Lipton Richard B, Lee Lulu, Saikali Nicolas P, Bell Jvawnna, Cohen Joshua M
Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, New York.
Kantar, San Mateo, California.
J Manag Care Spec Pharm. 2020 Oct;26(10):1344-1352. doi: 10.18553/jmcp.2020.20103. Epub 2020 Jul 17.
The functional impairment associated with migraine can cause physical, emotional, and economic ramifications that can affect occupational, academic, social, and family life. Understanding the relationship between headache-free days (HFDs) and the disease burden of migraine may help with decisions regarding treatment and management of migraine.
To determine the relationship between burden of disease measures and HFDs among individuals with migraine experiencing ≥ 4 headache days in the previous 30 days.
The 2016 U.S. National Health and Wellness Survey (N = 97,503) was self-administered to a nationally representative sample of adults. Respondents with a migraine diagnosis who reported ≥ 4 headache days a month were included in the analysis. The primary independent variable was the number of HFDs assessed as both a continuous (HFDs in the previous 30 days) and categorical (0-10, 11-20, and 21-26 HFDs) measure. HFDs were used to predict outcomes using separate generalized linear models. Outcomes included effect on functional status and well-being, measured by the 6-item Headache Impact Test (HIT-6) score; number of days of work and/or household activities missed due to migraine; annualized indirect costs due to work productivity loss (assessed via the Work Productivity and Activity Impairment questionnaire); and annualized direct costs due to health care resource use (health care provider visits, emergency room visits, and hospitalizations).
The survey included 372 respondents with diagnosed migraine and ≥ 4 headache days per month. Using HFDs as a continuous variable, each additional HFD was associated with a 0.15-point reduction in HIT-6 scores, a 5% reduction in both number of work days and household activities missed, and a 4% reduction in indirect costs; thus, a 5-day increase in HFDs would lead to a 0.75-point reduction in HIT-6 scores, 25% reduction in days of work or household activities missed, and 20% reduction in indirect costs. Analyzing HFDs as a categorical variable, respondents experiencing 21-26 HFDs had lower HIT-6 total scores than those with 0-10 HFDs (adjusted means: 66.59 vs. 63.91; = 0.001) or those with 11-20 HFDs (65.66 vs. 63.91, = 0.015). Respondents experiencing 21-26 HFDs missed fewer work days than those with 0-10 HFDs (4.44 vs. 1.46, = 0.002) or those with 11-20 HFDs (3.36 vs. 1.46, = 0.009). Similarly, respondents with 11-20 HFDs (22.99 vs. 9.72, < 0.001) and those with 21-26 HFDs (22.99 vs. 7.34, = 0.001) were associated with fewer days of household activities missed due to migraine compared with respondents with 0-10 HFDs. Respondents with 21-26 HFDs per month had significantly lower indirect costs ($16,975 vs. $6,919, = 0.025) than those with 0-10 HFDs.
A higher number of HFDs is associated with decreased headache-related disability among those with migraine. Interventions that increase the total number of HFDs may reduce the burden and cost associated with migraine.
This study was funded by Teva Pharmaceutical Industries (Petach Tikva, Israel). Cohen is an employee of Teva Branded Pharmaceutical Products R&D (USA); Bell was employed by Teva Pharmaceutical Industries at the time of this study and has stock/stock options in Teva Pharmaceutical Industries. Lee is employed by Kantar, which received payment from Teva Pharmaceutical Industries for data analyses performed for this study. Lipton has received research support from the NIH, the Migraine Research Foundation, and the National Headache Foundation. He has reviewed for the NIA and NINDS; holds stock options in eNeura Therapeutics and Biohaven Holdings; and serves as consultant, advisory board member, or has received honoraria from the American Academy of Neurology, Alder, Allergan, American Headache Society, Amgen, Autonomic Technologies, Avanir, Biohaven, Biovision, Boston Scientific, Dr. Reddy's, electroCore, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, Merck, Pernix, Pfizer, Supernus, Teva, Trigemina, Vector, and Vedanta. Saikali serves on the advisory board and as speaker for Allergan, Amgen, Promius, Supernus, and Teva Pharmaceuticals. He serves as a speaker for Assertio, Avanir, Cefaly, Egalet, Eli Lilly, Gammacore, and Pernix. This study has been presented as a poster at the American Academy of Neurology 2018 Annual Meeting, April 21-27, 2018, in Los Angeles, CA; Headache Update 2017, July 13-16, 2017, in Lake Buena Vista, FL; and the American Headache Society 2017 Annual Meeting, June 8-11, 2017, in Boston, MA.
