Patients In Spain Research Articles

The epidemiological status of osteoporotic hip fractures: A bicentric comparative and retrospective study.

Osteoporotic hip fractures have posed a significant burden to society, and more epidemiological data is required. To compare the epidemiological differences of hip fracture patients in Spain and China. This was a retrospective comparative study. Comparisons were made in terms of morbidity, demographic and anthropometric characteristics, length of stay, cost of hospitalization, and mortality by consulting the medical histories of osteoporotic hip fractures in two hospitals. The t test was used for measurement data, and the X2 test was used for count data. The difference is statistically significant when p< 0.05. A total of 757 patients were enrolled in this study, with 426 from Virgen Macarena University Hospital (HUVM) and 331 from Xi'an Daxing Hospital (XDH). The average age was 81.4 ± 9.26 and 76.0 ± 8.08 years; the proportion of women was 74.9% and 68.0%, respectively. The incidence of osteoporotic hip fractures in Seville residents over 50 years old was approximately 239 per 100,000 residents, compared to 158 per 100,000 residents in Xi'an. The timing of surgery in Spanish patients was significantly longer than in Chinese patients, 78.7 ± 48.2 vs. 60.7 ± 43.1 hours, p= 0.000. There were 81 deaths in Spain and 43 deaths in China during the one-year follow-up period (p= 0.026). In terms of incidence, demographics, surgical methods, and mortality, there are significant differences between hip fracture patients in Seville, Spain and Xi'an, China.

Cost-effectiveness of benralizumab versus mepolizumab and dupilumab in patients with severe uncontrolled eosinophilic asthma in Spain

Objective To assess the cost-effectiveness of benralizumab (benra) vs. mepolizumab (mepo) and dupilumab (dupi) for the treatment of patients with severe uncontrolled asthma from the Spanish Health System perspective. Methods Exacerbations avoided, quality-adjusted life years (QALYs) gained and costs in a 5-year period were estimated with a Markov model for a cohort of 1,000 patients in which, based on published evidence, 31% of the patients received biologics + oral corticosteroids (OCS) and 69% received only biologics. Efficacy data (exacerbation reduction and OCS elimination) were derived from a matching-adjusted indirect comparison. Published EQ-5D utilities per health state (biologic alone, biologic + OCS, standard of care + OCS, exacerbations, and post-exacerbations) were used for QALY estimation. Utility decrements associated with exacerbation management [-0.1 (OCS or emergency visits), −0.2 (hospitalization)] derived from the literature were applied. Costs (€, 2022) included drug acquisition (ex-factory price), administration and disease management. An expert panel (2 pneumologists and 1 pharmacist) validated all inputs. Results Benra was more effective (52.21 QALYs) than mepo (51.39 QALYs) and dupi (51.30 QALYs). Benra avoided more exacerbations (2.87 exacerbations) compared to mepo (4.70 exacerbations) and dupi (5.11 exacerbations) for the 5-year horizon. Total costs/patient were €56,093.77 (benra), €59,280.45 (mepo) and €62,991.76 (dupi), resulting in benra dominating (more QALYs with lower costs) vs. mepo and dupi. Conclusions Benralizumab can be considered as a dominant treatment alternative vs. other biologic drugs for the treatment of uncontrolled severe eosinophilic asthma patients in Spain.

Utility of PHQ-2, PHQ-8 and PHQ-9 for detecting major depression in primary health care: a validation study in Spain.

Primary health care (PHC) professionals may play a crucial role in improving early diagnosis of depressive disorders. However, only 50% of cases are detected in PHC. The most widely used screening instrument for major depression is the Patient Health Questionnaire (PHQ), including the two-, eight- and nine-item versions. Surprisingly, there is neither enough evidence about the validity of PHQ in PHC patients in Spain nor indications about how to interpret the total scores. This study aimed to gather validity evidence to support the use of the three PHQ versions to screen for major depression in PHC in Spain. Additionally, the present study provided information for helping professionals to choose the best PHQ version according to the context. The sample was composed of 2579 participants from 22 Spanish PHC centers participating in the EIRA-3 study. The reliability and validity of the three PHQ versions for Spanish PHC patients were assessed based on responses to the questionnaire. The PHQ-8 and PHQ-9 showed high internal consistency. The results obtained confirm the theoretically expected relationship between PHQ results and anxiety, social support and health-related QoL. A single-factor solution was confirmed. Regarding to the level of agreement with the CIDI interview (used as the criterion), our results indicate that the PHQ has a good discrimination power. The optimal cut-off values were: ⩾2 for PHQ-2, ⩾7 for PHQ-8 and ⩾8 for PHQ-9. PHQ is a good and valuable tool for detecting major depression in PHC patients in Spain.

