Burden of migraine in Brazil: A cross-sectional real-world study.

OBJECTIVE: 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). BACKGROUND: Despite existing data on how migraine affects populations worldwide, there are limited data on the burden of migraine in Latin America. METHODS: 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. RESULTS: 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. CONCLUSION: Migraine is associated with poorer HRQoL, higher all-cause HRU, and greater activity impairment and work productivity loss versus non-migraine controls in Brazil.

The impact of symptom severity on the humanistic and economic burden of inflammatory bowel disease: a real-world data linkage study.

OBJECTIVE: Few studies have examined the association between inflammatory bowel disease (IBD) severity, and humanistic, and economic burden. We addressed this gap using a unique real-world data source that links self-reported patient data from the US National Health and Wellness Survey (NHWS) to claims data. METHODS: This cross-sectional study linked the 2015-2018 US NHWS data with medical, and pharmacy claims. Patients (≥18 years) who self-reported a physician diagnosis of IBD (ulcerative colitis [UC], or Crohn's disease [CD]) in the NHWS, and had a medical or pharmacy claim indicating a possible diagnosis of IBD were included. Disease symptom severity was defined by a weighted symptom score and main outcomes include health-related quality of life (HRQoL), work productivity (WPAI), healthcare resource use (HRU), and associated costs. RESULTS: Overall, 687 patients with IBD were included, of which 347 were identified with UC and 340 with CD. Validation analysis showed that 94.7% of UC and 88.7% of patients with CD who self-reported diagnosis of CD or UC in NHWS had evidence of diagnosis and/or treatment patterns in claims. Patients with both UC and CD with moderate or severe symptoms had significantly lower HRQoL, increased work productivity loss, greater HRU, and associated costs compared with patients with mild symptoms. CONCLUSIONS: Patients with moderate/severe UC or CD experience substantial humanistic, and economic burden compared with patients with mild UC or CD. These factors should be considered within treatment goals for patients in order to provide holistic care beyond the treatment of objective markers or disease severity and symptoms alone.

Burden of Illness Among People with Migraine and ≥ 4 Monthly Headache Days While Using Acute and/or Preventive Prescription Medications for Migraine.

BACKGROUND: 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. OBJECTIVE: To characterize the burden of migraine among patients reporting ≥ 4 monthly headache days while taking acute and/or preventive migraine medications. METHODS: 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. RESULTS: 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%, P < 0.001) or generalized anxiety disorder (15.2% vs. 8.6%, P = 0.043) and were on long-term disability (13.7% vs. 5.6%, P = 0.003). Absenteeism (11.8% vs. 6.3%, P = 0.030); presenteeism (36.0% vs. 17.5%, P < 0.001); overall work impairment (41.0% vs. 20.9%, P < 0.001); and activity impairment (45.4% vs. 25.4%, P < 0.001) were greater in treated migraine patients versus nonmigraine controls. Treated migraine patients had higher all-cause HRU and higher all-cause direct ($24,499.90 vs. $15,318.91, P = 0.013) and indirect ($14,770.57 vs. $5,764.93, P < 0.001) costs than nonmigraine controls. CONCLUSIONS: 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. DISCLOSURES: 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 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.

Sociodemographic disparities in the management of type 2 diabetes in the United States.

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 = 4552) 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 1 January 2015 and 31 December 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 of 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.

Asthma control is associated with economic outcomes, work productivity and health-related quality of life in patients with asthma.

BACKGROUND: The 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. METHODS: Data 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. RESULTS: Of 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 (p<0.001) and lower mean direct costs ($6012 vs $8554 and $15 262, respectively; p<0.001); well-controlled asthma was also associated with significantly lower mean scores for work absenteeism, work presenteeism, overall work impairment and activity impairment (all p<0.001), and lower mean indirect costs ($6353 vs $10 448 and $14 764, respectively; p<0.001). Clinically meaningful differences favouring well-controlled asthma were seen for all HRQoL measures, with statistically significantly higher adjusted mean EQ-5D-5L index and SF-6D Health Utilities Index scores (derived from SF-36V.2) for patients with well-controlled asthma compared with partly controlled or poorly controlled asthma (p<0.001). CONCLUSIONS: The 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.

