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Aims To determine the first manifestation of cardiovascular or kidney disease (CVKD) and associated resource use in type 2 diabetes mellitus (T2DM) patients during seven years of follow-up. Methods Observational-retrospective secondary data study using medical records of patients aged ≥18 years with T2DM and without prior CVKD between 2013 and 2019. The index date was 01/01/2013 (fixed date). The manifestation of CVKD was defined by the first diagnosis of heart-failure (HF), chronic-kidney disease (CKD), myocardial-infarction (MI), stroke or peripheral-artery disease (PAD). The main variables were baseline characteristics, manifestation of CVKD, mortality, resource use and costs. Descriptive analyses and Cox model were applied to the data. Results 26,542 patients were selected (mean age: 66.6 years, women: 47.8%, mean duration of T2DM: 17.1 years). 18.7% (N = 4974) developed a first CVKD manifestation during the seven years [distribution: HF (22.4%), CKD (36.6%), MI (14.5%), stroke (15.3%) and PAD (11.3%)]. Overall mortality was 8.3% (N = 2214). The mortality risk of the group that developed HF or CKD as the first manifestation compared to the CVKD-free cohort was higher [HR: 2.5 (95% CI: 1.8–3.4) and 1.8 (95% CI: 1.4–2.3)], respectively. The cumulative costs per patient of HF (€50,942.80) and CKD (€48,979.20) were higher than MI (€47,343.20) and stroke (€47,070.30) and similar to PAD (€51,240.00) vs. €13,098.90 in patients who did not develop CVKD, p Conclusions In T2DM patients, HF and CKD were the first most common manifestations and had higher mortality and re-hospitalisation rates. HF and CKD were associated with the highest resource use and costs for the Spanish National-Health-System.

Introduction and objectives To describe the epidemiology and treatment of a large contemporary cohort of patients with heart failure (HF). Methods Observational, retrospective, population-based study using the BIG-PAC database, which includes people aged ≥ 18 years seeking care for HF between 2017 and 2019. The main variables were the prevalence/annual incidence rate, comorbidities, clinical variables, and medication administered. Results We identified 19 762 patients with HF from a total of 1 189 003 persons seeking medical attention from 2017 to 2019 (2019: mean age, 78.3 years; 53.0% men). Distribution by type of left ventricular ejection fraction (LVEF) was as follows: 51.7% reduced, 40.2% preserved, and 8.1% mid-range. In 2019, the prevalence was 1.89% (95%CI, 1.70-2.08), with an incidence rate of 2.78 new cases per 1000 persons/y. No statistically significant differences were observed in prevalence and/or incidence from 2017 to 2019. Among patients with HF with reduced ejection fraction (HFrEF), 64% received beta-blockers, 80.5% angiotensin-converting enzyme inhibitor/angiotensin receptor blockers or sacubitril-valsartan, and 29.8% an aldosterone antagonist. In addition, from the diagnosis (baseline) to 24 months of follow-up, there was discreet treatment optimization, which was notable in the first 3 to 6 months. Conclusions Epidemiological data on HF remained stable during the study period, with a lower prevalence than that reported in non–population-based studies. There is wide room for improvement in the optimization of medical treatment of HFrEF.

Depressive Disorders are the most common psychiatric diagnoses in the general population. To estimate the frequency, costs associated with Depressive Disorders in usual clinical practice, and in the whole Spanish population, a longitudinal, retrospective, observational study was carried out using data from the BIG-PAC database®. Study population: all patients aged ≥ 18 years with a diagnosis of a Depressive Disorder in 2015-2017. Prevalence was computed as the proportion of Depressive Disorder cases in the adult general population, and the incidence rate, as the number of new Depressive Disorder cases diagnosed per 1,000 person-years in the population using health services, during 2015-2017. We collected demographic variables, comorbidity, direct health costs, and indirect costs (temporary and permanent disability). Health costs related to Depressive Disorders were estimated according to the annual resource use rate (resource/patient/year). Indirect costs were calculated according to the human capital method. Using the study data and information from the Spanish National Institute of Statistics, we estimated the cost of Depressive Disorders corresponding to the Spanish adult population, including premature mortality. 69,217 Depressive Disorder patients aged ≥ 18 years who met the inclusion/exclusion criteria were studied (mean age: 56.8 years; female: 71.4%). Prevalence of Depressive Disorders in the general population was 4.73% (95% CI: 4.70-4.76%). Annual incidence rates (2015-2017) were 7.12, 7.35 and 8.02 per 1,000 person-years, respectively. Total costs observed in our Depressive Disorder patients were € 223.9 million (corresponding to a mean of € 3,235.3; mean/patient/year), of which, 18.4% were direct health care costs and 81.6%, non-health indirect costs (18% temporary occupational disability, 63.6% permanent disability). Considering also the cost of premature death, the mean cost per patient/year was € 3,402 and the estimated societal costs of Depressive Disorders in Spain were € 6,145 million. The prevalence and incidence of Depressive Disorders are consistent with other series reviewed. Resource use and total costs (especially non-health costs) were high.

