tandf: Current Medical Research and Opinion: Table of Contents

tandf: Current Medical Research and Opinion: Table of Contents

Abstract Abstract Objective: Despite guidelines that identify potential patients eligible for preventive migraine medications, their underutilization leaves patients at risk of acute medication overuse, disease progression, and higher healthcare resource utilization and disability. This exploratory, retrospective, observational study aimed to identify which factors predict preventive migraine medication initiation. Demographics and initiation of acute medication use were hypothesized to be predictive of initiation of preventive migraine medication. Methods: The Truven Health Analytics MarketScan 1 U.S. Commercial and Medicare Supplemental claims database (2011-2013) was used to identify adults newly diagnosed with migraine. Patients were divided into 2 subgroups: initiated a preventive migraine medication (antidepressants, anti-epileptics, beta-blockers, or neurotoxins) within 1 year of migraine diagnosis and did not initiate a preventive migraine medication. Logistic regression models were constructed to identify factors associated with preventive migraine medication initiation. Results: Study population included 147,923 patients: 43,660 preventive migraine medication initiators and 104,263 non-preventive migraine medication patients. Best-fit model for predicting preventive migraine medication initiation included: female gender (odds ratio = 1.181 [95% CI = 1.144,1.218]; measured at date of first migraine diagnosis); headache diagnosis prior to migraine diagnosis (odds ratio = 1.538 [95% CI = 1.498,1.579]; measured 1-year before first migraine diagnosis); and sleep disorder (odds ratio = 1.206 [95% CI = 1.161,1.252]), headache/migraine-specific Emergency Department (ED) visit (odds ratio = 1.224 [95% CI = 1.168,1.283]), neurologist visit (odds ratio = 1.502 [95% CI = 1.459,1.547]), and acute medication refills with <90-day gap (odds ratio = 1.509 [95% CI = 1.470,1.549]) each measured at 1-year before first preventive migraine medication. Conclusions: In addition to consistent acute medication refills, specific comorbidity diagnoses, headache/migraine-specific ED utilization, and neurologist care are predictive of preventive migraine medication initiation in the 1-year post-incident migraine diagnosis. Keywords: Migraine , preventive medication , acute medication , treatment patterns , comorbidity , disability Introduction Migraine is one of the most common neurological diseases, affecting nearly 12% of the U.S. population 1–3 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 . Buse DC , Loder EW , Gorman JA , et al. Sex differences in the prevalence, symptoms, and associated features of migraine, probable migraine and other severe headache: results of the American Migraine Prevalence and Prevention (AMPP) Study . Headache. 2013 ;53: 1278 – 1299 . Lipton RB , Bigal ME , Diamond M , AMPP Advisory Group, et al. Migraine prevalence, disease burden, and the need for preventive therapy . Neurology. 2007 ;68: 343 – 349 . . It is associated with effects on day-to-day functioning that can be severely debilitating 1 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 . [Crossref] , [PubMed] , [Google Scholar] , 4 Blumenfeld AM , Varon SF , Wilcox TK , et al. Disability, HRQoL and resource use among chronic and episodic migraineurs: results from the International Burden of Migraine Study (IBMS) . Cephalalgia. 2011 ;31: 301 – 315 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] , 5 GBD 2015 Neurological Disorders Collaborator Group. Global, regional, and national burden of neurological disorders during 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015 . Lancet Neurol. 2017 ;16: 877 – 897 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] . Recent studies have shown that burden of disease is increased, including an increase in the number of comorbidities, among patients with migraine who failed acute treatment 6 Korolainen MA , Kurki S , Lassenius MI , et al. Burden of migraine in Finland: health care resource use, sick-leaves and comorbidities in occupational health care . J Headache Pain. 2019 ;20: 13 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] ; burden also increased with the addition of each preventive migraine medications (PMMs) 6 Korolainen MA , Kurki S , Lassenius MI , et al. Burden of migraine in Finland: health care resource use, sick-leaves and comorbidities in occupational health care . J Headache Pain. 2019 ;20: 13 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] , 7 Martelletti P , Schwedt TJ , Lanteri-Minet M , et al. My Migraine Voice survey: a global study of disease burden among individuals with migraine for whom preventive treatments have failed . J Headache Pain. 2018 ;19: 115 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] . Recommendations for preventive treatments for migraine based on the U.S., Canadian, and European evidence-based guidelines have been published and include both recommendations for PMMs and behavioral interventions 8–11 Carville S , Padhi S , Reason T , et al. Guideline Development Group. Diagnosis and management of headaches in young people and adults: summary of NICE guidance . BMJ. 2012 ;345: e5765 . Holland S , Silberstein SD , Freitag F , et al. Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults: report of the quality standards subcommittee of the American Academy of Neurology and the American Headache Society . Neurology. 2012 ;78: 1346 – 1353 . Pringsheim T , Davenport W , Mackie G , et al. Canadian Headache Society Prophylactic Guidelines Development Group. Canadian Headache Society guideline for migraine prophylaxis . Can J Neurol Sci. 2012 ;39: S1 – S59 . Silberstein SD , Holland S , Freitag F , et al. Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: Report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society . Neurology. 2012 ;78: 1337 – 1345 . (Erratum in: Neurology. 2013;80:871.) . The following pharmacologic agents have been recommended by the American Academy of Neurology/American Headache Society as PMMs based on evidence, and expert consensus: Established efficacy (Level A) for metoprolol, timolol, propranolol, divalproex sodium, sodium valproate, topiramate, frovatriptan; probably effective (Level B) for nadolol, amitriptyline, venlafaxine, atenolol, naratriptan, zolmitriptan; possibly effective (Level C) for candesartan, lisinopril, clonidine, guanfacine, carbamazepine, nebivolol, pindolol; and inadequate or conflicting data to support or refute use for gabapentin, fluoxetine, fluvoxamine, protriptyline, acenocoumarol, warfarin, picotamide, bisoprolol, nicardipine, nifedipine, nimodipine, verapamil, acetazolamide, cyclandelate 11 Silberstein SD , Holland S , Freitag F , et al. Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: Report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society . Neurology. 2012 ;78: 1337 – 1345 . (Erratum in: Neurology. 2013;80:871.) [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] . OnabotulinumtoxinA is approved by the U.S. Food and Drug Administration for the prevention of chronic migraine. As per Canadian Headache Society guidelines, 11 drugs received a “strong” recommendation for use (topiramate, propranolol, nadolol, metoprolol, amitriptyline, gabapentin, candesartan, Petasites [butterbur], riboflavin, coenzyme Q10, and magnesium citrate) 10 Pringsheim T , Davenport W , Mackie G , et al. Canadian Headache Society Prophylactic Guidelines Development Group. Canadian Headache Society guideline for migraine prophylaxis . Can J Neurol Sci. 2012 ;39: S1 – S59 . [PubMed] , [Web of Science ®] , [Google Scholar] . Treatment recommendations for migraine clearly document when a preventive treatment should be initiated, as well as specific recommended medications that should be prescribed 8–12 Carville S , Padhi S , Reason T , et al. Guideline Development Group. Diagnosis and management of headaches in young people and adults: summary of NICE guidance . BMJ. 2012 ;345: e5765 . Holland S , Silberstein SD , Freitag F , et al. Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults: report of the quality standards subcommittee of the American Academy of Neurology and the American Headache Society . Neurology. 2012 ;78: 1346 – 1353 . Pringsheim T , Davenport W , Mackie G , et al. Canadian Headache Society Prophylactic Guidelines Development Group. Canadian Headache Society guideline for migraine prophylaxis . Can J Neurol Sci. 2012 ;39: S1 – S59 . Silberstein SD , Holland S , Freitag F , et al. Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: Report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society . Neurology. 2012 ;78: 1337 – 1345 . (Erratum in: Neurology. 2013;80:871.) García-Azorin D , Santos-Lasaosa S , Gago-Veiga AB , et al. Real world preventative drug management of migraine among Spanish neurologists . J Headache Pain. 2019 ;20: 19 . . However, original findings from the American Migraine Prevalence and Prevention study estimated that only 13% of all patients with migraine received PMM, and an estimated 39% were appropriate candidates for PMM 3 Lipton RB , Bigal ME , Diamond M , AMPP Advisory Group, et al. Migraine prevalence, disease burden, and the need for preventive therapy . Neurology. 2007 ;68: 343 – 349 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] . More recent data suggest that an estimated 25% of patients with episodic migraine and only 41% with chronic migraine are current users of a preventive treatment in the U.S. 13 Blumenfeld AM , Bloudek LM , Becker WJ , et al. Patterns of use and reasons for discontinuation of prophylactic medications for episodic migraine and chronic migraine: results from the second International Burden of Migraine Study (IBMS-II) . Headache. 2013 ;53: 644 – 655 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] . Patients who are eligible for PMM but not using any often manage their disease solely with acute medications, including over-the-counter medications, opioids, and/or barbiturates 14–17 Burch RC , Loder S , Loder E , et al. The prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studies . Headache. 2015 ;55: 21 – 34 . Buse DC , Pearlman SH , Reed ML , et al. Opioid use and dependence among persons with migraine: results of the AMPP study . Headache. 2012 ;52: 18 – 36 . Ferrari A , Baraldi C , Sternieri E . Medication overuse and chronic migraine: a critical review according to clinical pharmacology . Expert Opin Drug Metab Toxicol. 