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. 2020 Jan-Dec:11:2150132720963680.
doi: 10.1177/2150132720963680.

Migraine Patients With Cardiovascular Disease and Contraindications: An Analysis of Real-World Claims Data

David W Dodick  1 , Anand S Shewale  2 , Richard B Lipton  3   4 , Seth J Baum  5 , Steven C Marcus  6 , Stephen D Silberstein  7 , Jelena M Pavlovic  3   4 , Nathan L Bennett  8 , William B Young  7 , Hema N Viswanathan  2 , Jalpa A Doshi  6 , Howard Weintraub  9
Affiliations

Migraine Patients With Cardiovascular Disease and Contraindications: An Analysis of Real-World Claims Data

David W Dodick et al. J Prim Care Community Health. 2020 Jan-Dec.

Abstract

Introduction: Triptans, the most commonly prescribed acute treatments for migraine attacks are, per FDA labeling, contraindicated in cardiovascular (CV) disease patients and have warnings and precautions for those with CV risk factors.

Methods: Headache specialists, cardiologists, and health economics and outcomes researchers convened to identify diagnostic codes for: (1) CV diseases contraindicating triptans based on FDA labeling; (2) conditions comprising "other significant underlying CV disease"; and (3) CV risk factors included as warnings and precautions for triptans. A retrospective, cross-sectional analysis of commercially insured adult US migraine patients in the 2017 Optum® Clinformatics® Data Mart (CDM) and the 2017 IBM® Watson Health MarketScan® Commercial Claims database was used to estimate the proportion of migraine patients with CV contraindications and warnings and precautions to triptans.

Results: Of the 56,662 migraine patients analyzed from Optum CDM, 13.5% had ≥1 CV disease as specified in triptan labeling and an additional 8.5% had ≥1 "other CV disease" judged by the panel to constitute a "significant underlying CV disease" (total: 22.0% migraine patients). Of 176 724 migraine patients analyzed from MarketScan, 12.2% had ≥1 CV disease as specified in the labeling and an additional 8.0% had ≥1 "other significant underlying CV disease" (total: 20.2% of migraine patients). An additional 25.4% and 25.1% of migraine patients had ≥2 CV risk factors in Optum CDM and MarketScan. In total, 47.4% and 45.3% of migraine patients in both databases had a CV disease specified as a contraindication, an "other CV disease" endorsed as significant, or ≥2 CV risk factors identified as warnings and precautions to triptans.

Conclusions: Analyses of more than 230,000 people with migraine showed that ≥20% of commercially insured US migraine patients have a CV condition that specifically contraindicates triptan treatment, and an additional 25% have ≥2 CV risk factors identified as warnings and precautions to triptans.

Keywords: acute treatment; cardiovascular disease; migraine; risk factors; triptan.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: David W. Dodick, MD, reports the following conflicts: Personal fees: AbbVie, AEON, Alder BioPharmaceuticals, Amgen, Amzak Health, Association of Translational Medicine, Autonomic Technologies, Axsome, Biohaven, Cerecin, Charleston Laboratories, Clexio, Daniel Edelman Inc., Dr Reddy’s Laboratories/Promius, electroCore LLC, Eli Lilly, eNeura, Equinox, Foresite Capital, Impel, Ipsen, Neurolief, Nocira, Novartis, Oppenheimer, Pieris, PSL Group Services, Revance, Salvia, Satsuma, Sun Pharma (India), Supernus, Teva, Theranica, University Health Network, Upjohn (Division of Pfizer), Vedanta, WL Gore, XoC, Zosano, and ZP Opco; Speaking fees: Amgen, Eli Lilly, Lundbeck, and Novartis Canada; CME fees or royalty payments: Academy for Continued Healthcare Learning, Cambridge University Press, Catamount, Chameleon, Global Access Meetings, Global Life Sciences, Global Scientific Communications, Haymarket, HealthLogix, Medicom Worldwide, MedLogix Communications, Mednet, Miller Medical, Oxford University Press, PeerView, Universal Meeting Management, UpToDate (Elsevier), WebMD Health/Medscape, and Wolters Kluwer Health; Stock options: Aural Analytics, Epien, Healint, King-Devick Technologies, Matterhorn, Nocira, Ontologics, Precon Health, Second Opinion/Mobile Health, and Theranica; Consulting without fee: Aural Analytics, Epien, Healint, Second Opinion/Mobile Health; Board of Directors: Epien, King-Devick Technologies, Matterhorn, Ontologics, Paranet North America, and Precon Health; Patent: 17189376.1-1466:vTitle: Botulinum Toxin Dosage Regimen for Chronic Migraine Prophylaxis, without fee; Research funding: American Migraine Foundation, Henry Jackson Foundation, PCORI, and US Department of Defense; Professional society fees or reimbursement for travel: American Academy of Neurology, American Brain Foundation, American Headache Society, American Migraine Foundation, Canadian Headache Society, and International Headache Society.

