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To assess the burden and consequences of migraine in Brazil in terms of health-related quality of life (HRQoL), work productivity and daily activities, and healthcare resource utilization (HRU).Despite existing data on how migraine affects populations worldwide, there are limited data on the burden of migraine in Latin America.This cross-sectional study used patient-reported data from the 2018 Brazil National Health and Wellness Survey. HRQoL scores (EuroQol 5-dimension 5-level [EQ-5D-5L]; 36-item Short Form Health Survey, version 2 [SF-36v2]; and Short Form 6-dimension [SF-6D]), impairments to work productivity and daily activities (Work Productivity and Activity Impairment questionnaire), and all-cause HRU were compared between migraine respondents and matched non-migraine controls.Of the 12,000 total respondents in the survey database, 1643 self-reported a physician diagnosis of migraine and were propensity score matched 1:1 with controls without migraine. HRQoL was lower in patients with migraine versus non-migraine controls, with significantly lower SF-36v2 physical (mean [± SD] 50.3 [7.5] vs. 52.0 [7.6]) and mental component (mean [± SD] 42.9 [10.2] vs. 46.0 [9.9]) summary scores and SF-6D (mean [± SD] 0.7 [0.1] vs. 0.7 [0.1]) and EQ-5D-5L (mean [± SD] 0.7 [0.2] vs. 0.8 [0.2]) utility scores (all p 0.001). Patients with migraine reported higher levels of work productivity loss (mean [± SD], 40.6% [31.4%] vs. 28.6% [30.9%], including absenteeism 12.8% [19.1%] vs. 8.4% [17.1%] and presenteeism 35.0% [28.7%] vs. 24.8% [28.0%]; all p 0.001); activity impairment (mean [± SD] 36.0% [28.8%] vs. 25.5% [28.1%]; p 0.001); and significantly higher HRU in the past 6 months (healthcare provider and emergency department visits [mean [± SD] 7.2 [9.5] vs. 4.5 [6.3] and 1.7 [3.8] vs. 0.9 [2.2]; both p 0.001] and hospitalizations [mean [± SD] 0.4 [2.7] vs. 0.2 [1.1]; p = 0.002]) than controls.Migraine is associated with poorer HRQoL, higher all-cause HRU, and greater activity impairment and work productivity loss versus non-migraine controls in Brazil.

Migraine is a chronic disease that reduces health-related quality of life. Little is known about the burden of migraine in individuals who are potential candidates for preventive treatment with ≥ 4 monthly headache days currently using migraine medications.To characterize the burden of migraine among patients reporting ≥ 4 monthly headache days while taking acute and/or preventive migraine medications.In this retrospective, cross-sectional study, data from the 2016 U.S. National Health and Wellness Survey (N = 97,503) compared the burden of migraine among individuals self-reporting a diagnosis of migraine by a health care professional and ≥ 4 monthly headache days while using acute and/or preventive prescription migraine medications to matched nonmigraine controls. Propensity score matching across different variables (e.g., age, gender, and body mass index) was used to identify matched controls from respondents who did not self-report a diagnosis of migraine. Migraine-associated burden was measured by impairment in work productivity and daily activities (Work Productivity and Activity Impairment questionnaire), all-cause health care resource utilization (HRU), and all-cause direct and indirect costs.This analysis included 197 treated migraine patients with ≥ 4 monthly headache days and 197 matched nonmigraine controls. Greater proportions of treated migraine patients reported comorbid depression (58.4% vs. 27.9%,Treated migraine patients with ≥ 4 monthly headache days reported significantly reduced work productivity and increased all-cause HRU and cost despite migraine treatment compared with nonmigraine controls. These findings highlight unmet needs in the treatment and management of migraine.This study was funded by Teva Pharmaceutical Industries (Petach Tikva, Israel). Cohen is an employee of Teva Branded Pharmaceutical Products RD (USA); Bell was an employee of Teva Pharmaceutical Industries at the time of this study and holds stock/stock options in Teva Pharmaceutical Industries. Lee is an employee of Kantar, which received funding from Teva Pharmaceutical Industries for data analyses performed for this study. Buse has served as a paid consultant to Amgen/Novartis, Allergan, Biohaven, Eli Lilly, Promius/Dr. Reddy's, and Teva Pharmaceuticals, but she was not compensated financially for work on this study. Yugrakh has received research support from Teva Pharmaceuticals and Cefaly Technology. Lipton has received research support from the NIH, the Migraine Research Foundation, and the National Headache Foundation; holds stock options in eNeura Therapeutics and Biohaven Holdings; serves as consultant, advisory board member, or has received honoraria from the American Academy of Neurology, Alder, Allergan, the 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. This study was presented as a poster at the American Academy of Neurology 2018 Annual Meeting, April 21-27, 2018, in Los Angeles, CA; PAINWeek 2018, September 4-8, 2018, in Las Vegas, NV; and the 2017 European Headache Federation (EHF) Congress, December 1-3, 2017, in Rome, Italy.