Epidemiología y distribución espacial de la psoriasis pustulosa generalizada en España: un análisis poblacional a nivel nacional basado en datos de ingresos hospitalarios (2016-2020)

IntroductionLittle has been published on the epidemiology of generalized pustular psoriasis (GPP). The aim of this study was to describe and analyze the geographic distribution of hospital admissions for GPP in Spain. MethodsWe performed a cross-sectional study using the hospital discharge database of the Spanish Basic Minimum Data Set (CMBD), which is a mandatory data set of all admissions to public hospitals in the country. We included patients with a primary diagnosis of psoriasis or GPP at discharge for the period 2016 to 2020. We performed a descriptive analysis of clinical and sociodemographic characteristics of patients admitted with GPP, a spatial analysis at the province level assessing the presence of geographic heterogeneity and a GPP disease map. ResultsWe detected 949 diagnoses of psoriasis and 744 primary diagnoses of GPP. Mean age of patients admitted with GPP was 62.2 years. Intensive care unit admissions were ordered for 6.1% of patients and 4.8% died. The overall incidence rate of GPP among newly hospitalized patients during the study period was 3.18 cases per 1,000,000 person-years. The geographic distribution varied widely, with higher rates observed in the north-west of the country. ConclusionsWe describe the characteristics of GPP hospitalized patients in Spain and provide the first disease map for the country. The findings could help guide future research and suggest the possibility of genetic or environmental factors driving geographic differences.

Cardiovascular features and risk of mortality in COVID-19 hospitalized patients in Spain during 2020. A nationwide study from the Minimum Basic Data Set

Abstract Introduction During the last two years scientific evidence has been gathered regarding the cardiovascular complications of Covid-19. Nevertheless nationwide studies are still required to better understand both the incidence of less frequent clinical findings, and the prognostic implications of cardiovascular COVID-19 complications. Purpose The aim of this study was to estimate the incidence of cardiovascular diseases among COVID-19 hospitalized patients in Spain during 2020, as well as their association with mortality, besides other clinical and epidemiological factors. Methods We used the Minimum Basic Data Set from the Spanish Ministry of Health (RAE-CMBD) to analyze the data of all COVID-19 hospitalized patients in Spain during 2020. This national database includes concurrent diagnostics of all studied patients codified according to the Tenth International Classification of Diseases (ICD-10). Logistic regression analysis was performed to evaluate the influence of the different clinical and epidemiological variables in the evolution of COVID-19 hospitalized patients. Odds ratios were obtained for each variable adjusting by age and sex, and also adjusting by the rest of clinical factors. The software used for analysis was STATA v 16.1. Results 75585 men (55.15%) and 61468 women (44.85%) were hospitalized due to COVID-19 during 2020 in Spain. The median age was 66 in men and 71 in women. Mortality was 14.92% in males, and 13.81% in females. 9.62% of patients were admitted to intensive care unit (ICU). Mortality in ICU was 29.13%. Heart Failure (7.8%), Atrial Fibrillation (7.7%), Pulmonary Embolism (3.46%), Supraventricular Arrythmias (1.18%), Cardiomyopathy (1.06%), Acute Coronary Syndrome (0.87%), Ischemic Stroke (0.33%), Myocarditis (0.12%) Pericarditis (0.06%), or Takotsubo Disease (0.05%), were relevant cardiovascular findings in COVID-19 hospitalized patients (Table 1). In the logistic regression multivariate analysis in COVID-19 patients we found epidemiological predictors of in-hospital mortality such as age (OR 2.38 for each decade), or male sex (OR 1.39). Among the clinical predictors of mortality we differentiated cardiovascular ones as Acute Coronary Syndrome (OR 1.51), Ischemic Stroke (OR 1.46), or Heart Failure (OR 1.43); and non cardiovascular ones such as admission to ICU (OR 3.12), Adult Respiratory Distress Syndrome (OR 2.74), need for Mecanical Ventilation (OR 2.52), Acute Kidney Failure (OR 2.07), Liver damage (OR 1.67), or Dementia (OR 1.66), (Table 2) Conclusion(s) Heart Failure, Pulmonary Embolism, Ischaemic Heart Disease, Atrial fibrillation, Ischemic Stroke, or Cardiomyopathy were among the main cardiovascular diseases associated to COVID-19. They increased in a different measure the risk of mortality in COVID-19, together with factors such as Mecanical ventilation, ICU admission, Acute kidney failure, Dementia, Liver damage, Adult Respiratory Distress Syndrome, older age, or male sex. Funding Acknowledgement Type of funding sources: None.

