{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T01:16:35Z","timestamp":1792026995845,"version":"4.4.0"},"reference-count":32,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2021,2,16]],"date-time":"2021-02-16T00:00:00Z","timestamp":1613433600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Calcitonin gene\u2010related peptide (CGRP) inhibitors were introduced in the United States (US) in 2018. To understand the changing patterns of preventive treatment following the introduction of these new agents, we must first characterize the patterns which preceded their introduction.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To characterize the burden, unmet need, and treatment patterns in patients with migraine initiating preventive migraine medications before the introduction of CGRP inhibitors in the US.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Between March 2016 and October 2017, we enrolled episodic (EM) and chronic migraine (CM) patients initiating or changing preventive treatment at primary care or neurology clinic visits in the US, in a real\u2010world observational study using a prospective cohort design. At baseline and monthly thereafter for 6\u00a0months, we collected data from study sites and patients on migraine frequency, treatment modifications, migraine impact on functioning, and work productivity for a descriptive analysis of migraine patient experience and treatment patterns.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      From the sample of 234 completers, 118 had EM (50.4%) and 116 had CM (49.6%). Mean age at enrollment was 41\u00a0years (SD\u00a0=\u00a012) and mean age at first migraine diagnosis was 22\u00a0years (SD\u00a0=\u00a011). Most participants were females (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0204\/234; 87.2%) and white (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0178\/234; 76.1%). The majority (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0164\/234; 70.1%) had not used preventive migraine treatment in the 5\u00a0years prior to enrollment (treatment na\u00efve). At baseline, mean monthly migraine days were 9.6\u00a0days (SD\u00a0=\u00a05.0) for the preventive treatment na\u00efve group and 12.4\u00a0days (SD\u00a0=\u00a07.0) for treatment experienced patients. The majority had severe Migraine Disability Assessment (Grade IV, total score \u226521), including 67.1% (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0110\/164) of the preventive treatment na\u00efve and 77.1% (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a054\/70) of the preventive treatment experienced patients. Headache Impact Test total scores indicating severe impairment (score &gt;59) occurred in 88.4% (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0145\/164) of the treatment na\u00efve and 88.6% (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a062\/70) of treatment experienced patients. Mean work productivity loss as measured by the Work Productivity and Activity Impairment questionnaire in the subsample of employed patients was 53.3% loss. The most used acute medications at baseline were nonsteroidal anti\u2010inflammatory agents (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0124\/234; 53.0%), acetaminophen\u2010based products (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0112\/234; 47.9%), and triptans (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0105\/234; 44.9%). The most commonly initiated preventive treatments were topiramate (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0100\/234; 42.7%), tricyclic antidepressants (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a039\/234; 16.7%), beta\u2010blockers (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a026\/234; 11.1%), and onabotulinumtoxinA (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a024\/234; 10.3%). Over the 6\u2010month follow\u2010up period, almost half of patients (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0116\/234, 49.6%) modified their preventive treatment and discontinued treatment (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a088\/312 total modifications; 28.2%) or modified their pattern of use by increasing, decreasing, or skipping doses (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0224\/312 total modifications; 71.8%), often without seeking medical advice. Avoiding side effects was the main reason reported among patients who discontinued (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a052\/88; 59.1%), decreased frequency or dose (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a037\/89; 41.6%), and skipped doses (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a029\/86; 33.7%). Perceived lack of efficacy was another frequent reason reported among those who discontinued (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a020\/88; 22.7%), decreased frequency or dose (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a015\/89; 16.9%), and skipped doses (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a018\/86; 20.9%). Despite initiation of preventive treatment and improvements observed in number of headache and migraine days, migraine patients continued to experience substantial disability, headache impact, and reduced productivity throughout the 6\u2010month follow\u2010up period.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Prior to 2018, the burden of migraine was high for patients initiating preventive treatments. Despite having more than 9\u00a0days of migraine per month on average, the majority (70.1%) of patients initiating prevention had been treatment na\u00efve, indicating underuse of preventive treatments. The preventive treatments used in this study were poorly tolerated and were reported by patients to lack efficacy, resulting in suboptimal adherence. The high discontinuation rates suggest that the preventive medications being offered during the period of the study did not meet the treatment needs of patients. In addition, the decisions by about half of patients to alter their prescribed treatment plan without consulting their provider can pose substantial health risks. These findings pertain to the broad set of preventive treatments initiated in this study and do not support inferences about individual preventive treatments, due to limitations in sample size. These findings suggest the need for more effective and better tolerated preventive treatment options.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14053","type":"journal-article","created":{"date-parts":[[2021,2,20]],"date-time":"2021-02-20T01:01:45Z","timestamp":1613782905000},"page":"438-454","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":47,"title":["Understanding the migraine treatment landscape prior to the introduction of calcitonin gene\u2010related peptide inhibitors: Results from the Assessment of TolerabiliTy and Effectiveness in MigrAINe Patients using Preventive Treatment (ATTAIN) study"],"prefix":"10.1111","volume":"61","author":[{"given":"Ariane K.","family":"Kawata","sequence":"first","affiliation":[{"name":"Evidera Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neel","family":"Shah","sequence":"additional","affiliation":[{"name":"Amgen Inc. 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