2015 ;11: 1127 – 1144 . Lipton RB , Buse DC , Serrano D , et al. Examination of unmet treatment needs among persons with episodic migraine: results of the American Migraine Prevalence and Prevention (AMPP) study . Headache. 2013 ;53: 1300 – 1311 . , which places them at significant risk or may be a marker for disease progression 18 Bigal ME , Lipton RB . Excessive acute migraine medication use and migraine progression . Neurology. 2008 ;71: 1821 – 1828 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] , 19 Katsarava Z , Buse DC , Manack AN , et al. Defining the differences between episodic migraine and chronic migraine . Curr Pain Headache Rep. 2012 ;16: 86 – 92 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] . This pattern of undertreatment often is associated with higher migraine-related disability (e.g. increased number of days of missed work or school per month) 4 Blumenfeld AM , Varon SF , Wilcox TK , et al. Disability, HRQoL and resource use among chronic and episodic migraineurs: results from the International Burden of Migraine Study (IBMS) . Cephalalgia. 2011 ;31: 301 – 315 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] , 20 Torres-Ferrús M , Quintana M , Fernandez-Morales J , et al. When does chronic migraine strike? A clinical comparison of migraine according to the headache days suffered per month . Cephalalgia. 2017 ;37: 104 – 113 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] , reduced patient functioning (i.e. restriction or prevention of activities across multiple areas of life) 4 Blumenfeld AM , Varon SF , Wilcox TK , et al. Disability, HRQoL and resource use among chronic and episodic migraineurs: results from the International Burden of Migraine Study (IBMS) . Cephalalgia. 2011 ;31: 301 – 315 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] , 21 Abu Bakar N , Tanprawate S , Lambru G , et al. Quality of life in primary headache disorders: a review . Cephalalgia. 2016 ;36: 67 – 91 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] , 22 Lantéri-Minet M , Duru G , Mudge M , et al. Quality of life impairment, disability and economic burden associated with chronic daily headache, focusing on chronic migraine with or without medication overuse: a systematic review . Cephalalgia. 2011 ;31: 837 – 850 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] , and higher healthcare resource utilization (HCRU) 23 Messali A , Sanderson JC , Blumenfeld AM , et al. Direct and indirect costs of chronic and episodic migraine in the United States: a web-based survey . Headache. 2016 ;56: 306 – 322 . [Crossref] , [PubMed] , [Google Scholar] , 24 Shah AM , Bendtsen L , Zeeberg P , et al. Reduction of medication costs after detoxification for medication-overuse headache . Headache. 2013 ;53: 665 – 672 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] . Research has indicated that the use of PMM decreases the patient burden and reduces HCRU 25 Wu J , Hughes MD , Hudson MF , et al. Antimigraine medication use and associated health care costs in employed patients . J Headache Pain. 2012 ;13: 121 – 127 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] , suggesting that PMM should be initiated when clinically warranted 26 Silberstein SD . Preventive migraine treatment . Continuum (Minneap Minn). 2015 ;21: 973 – 989 . [PubMed] , [Google Scholar] . The overall goal of this study was to examine available information in the U.S. claims database to identify and execute predictive modeling for patients who initiated preventive migraine medications. Although data on headache frequency and severity were not available in this database, many other patient-specific variables are likely predictive. Specifically, this exploratory study aimed to identify which patients in the medical claims database were most likely eligible for prevention, by determining variables that are predictive of PMM initiation within 12 months of migraine diagnosis. Of specific interest was the association of PMM initiation with acute migraine medication (i.e. opioids, triptans, barbiturates, isometheptenes, and ergots) use patterns. Other variables of interest included patient demographics, type of health insurance plan, selected comorbidities and symptoms (i.e. obesity, sleep disorders, cardiovascular disease, allodynia, diabetes mellitus), and HCRU. Specifically, this research addressed the following objectives: (1) determine if acute medication refills is a predictor of PMM initiation and (2) identify other predictors that are associated with PMM initiation. This is important to address given that administrative claims datasets have limited clinical variables, and identifying a predictive model with the available data could enable changes in health insurance policies to facilitate earlier interventions for patients with a greater risk. Early use of an efficacious and tolerable PMM has the potential to reduce the overuse of acute medications, decrease the risk of disease progression, prevent unnecessary HCRU, and improve patient outcomes 13 Blumenfeld AM , Bloudek LM , Becker WJ , et al. Patterns of use and reasons for discontinuation of prophylactic medications for episodic migraine and chronic migraine: results from the second International Burden of Migraine Study (IBMS-II) . Headache. 