Routine Clinical Practice In Spain Research Articles

Abstract PO1-16-08: Real-World Outcomes of Patients Receiving First-line Palbociclib Plus Endocrine Therapy in Spain: Subgroup Analysis Based on Tumor Grade, Progesterone Receptor, Ki-67 and Histological Subtype from PALBOSPAIN Study

Abstract Background PALBOSPAIN (NCT04874025) is an observational, multicenter study evaluating real-world patterns and outcomes of first-line treatment with palbociclib plus endocrine therapy (ET) in routine clinical practice in Spain. Results from real-world progression-free survival (rwPFS) and overall survival (OS) in the total population, as well as subgroup analysis according to endocrine sensitivity, age, menopausal status, location and number of metastatic sites have been previously reported. Here, we present the prognostic impact of pathological features in metastatic breast cancer patients treated with Palbociclib plus endocrine therapy. Methods Patients diagnosed with hormone-receptor positive and HER2 negative ABC who started first-line treatment with palbociclib plus ET between November 2017 and November 2019 were included. We retrospectively collected clinical-pathological and treatment response data from patient medical records. Estrogen receptor (ER), Progesterone receptor (PR), and Ki67 were assessed by immunohistochemistry (IHC). HER2 was assessed by IHC or fluorescence in situ hybridization (FISH). To evaluate the prognostic role of proliferation index, Ki-67 cut-off was set at 20%. If results of several biopsies were available, the most recent one was used for analysis. Survival analysis (rw-PFS, OS) were estimated using the Kaplan–Meier method with log-rank test. Times for event-free patients at the time of data cutoff in all survival analyses were calculated from the date of treatment start to the date of last follow-up. The association between prognostic factors and survival was examined using Cox proportional hazards regression model. Results A total of 762 patients from 35 hospitals met inclusion and exclusion criteria and were included in the analysis. The cut-off date for this analysis was July 2022 and the median duration of follow-up was 29 months. The distribution of the pathological features is shown in Table 1. Patients with histological grade 1 tumors had a median rwPFS of 33 months, while grade 2 tumors experienced a median rwPFS of 24 months and grade 3 tumors had the poorest outcome with a median rwPFS of 19 months. Median OS was 43, 42 and 40 months for grade 1, 2 and 3 respectively. Patients with Ki-67 < 20% had better rwPFS (35 vs 20 months; HR 0.60, p=0.004) and OS (not reached [NR] vs 35 months; HR 0.66, p=0.002) than those with Ki-67 ≥20% Patients with low ki-67 had better outcomes compared with those with high Ki-67. rwPFS (35 vs 20 months; HR 0.60, p=0.004) and OS (not reached [NR] vs 35 months; HR 0.66, p=0.002) for Ki 67 < 20% and ≥20% respectively. No differences were found according to histological subtype, with similar median rwPFS (23 vs 25 months; HR 0.96, p= 0.77) and OS (42 vs 43 months; HR 0.94, p=0.74) for ductal and lobular carcinomas respectively. Double hormone receptor positive tumors (ER+/PR+) had significant longer rwPFS (27 vs 18 months; HR 0.72, p=0.001) and OS (44 vs 40 months; HR 0.73, p= 0.01) compared with ER+/PR- tumors. Conclusions Grade 3 tumors, Ki 67 ≥20% and absence of PR are associated with reduced rw-PFS and OS in patients treated with palbociclib plus ET in clinical practice. Pathologic results have a prognostic role and may be useful to identify patients who derive more benefit with first-line CDK 4/6 inhibitors plus ET treatment. Table 1 Pathological Characteristics in PALBOSPAIN study Citation Format: Fernando Moreno, Meritxell Bellet- Ezquerra, Luis Manso, Fernando Henao, Antonio Antón, Serafin Morales Murillo, Pablo Tolosa, Verónica Obadía, Teresa Sampedro, Raquel Andrés, Lourdes Calvo, Elena Galve, Rafael López, Francisco Ayala de la Peña, Sara López-Tarruella, Blanca Hernando, Laia Boronat, J. Ignacio Chacón, Noelia Martínez-Jáñez. Real-World Outcomes of Patients Receiving First-line Palbociclib Plus Endocrine Therapy in Spain: Subgroup Analysis Based on Tumor Grade, Progesterone Receptor, Ki-67 and Histological Subtype from PALBOSPAIN Study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-16-08.