Victoria Neches García,1 Laura Amanda Vallejo-Aparicio,1 Afisi S Ismaila,2,3 Antoni Sicras-Mainar,4 Aram Sicras-Navarro,4 Cruz González,5 Rafael Cuervo,6 Soham Shukla,2 Marcos García-Peñuela6 1Market Access, GlaxoSmithKline, Madrid, Spain; 2Value Evidence and Outcomes, GlaxoSmithKline, Collegeville, PA, USA; 3Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada; 4Real Life Data, Atrys Health, Barcelona, Spain; 5Pneumology Unit, Hospital Clínico Universitario de Valencia, Valencia, Spain; 6Medical Affairs, GlaxoSmithKline, Madrid, SpainCorrespondence: Victoria Neches García, Market Access, GlaxoSmithKline, P.T.M Severo Ochoa, 2 28760 Tres Cantos, Madrid, Spain, Tel +34 677 50 37 57, Email victoria.x.neches@gsk.comPurpose: To determine the clinical and economic impact of inhaled corticosteroid (ICS) withdrawal in Spanish patients with COPD receiving triple therapy (TT) with ICS, long-acting β2-agonist (LABA), and long-acting muscarinic antagonist (LAMA).Patients and Methods: This was an observational, retrospective study of BIG-PAC database medical records. Patients aged ≥ 40 years receiving TT from 2016 to 2018 were followed for 1 year. Two cohorts were identified: patients continuing TT (ICS+LABA+LAMA), and patients receiving TT with ICS withdrawn (LABA+LAMA). Variables included medication, exacerbations (moderate and severe), pneumonia, mortality, health resource use (HRU), and cost per patient/year. Cohorts were compared using propensity score matching (PSM). Multivariate statistical analysis using analysis of covariance and Cox proportional risks was conducted.Results: Of 6541 patients included, 5740 (87.8%) continued TT and 801 (12.2%) had ICS withdrawn. Patients with ICS withdrawal were younger, had lower disease burden, higher ICS doses, and more exacerbations compared with those continuing ICS. PSM matched 795 patients in each cohort. Mean age was 68.5 years (SD: 11.2), 69.9% were male, and mean Charlson index was 2.0. Patients with ICS withdrawal had more total exacerbations in the 12 months following withdrawal compared with patients continuing TT (36.6% vs 31.4%; p=0.030). No significant differences were found for pneumonia (3.3% vs 3.6%; p=0.583) and mortality (9.9% vs 7.5%; p=0.092). Median time to first exacerbation was shorter in patients with ICS withdrawal compared with those continuing ICS (HR: 0.69, 95% CI: 0.57– 0.83; p< 0.001). Mean health cost per patient/year among patients with ICS withdrawal was higher than those continuing TT (€ 2993 vs € 2130; p< 0.001).Conclusion: ICS withdrawal in patients with COPD receiving TT was associated with increased exacerbations, HRU, and costs compared with continuing TT, with health and economic impacts on patients and the Spanish National Healthcare System, respectively. Pneumonia and mortality rates were similar between groups.Keywords: inhaled corticosteroid withdrawal, COPD, exacerbations, resource use, health costs