A socio-ecological approach to reduce the physical activity drop-out ratio in primary care-based patients with type 2 diabetes: the SENWI study protocol for a randomized control trial

BackgroundPhysical activity (PA) is a key behaviour for patients with type 2 diabetes (T2DM). However, healthcare professionals’ (HCP) recommendations (walking advice), which are short-term and individually focused, did not reduce the PA drop-out ratio in the long run. Using a socio-ecological model approach may contribute to reducing patient dropout and improving adherence to PA. The aim of this study is threefold: first, to evaluate the effectiveness of a theory-driven Nordic walking intervention using a socio-ecological approach with T2DM patients in Spain; second, to explore the feasibility on the PA adherence process in T2DM patients while participating in the SENWI programme; and third, to understand the HCPs’ opinion regarding its applicability within the Spanish healthcare system.MethodsA three-arm randomized control trial (n = 48 each group) will assess the efficacy of two primary care-based PA interventions (Nordic walking vs. Nordic walking plus socio-ecological approach; two sessions per week for twelve weeks) compared to a control group (usual HCPs’ walking advice on PA). Inclusion criteria will include physically inactive patients with T2DM, older than 40 years and without health contraindications to do PA. PA levels and drop-out ratio, quality of life and metabolic and health outcomes will be assessed at baseline, post-intervention and at 9- and 21-month follow-ups. The effect of the different interventions will be assessed by a two-factor analysis of variance: treatment group vs time. Also, a two-factor ANOVA test will be performed with linear mixed models for repeated measures.A qualitative analysis using focus groups will explore the reasons for the (in)effectiveness of the new PA interventions. Qualitative outcomes will be assessed at post-intervention using thematic analysis.DiscussionCompared with the general PA walking advice and Nordic walking prescriptions, integrating a socio-ecological approach into Spanish primary care visits could be an effective way to reduce the PA drop-out ratio and increase PA levels in patients with T2DM. Such interventions are necessary to understand the role that multiple socio-complex process in day-to-day PA behaviour has in patients with T2DM in the Spanish context.Trial registrationClinicalTrials.gov NCT05159089. Physical Activity Drop-out Ratio in Patients’ Living with Type 2 Diabetes. Prospectively registered on 15 December 2021.

1-year hospital readmissions due to cardiovascular causes after a heart failure episode in elderly patients in Spain

Abstract Background The prevalence of heart failure (HF) increases with age, one of the leading causes of hospitalization and death in the elderly. However, there are little data about the long-term readmission rate of elderly patients after an episode of HF admission in Spain. Purpose Study 1-year hospital readmissions due to cardiovascular causes in patients ≥75 years discharged to a hospital due to HF in Spain. Methods We performed a retrospective analysis of the Minumum basic dataset of Spain, including all episodes of HF discharged from public hospitals in Spain between 2016 and 2019. The codification was made with ICD-10. We selected patients ≥75 years with HF as the principal diagnosis. We analyzed predictors of readmissions 365 days after the index episode of HF hospitalization with Poisson regression. Results 236,463 index episodes of HF in&amp;gt;75 years were included. 59.1% were female, and the mean age was 85 (SD 5.6) years. 35.0% had HF-pef, 4.3% HF-ref, and 60.7% had unknown LVEF HF. 39.6% of patients had at least one readmission (mean 1.7 readmissions by year for these patients), with no differences in sex or age. Patients with non-cardiovascular comorbidities (renal failure, chronic lung disorders, and severe hematological disorders) as well as coronary atherosclerosis and diabetes were more likely to be readmitted (Table 1). Conclusions After a hospital discharge for HF in patients ≥75 years, the crude ratio of readmission due to cardiovascular causes at 1-year was 39.6%. Readmissions were more likely in patients with non-cardiovascular comorbidities, predominantly renal, hematological, and chronic respiratory disorders, and those with diabetes and coronary atherosclerosis. Funding Acknowledgement Type of funding sources: None.

Cost-benefit analysis of ALK diagnosis vs. non-diagnosis in patients with advanced non-small cell lung cancer in Spain.

In recent years, target therapies to specific molecular alterations in advanced non-small cell lung cancer (NSCLC) have been identified and have shown superior efficacy compared to non-targeted treatments. Anaplastic lymphoma kinase (ALK) is one of the therapeutic targets; nevertheless, ALK diagnosis is not performed in all NSCLC patients in Spain. The objective of this study is to estimate in monetary terms the benefit for the Spanish society of ALK diagnosis in advanced NSCLC patients. A cost-benefit analysis of ALK diagnosis vs. non-diagnosis in advanced NSCLC patients was carried out from the Spanish social perspective, with a time horizon of 5 years. Costs, benefits and the cost-benefit ratio were measured. The analysis has considered the overall survival in advanced NSCLC patients treated with the ALK-tyrosine kinase inhibitor (TKI) alectinib. The natural history of NSCLC was simulated using a Markov model. A 3% discount rate was applied to both costs and benefits. The result was tested using a deterministic sensitivity analysis. The cost of ALK diagnosis vs. non-diagnosis in the base case would be €10.19 million, generating benefits of €11.71 million. The cost-benefit ratio would be €1.15. In the sensitivity analysis, the cost-benefit ratio could range from €0.89 to €2.10. The results justify the universal application of ALK diagnosis in advanced NSCLC, which generates a benefit for Spanish society that outweighs its costs and allows optimal treatment with targeted therapies for these patients.