Objective: To examine the potential sociodemographic disparities in type 2 diabetes (T2D) management and care among US adult individuals, after controlling for clinical and behavioral factors. Methods: This was a retrospective cohort study of individuals with T2D (N = 4,552) from a linked database of the National Health and Wellness Survey and a large US ambulatory electronic health record (EHR) database. This study period was between January 1, 2015 and December 31, 2018 and individuals were followed up for at least 6 months through EHR after the completion of the survey. The sociodemographic characteristics included gender, race, ethnicity, marital status, education, employment status, household income, insurance status, and geographic region. The independent variables included testing and control of HbA1c, blood pressure (BP), and low-density lipoprotein-cholesterol (LDL-C); hypoglycemia, emergency room (ER) visits, and all-cause hospitalization. Multivariable analyses were conducted using generalized linear models. Results: The percentage for uncontrolled HbA1c was 38.6%. With clinical and behavioral characteristics adjusted, individuals living in the Northeast region had 30% higher odds of having HbA1c testing than those who lived in the South. Blacks and Asians were less likely to have HbA1c control than Whites. Uninsured individuals had a lower likelihood of receiving HbA1c, BP, or LDL-C testing compared with commercial insurers. Individuals with low income were more likely to have higher ER visits and hospitalizations. Conclusion: Potential sociodemographic disparities exist in T2D management and care in the US, indicating the needs for improvement in healthcare access, educational and behavioral programs, as well as disease and treatment management in these subgroups.

AIMS To evaluate the clinical and patient-reported outcomes and healthcare utilization and costs associated with patient-reported hypoglycaemia in US adults with type 2 diabetes (T2D) treated with basal insulin. MATERIALS AND METHODS This was an observational, cross-sectional, survey-based study of adults with T2D on basal insulin ± oral antidiabetes drugs (OADs) or rapid-acting/premixed insulin, who had in the past ever experienced hypoglycaemia, using US data from the National Health and Wellness Survey. Eligible patients were categorized as having no hypoglycaemia (38.7%), non-severe hypoglycaemia (55.1%), or severe hypoglycaemia (6.2%) in the preceding 3 months. Outcomes included health-related quality of life (HRQoL), work productivity and activity impairment, healthcare resource utilization, and estimated direct and indirect costs. Multivariable regression models were performed to control for patient characteristics. RESULTS Patients who experienced severe hypoglycaemia had significantly (P < .05) lower HRQoL scores, greater overall impairment of work productivity and activity, greater healthcare resource utilization, and higher costs compared with those who experienced non-severe or no hypoglycaemia. Patients with non-severe hypoglycaemia also reported an impact on the number of provider visits, indirect costs, and HRQoL. CONCLUSIONS Patients with T2D using basal insulin ± OADs or rapid-acting/premixed insulin in the United States who experienced severe hypoglycaemia had greater impairment of activity and work productivity, utilized more healthcare resources, and incurred higher associated costs than those with non-severe or no hypoglycaemia. The study also demonstrated the impact that non-severe hypoglycaemic events have on economic and HRQoL outcomes. Reducing the incidence and severity of hypoglycaemia could lead to clinically meaningful improvements in HRQoL and may result in lower healthcare utilization and associated costs.

Introduction Usage patterns and effectiveness of a longer-acting formulation of insulin glargine at a strength of 300 units per milliliter (Gla-300) have not been studied in real-world clinical practice. This study evaluated differences in dosing and clinical outcomes before and after Gla-300 treatment initiation in patients with type 2 diabetes starting or switching to treatment with Gla-300 to assess whether the benefits observed in clinical trials translate into real-world settings. Methods This was a retrospective observational study using medical record data obtained by physician survey for patients starting treatment with insulin glargine at a strength of 100 units per milliliter (Gla-100) or Gla-300, or switching to treatment with Gla-300 from treatment with another basal insulin (BI). Differences in dosing and clinical outcomes before versus after treatment initiation or switching were examined by generalized linear mixed-effects models. Results Among insulin-naive patients starting BI treatment, no difference in the final titrated dose was observed in patients starting Gla-300 treatment versus those starting Gla-100 treatment [least-squares (LS) mean 0.43 units per kilogram vs 0.44 units per kilogram; P = 0.77]. Both groups had significant hemoglobin A1c level reductions (LS mean 1.21 percentage points for Gla-300 and 1.12 percentage points for Gla-100 ; both P