Effectiveness and safety of a 1L polyethylene glycol and ascorbic acid preparation for colonoscopy in routine clinical practice in Spain.

Large clinical trials and small real-world studies show that a 1L polyethylene glycol and ascorbic acid solution (1L PEG-ASC) is an effective and safe bowel preparation for colonoscopy. Here, the effectiveness and safety of 1L PEG-ASC was evaluated in a large cohort of patients in routine clinical practice in Spain. A sub-analysis was performed in an observational, multicenter, retrospective study assessing the effectiveness and safety of 1L PEG-ASC in adult patients undergoing a colonoscopy at 10 centers in Spain. Cleansing quality was assessed with the Boston Bowel Preparation Scale, scores ≥6 with all segmental scores ≥2 was considered adequate colon cleansing, high-quality was considered as cleansing ≥8 or =3 in the right colon. Polyp and adenoma detection rates, and adverse events were also assessed. Data was collected from 7160 patients: 48.3% males; mean age 58.0, 33.6% ≥65 years old. Adequate overall bowel cleansing was achieved in 95.6% of patients (95% CI 95.1%-96.0%), high quality cleansing in 74.4% (95% CI 73.4%-75.4%) and high-quality right colon cleansing in 66.0% (95% CI 64.9-67.1). The adequate overall cleansing rate was 97.0% with a split-dose and 94.0% with same-day regimen (P<0.0001), and high-quality right colon cleansing was 69.0% and 62.5% (P<0.0001), respectively. Colonoscopy was completed in 97.2% of cases. A multivariate regression analysis revealed that an overnight split-dose regimen and age <65 years were independent predictors of adequate bowel cleansing of the overall colon, age <65 years and female gender were independent predictors of HQ cleansing of the overall colon, and the three covariates were independent predictors of HQ cleansing of the right colon. At least one adverse event was experienced by 3.3% of participants, with nausea (1.5%) and vomiting (1.2%) being the most frequent. This sub-analysis confirmed 1L PEG-ASC to be an effective and safe bowel cleansing preparation in a real world setting in Spain.

Real-World Health Care Outcomes and Costs Among Patients With Juvenile Idiopathic Arthritis in Spain

Background: Juvenile idiopathic arthritis (JIA) is the most frequent chronic rheumatic disease in children. If inflammation is not adequately treated, joint damage, long-term disability, and active disease during adulthood can occur. Identifying and implementing early and adequate therapy are critical for improving clinical outcomes. The burden of JIA on affected children, their families, and the healthcare system in Spain has not been adequately assessed. The greatest contribution to direct costs is medication, but other expenses contribute to the consumption of resources, negatively impacting healthcare cost and the economic conditions of affected families. Objective: To assess the direct healthcare, indirect resource utilization, and associated cost of moderate-to-severe JIA in children in routine clinical practice in Spain. Methods: Children were enrolled in this 24-month observational, multicentric, cross-sectional, retrospective study (N = 107) if they had been treated with biologic disease-modifying anti-rheumatic drugs (bDMARDs), had participated in a previous study (ITACA), and continued to be followed up at pediatric rheumatology units at 3 tertiary Spanish hospitals. Direct costs included medication, specialist and primary care visits, hospitalizations, emergency visits or consultations, surgeries, physiotherapy, and tests. Indirect costs included hospital travel expenses and loss of caregiver working hours. Unitary costs were obtained from official sources (€, 2020). Results: Overall, children had inactive disease/low disease activity according to JADAS-71 score and very low functional disability as measured by Childhood Health Assessment Questionnaire score. Up to 94.4% of children received treatment, mainly with bDMARDs as monotherapy (84.5%). Among anti-TNFα treatments, adalimumab (47.4%) and etanercept (40.2%) were used in similar proportions. Annual mean (SD) total JIA cost was €7516.40 (€5627.30). Average cost of pharmacological treatment was €3021.80 (€3956.20), mainly due to biologic therapy €2789.00 (€3399.80). Direct annual cost (excluding treatments) was €3654.60 (€3899.00). Indirect JIA cost per family was €747.20 (€1452.80). Conclusion: JIA causes significant costs to the Spanish healthcare system and affected families. Public costs are partly due to the high cost of biologic treatments, which nevertheless remain an effective long-term treatment, maintaining inactive disease/low disease activity state; a very low functional disability score; and a good quality of life.