偏头痛相关的功能障碍会引发身体、情绪和经济方面的后果，进而影响职业、学业、社交和家庭生活。了解无头痛日（HFDs）与偏头痛疾病负担之间的关系，可能有助于做出有关偏头痛治疗和管理的决策。
确定在过去30天内头痛天数≥4天的偏头痛患者中，疾病负担指标与无头痛日之间的关系。
对2016年美国国家健康与 Wellness 调查（N = 97,503）进行自我管理，该调查针对全国具有代表性的成年人样本。分析中纳入了诊断为偏头痛且每月报告头痛天数≥4天的受访者。主要自变量是无头痛日的数量，评估时既作为连续变量（过去30天内的无头痛日），也作为分类变量（0 - 10、11 - 20和21 - 26个无头痛日）。使用单独的广义线性模型，以无头痛日来预测结果。结果包括对功能状态和幸福感的影响，通过6项头痛影响测试（HIT - 6）评分衡量；因偏头痛错过的工作和/或家务活动天数；因工作生产力损失导致的年度间接成本（通过工作生产力和活动障碍问卷评估）；以及因医疗资源使用导致的年度直接成本（医疗保健提供者就诊、急诊室就诊和住院）。
该调查包括372名诊断为偏头痛且每月头痛天数≥4天的受访者。将无头痛日作为连续变量时，每增加一个无头痛日，HIT - 6评分降低0.15分，错过的工作日和家务活动天数均减少5%，间接成本降低4%；因此，无头痛日增加5天会导致HIT - 6评分降低0.75分，错过的工作或家务活动天数减少25%，间接成本降低20%。将无头痛日作为分类变量分析时，经历21 - 26个无头痛日的受访者的HIT - 6总分低于经历0 - 10个无头痛日的受访者（调整后均值：66.59对63.91；P = 0.001）或经历11 - 20个无头痛日的受访者（65.66对63.91，P = 0.015）。经历21 - 26个无头痛日的受访者错过的工作日比经历0 - 10个无头痛日的受访者少（4.44对1.46，P = 0.002）或比经历11 - 20个无头痛日的受访者少（3.36对1.46，P = 0.009）。同样，与经历0 - 10个无头痛日的受访者相比，经历11 - 20个无头痛日的受访者（22.99对9.72，P < 0.001）和经历21 - 26个无头痛日的受访者（22.99对7.34，P = 元0.001）因偏头痛错过的家务活动天数更少。每月经历21 - 26个无头痛日的受访者的间接成本（16,975美元对6,919美元，P = 0.025）显著低于经历0 - 10个无头痛日的受访者。
无头痛日数量较多与偏头痛患者中与头痛相关的残疾减少有关。增加无头痛日总数的干预措施可能会减轻与偏头痛相关的负担和成本。
本研究由梯瓦制药工业公司（以色列佩塔提克瓦）资助。科恩是梯瓦品牌制药产品研发公司（美国）的员工；贝尔在本研究开展时受雇于梯瓦制药工业公司，且在该公司拥有股票/股票期权。李受雇于凯度公司，该公司因为本研究进行数据分析而从梯瓦制药工业公司获得报酬。利普顿获得了美国国立卫生研究院、偏头痛研究基金会和国家头痛基金会的研究支持。他为美国国立衰老研究所和美国国立神经疾病与中风研究所进行过评审；在eNeura Therapeutics和Biohaven Holdings拥有股票期权；并担任美国神经病学学会、Alder、艾尔建、美国头痛协会、安进、自主技术公司、Avanir、Biohaven、Biovision、波士顿科学公司、雷迪博士实验室、electroCore、礼来公司、eNeura Therapeutics、葛兰素史克公司、默克公司、Pernix、辉瑞公司、Supernus、梯瓦公司、Trigemina、Vector和韦丹塔公司的顾问、咨询委员会成员或接受过这些公司的酬金。赛卡利是艾尔建、安进、Promius、Supernus和梯瓦制药公司的顾问委员会成员及演讲者。他是Assertio、Avanir、Cefaly、Egalet、礼来公司、Gammacore和Pernix的演讲者。本研究已作为海报在美国神经病学学会2018年年会（2018年4月21 - 27日，加利福尼亚州洛杉矶）、2017年头痛更新会议（2017年7月13 - 16日，佛罗里达州布埃纳维斯塔湖）以及美国头痛协会2017年年会（2017年6月8 - 11日，马萨诸塞州波士顿）上展示。