Anand S. Shewale, MS, PhD, is an employee of AbbVie, and may hold AbbVie stock.

Richard B. Lipton, MD, serves on the editorial boards of Neurology and Cephalalgia and as senior advisor to Headache. He has received research support from the NIH, the Migraine Research Foundation, and the National Headache Foundation. He has reviewed for the NIA and NINDS; serves as consultant, advisory board member, or has received honoraria from or research support from AbbVie, AEON, Amgen, Axsome, Biohaven, Dr. Reddy’s, electroCore, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, Impel, Merck, Novartis, Satsuma, Teva, Vector, and Vedanta. He receives royalties from Wolff’s Headache, 8th Edition (Oxford University Press, 2009) and Informa. He holds stock options in Biohaven and eNeura Therapeutics.

Seth J. Baum, MD, has nothing to disclose.

Steven C. Marcus, PhD, is a consultant for AbbVie.

Stephen D. Silberstein, MD, is a consultant and/or advisory panel member for and has received honoraria from AbbVie, Alder Biopharmaceuticals, Amgen, Avanir, electroCore Medical, eNeura, Labrys Biologics, Medscape, Medtronic, Neuralieve, NINDS, Pfizer, and Teva. His employer receives research support from AbbVie, Amgen, Cumberland Pharmaceuticals, electroCore Medical, Eli Lilly, Labrys Biologics, Mars, and Troy Healthcare.

Jelena Pavlovic, MD, PhD, is a consultant and/or advisory panel member, receives honoraria from AbbVie, Alder Biopharmaceuticals, Amgen, Biohaven, and Promius. She is funded by NIH/NIA K23 AG049466-01A1.

Nathan L. Bennett, MD, has performed clinical research for AbbVie, Amgen, Avanir, electroCore, Impax, Lilly, and Teva, and has served as a consultant/on an advisory board for AbbVie, Amgen, Lilly, Pernix, Promius, and Supernus, and as a speaker for AbbVie, Amgen, Avanir, Promius, Supernus, and Teva.

William B. Young, MD, is a consultant or acts on an advisory board for Biohaven, Lilly, Teva, and Theranica; is a speaker for Lilly and Teva; and has conducted research for Amgen, Cumberland, Eli Lilly, Novartis, PCORI, Satsuma, Scion, Teva, and Zosano.

Hema N. Viswanathan, BPharm, PhD, was an employee of AbbVie at the time of this study, and holds AbbVie stock.

Jalpa A. Doshi, PhD, is a consultant for AbbVie.

Howard Weintraub, MD, has conducted clinical research for Akcea, Amarin, Amgen, NovoNordisk, and Sanofi/Regeneron, and has served as a consultant and/or advisory panel member for AbbVie, Amarin, Amgen, AstraZeneca, and Sanofi/Regeneron. He has received speaking honoraria from Amarin and Amgen.

Figures

Figure 1.
Figure 1.
Sample selection. Abbreviation: CDM, Clinformatics Data Mart. aContinuous enrollment was defined as 12 months.
See this image and copyright information in PMC

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