In vitro activity of imipenem/relebactam against Pseudomonas aeruginosa isolates recovered from ICU patients in Spain and Portugal (SUPERIOR and STEP studies).

To study the in vitro activity of imipenem/relebactam and comparators and the imipenem/relebactam resistance mechanisms in a Pseudomonas aeruginosa collection from Portugal (STEP, 2017-18) and Spain (SUPERIOR, 2016-17) surveillance studies. P. aeruginosa isolates (n = 474) were prospectively recovered from complicated urinary tract (cUTI), complicated intra-abdominal (cIAI) and lower respiratory tract (LRTI) infections in 11 Portuguese and 8 Spanish ICUs. MICs were determined (ISO broth microdilution). All imipenem/relebactam-resistant P. aeruginosa isolates (n = 30) and a subset of imipenem/relebactam-susceptible strains (n = 32) were characterized by WGS. Imipenem/relebactam (93.7% susceptible), ceftazidime/avibactam (93.5% susceptible) and ceftolozane/tazobactam (93.2% susceptible) displayed comparable activity. The imipenem/relebactam resistance rate was 6.3% (Portugal 5.8%; Spain 8.9%). Relebactam restored imipenem susceptibility to 76.9% (103/134) of imipenem-resistant isolates, including MDR (82.1%; 32/39), XDR (68.8%; 53/77) and difficult-to-treat (DTR) isolates (67.2%; 45/67). Among sequenced strains, differences in population structure were detected depending on the country: clonal complex (CC)175 and CC309 in Spain and CC235, CC244, CC348 and CC253 in Portugal. Different carbapenemase gene distributions were also found: VIM-20 (n = 3), VIM-1 (n = 2), VIM-2 (n = 1) and VIM-36 (n = 1) in Spain and GES-13 (n = 13), VIM-2 (n = 3) and KPC-3 (n = 2) in Portugal. GES-13-CC235 (n = 13) and VIM type-CC175 (n = 5) associations were predominant in Portugal and Spain, respectively. Imipenem/relebactam showed activity against KPC-3 strains (2/2), but was inactive against all GES-13 producers and most of the VIM producers (8/10). Mutations in genes affecting porin inactivation, efflux pump overexpression and LPS modification might also be involved in imipenem/relebactam resistance. Microbiological results reinforce imipenem/relebactam as a potential option to treat cUTI, cIAI and LRTI caused by MDR/XDR P. aeruginosa isolates, except for GES-13 and VIM producers.

Long-Term Consequences of COVID-19 Lockdown in Neovascular AMD Patients in Spain: Structural and Functional Outcomes after 1 Year of Standard Follow-Up and Treatment.

Consequences of the COVID-19 pandemic on medical care have been extensively analyzed. Specifically, in ophthalmology practice, patients suffering age-related macular degeneration (AMD) represent one of the most affected subgroups. After reporting the acute consequences of treatment suspension in neovascular AMD, we have now evaluated these same 242 patients (270 eyes) to assess if prior functional and anatomical situations can be restored after twelve months of regular follow-up and treatment. We compared data from visits before COVID-19 outbreak and the first visit after lockdown with data obtained in subsequent visits, until one year of follow-up was achieved. For each patient, rate of visual loss per year before COVID-19 pandemic, considered “natural history of treated AMD”, was calculated. This rate of visual loss significantly increased during the lockdown period and now, after twelve months of regular follow-up, is still higher than before COVID outbreak (3.1 vs. 1.6 ETDRS letters/year, p < 0.01). Percentage of OCT images showing active disease is now lower than before the lockdown period (51% vs. 65.3%, p = 0.0017). Although anatomic deterioration, regarding signs of active disease, can be apparently fully restored, our results suggest that functional consequences of temporary anti-VEGF treatment suspension are not entirely reversible after 12 months of treatment, as BCVA remains lower and visual loss rate is still higher than before the COVID-19 pandemic.

Results of a survey on the treatment of adolescents and young adult (AYA) sarcoma patients in Spain at present time.

We aimed to analyse health care services for adolescents and young adults (AYA) with sarcomas in Spain. A survey was sent to all Spanish cancer centres, including questions about demographic, facilities, and treatment strategies for AYAs with sarcomas in the last 2years. Thirty-five units participated in the survey, 17 paediatric and 15 adult units. There were three specialized AYA units. First line regimen varied depending on whether the treating unit was paediatric or not, for osteosarcomas, rhabdomyosarcomas, and non-rhabdomyosarcomas. By contrast, 91.4% of Ewing sarcomas were treated according to EE2012. In the relapse setting, differences between units were higher in all tumours. Additionally, 48% of the units reported not having trials for this population. There are major differences in the treatment of AYAs with sarcomas between adult and paediatric units. Enormous efforts are needed to homogenize treatments and increase the access to innovation.