To assess asthma control and associations with health-related quality of life (HRQoL) and economic outcomes among patients with asthma and allergic comorbidities treated with inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) combination therapy.Data from the 2011-2013 US National Health and Wellness Survey were used to identify patients with asthma currently treated with ICS and LABA combination therapy (N = 1923). Patients were included if they self-reported a physician diagnosis of asthma and at least one allergic/asthma-related comorbid condition (e.g., nasal allergies, atopic dermatitis). Asthma Control Test scores categorized patients as very poorly (scores ≤ 15; 29.3%), not well (16-19; 25.1%), or well controlled (20-25; 45.7%). Outcomes included HRQoL (SF-36v2; SF-12v2), work productivity and activity impairment, healthcare utilization (HRU), and annual indirect and direct costs. Generalized linear models, controlling for covariates, examined whether outcomes differed by asthma control.Over half of the patients had very poorly or not well-controlled asthma (54.4%). Patients with very poorly controlled versus well-controlled asthma reported significantly greater decreases in HRQoL, greater overall work impairment, and higher HRU (all, p0.05). Very poorly controlled patients incurred over double the indirect costs and nearly one and a half times the direct and total costs of well-controlled patients.Increasing level of asthma control was related to improved HRQoL and lower costs. The considerably high prevalence of uncontrolled asthma among patients on ICS and LABA suggests poor treatment adherence or unmet needs in current treatment and may require step-up therapy in appropriate patients according to clinical guidelines.

Invasive meningococcal disease (IMD) caused by the bacteria Neisseria meningitidis is rare but potentially fatal. For healthy adolescents, the US Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination with MenACWY and recommends MenB vaccination under shared clinical decision-making (previously “Category B”). The recommendation for MenB vaccination was the first category B recommendation in adolescents, and it is unclear how healthcare providers (HCPs) implement these guidelines. This 2017 web-based survey of US HCPs explored characteristics associated with prescribing or receiving MenB and MenACWY vaccines, HCP knowledge of vaccine recommendations, and real-world practice patterns. Of 529 respondents, 436 prescribed MenB vaccines to their eligible adolescent/young adult patients and 93 prescribed MenACWY vaccines only. MenB vaccine prescribers were more likely to be pediatricians compared with MenACWY vaccine only prescribers, and patients who received MenB vaccines were more likely to be non-Hispanic whites living in shared spaces (eg, college dormitories) than those not receiving the vaccine. Seventy-seven percent of HCPs indicated that they prescribe MenACWY vaccines consistently with ACIP recommendations (to all members of an age group), whereas only 7% indicated that they prescribe MenB vaccines consistently with ACIP recommendations (individual clinical decision making). Patient-related factors, disease-related factors, and guidelines all influenced HCP decisions to prescribe meningococcal vaccines. Providing HCPs with clear guidance on how to initiate discussion of MenB vaccines with patients and their caregivers may aid in fully protecting US adolescents against meningococcal disease caused by 5 of the disease-causing serogroups.

The objective of this study was to examine the relationship between adherence to treatment with sodium channel blockers (SCBs) and health-related quality of life (HRQoL), work productivity and activity impairment (WPAI), healthcare resource utilization (HRU), and associated costs among patients with epilepsy.This retrospective cross-sectional study used data from the 2017 US National Health and Wellness Survey (NHWS; N = 75,004). Health-related quality of life (Study Short-Form 36-Item Health Survey version 2 [SF-36v2]), WPAI (Work Productivity and Activity Impairment-General Health [WPAI-GH] questionnaire), HRU, and annual costs were compared among respondents with epilepsy using SCBs categorized as low/medium adherence (n = 120) and high adherence (n = 80) using generalized linear models, controlling for patient characteristics.Mental component score, Short-Form 6-Dimension (SF-6D) health utility index, bodily pain, mental health, physical functioning, role emotional, social functioning, and vitality scores were significantly lower in low/medium adherence respondents than in high adherence respondents (for all, p 0.05). Only activity impairment was significantly higher in low/medium adherence respondents compared with the high adherence group (p 0.001). Healthcare resource utilization did not differ significantly between the two groups; however, the number of emergency room (ER) visits and total costs were lower in the high adherence group (p = 0.038) compared with the low/medium adherence group (p = 0.040).High adherence to SCBs was associated with improved HRQoL, lower WPAI, and lower HRU and associated costs among patients with epilepsy. Therefore, adherence to SCBs may be an important factor in improving the abovementioned patient-reported outcomes. Findings from this study can help provide further impetus to healthcare policymakers and clinicians for addressing the low antiepileptic drug (AED) adherence levels in adult patients with epilepsy.

