Patient preference for early onset of efficacy of preventive migraine treatments.

OBJECTIVE: The objective of this study was to ascertain to what extent adults with migraine value an early onset of efficacy for preventive migraine treatments. BACKGROUND: In placebo-controlled clinical trials, treatment with eptinezumab resulted in a lower proportion of adults with migraine on the first day following infusion (day 1; 14% point-reduction for chronic migraine [CM] in PROMISE-2 and 8% point-reduction for episodic migraine [EM] in PROMISE-1). METHODS: Adults with migraine completed an online preference-elicitation thresholding exercise to ascertain to what extent they value not having a migraine on day 1 postdosing relative to a clinically relevant reduction in number of migraine days during the first month postdosing (≥2 migraine-free days for CM and ≥1 migraine-free days for EM). RESULTS: One hundred and one participants (mean age, 50.6 ± 12.4 years; 81 [80%] women) were included. In participants with CM, 29 of 50 (58%) considered the eptinezumab-generated reduction in the likelihood of migraine on day 1 postdosing to be at least as important as a clinically relevant reduction in number of migraine days the first month postdosing, whereas 37 of 50 (74%) considered a clinically relevant reduction of migraine days the first month postdosing to have a value equivalent to the eptinezumab-generated reduction in the likelihood of migraine on day 1 postdosing. In participants with EM, 18 of 35 (51%) considered the eptinezumab-generated reduction in the likelihood of migraine on day 1 postdosing to be at least as important as a clinically relevant reduction in migraine days the first month postdosing, whereas 24 of 35 (69%) considered a clinically relevant reduction of migraine days the first month postdosing to have a value equivalent to the eptinezumab-generated reduction in the likelihood of migraine on day 1 postdosing. CONCLUSION: Most participants considered the reduction in the likelihood of migraine offered by eptinezumab on day 1 postdosing to be at least as important as a clinically relevant reduction in migraine days the first month postdosing.

Obesity in Germany and Italy: prevalence, comorbidities, and associations with patient outcomes.

PURPOSE: This study investigated the association between body mass index (BMI) and three comorbid conditions (type 2 diabetes [T2D], prediabetes, and hypertension) on humanistic and economic outcomes. PATIENTS AND METHODS: This retrospective observational study collected data from German (n=14286) and Italian (n=9433) respondents to the 2013 European Union National Health and Wellness Survey, a cross-sectional, nationally representative online survey of the general adult population. Respondents were grouped, based on their self-reported BMI, and stratified into three other comorbid conditions (T2D, prediabetes, and hypertension). Generalized linear models, controlling for demographics and health characteristics, tested the relationship between BMI and health status, work productivity loss, and health care resource utilization. Indirect and direct costs were calculated based on overall work productivity loss and health care resource utilization, respectively. The same generalized linear models were also performed separately for those with T2D, prediabetes, and hypertension. RESULTS: The sample of German respondents was 50.16% male, with a mean age of 46.68 years (SD =16.05); 35.24% were classified as overweight and 21.29% were obese. In Italy, the sample was 48.34% male, with a mean age of 49.27 years (SD =15.75); 34.85% were classified as overweight, and 12.89% were obese. Multivariable analyses demonstrated that, in both countries, higher BMI was associated with worse humanistic outcomes and only those from Germany also reported greater direct and indirect costs. Differences in the impact of BMI on outcomes by country were additionally found when the sample was stratified into those with prediabetes, T2D, and hypertension. CONCLUSION: The high percentage of patients who are overweight or obese in Germany and Italy remains problematic. Better elucidating the impact of overweight or obese BMI, as well as the incremental effects of relevant comorbid conditions, on humanistic and economic outcomes is critical to quantify the multifaceted burden on individuals and society.

Obesity in Mexico: prevalence, comorbidities, associations with patient outcomes, and treatment experiences.

OBJECTIVE: The goal of this study is to investigate obesity and its concomitant effects including the prevalence of comorbidities, its association with patient-reported outcomes and costs, and weight loss strategies in a sample of Mexican adults. METHODS: Mexican adults (N=2,511) were recruited from a combination of Internet panels and street intercepts using a random-stratified sampling framework, with strata defined by age and sex, so that they represent the population. Participants responded to a survey consisting of a range of topics including sociodemographics, health history, health-related quality of life (HRQoL), work productivity, health care resource use, and weight loss. RESULTS: The sample consisted of 50.6% male with a mean age of 40.7 years (SD=14.5); 38.3% were overweight, and 24.4% were obese. Increasing body mass index (BMI) was associated with increased rates of type 2 diabetes, prediabetes, and hypertension, poorer HRQoL, and decreased work productivity. Of the total number of respondents, 62.2% reported taking steps to lose weight with 27.6% and 17.1% having used an over-the-counter/herbal product and a prescription medication, respectively. Treatment discontinuation rates were high. CONCLUSION: Findings indicated that 62% of participants reported, at least, being overweight and that they were experiencing the deleterious effects associated with higher BMI despite the desire to lose weight. Given the rates of obesity, and its impact on humanistic and societal outcomes, improved education, prevention, and management could provide significant benefits.