Screening for strongyloidiasis in Spain in the context of the SARS-CoV-2 pandemic: Results of a survey on diagnosis and treatment

IntroductionThe generalization of treatment with dexamethasone or other immunosuppressants in patients with SARS-CoV-2 infection may increase the risk of occurrence of severe forms of strongyloidiasis. A nationwide survey was conducted to better understand the diagnostic and therapeutic situation of strongyloidiasis in SARS-CoV-2 co-infected patients in Spain. Materials and methodsA survey was designed and sent to all SEIMC members during February and March 2021. Responses were exported for computer processing to Microsoft Excel 2017 and statistically processed with the free software PSPP. Results189 responses were received, of which 121 (64%) were selected for further processing. Eighty-four centers (69.5%) had no specific strongyloidiasis screening protocol. Forty-two centers (34.7%) had serological techniques available in their laboratories and the rest were sent to a reference laboratory. Only 22 centers (18%) screened for strongyloidiasis in SARS-CoV-2 infected patients. A total of 227 cases of strongyloidiasis were diagnosed in patients with SARS-CoV-2 infection. In four cases patients developed a massive hyperinfestation syndrome leading to the death of one patient. ConclusionCOVID-19 has highlighted the need to unify screening and treatment protocols for imported pathologies such as strongyloidiosis. Efforts to disseminate knowledge are needed to ensure that this potentially fatal disease is adequately treated in patients with the highest risk of complications, such as those with COVID-19.

Changes in the Epidemiology of Diabetic Retinopathy in Spain: A Systematic Review and Meta-Analysis.

Background. The aim of the present study was to determine the prevalence and incidence of diabetic retinopathy (DR) and its changes in the last 20 years in type 2 diabetes mellitus (T2DM) patients in Spain. Methods. A systematic review with a meta-analysis was carried out on the studies published between 2001–2020 on the prevalence and incidence of DR and sight-threatening diabetic retinopathy (STDR) in Spain. The articles included were selected from four databases and publications of the Spanish Ministry of Health and Regional Health Care System (RHCS). The meta-analysis to determine heterogeneity and bias between studies was carried out with the MetaXL 4.0. Results. Since 2001, we have observed an increase in the detection of patients with DM, and at the same time, screening programs for RD have been launched; thus, we can deduce that the increase in the detection of patients with DM, many of them in the initial phases, far exceeds the increased detection of patients with DR. The prevalence of DR was higher between 2001 and 2008 with values of 28.85%. These values decreased over the following period between 2009 and 2020 with a mean of 15.28%. Similarly the STDR prevalence decrease from 3.67% to 1.92% after 2008. The analysis of the longitudinal studies determined that the annual DR incidence was 3.83%, and the STDR annual incidence was 0.41%. Conclusion. In Spain, for T2DM, the current prevalence of DR is 15.28% and 1.92% forSTDR. The annual incidence of DR is 3.83% and is 0.41% for STDR.

Real-world study on adoption of standard-of-care for transplant-eligible newly diagnosed multiple myeloma patients between 2017 and 2020/2021 across France, Germany, Spain, and Italy.

This non-interventional observational study described the current standard-of-care for transplant-eligible newly diagnosed multiple myeloma (TE-NDMM) patients in France, Germany, Spain, and Italy, and recorded the evolution in regimen adoption in distinct elements of frontline treatment during 2017-2020/2021. Clinical information on ongoing (I) or previous (II) TE-NDMM patients was extracted from the Cancerology database. Proportions of patients receiving regimens in each element and the evolution in regimen adoption were determined for the entire population and each country. Most common induction regimens among I patients were VRd in France (75.3%) and Spain (44.1%), VTd in Italy (65.2%), and regimens other than VRd/VTd/VCd in Germany. Maintenance was ongoing/planned for 78.3%, 62.3%, 65.2%, and 61.4% patients in France, Germany, Spain, and Italy, respectively. Among II patients, VRd induction increased from 27.0% in 2017 to 65.7% in 2019 in France, remained relatively low in Spain and Germany, and not present in Italy. In Italy and Spain, VTd induction declined from 72.4% and 58.3% in 2017 to 52.8% and 17.3% in 2019, respectively. VCd induction in Germany declined from 85.2% in 2017 to 64.1% in 2019. The use of bortezomib triplets in induction varied markedly over time and between selected countries.