Lulu K Lee,1 Nozomi Ebata,2 Patrick Hlavacek,3 Marco DiBonaventura,4 Joseph C Cappelleri,5 Alesia Sadosky3 1Health Outcomes Practice, Kantar Health, Foster City, CA, USA; 2Neuroscience & Pain Medical Affairs, Pfizer Japan Inc., Tokyo, Japan; 3Global Health & Value, Pfizer Inc., 4Health Outcomes Practice, Kantar Health, New York, NY, 5Statistics, Pfizer Inc., Groton, CT, USA Purpose: The aim of this study was to examine the health and economic burden associated with fibromyalgia among adults in Japan.Materials and methods: Data from the 2011–2014 Japan National Health and Wellness Survey (n=115,271), a nationally representative survey of adults, were analyzed. The greedy matching algorithm was used to match the respondents who self-reported a diagnosis of fibromyalgia with those not having fibromyalgia (n=256). Generalized linear models, controlling for covariates (eg, age and sex), examined whether the respondents with fibromyalgia differed from matched controls based on health status (health utilities; Mental and Physical Component Summary scores from Medical Outcomes Study: 12-item Version 2 and 36-item Version 2 Short Form Survey), sleep quality (ie, sleep difficulty symptoms), work productivity (Work Productivity and Activity Impairment Questionnaire – General Health Version 2.0), health care resource use, and estimated annual indirect and direct costs (based on published annual wages and resource use events) in Japanese yen (¥). Results: After adjustment for covariates, respondents with fibromyalgia relative to matched controls scored significantly lower on health utilities (adjusted means =0.547 vs 0.732), Mental Component Summary score (33.15 vs 45.88), and Physical Component Summary score (39.22 vs 50.81), all with P

Lulu K Lee,1 Amir Goren,1 Natalie N Boytsov,2 Craig F Donatucci,2 Kevin T McVary3 1Health Outcomes Practice, Kantar Health, New York, NY, 2US Real World Outcomes Research, Eli Lily & Company, Indianapolis, IN, 3Division of Urology, Southern Illinois University School of Medicine, Springfield, IL, USA Objective: Erectile dysfunction (ED) and benign prostatic hyperplasia (BPH) frequently co-occur in men aged ≥40, along with lower urinary tract symptoms (LUTS) secondary to BPH. Given little real-world evidence on treatment use or satisfaction with treatment for concurrent BPH/LUTS and/or ED, this study examined medication regimens and differences in satisfaction and health-related quality of life (HRQoL) across regimens among men with concurrent BPH and ED. Methods: A cross-sectional study was conducted using an Internet survey of participants recruited through an online panel. Respondents (N=736) included men (aged ≥40) who self-reported a diagnosis of both ED and BPH with prescription treatment in the past 3 months for both conditions. Treatment satisfaction (eg, convenience and ease of planning) and HRQoL (eg, International Prostate Symptom Score, sleep quality) were self-reported. Generalized linear models examined the association of regimen with treatment satisfaction and HRQoL, adjusting for covariates (eg, age and comorbidities). Results: Final analyses included participants (N=507) using: tadalafil once-daily monotherapy (22%), tadalafil for ED with an alternate BPH therapy (36%), or another phosphodiesterase type-5 inhibitor (PDE5-I) combination (41%). These groups represented the major categories of treatment regimens found in the sample, excluded participants with ambiguous regimens, and were aligned with current standard of care for BPH and ED. Overall, patients reported moderate levels of BPH and a moderate-to-severe degree of ED. Tadalafil monotherapy patients had higher treatment satisfaction scores and greater reported ease of treatment planning and convenience than PDE5-I combination patients. No significant intergroup differences were found on HRQoL. Conclusion: A majority of patients (59%) took tadalafil alone or in combination for BPH/ED treatment. Tadalafil monotherapy patients reported greater treatment satisfaction than patients taking PDE5-I combination therapy. Higher satisfaction for both effectiveness and convenience of once-daily tadalafil may inform both patient and clinician decisions regarding pharmacotherapy regimens. Keywords: once-daily tadalafil, alpha1-adrenergic blockers, 5-alpha-reductase inhibitors, International Prostate Symptom Score, treatment convenience, treatment satisfaction, Treatment Satisfaction Questionnaire for Medication