Real-World Health Care Outcomes and Costs Among Patients With Juvenile Idiopathic Arthritis in Spain.

Background: Juvenile idiopathic arthritis (JIA) is the most frequent chronic rheumatic disease in children. If inflammation is not adequately treated, joint damage, long-term disability, and active disease during adulthood can occur. Identifying and implementing early and adequate therapy are critical for improving clinical outcomes. The burden of JIA on affected children, their families, and the healthcare system in Spain has not been adequately assessed. The greatest contribution to direct costs is medication, but other expenses contribute to the consumption of resources, negatively impacting healthcare cost and the economic conditions of affected families. Objective: To assess the direct healthcare, indirect resource utilization, and associated cost of moderate-to-severe JIA in children in routine clinical practice in Spain. Methods: Children were enrolled in this 24-month observational, multicentric, cross-sectional, retrospective study (N = 107) if they had been treated with biologic disease-modifying anti-rheumatic drugs (bDMARDs), had participated in a previous study (ITACA), and continued to be followed up at pediatric rheumatology units at 3 tertiary Spanish hospitals. Direct costs included medication, specialist and primary care visits, hospitalizations, emergency visits or consultations, surgeries, physiotherapy, and tests. Indirect costs included hospital travel expenses and loss of caregiver working hours. Unitary costs were obtained from official sources (€, 2020). Results: Overall, children had inactive disease/low disease activity according to JADAS-71 score and very low functional disability as measured by Childhood Health Assessment Questionnaire score. Up to 94.4% of children received treatment, mainly with bDMARDs as monotherapy (84.5%). Among anti-TNFα treatments, adalimumab (47.4%) and etanercept (40.2%) were used in similar proportions. Annual mean (SD) total JIA cost was €7516.40 (€5627.30). Average cost of pharmacological treatment was €3021.80 (€3956.20), mainly due to biologic therapy €2789.00 (€3399.80). Direct annual cost (excluding treatments) was €3654.60 (€3899.00). Indirect JIA cost per family was €747.20 (€1452.80). Conclusion: JIA causes significant costs to the Spanish healthcare system and affected families. Public costs are partly due to the high cost of biologic treatments, which nevertheless remain an effective long-term treatment, maintaining inactive disease/low disease activity state; a very low functional disability score; and a good quality of life.

Humoral Response to SARS-COV-2 Vaccination in Patients with Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder: A Real-World Study.

The risk of SARS-CoV-2 infection or severe coronavirus disease 2019 (COVID-19) has been shown to increase in patients with multiple sclerosis (MS). Vaccination is recommended in this patient population, and the effect of disease-modifying treatments (DMTs) on response to vaccination should be considered. This prospective, observational, cross-sectional study investigated humoral response after COVID-19 vaccination as well as possible predictors for response in patients with MS and other neuroinflammatory diseases who received DMTs in routine clinical practice in Spain. Responses were compared versus those seen in healthy controls. After vaccination against COVID-19, most patients with MS developed an immune response comparable to that of healthy individuals. However, approximately half of patients receiving a sphingosine-1-phosphate modulator (SP1-M, fingolimod or siponimod) or a B-cell-depleting agent (aCD20, ocrelizumab or rituximab) did not develop protective antibodies, although patients receiving other DMTs had humoral immune responses comparable to healthy controls. Lymphocyte count was not associated with reduced humoral response in patients receiving an SP1-M or aCD20, whereas, in patients receiving an aCD20 or SP1-M, older age was associated with lower anti-SARS-CoV-2 spike protein immunoglobulin G antibody levels. Treatment with aCD20 or SP1-M therapies appears to be associated with a lower humoral response to vaccines against SARS-CoV-2. Vaccination prior to initiation of these DMTs should be recommended whenever possible.

