, Reuter U. Calcitonin gene-related peptide monoclonal antibodies for migraine prevention: comparisons across randomized controlled studies. Curr Opin Neurol. 2017;30:272–80.

Article  PubMed  CAS  Google Scholar 

Saely S, Croteau D, Jawidzik L, Brinker A, Kortepeter C. Hypertension: a new safety risk for patients treated with erenumab. Headache. 2021;61:202–8.

Finocchi C, Sassos D. Headache and arterial hypertension. Neurol Sci. 2017;38:67–72.

Article  PubMed  Google Scholar 

Gupta S, Mehrotra S, Villalón CM, Garrelds IM, de Vries R, van Kats JP, et al. Characterisation of CGRP receptors in human and porcine isolated coronary arteries: evidence for CGRP receptor heterogeneity. Eur J Pharmacol. 2006;530:107–16.

Article  PubMed  CAS  Google Scholar 

Gulbenkian S, Saetrum Opgaard O, Ekman R, Costa Andrade N, Wharton J, Polak JM, et al. Peptidergic innervation of human epicardial coronary arteries. Circ Res. 1993;73:579–88.

Article  PubMed  CAS  Google Scholar 

Smillie S-J, King R, Kodji X, Outzen E, Pozsgai G, Fernandes E, et al. An ongoing role of α-calcitonin gene-related peptide as part of a protective network against hypertension, vascular hypertrophy, and oxidative stress. Hypertension. 2014;63:1056–62.

Article  PubMed  CAS  Google Scholar 

Dodick DW, Tepper SJ, Ailani J, Pannacciulli N, Navetta MS, Loop B, et al. Risk of hypertension in erenumab-treated patients with migraine: analyses of clinical trial and postmarketing data. Headache. 2021;61:1411–20.

Article 

Comments (0)

No login
gif