BackgroundThe objective of this analysis was to examine the association between asthma control (based on Asthma Control Test (ACT) responses) and healthcare resource utilisation (HRU), work productivity and health-related quality of life (HRQoL) among a nationwide sample of US adults with a self-reported diagnosis of asthma and without comorbid chronic obstructive pulmonary disease.MethodsData were obtained from the 2015 and 2016 self-administered, internet-based National Health and Wellness Surveys. Patients were grouped by ACT score (≤15: poorly controlled; 16–19: partly controlled; 20–25: well-controlled asthma). Study outcomes included HRU (patient-reported healthcare provider visits, emergency department visits and hospitalisations during the previous 6 months); work productivity, measured using the Work Productivity and Activity Impairment-General Health Scale; HRU-associated costs and work productivity loss and HRQoL, measured using EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) and the Short Form Health Survey-36V.2 (SF-36V.2). Incremental differences in outcomes between groups were assessed using generalised linear models adjusted for covariates.ResultsOf 7820 eligible adults, 17.4% had poorly controlled, 20.1% partly controlled and 62.5% well-controlled asthma. Well-controlled asthma was associated with significantly lower HRU (pConclusionsThe study demonstrates a clear relationship between asthma control and its impact on HRU, costs, work productivity and HRQoL. This will allow for better identification and management of patients with poorly controlled asthma.

Background The real-world experience of women receiving extended-cycle combined oral contraception (COC) versus monthly-cycle COC has not been reported. Methods Data were from the United States 2013 National Health and Wellness Survey. Eligible women (18–50 years old, premenopausal, without hysterectomy) currently using extended-cycle COC (3 months between periods) were compared with women using monthly-cycle COC. Treatment satisfaction (1 “extremely dissatisfied” to 7 “extremely satisfied”), adherence (8-item Morisky Medication Adherence Scale©), menstrual cycle-related symptoms, health-related quality of life (HRQOL) and health state utilities (Medical Outcomes Short Form Survey-36v2®), depression (9-item Patient Health Questionnaire), sleep difficulties, Work Productivity and Activity Impairment-General Health, and healthcare resource use were assessed using one-way analyses of variance, chi-square tests, and generalized linear models (adjusted for covariates). Results Participants included 260 (6.7%) women using extended-cycle and 3616 (93.3%) using monthly-cycle COC. Women using extended-cycle COC reported significantly higher treatment satisfaction (P = 0.001) and adherence (P = 0.04) and reduced heavy menstrual bleeding (P = 0.029). A non-significant tendency toward reduced menstrual pain (39.5% versus 47.3%) and menstrual cycle-related symptoms (40.0% versus 48.7%) was found in women using extended-cycle versus monthly-cycle COC. Significantly more women using extended-cycle COC reported health-related diagnoses, indicating preferential prescription for extended-cycle COC among women reporting more health problems. Consistent with this poorer health, more women using extended-cycle COC reported fatigue, headache, and activity impairment (P values

e18568 Background: The burden of cancer has largely focused on the patient. However, caregivers also experience considerable burden. The study's aim was to use social media posts to better understand the emotional journey of caregivers who provide care for patients with leukemia from their own perspective. Methods: Publicly available social media posts (in English) mentioning chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), and acute promyelocytic leukemia (APL) from blogs, discussion boards, and Facebook were collected and linguistically analyzed. Results: A total of 145 social media posts by CML caregivers, 149 posts by CLL caregivers, and 65 posts by APL caregivers were analyzed. Common themes emerged among CML, CLL, and APL caregivers as they journeyed from pre-diagnosis, to diagnosis, and to survivorship alongside their loved ones. At the pre-diagnosis phase, caregivers expressed uneasiness or worry about the symptoms their loved ones were experiencing. Additionally, caregivers were often frustrated with doctors because they felt that their loved ones’ symptoms were ignored, which led to a delay in diagnosis. Once the diagnosis was confirmed, caregivers were shocked and scared. Further, caregivers were desperate for information on the disease and what the future would hold. During the survivorship phase of the journey, an amalgam of complex positive and negative emotions emerged among caregivers. Caregivers can become obsessed with finding ways to treat their loved ones, including use of alternative medicine. Caregivers experienced both positive (a more “enriched relationship”) and negative (felt alone or pushed away) relationship changes. Many caregivers were proud of their loved ones’ remission and felt triumphant. Caregivers felt a sense of gratitude toward doctors, friends, family, and social media sites for their support. Conclusions: Caregivers of CML, CLL, and APL patients experience a gamut of emotions at every stage of the disease. Additionally, the relationship between caregivers and loved ones can be negatively affected. Findings suggest that relationship counseling and social support groups could potentially relieve some caregiver burden.