OP23 Early Detection Tools For Emotional Distress In Adult Cancer Patients In Spain: A Health Technology Assessment Report

IntroductionPatient-reported outcome measures are being increasingly considered both in clinical practice and in the field of health technology assessment. Although emotional distress is currently recognized as the sixth vital sign in cancer care, its early detection and screening is not yet included in routine clinical practice in Spain. The main objective of this study was to assess the psychometric properties and diagnostic accuracy of validated tools for the early detection of distress among adults with cancer in the Spanish context, at the request of the Spanish National Health System (NHS) Cancer Strategy.MethodsA systematic review was carried out to analyze development and validation studies. The Quality Assessment of Diagnostic Accuracy Studies tool (QUADAS-2) was used for the risk of bias assessment, and a multicriteria global assessment was used for the tests. Ethical and organizational aspects were also addressed.ResultsFifteen validation studies were included, corresponding to seven tests. The tools considered were the Distress Thermometer (DT), the Brief Symptom Inventory-18 (BSI-18), the Edmonton Symptom Assessment System-revised (ESAS-r), the Hospital Anxiety and Depression Scale (HADS), the Visual Analog Scale for Anxiety and Depression (VAS-AD), the Detection of Emotional Distress (DED) scale, and the Psychosocial and Spiritual Needs Evaluation (ENP-E) scale. Evidence of validity, reliability (internal consistency), and diagnostic accuracy (sensitivity, specificity, and area under the receiver operating characteristic curve) were summarized. Three scales were rated as poor (VAS-AD, BSI-18, and ESAS-r), the ENP-E scale was rated as acceptable, and three scales were rated as moderate (DT, DED, and HADS).ConclusionsThe DT (single-item measure) stands out as an appropriate tool for early detection of emotional distress in the Spanish NHS. The use of this scale could be considered a first stage, to be combined later with a longer scale to improve screening specificity. The HADS scale could be utilized for this purpose. The use of these tools should be framed within a structured screening program that ensures further evaluation and subsequent psychological care when needed.

Results of semaglutide in patients older than 70 years, a real-world study of efficacy and safety.

The aim of this study is to investigate the use of once-weekly semaglutide in a real population of patients with type 2 diabetes mellitus (T2DM) over 70 years in two Spanish hospitals. An observational, retrospective, and multicenter clinical study was designed. It included 60 patients with T2DM, with a mean age of 76.5 years, 63.3% women, and a mean of 15.5 years of evolution of T2DM, all managed in the outpatient clinical setting. The primary endpoint was the change in HbA<inf>1c</inf> from baseline to the end of the study. The secondary endpoints included changes in body weight and the proportion of patients achieving HbA<inf>1c</inf> <7.0% and body weight loss >5%. After 12 months of follow-up, the reductions in HbA<inf>1c</inf> were -0.61±0.9% (P<0.0001) in the total cohort. Body weight reductions were -8.2±5.3 kg (P<0.0001). Overall, 67% reached the objective of an HbA<inf>1c</inf> level of <7%, and 73% achieved a weight loss of ≥5%. In routine clinical practice in Spain, the use of semaglutide once a week was associated with statistically significant and clinically relevant improvements in HbA<inf>1c</inf> and body weight in adults aged over 70 years with T2DM, without notable adverse effects, which supports real-world use.

Effectiveness and safety of encorafenib-cetuximab in BRAFV600E metastatic colorectal cancer: Confidence study.

126 Background: BRAFV600E mutant metastatic colorectal cancer (mCRC) has a poor prognosis. The BEACON trial demonstrated an improvement in tumor response, overall survival (OS), and progression-free survival (PFS) when administering encorafenib-cetuximab (EC) to patients (pts) who progressed after 1 or 2 therapy lines. This study provides a retrospective analysis of the effectiveness and safety of EC in the real-world setting in Spain. Methods: This retrospective analysis included BRAFV600E mCRC pts treated with EC in 2nd line treatment, recruited from March to July 2022. The Co-primary study endpoints included effectiveness based on PFS and OS. Secondary endpoints included sociodemographic and clinical characteristics of patients before EC initiation, overall response rate (ORR), and safety. Results: From March to July 2022, 81 evaluable pts were included. Sociodemographic and clinical characteristics are displayed.A median (interquartile range [IQR]) of 6.0 (4.0-13.0) cycles of encorafenib and 6.0 (4.0-14.5) cycles of cetuximab were administered. Median treatment duration was 4.4 (2.6-7.8) months (m) and 4.4 m (2.8-7.6) respectively. The ORR and disease control rate was 33.8 % (CI 95% 23.4-45.5) and 68.8 (CI 95% 57.3 – 78.9) respectively. One (1.2%) pt achieved complete response At data cut-offwith a 9.7 median follow-up, 50 (61.7%) pts had died, all of them due to disease progression. Median (95% Confidence Interval, CI) OS was 12.6 m (8.0-17.3) and median PFS was 5.0 m (3.8-6.2). The 12-m OS and 12-m PFS rates were 54.6% (95% CI, 43.3-65.9) and 19.9% (10.5-29.3) respectively. Pts with neutrophils/lymphocyte ratio (NLR) ≥3 had worse OS (HR, 1.8 95% CI 1.0-3.2; p &lt; 0.049) and worse PFS (HR, 2.3, 1.4-3.8; p &lt; 0.002). Disease progression (86.7%) was the most frequent cause of treatment discontinuation, followed by unacceptable AEs (3.7%). Eleven pts (13.5%) experienced treatment-related graded 3 or 4 AEs, mainly acne (3.7%). Treatment-related deaths were not reported. Conclusions: This study provides real-world data of BRAFV600E mCRC pts treated with EC combination in routine clinical practice in Spain. EC effectiveness and safety were consistent with the results obtained in clinical trials. [Table: see text]