Clinical Characteristics, Treatment Persistence, and Outcomes Among Patients With COPD Treated With Single- or Multiple-Inhaler Triple Therapy: A Retrospective Analysis in Spain

COPD is a leading cause of death and disability. COPD therapy goals include reducing exacerbations and improving symptom control. Single-inhaler triple therapy (SITT) or multiple-inhaler triple therapy (MITT) is indicated for patients with frequent exacerbations despite bronchodilator therapy. No available evidence compares SITT vsMITT in Spain in terms of treatment persistence, exacerbations, and other outcomes. Do COPD patients in Spain initiating SITT vsMITT have improved persistence, exacerbations, and health care resource utilization? This real-world, observational, retrospective cohort study analyzed electronic health records in the Spanish National Healthcare System BIG-PAC database to identify COPD patients aged≥ 40 years initiating SITT or MITT (using two or three inhalers) between June 1, 2018 and December 31, 2019. Comparative data on persistence (allowing up to 60days without prescription refill), exacerbation rates, and health care resource utilization and costs during 12-month follow-up were analyzed. Multivariate adjusted analyses were performed. Eligible patients (N= 4,625) initiating SITT (n= 1,011) or MITT (n= 3,614) had a mean age of 70.9 years; most were male (73.9%) with mainly moderate (62.0%) or severe (26.5%) airflow limitation. Between-cohort baseline characteristics were similar. At 12-month follow-up, SITT patients had higher persistence (hazard ratio [HR]= 1.37; 95%CI= 1.22-1.53; P< .001), reduced risk of exacerbations (HR= 0.68; 95%CI= 0.61-0.77; P= .001), and lower all-cause mortality risk (HR= 0.67; 95%CI= 0.63-0.71, P= .027), compared with MITT patients. SITT was associated with significantly reduced health care resource use (mean annual cost savings: €403 vsMITT). For both SITT and MITT, persistence was associated with improved exacerbation rates vsnonpersistence, and substantial adjusted mean annual cost savings (€2,115 and €2,700, respectively). Patients initiating SITT had a clinically relevant improvement in persistence leading to reductions in mortality, incidence of exacerbations, and health care resource use with consequent mean cost savings.

Pulmonologists' Opinion on the Use of Inhaled Corticosteroids in Chronic Obstructive Pulmonary Disease Patients in Spain: A Cross-Sectional Survey.

IntroductionIdentifying the variables that guide decision-making in relation to the use of inhaled corticosteroids (ICS) can contribute to the appropriate use of these drugs. The objective of this study was to identify the clinical variables that physicians consider most relevant for prescribing or withdrawing ICS in COPD.MethodsA cross-sectional survey was conducted in Spain from November 2020 to May 2021. Therapeutic decisions on the use of ICS in 11 hypothetical COPD patient profiles were collected using an online survey answered by specialists with experience in the management of patients with COPD. Mixed-effects logistic regression was used to analyze the impact of patients’ characteristics in the therapeutic decision for prescribing ICS or proceeding to its withdrawal.ResultsA total of 74 pulmonologists agreed to collaborate in the survey and answered the questionnaire. The results showed great variability, with only 2 profiles achieving consensus for starting or withdrawing the treatment. The frequency and severity of exacerbations influenced the decision to prescribe ICS in a dose-response fashion (1 exacerbation odds ratio (OR) = 1.86, 95% confidence interval (CI) 1.02 to 3.43, two exacerbations OR = 11.6, 95% CI: 4.47 to 30.2 and three OR = 123, 95% CI: 25 to 601). Similarly, increasing blood eosinophils and history of asthma were associated with ICS use. On the other hand, pneumonia reduced the probability of initiating treatment with ICS (OR = 0.54 [0.29 to 0.98]). Lung function and dyspnea degree did not influence the clinician’s therapeutic decision. The results for withdrawal of ICS were similar but in the opposite direction.ConclusionIn accordance with guidelines, exacerbations, blood eosinophils and history of asthma or pneumonia are the factors considered by pulmonologist for the indication or withdrawal of ICS. However, the agreement in prescription or withdrawal of ICS when confronted with hypothetical cases is very low, suggesting a great variability in clinical practice.