Disparities in healthcare providers' interpretations and implementations of ACIP's meningococcal vaccine recommendations.

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.

Burden of relapsing-remitting multiple sclerosis on workers in the US: a cross-sectional analysis of survey data.

BACKGROUND: Multiple sclerosis (MS) is prevalent among working age individuals (20-60 years), leading to high burden on work productivity. Few data are available about the absenteeism and presenteeism in employed individuals with MS in comparison to non-MS personnel. This study aimed to quantify the burden of illness of employed US adults with relapsing-remitting multiple sclerosis (RRMS) and examine burden by levels of work impairment. METHODS: A retrospective cross-sectional analysis was conducted using patient-reported responses from the US National Health and Wellness Survey (NHWS). Data from NHWS 2015-2016 were analyzed from 196 employed RRMS respondents who were matched 1:4 to employed respondents without MS based on demographic and general health characteristics. Demographic and general health characteristics for employed RRMS individuals were analyzed by levels of work impairment (none, 1-30%; 31-68%; 69-100%). Work productivity (absenteeism, presenteeism, and work impairment), decrements in health-related quality of life (HRQoL) (short form-36, EQ-5D), and healthcare resource utilization (HCRU) were compared to determine the burden of RRMS. RESULTS: After propensity score matching, the levels of absenteeism and presenteeism were 2 and 1.8 times higher in the employed RRMS population than the employed non-MS population, respectively (P < 0.001 for both). HRQoL was significantly lower in employed respondents with RRMS than those without MS (P < 0.001 for all). Employed respondents with RRMS had significantly more HCRU over 6 months compared to those without MS (P < 0.001). Furthermore, among employed RRMS respondents, greater levels of impairment were associated with increasing disease severity, greater healthcare resource use, fatigue, and cognitive impairment and inversely associated with mental and physical HRQoL (P < 0.0001 for all). CONCLUSIONS: Among employed individuals, respondents with RRMS had lower, work productivity, HRQoL, and higher HCRU as compared with those without MS. Given the large impact RRMS has on work impairment, a need exists to manage individuals on therapies that improve HRQoL, reduce symptoms, and improve their ability to perform in the workforce.

Association between adherence to sodium channel blockers and patient-reported outcomes: Analysis of US survey data among patients with epilepsy.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Treatment Dosing Patterns and Clinical Outcomes for Patients with Type 2 Diabetes Starting or Switching to Treatment with Insulin Glargine (300 Units per Milliliter) in a Real-World Setting: A Retrospective Observational Study.

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 < 0.001). The relative risk of hypoglycemic events after Gla-300 treatment initiation was lower than that after Gla-100 treatment initiation [0.31, 95% confidence interval (CI) 0.12-0.81; P = 0.018] at similar daily doses. The daily dose of BI was significantly lower after switching to treatment with Gla-300 from treatment with another BI (0.73 units per kilogram before switch vs 0.58 units per kilogram after switch; P = 0.02). The mean hemoglobin A1c level was significantly lower after switching than before switching (adjusted difference - 0.95 percentage points, 95% CI - 1.13 to - 0.78 percentage points ; P < 0.0001). Hypoglycemic events per patient-year were significantly lower (relative risk 0.17, 95% CI 0.11-0.26; P < 0.0001). CONCLUSIONS: Insulin-naive patients starting Gla-300 treatment had fewer hypoglycemic events, a similar hemoglobin A1c level reduction, and no difference in insulin dose versus patients starting Gla-100 treatment. Patients switching to Gla-300 treatment from treatment with other BIs had significantly lower daily doses of BI, with fewer hypoglycemic events, without compromise of hemoglobin A1c level reduction. These findings suggest Gla-300 in a real-world setting provides benefits in terms of dosing, with improved hemoglobin A1c level and hypoglycemia rates. FUNDING: Sanofi US Inc. (Bridgewater, NJ, USA).