Experience with the management of patients requiring home enteral nutrition in routine clinical practice in Spain: the ECONES study.

enteral nutrition is an effective method for restoring the nutritional status in patients unable to eat or fulfil nutritional requirements orally. the ECONES study aimed to describe the treatment of patients requiring home enteral nutrition (HEN) in routine practice and the experience of specialists with the high-protein hypercaloric formula 2.0 with fiber IS50 (HP/HC 2.0). Spanish specialists answered a 38-questions survey about their last six patients with HEN and their treatment with HP/HC 2.0 formula. the formulas were chosen based on the patients' requirements. HP/HC 2.0 was administered in a mean of 31.5 % of patients, and for a mean of 42.2 % of those, it was selected since the beginning of treatment. According to 92.4 % of specialists, the HP/HC 2.0 was considered as adequate based on nutritional requirements. Among adverse reactions, specialists reported diarrhea, bloating and constipation. Specialists reported that caregivers (90.6 %) stated that HP/HC 2.0 was well tolerated by patients (90.6 %) and expressed comfort with the frequency (75.3 %) and administration time (82.9 %). according to the specialists, formulas are chosen based on patients' characteristics. Patients with high nutritional needs benefit from the HP/HC 2.0 formula as it allows volume restriction, presents few adverse events, and improves the quality of life of the patients.

Identification of Secondary Prevention Patients Eligible for PCSK9 Inhibitors Therapy According to the Routine Clinical Practice in Spain.

Many patients at very high risk of cardiovascular (CV) events would benefit from lipid-lowering therapies (LLT) intensification to decrease their risk. This study aimed to identify the real-world secondary prevention patients potentially eligible for proprotein convertase subtilisin-kexin type9 inhibitors (PCSK9i) in Spain. This retrospective cohort study included adult patients registered in the IQVIA Spanish Electronic Medical Records outpatient database (2014-2020), diagnosed with myocardial infarction (MI), unstable angina (UA), ischaemic stroke (IS), transient ischaemic attack (TIA) or peripheral artery disease (PAD) and with ≥ 1 low-density lipoprotein cholesterol (LDL-C) or total cholesterol measurements. Longitudinal data were collected from the initial diagnosis to the end of the study period or follow-up loss. The study included 9516 patients, 63.9% male, mean (SD) age 67.7 (12.5) years and mean LDL-C 117.3 (38.8) mg/dL. MI, IS and PAD were the most severe events reported during the study period (28.5%, 18.7% and 29.3% of patients, respectively). At the time of last available LDL-C assessment (≥ 3months post-event), 64.4% patients were on LLT. Of those, 45.4%, 46.9% and 7.7% were on high-, moderate- and low-intensity LLT. Overall, 9.6% patients achieved LDL-C < 55mg/dL (24.2% LDL-C < 70mg/dL). Furthermore, 17.9% patients receiving optimized oral LLT showed LDL-C > 100mg/dL (LDL-C reimbursement threshold for PCSK9i in Spain). Up to 82% of patients with atherosclerotic CV disease do not achieve LDL-C levels recommended by the 2019 ESC/EAS guidelines despite being on optimized oral LLT therapy. In 17.9% of these patients LDL-C levels exceed 100mg/dL, being eligible for PCSK9i in Spain.