2013 ;53: 644 – 655 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] , 25 Wu J , Hughes MD , Hudson MF , et al. Antimigraine medication use and associated health care costs in employed patients . J Headache Pain. 2012 ;13: 121 – 127 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] . Methods Study design and data sources This retrospective observational cohort study extracted and analyzed claims data from the Truven Health Analytics MarketScan 1 U.S. Commercial and Medicare Supplemental claims database claims database from 01 January 2010 to 31 December 2014. This was an exploratory study with pre-specified objectives and analysis plan. The Truven patient population consists of more than 240 million commercially insured patients, covered dependents, and retirees with employer-sponsored supplemental Medicare coverage. These data contain de-identified administrative claims capturing patient-level data on age, gender, geographic region, and HCRU (e.g. emergency department [ED] visits, inpatient/outpatient visits, prescriptions), expenditures, and enrollment across inpatient, outpatient, prescription drug, and carve-out services. The Truven Health Analytics MarketScan research databases link paid claims and encounter data, capturing when services occurred, and diagnosis codes via the International Classification of Diseases, Tenth Revision (ICD-9); Healthcare Common Procedure Coding System; and Current Procedural Terminology codes. Institutional review board approval and patient consent to release information were not required due to the de-identified nature of this existing data source, and methods to protect both patients and healthcare sites. Patient selection Patients of at least 18 years of age with at least 1 migraine diagnosis during an index period from 01 January 2011 to 31 December 2013 were identified for cohort inclusion (index date = first migraine diagnosis during this period) ( Supplementary Figure ). In addition, patients where this index migraine diagnosis was on an outpatient claim were required to have an additional migraine diagnosis in the 3-year time period after the index event. In the case that the index migraine diagnosis was on an inpatient claim, no additional migraine diagnosis was required. For the purpose of this study, patients with a migraine diagnosis or claims for any PMM (established, probably, or possibly effective) per the U.S. treatment guidelines 9 Holland S , Silberstein SD , Freitag F , et al. Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults: report of the quality standards subcommittee of the American Academy of Neurology and the American Headache Society . Neurology. 2012 ;78: 1346 – 1353 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] , 11 Silberstein SD , Holland S , Freitag F , et al. Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: Report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society . Neurology. 2012 ;78: 1337 – 1345 . (Erratum in: Neurology. 2013;80:871.) [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] in the 1-year pre-index were excluded. This exclusion limited the cohort to newly diagnosed (incident) patients with migraine (i.e. patients who received their diagnosis from a healthcare professional). The patients were permitted to have a (non-migraine) headache diagnosis during the 1-year pre-index period. This study included 2 index events: date of first migraine diagnosis described above (hereafter referred to as migraine diagnosis date) and date of first PMM (hereafter referred to as PMM initiation date). The PMM initiation date for patients not initiating a PMM (hereafter referred to as non-PMM) was a random date post-migraine diagnosis date that met the distribution of the PMM initiation date for the PMM initiators for every 30-day interval. The inclusion criteria required 12 months of pre- and post-migraine diagnosis date continuous medical and prescription enrollment. All patients receiving Medicaid assistance were excluded due to the heterogeneity of the patient population and a notably different health services and reimbursement structure compared with commercial providers. Patients with claims for human immunodeficiency virus infection or cancer from 1-year pre-migraine diagnosis date to 1-year post-migraine diagnosis date were not included in this study. Patients with an ICD-9 code for a non-migraine disease treated by that PMM class (i.e. received an anti-epileptic/antihypertensive/beta-blocker/antidepressant drug during the 1-year post-migraine diagnosis AND received an epilepsy/hypertension/congestive heart failure/depression diagnosis in the 1 year before receiving the specific drug class) were also excluded. In addition, patients with a claim for any PMM without proven efficacy (Level C) per the treatment guidelines during the 1-year post-migraine diagnosis date period were excluded in an effort to increase the validity of medication use specific to treating migraine 9 Holland S , Silberstein SD , Freitag F , et al. Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults: report of the quality standards subcommittee of the American Academy of Neurology and the American Headache Society . Neurology. 2012 ;78: 1346 – 1353 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] , 11 Silberstein SD , Holland S , Freitag F , et al. Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: Report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society . Neurology. 