P1035: COUNTRY DIFFERENCES IN THE BURDEN OF PATIENTS WITH HYPEREOSINOPHILIC SYNDROME IN EUROPE

Background: Hypereosinophilic syndrome (HES) is a group of rare blood disorders characterized by peripheral eosinophilia that can lead to tissue and organ damage. Diagnosis and management of HES can be challenging owing to differences in patient characteristics, disease characteristics and clinical manifestations. At present, there is limited information available on the burden of HES in Europe. Aims: To describe real-world patient demographics, disease characteristics, clinical manifestations, treatment patterns, and clinical outcomes for patients with HES across Europe. Methods: This retrospective chart review study included patients ≥6 years old with a confirmed diagnosis of HES and ≥1 year of follow-up data from index (first physician encounter: Jan 2015–Dec 2019). Chart review was conducted by physicians in 5 European countries (France, Germany, Italy, Spain, and the United Kingdom [UK]). Data from a similar number of patients were reviewed and included across each country. Patients could be newly diagnosed during the patient identification window or could be diagnosed prior to their index date, allowing for the inclusion of patients with differing disease duration and organ involvement. Patient demographics, disease characteristics, clinical manifestations, treatment patterns, and clinical outcomes were summarized and described across the overall population and separately by country. Results: Overall, 280 patients were included in the study. Most patients were male (65.0%), with the highest proportion of male patients in Spain (73.1%) and France (75.4%). The majority of patients (55.4%) had idiopathic HES. The most common comorbidity overall was asthma (45.0%); however, in the UK, anxiety/depression was more common than asthma (51.6% vs 41.9%), and in France, both anxiety/depression and hypertension were more common than asthma (37.7% vs 23.0% and 36.1% vs 23.0%, respectively) (Table). Most patients (88.6%) were newly diagnosed with HES during the study time frame. Italy had the highest proportion of patients (17.3%) diagnosed prior to the study while Germany had the lowest (1.9%). The overall mean (standard deviation [SD]) number of distinct clinical manifestations was 3.7 (3.7), with the highest mean (SD) numbers of clinical manifestations observed in Italy (4.6 [4.7]) and Spain (4.7 [3.7]). Patients across all 5 countries were treated with 4 classes of therapy: oral corticosteroids (OCS; 89.3%), immunosuppressants or cytotoxic agents (63.6%), and biologics (43.9%), other therapies (10.7%). Spain had the highest mean (SD) maximum daily dose of OCS (42.4 [19.6] mg). In total, 22.9% of patients experienced a flare, and the mean (SD) number of flares in patients with ≥1 flare was 0.5 (0.3) flares/year. Patients in France, Germany, and the UK had the highest mean (SD) numbers of flares (0.7 [0.6], 0.6 [0.3], and 0.6 [0.3] flares/year, respectively). The overall mean (SD) duration of flares was 2.9 (3.2) months, with the longest flare duration observed in France (4.8 [6.3] months) and the shortest in the UK (1.6 [1.2]). Image:Summary/Conclusion: These results demonstrate that in patients with HES, there are differences in patient and disease characteristics as well as treatment strategies across Europe. These differences likely contribute to challenges in the diagnosis and management of HES and highlight the need for a common strategy to address these difficulties.

P973: REAL-WORLD STUDY ON ADOPTION OF STANDARD OF CARE (SOC) FOR FRONTLINE TRANSPLANT-ELIGIBLE MULTIPLE MYELOMA (FLTEMM) PATIENTS BETWEEN 2017 AND 2020/2021 ACROSS FRANCE, GERMANY, SPAIN, AND ITALY

Background: Newer therapies for frontline transplant-eligible multiple myeloma (FLTEMM) are underway, but an accurate and updated overview of standard MM treatment management is lacking. Repeated analyses and real-world data are warranted to describe current MM standard of care (SoC), treatment lines, and patient clinical outcomes in daily practice. Aims: This non-interventional, cross-sectional, retrospective observational database study described the current SoC for FLTEMM patients in France, Germany, Spain, and Italy, and recorded the evolution in regimen adoption in distinct elements of frontline treatment (induction, consolidation, and maintenance) during 2017-2020/2021. Methods: Clinical information on ongoing (population I) or previous (population II) FLTEMM patients was extracted from the Cancerology database. The primary objective was to describe the treatment regimen considered current SoC for FLTEMM management in all four countries using study population I, and to study the evolution in the use of different regimens in induction phase using study population II. The secondary objective was to describe clinical outcomes, including best tumor response and minimal residual disease (MRD) status, associated with each induction regimen in study population II. Results: In study populations I and II, the median (min, max) age of the patients at induction initiation was 59.0 (35.0, 86.0) and 60.0 (23.0, 80.0) years and 62.9% (227/361) and 64.8% (287/443) patients were male, respectively. In study population I, the most common induction regimens were bortezomib/lenalidomide/dexamethasone (VRd) in France (75.3%, 33/44) and Spain (44.1%, 53/120), bortezomib/thalidomide/dexamethasone (VTd) in Italy (65.2%, 76/116), and others in Germany (58.9%, 48/81) (including daratumumab-based [19.8%, 16/81] or not). Maintenance was ongoing or planned for 78.3% (34/44), 62.3% (51/81), 65.2% (78/120), and 61.4% (71/116) patients in France, Germany, Spain, and Italy, respectively. Among study population I patients on an ongoing maintenance regimen, lenalidomide was received by 99.6% (20/20) patients in France, 86.8% (34/40) in Germany, 80.2% (45/56) in Spain, and 90.7% (30/33) in Italy. In study population II, VRd use as 1L induction increased from 27.0% (10/36) in 2017 to 65.7% (12/18) in 2019 in France and was relatively low in Germany, Spain, and Italy. The most common 1L induction regimen in Germany was VCd, but its use decreased from 85.2% (31/37) in 2017 to 64.1% (24/38) in 2019. VTd was the most common 1L induction in Spain and Italy, but its use declined from 58.3% (16/27) and 72.4% (34/47) in 2017 to 17.3% (4/22) and 52.8% (19/36) in 2019, respectively. In total, 37.5% (166/443) study population II patients achieved at least a complete response, which was the highest for those on VRd (59.2% versus 34.3% for VTd, 33.4% for VCd, and 33.7% for other non-daratumumab-based regimens, respectively). In total, 42.5% (188/443) study population II patients were tested for MRD status and 18.2% (81/443) were found negative. MRD testing rate varied from 26.2% in France to 14.8% in Germany, 84.4% in Spain, and 47.7% in Italy. Summary/Conclusion: The use of bortezomib triplets in induction varied markedly over time and between selected countries. Despite not being approved by the European Medicines Agency specifically for FLTEMM patients, VRd use tended to increase with time in France and to a lesser extent in Spain and Italy in this population.