Survey on the management of Pompe disease in routine clinical practice in Spain

BackgroundDespite the availability of several clinical guidelines, not all health professionals use their recommendations to manage patients with Pompe disease, a rare genetic disorder involving high-impact therapy. Through several discussion meetings and a survey, the present study aimed to learn about the management of Pompe disease in routine clinical practice in Spain, to improve clinical care in a real-life situation.ResultsThe survey was sent to 42 healthcare professionals who manage patients with Pompe disease in their clinical practice. Although most respondents followed the clinical guidelines, clinical practice differed from the expert recommendations in many cases. Approximately 7% did not request a genetic study to confirm the diagnosis before starting treatment, and 21% considered that only two dried blood spot determinations suffice to establish the diagnosis. About 76% requested anti-GAA antibodies when there is a suspicion of lack of treatment efficacy, though a significant percentage of respondents have never requested such antibodies. According to 31% of the respondents, significant impairment of motor function and/or respiratory insufficiency is a requirement for authorizing medication at their hospital. Up to 26% waited for improvements over the clinical follow-up to maintain treatment and withdrew it in the absence of improvement since they did not consider disease stabilization to be a satisfactory outcome.ConclusionsThe results highlight the lack of experience and/or knowledge of some professionals caring for patients with Pompe disease. It is necessary to develop and disseminate simple guidelines that help to apply the expert recommendations better or centralize patient follow-up in highly specialized centers.

Resource utilization associated with the management of potential interactions between direct-acting antivirals for chronic hepatitis C treatment and cardiovascular and central nervous system drugs

Objective: Patients with chronic Hepatitis C Virus Infection (HCV) present high rates of comorbidity and polypharmacy. We aimed to assess the additional actions and resource utilization required for the management of potential drug-drug interactions (pDDIs) in HCV patients showing cardiovascular (CVS) and central nervous system (CNS) comorbidities, treated with sofosbuvir/velpatasvir (SOF/VEL) compared to glecaprevir/pibrentasvir (GLE/PIB) in routine clinical practice in Spain. Methods: The most prevalent CVS and CNS drugs in HCV patients were identified from real-world published data. The pDDIs between SOF/VEL, GLE/PIB and comedications, and their management recommendations were identified on the University of Liverpool Hepatitis Drug Interaction Group website. An expert panel defined real-world management of pDDIs, and a consensus was reached on actions required on the concomitant drug and resource utilization. Results: Additional actions are required in 89% of the CVS drugs when co-administered with GLE/PIB, while 39% were required with SOF/VEL (dose adjustment: 39% vs 17%; drug suspension: 28% vs 11%; drug substitution: 22% vs 11%; drug restart after DAA treatment: 33% vs 22%); additional visits and/or tests are needed in 50% and 22%, respectively. Regarding CNS drugs, 71% required additional actions when co-administered with GLE/PIB, while 14% require them with SOF/VEL (dose adjustment: 57% vs 0%; drug substitution: 14% vs 14%); additional visits and/or tests are needed in 71% and 14%, respectively. Conclusion: In routine clinical practice, fewer actions and less resource utilization are needed to manage pDDIs with SOF/VEL than with GLE/PIB, when treating HCV patients with CVS and CNS comorbidities. Keywords: chronic hepatitis C; drug-drug interactions; pangenotypic direct acting antivirals; resource utilization; comorbidity.

RWD81 Analysis of Clinical Outcomes, Health Resource Use and Costs of Patients With Non-Valvular Atrial Fibrillation Treated With Apixaban vs Acenocoumarol in Routine Clinical Practice in Spain

Our study aims to compare the use of healthcare resources and costs associated to the management of patients with non-valvular atrial fibrillation (NVAF), according to medical practice in Spain.

Clinical and economic consequences of ozenoxacin vs. other topical antibiotics for the treatment of impetigo: a real-life study in Spain.