Background Migraine represents a serious burden for national health systems. However, preventive treatment is not optimally applied to reduce the severity and frequency of headache attacks and the related expenses. Our aim was to assess the persistence to traditional migraine prophylaxis available in Spain and its relationship with the healthcare resource use (HRU) and costs. Methods Retrospective observational study with retrospective cohort design of individuals with migraine treated with oral preventive medication for the first time from 01/01/2016 to 30/06/2018. One-year follow-up information was retrieved from the Big-Pac™ database. According to their one-year persistence to oral prophylaxis, two study groups were created and describe regarding HRU and healthcare direct and indirect costs using 95% confidence intervals (CI). The analysis of covariance (ANCOVA) was performed as a sensitivity analysis. Patients were considered persistent if they continued on preventive treatment until the end of the study or switched medications within 60 days or less since the last prescription. Non-persistent were those who permanently discontinued or re-initiated a treatment after 60 days. Results Seven thousand eight hundred sixty-six patients started preventive treatment (mean age (SD) 48.2 (14.8) and 80.4% women), of whom 2,545 (32.4%) were persistent for 6 months and 2,390 (30.4%) for 12 months. Most used first-line preventive treatments were antidepressants (3,642; 46.3%) followed by antiepileptics (1,738; 22.1%) and beta-blockers (1,399; 17.8%). The acute treatments prescribed concomitantly with preventives were NSAIDs (4,530; 57.6%), followed by triptans (2,217; 28.2%). First-time preventive treatment prescribers were mostly primary care physicians (6,044; 76.8%) followed by neurologists (1,221; 15.5%). Non-persistent patients required a higher number of primary care visits (mean difference (95%CI): 3.0 (2.6;3.4)) and days of sick leave (2.7 (0.8;4.5)) than the persistent ones. The mean annual expenditure was €622 (415; 829) higher in patients who not persisted on migraine prophylactic treatment. Conclusions In this study, we observed a high discontinuation rate for migraine prophylaxis which is related to an increase in HRU and costs for non-persistent patients. These results suggest that the treatment adherence implies not only a clinical benefit but also a reduction in HRU and costs.

There is little evidence on the relationship between achieved low-density lipoprotein cholesterol (LDL-C) levels and costs in patients on lipid-lowering therapy (LLT). We described healthcare resource use and costs (direct and indirect) by achieved LDL-C in patients receiving LLT after a recent myocardial infarction (MI) in Spain.This was a retrospective observational study of anonymized electronic medical records from seven regions in Spain (BIG-PACOf 6025 patients (mean age, 69.7 years; 77% male), only 11% achieved LDL-C goals as defined in the 2016 ESC/EAS guidelines ( 70 mg/dL), and just 1% reached the lower target ( 55 mg/dL) in the current 2019 guidelines. Achieving lower LDL-C levels translated to lower healthcare resource use and costs. Mean total (direct and indirect) costs ranged from €5044 for patients with LDL-C 55 mg/dL to €7567 for patients with LDL-C ≥ 130 mg/dL.Very few patients achieved recommended LDL-C goals despite using LLT. Achieving lower LDL-C levels after an MI might be associated with lower healthcare resource use and costs. Use of more intensive LLT, leading to greater reductions in LDL-C, could therefore be beneficial both from a clinical and an economic perspective.

Economic burden of community-acquired pneumonia (CAP) is recognized. Few studies have documented such burden in adults stratified by age, risk status, and by care setting. Spanish data available is scarce. A retrospective, multicenter study in seven regions of Spain (2017–2019) was conducted. Patients ≥18 years with a primary all-cause CAP episode diagnosis were identified. Episode-level variables included risk-stratum based on presence of an immunocompromising/chronic condition, age, number and length of hospitalized and outpatient episodes, and CAP-related healthcare costs/sick leaves were included. 7,108 episodes [mean age (SD): 59.2 (19.6), 50.42% male, 31.0% hospitalized] were analyzed. Low-risk group accounted for 47.7% of all CAP episodes, 31.5% moderate-risk and 20.8% high-risk. Pneumococcus was identified in 42.2% of cases. Mean CAP episode length was 22.9 days for hospitalized and 13.7 days for outpatient episode. Total healthcare cost for episode was higher in inpatient vs. outpatient: €3,955 vs. €511, p < 0.001, with higher sick leave cost (€3,281 vs. €2,632, p < 0.001), respectively. CAP required hospitalization cost is high regardless of age or comorbidities for the Spanish NHS. Given that almost half of the patients in this study did not have traditional risk factors for CAP, better preventative strategies should seriously be considered.