2012 ;78: 1337 – 1345 . (Erratum in: Neurology. 2013;80:871.) [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] . Finally, patients prescribed naratriptan and zolmitriptan (drugs only recommended for short-term use associated with menstrual headache) were also excluded. This migraine cohort was then subgrouped into (1) patients receiving an established or probably effective (Level A or B) PMM in the 1-year post-migraine diagnosis date period and (2) non-PMM initiators in the 1-year post-migraine diagnosis date period 9 Holland S , Silberstein SD , Freitag F , et al. Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults: report of the quality standards subcommittee of the American Academy of Neurology and the American Headache Society . Neurology. 2012 ;78: 1346 – 1353 . [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] , 11 Silberstein SD , Holland S , Freitag F , et al. Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: Report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society . Neurology. 2012 ;78: 1337 – 1345 . (Erratum in: Neurology. 2013;80:871.) [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] . These 2 subgroups were mutually exclusive. Descriptive analyses A series of descriptive analyses were performed for each subgroup (PMM and non-PMM), including gender, disease-relevant comorbidity frequencies and symptoms (i.e. obesity [ICD-9: 278.0, 278.00, 278.01, 278.02, 278.03], sleep disorders [ICD-9: 780.5x, 307.4x, 327.xx,], cardiovascular disease [see supplement], allodynia [ICD-9: 782.0], diabetes mellitus [(ICD-9: 250.xx)]), age, insurance type, geographic region, and receipt of a headache diagnosis (ICD-9: 784.0, 339.xx, 307.81) in the 1-year pre-migraine diagnosis date period (ICD-9: 346.xx). The number of headache diagnosis codes (defined as ICD-9: 784.0, 339.xx, 307.81 in this study) per patient in the 1-year pre-migraine diagnosis date period and measures of HCRU (all-cause and migraine-related) were also analyzed. The results of these descriptive analyses were reviewed for clinically meaningful differences in order to identify variables for inclusion in the predictive model. Cohort attrition was based on patient selection criteria. Average and median time to PMM initiation was also calculated. Analyses were performed using SAS, Version 9.2 (SAS Inc, Cary, NC, USA). Predictive modeling Logistic regression models were constructed comparing patients that initiated a PMM vs non-PMM initiators (within 1 year of first migraine diagnosis during 2011–2013) as the outcome variable; all variables were measured during the 1-year pre-PMM initiation date period, except where noted. Modified purposeful selection techniques 27 Bursac Z , Gauss CH , Williams DK , et al. Purposeful selection of variables in logistic regression . Source Code Bio Med. 2008 ;3: 17 . [Crossref] , [PubMed] , [Google Scholar] were used to build the final multivariate logistic regression models, which used stepwise methods to evaluate predictors for inclusion. Both clinical and theoretical judgment based on the existing literature were applied to select the predictors in the initial model, which at the migraine diagnosis date included gender and at the PMM initiation date included age, geographic region, and plan type (Commercial vs Medicare). Predictors during the 1-year pre-migraine diagnosis date period included headache diagnosis; and predictors during the 1-year pre-PMM initiation date period included number of outpatient visits, ED visits, headache/migraine-specific ED visits (defined as an ED visit with a migraine or headache diagnosis code [346.xx, 307.81, 784.0, 339.1, 339.3] AND 1 of the recommended treatments OR a triptan or opioid) 11 Silberstein SD , Holland S , Freitag F , et al. Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: Report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society . Neurology. 2012 ;78: 1337 – 1345 . (Erratum in: Neurology. 2013;80:871.) [Crossref] , [PubMed] , [Web of Science ®] , [Google Scholar] , neurologist visits, obesity, sleep disorders, cardiovascular disease, allodynia, diabetes mellitus, and consistent acute medication refills (defined as no gap in administrative claims for prescription refills that are received by the patient for any acute medication >90 days in the year pre-index). The acute medication classes included opioids, triptans, barbiturates, isometheptene, and ergots. Nonsteroidal anti-inflammatory drugs were not included due to their common use in both non-migraine pain and migraine disorders, and the inability to capture over-the-counter use. Results Patient disposition, demographics, and headache/migraine-specific diagnosis, and comorbidities From the database, 1,186,112 patients were identified to have at least 2 outpatient (or 1 inpatient) migraine diagnoses claims (ICD-9: 346.xx) from 1 January 2011 to 31 December 2013; reasons for patient exclusion are summarized in Figure 1 . The final sample who met all study inclusion and exclusion criteria consisted of 147,923 patients, including 43,660 patients who initiated a PMM and 104,263 non-PMM patients ( Table 1 ). Predicting initiation of preventive migraine medications: exploratory study in a large U.S. medical claims database All authors



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