Impetigo is a common dermatological paediatric infection that can be treated with topical antibiotics: the common are mupirocin (MUP), fusidic acid (FA) and, most recently, ozenoxacin (OZ). This study assesses the clinical and economic consequences of the use of OZ vs. MUP and vs. FA for the treatment of impetigo in routine clinical practice in Spain. This is a retrospective observational study using real-life data from electronic medical records of patients with impetigo who started treatment with OZ, MUP or FA (maximum follow-up: 3 months; n = 10,974). We compared treatment duration, comorbidities, use of systemic medication, complications, utilization of resources and associated costs across treatments (p<0.05). Cost-effectiveness of OZ was assessed from a social perspective. Complication rates and treatment duration were the effectiveness measures. Mean age was 12.6 (standard deviation [SD]: 16.6) years; 48.6% were male; treatment: 9.3% (OZ), 56.4% (MUP), 34.5% (FA). The percentage of patients ending treatment after 2 weeks was 87.6% (OZ) vs. 83.2% (MUP) vs. 82.4% (FA); p<0.001; complication rates were 1.8% (OZ), 3.3% (MUP) and 3.2% (FA), p<0.001; mean costs were €158 (OZ), €265 (MUP) and €287 (FA), p<0.001. OZ is a cost-effective and dominant alternative for the treatment of impetigo.

Real-world use of once-weekly semaglutide in patients with type 2 diabetes at an outpatient clinic in Spain.

ObjectivesTo investigate the use of once-weekly semaglutide in a real population of people with type 2 diabetes mellitus (T2DM) in three Spanish hospitals.MethodAn observational, retrospective and multicenter clinical study was designed that included 166 participants with T2DM, distinguishing between a group naïve to GLP-1RA (n=72) and another switching from another GLP-1RA (n=94), all managed in the outpatient clinical setting. The primary endpoint was the change in HbA1c from baseline to the end of the study. The secondary endpoints included changes in body weight and the proportion of people with T2DM, achieving HbA1c <7.0% and body weight loss >5%.ResultsAfter 24 months of follow-up, the reductions in HbA1c were -0.91 ± 0.7% (p<0.001) in the total cohort, -1.13 ± 1.38% (p<0.019) for GLP-1RA-naïve participants, and -0.74 ± 0.9% (p<0.023) for GLP-1RA-experienced participants. Body weight reductions were -12.42 ± 9.1% in GLP-1RA-naïve participants vs. -7.65 ± 9.7% in GLP-1RA-experienced participants (p<0.001). In the total cohort, 77.1% reached the objective of an HbA1c level <7%, and 12.7% reached between 7.1% and 7.5%. Additionally, 66.9% achieved a weight reduction ≥5%. Of all cohort, 90% received 1 mg of semaglutide once a week. The reported adverse events were consistent with the known safety profile of semaglutide.ConclusionsIn routine clinical practice in Spain, the use of semaglutide once a week was associated with statistically significant and clinically relevant improvements in HbA1c and body weight in a wide range of adults with T2DM, without notable adverse effects, which supports real-world use.

Dyslipidemia observatory: Treatment of hypercholesterolemia in Spain, context and levers for improvement in clinical practice

Introduction and objectivesThe treatment of dyslipidemia exhibits wide variability in clinical practice and important limitations that make lipid-lowering goals more difficult to attain. Getting to know the management of these patients in clinical practice is key to understand the existing barriers and to define actions that contribute to achieving the therapeutic goals from the most recent Clinical Practice Guidelines. MethodsObservatory where the information gathered is based on routine clinical practice and the experience from the healthcare professionals involved in the treatment of dyslipidemia in Spain. The information is collected by health area through: (i) face-to-face meeting with three different medical specialties and (ii) quantitative information related to hypercholesterolemia patients’ management (ad-hoc questionnaire). Information includes patients’ profiles, assistance burden, guidelines and protocols used, goal attainment, limitations and opportunities in clinical practice. Results145 health areas are planned to be included, with the participation of up to 435 healthcare professionals from the 17 Autonomous Regions of Spain. Information collection will result in aggregated data from over four thousand patients. ConclusionsThis Observatory aims to understand how hypercholesterolemia is being treated in routine clinical practice in Spain. Even though the preliminary results show important improvement areas in the treatment of dyslipidemias, mechanisms to drive a change towards health outcomes optimization are also identified.

Once-Weekly Semaglutide Use in Patients with Type 2 Diabetes: Results from the SURE Spain Multicentre, Prospective, Observational Study.