Real-world experience of women using extended-cycle vs monthly-cycle combined oral contraception in the United States: the National Health and Wellness Survey.

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 < 0.05). There were no other significant differences between groups. CONCLUSIONS: This real-world observational study supports extended-cycle COC as a valuable treatment option with high satisfaction, high adherence, and reduced heavy menstrual bleeding.

Association of hypoglycaemia severity with clinical, patient-reported and economic outcomes in US patients with type 2 diabetes using basal insulin.

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.

Asthma control and disease burden in patients with asthma and allergic comorbidities.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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, p < 0.05). 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. CONCLUSIONS: 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.

Humanistic and economic burden of nausea and vomiting among migraine sufferers.

BACKGROUND: While studies have demonstrated the economic burden of migraines in terms of quality of life, health care resource use (HRU), and costs, there exists a notable paucity of data comparing such outcomes among migraineurs with nausea and vomiting (N/V) and those without. The current study aimed to address this gap. METHODS: This was a retrospective study using data from the 2013 US National Health and Wellness Survey, a cross-sectional, internet-based survey. Respondents self-reported their migraine with or without N/V along with demographics and outcomes including depression (Patient Health Questionnaire total score; PHQ-9), sleep problems (11-item total score of sleep problems), HRU (number of physician visits, emergency room [ER] visits, and hospitalizations) and Work Productivity and Activity Impairment-General Health Scale (WPAI-GH), and associated mean annual costs. Generalized linear models, adjusting for covariates, assessed the burden of N/V on all outcomes. RESULTS: Among all migraineurs (N=7,855), 73.4% were female, mean age was 41.82 years old, and 57.6% reported experiencing N/V. Adjusting for covariates, migraineurs with N/V vs without N/V had higher mean PHQ-9 scores (7.91 vs 7.02, p<0.001) and mean sleep problems (3.29 vs 2.64, p<0.001). Mean ER visits were more frequent among migraineurs with N/V than those without N/V (0.48 vs 0.38, p=0.001). This difference translated into a 26.3% increase in estimated mean ER costs (N/V=US$1,499 vs without N/V=US$1,187, p=0.002). Mean percentage activity impairment was higher in migraineurs with N/V than in those without N/V (37.73% vs 35.12%, p=0.002) and migraineurs with N/V had higher work productivity loss costs (N/V=US$10,344 vs without N/V=US$9,218, p=0.016). CONCLUSION: Migraine patients with N/V reported worse depression, sleep problems, and activity impairment, and higher ER visits than those without N/V. Migraine with N/V was also associated with an increase in mean annual ER visit costs and work productivity loss costs. Study findings suggest unmet needs with current treatment options for migraine patients with N/V.

Humanistic and economic burden of fibromyalgia in Japan.

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<0.001; these differences exceeded the clinically meaningful levels. In addition, those with fibromyalgia reported significantly poorer sleep quality than those without fibromyalgia. Respondents with fibromyalgia compared with those without fibromyalgia experienced significantly more loss in work productivity and health care resource use, resulting in those with fibromyalgia incurring indirect costs that were more than twice as high (adjusted means =¥2,826,395 vs ¥1,201,547) and direct costs that were nearly six times as high (¥1,941,118 vs ¥335,140), both with P<0.001. CONCLUSION: Japanese adults with fibromyalgia experienced significantly poorer health-related quality of life and greater loss in work productivity and health care use than those without fibromyalgia, resulting in significantly higher costs. Improving the rates of diagnosis and treatment for this chronic pain condition may be helpful in addressing this considerable humanistic and economic burden.

Treatment satisfaction among men with concurrent benign prostatic hyperplasia and erectile dysfunction treated with tadalafil or other phosphodiesterase type-5 inhibitor combinations.

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.