Clinical characteristics of lurasidone-treated patients in Spain using Natural Language Processing – A real-world data study with Electronic Health Records

IntroductionSchizophrenia is a chronic neuropsychiatric disorder which affects over 20 million people worldwide. Atypical antipsychotics are the first-line choice for the treatment of schizophrenia due to improved tolerability and diminished risk of extrapyramidal symptoms. Lurasidone is an atypical antipsychotic approved in Spain for the treatment of schizophrenia in September 2019. An RWD-based picture of lurasidone use is necessary to better understand its impact in routine clinical practice.ObjectivesTo set up a methodology based on Natural Language Processing (NLP) and machine learning for the analysis of the free-text information contained in the EHRs of patients treated with lurasidone in Spain.MethodsA multicenter, retrospective study based on RWD collected in EHRs of lurasidone users will be conducted in hospitals from the Spanish National Healthcare System. Information extracted from the free text in EHRs using NLP will be treated and analyzed as big data.ResultsA study database for lurasidone-treated patients in Spain has been instituted using the EHRead® technology ( Figure 1), which applies machine learning and deep learning to extract, analyze, and interpret the free-text information written in their de-identified EHRs. Sociodemographic and clinical variables in EHRs from September 2019 until the most recent data available are being collected to describe the target patient population and address treatment-related outcomes.ConclusionsNLP of free text in EHRs of lurasidone-treated patients renders a real-world picture of lurasidone usage in Spain. Studies using artificial intelligence techniques represent a novel source of information regarding psychiatric disorders and their clinical management.DisclosureI. Gabarda is employee at Angelini Pharma España, S.L.U. and C. de la Pinta is employee at Medsavana.

The CNIC-Polypill reduces recurrent major cardiovascular events in real-life secondary prevention patients in Spain: The NEPTUNO study

BackgroundTo evaluate the effectiveness of a cardiovascular polypill including aspirin, ramipril and atorvastatin (CNIC-Polypill), on the incidence of recurrent major cardiovascular events (MACE) and risk factor control in patients with established atherosclerotic cardiovascular disease (ASCVD) vs different pharmacological therapeutic strategies. MethodsRetrospective, observational study using data from electronic-health records. Patients were distributed into 4 different cohorts: CNIC-Polypill (case cohort) vs 3 control cohorts: same monocomponents taken separately (Monocomponents), equipotent drugs (Equipotent) and other drugs not included in the previous cohorts (Other therapies). Patients were followed for 2 years or until MACE or death. ResultsAfter propensity score matching, a total of 6456 patients (1614 patients per cohort) were analysed. After 2 years, the risk of recurrent MACE was lower in the CNIC-Polypill cohort compared to the control groups (22%; p = 0.017, 25%; p = 0.002, 27%; p = 0.001, higher in the Monocomponents, Equipotent and Other therapies cohorts, respectively). The incremental proportion of patients who achieved blood pressure (BP) and low-density lipoprotein cholesterol (LDLc) control from baseline was higher in the CNIC-Polypill cohort vs control cohorts (BP controlled patients: +12.5% vs + 6.3%; p < 0.05, +2.2%; p < 0.01, +2.4%; p < 0.01, LDLc controlled patients: +10.3% vs + 4.9%; p < 0.001, +5.7%; p < 0.001, +4.9%; p < 0.001, respectively). Medication persistence was higher in patients treated with the CNIC-Polypill (72.1% vs 62.2%, 60.0% and 54.2%, respectively; p < 0.001) at study end. ConclusionsIn secondary prevention patients, compared with control groups, treatment with the CNIC-Polypill was associated with significant reductions in the accumulated incidence of recurrent MACE, improved BP and LDLc control rates, and increased medication persistence.