Medical expenditures in patients with high risk of diabetes: Effects of BMI, hypertension, and health-related quality of life.

OBJECTIVE: To evaluate the health-related quality of life (HRQOL) of patients with diabetes and persons at high risk of developing diabetes and the association between HRQOL scores and subsequent medical expenditures in these persons. METHODS: Data came from the Medical Expenditure Panel Survey. Body mass index (BMI) and hypertension were used to identify risk of diabetes. Burden was assessed by comparing SF-12 physical (PCS) and mental (MCS) summary scores in patients with diabetes and those at risk of having diabetes to the age- and gender-adjusted PCS and MCS of those with normal BMI and no hypertension. Associations between PCS and MCS and medical expenditures were modeled using a two-part model that controlled for clinical and demographic factors. Percent increase in expenditure associated with PCS and MCS differences was evaluated as the ratio of estimated expenditure, holding other factors fixed. RESULTS: Diabetes risk factors were associated with up to 9-point lower PCS and 3-point lower MCS score. Overall, 1-, 2-, 5-, and 10-point lower PCS scores were associated with 2.9%, 5.8%, 15.0%, and 31.8% higher expenditures, and lower MCS scores were associated with 1.3%, 2.6%, 6.5%, and 13.5% higher expenditures, respectively. CONCLUSIONS: The reported associations can help clinicians and researchers interpret the magnitude of HRQOL score differences.

A Danish cost-effectiveness model of escitalopram in comparison with citalopram and venlafaxine as first-line treatments for major depressive disorder in primary care.

The objective of this study was to model the cost-effectiveness of escitalopram in comparison with generic citalopram and venlafaxine in primary care treatment of major depressive disorder (baseline scores 22-40 on the Montgomery-Asberg Depression Rating Scale, MADRS) in Denmark. A three-path decision analytic model with a 6-month horizon was used. All patients started at the primary care path and were referred to outpatient or inpatient secondary care in the case of insufficient response to treatment. Model inputs included drug-specific probabilities derived from systematic literature review, ad-hoc survey and expert opinion. Main outcome measures were remission defined as MADRS < or = 12 and treatment costs. Analyses were conducted from healthcare system and societal perspectives. The human capital approach was used to estimate societal cost of lost productivity. Costs were reported in 2004 DDK. The expected overall 6-month remission rate was higher for escitalopram (64.1%) than citalopram (58.9%). From both perspectives, the total expected cost per successfully treated patient was lower for escitalopram (DKK 22,323 healthcare, DKK 72,399 societal) than for citalopram (DKK 25,778 healthcare, DKK 87,786 societal). Remission rates and costs were similar for escitalopram and venlafaxine. Robustness of the findings was verified in multivariate sensitivity analyses. For patients in primary care, escitalopram appears to be a cost-effective alternative to (generic) citalopram, with greater clinical benefit and cost-savings, and similar in cost-effectiveness to venlafaxine.

Can discrete event simulation be of use in modelling major depression?

BACKGROUND: Depression is among the major contributors to worldwide disease burden and adequate modelling requires a framework designed to depict real world disease progression as well as its economic implications as closely as possible. OBJECTIVES: In light of the specific characteristics associated with depression (multiple episodes at varying intervals, impact of disease history on course of illness, sociodemographic factors), our aim was to clarify to what extent "Discrete Event Simulation" (DES) models provide methodological benefits in depicting disease evolution. METHODS: We conducted a comprehensive review of published Markov models in depression and identified potential limits to their methodology. A model based on DES principles was developed to investigate the benefits and drawbacks of this simulation method compared with Markov modelling techniques. RESULTS: The major drawback to Markov models is that they may not be suitable to tracking patients' disease history properly, unless the analyst defines multiple health states, which may lead to intractable situations. They are also too rigid to take into consideration multiple patient-specific sociodemographic characteristics in a single model. To do so would also require defining multiple health states which would render the analysis entirely too complex. We show that DES resolve these weaknesses and that its flexibility allow patients with differing attributes to move from one event to another in sequential order while simultaneously taking into account important risk factors such as age, gender, disease history and patients attitude towards treatment, together with any disease-related events (adverse events, suicide attempt etc.). CONCLUSION: DES modelling appears to be an accurate, flexible and comprehensive means of depicting disease progression compared with conventional simulation methodologies. Its use in analysing recurrent and chronic diseases appears particularly useful compared with Markov processes.