Background: To determine the incidence of Treatment-Resistant Depression (TRD) in Spain and to estimate its economic burden, using real world data. Methods: A retrospective, observational-study was carried out using data from the BIG-PAC database®. Patients aged ≥18 years with a diagnosis of major depressive-disorder (MDD) who initiated a new antidepressant treatment in 2015-2017 were included. The patients were classified as TRD and non-TRD. Patients were classified as TRD if they had, during the first year of antidepressant treatment: a) failure with ≥2 antidepressants including the prescription of ≥3 antidepressants (N06A) or ≥2 antidepressant and ≥1 antipsychotic (N05A; including lithium) b) antidepressants administered for ≥ 4 weeks each, and c) the time between the end of one treatment and the initiation of the next was ≤ 90 days. Inherent limitations of data collection from databases should also be considered in this analysis (e.g., lack of information about adherence to treatment). Follow-up period: 18 months. The incidence rate was calculated as the number of TRD patients per 1,000 persons-year divided by the population attended. Outcomes: direct healthcare and indirect costs. Two sensitivity analyses were performed varying the index date and the period used to define TRD patients (6 vs.12 months). Results: 21,630 patients with MDD aged ≥ 18 years (mean age: 53.2 years; female: 67.2%) were analyzed, of whom 3,559 met TRD criteria, yielding a 3-year cumulative incidence of 16.5% (95%CI: 16%-17%) among MDD patients. The annual population incidence rate of TRD in 2015-2017, was 0.59, 1.02 and 1.18/1,000 person-years, respectively (mean: 0.93/1,000 person-year). Overall, mean total costs per MDD patient were €4,147.9, being higher for TRD than for non-TRD patients (€6,096 vs. €3,846; p

Objective This work aims to describe the clinical characteristics and therapeutic management and to determine cardiovascular outcomes after one year of follow-up in a contemporaneous population with heart failure (HF) with and without type 2 diabetes in Spain. These factors were also analyzed in the DAPA-HF-like population (patients who met most inclusion criteria of the DAPA-HF trial) and in patients treated with SGLT2 inhibitors at baseline. Methods This work is an observational, retrospective, population-based study using the BIG-PAC database. The index date was January 1, 2019. People aged ≥ 18 years who received care for HF in 2019 were selected. Events that occurred in 2019 were analyzed. Results We identified 21,851 patients with HF (age 78.0 ± 11.3 years, 53.0% men, 50.9% with HF with reduced left ventricular ejection fraction, 44.5% in NYHA functional class II). HF prevalence was 1.88% and incidence was 2.83 per 1,000 person-years. Regarding HF treatments, 66.1% were taking renin-angiotensin system inhibitors, 69.4% beta blockers, 31.2% aldosterone antagonists, and 7.5% sacubitril/valsartan. During the year of follow-up, 29.8% had HF decompensation which led to hospitalization (mean time to first event of 120.9 ± 72.5 days), 12.3% died, and 8.1% died during hospitalization. Events were more common among patients with type 2 diabetes. Hospitalizations for HF were more common in the DAPA-HF-like population. Conclusions In Spain, the population with HF is elderly and has many comorbidities. Approximately half of patients have HF with reduced left ventricular ejection fraction. There is room for improvement in HF management, particularly through the use of drugs that reduce both HF hospitalization and mortality, in order to reduce the burden of HF.

To evaluate treatment persistence in patients with polymedicated type 2 diabetes (DM2) receiving new treatment with brand-name vs. generic metformin 850mg in usual clinical practice.Observational, retrospective study based on the medical records of patients aged ≥50 years who initiated metformin treatment (brand-name vs. generic) between 01/01/2016 and 31/12/2017. The follow up was two years.treatment persistence and clinical consequences (metabolic control [HbA1c] and hospital admissions). Each patient in the brand-name group (reference) was paired with a patient from the generic group using propensity score matching. A Cox proportional risk model was constructed (p0.05).863 patients receiving brand-name metformin were matched (ratio 1:1) with patients receiving generic metformin. The median age was 60.8 years (SD: 8.8) years and 52.6% were female. Persistence at 24 months was 8.6% higher for brand-name vs. generic metformin (63.2% vs. 58.2%; p=0.034). The hazard ratio for brand-name metformin was 0.83 (95% CI: 0.71-0.96, p=0.013). During the follow-up there was a greater percentage reduction of HbA1c in the brand-name vs. generic group (-6.8% vs. -4.1%; p=0.013). There was a non-significant 19.1% reduction in hospital admissions in the brand-name vs. generic group (8.9% vs. 11.0%; p=0.148).Polymedicated patients who initiated new brand-name metformin treatment for DM2 had greater treatment persistence than those who initiated it with generic metformin and had better metabolic control (percentage reduction in HbA1c).