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Kavita Gajria,1 Lulu K Lee,2 Natalia M Flores,2 Ernesto Aycardi,1 Sanjay K Gandhi1 1Global Health Economics Research, Teva Pharmaceuticals, New York, NY, USA; 2Health Outcomes Practice, Kantar Health, Foster City, CA, USA 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

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

Lee LK, Ebata N, Hlavacek P, DiBonaventura M, Cappelleri JC, Sadosky A. Humanistic and economic burden of fibromyalgia in Japan. Journal of Pain Research. 2016;9:967–978.Figures 3, 4, 5, and 6 contain errors in the key. Fibromyalgia should be dark gray and matched controls should be light gray.Read the original article.