Type 2 diabetes (T2D) is a complex disease for which an individualised treatment approach is recommended. Once-weekly (OW) semaglutide is a glucagon-like peptide-1 receptor agonist approved for the treatment of insufficiently controlled T2D. The aim of this study was to investigate the use of OW semaglutide in adults with T2D in a real-world context. SURE Spain, from the 10-country SURE programme, was a prospective, multicentre, open-label, observational study, approximately 30 weeks in duration. Adults with T2D and ≥1 documented HbA1c value ≤12 weeks before semaglutide initiation were enrolled. Change in HbA1c from baseline to end of study (EOS) was the primary endpoint, with change in body weight (BW), waist circumference, and patient-reported outcomes as secondary endpoints. Of the 227 patients initiating semaglutide, 196 (86.3%) completed the study on-treatment with semaglutide. The estimated mean changes in HbA1c and body weight between baseline and EOS were −1.3%-points (95% confidence interval (CI) −1.51;−1.18%-points) and −5.7 kg (95% CI −6.36;−4.98 kg). No new safety concerns were identified. Therefore, in routine clinical practice in Spain, OW semaglutide was shown to be associated with statistically significant and clinically relevant reductions in HbA1c and BW in adults with T2D.

Protocolo del observatorio de las dislipemias: Tratamiento de la hipercolesterolemia en España, contexto e identificación de medidas de mejora en práctica clínica habitual

Introduction and objectivesThe treatment of dyslipidemia exhibits wide variability in clinical practice and important limitations that make lipid-lowering goals more difficult to attain. Getting to know the management of these patients in clinical practice is key to understand the existing barriers and to define actions that contribute to achieving the therapeutic goals from the most recent Clinical Practice Guidelines. MethodsObservatory where the information gathered is based on routine clinical practice and the experience from the healthcare professionals involved in the treatment of dyslipidemia in Spain. The information is collected by health area through: (i) face-to-face meeting with three different medical specialties and (ii) quantitative information related to hypercholesterolemia patients’ management (ad-hoc questionnaire). Information includes patients’ profiles, assistance burden, guidelines and protocols used, goal attainment, limitations and opportunities in clinical practice. Results145 health areas are planned to be included, with the participation of up to 435 healthcare professionals from the 17 Autonomous Regions of Spain. Information collection will result in aggregated data from over four thousand patients. ConclusionsThis observatory aims to understand how hypercholesterolemia is being treated in routine clinical practice in Spain. Even though the preliminary results show important improvement areas in the treatment of dyslipidemias, mechanisms to drive a change towards health outcomes optimization are also identified.

POSB393 Profile of Patients with Type 1 or Type 2 Diabetes Treated with Insulin Lispro 100 Units/ML Junior Kwikpen in Routine Clinical Practice in Spain

Insulin lispro 100 units /mL Junior KwikPen (JrKwikPen) is a disposable pre-filled pen that delivers 0.5–30 units (U) in increments of 0.5 U, which allows for more accurate insulin dose adjustment and more precise glycaemic control. This study describes sociodemographic, clinical, and treatment characteristics of patients with diabetes who initiated treatment with JrKwikPen in real world practice in Spain. This observational retrospective study, based on IQVIA’s electronic medical records databases, included patients of all ages with type 1 diabetes (T1D) or type 2 diabetes (T2D) who started treatment with JrKwikPen between 1st May 2018 and 31st December 2020. Patient characteristics and concomitant treatment at JrKwikPen initiation (index date) and prior medical/treatment history were analysed descriptively by type of diabetes and age groups. A total of 416 patients were included. Main characteristics for T1D/T2D groups (N=326/90) were, respectively: female, 61.7%/65.6%; mean age (standard deviation [SD]), 32.5 (20.7)/55.5 (16.6) years; time since first diabetes record, 5.8 (5.1)/7.9 (4.2) years; body mass index (BMI), 20.8 (4.2)/24.8 (4.8) kg/m2 (N=106/44); haemoglobin A1c (HbA1c), 8.2 (2.0)%/8.0 (1.4)% (N=67/38); presence of diabetes-associated comorbidities, 27.9%/64.4%. Only 32.8% of patients with T1D were <18 years. Among JrKwikPen users 12.3% (T1D/T2D, 6%/6.3%) were ≥65 years, 20.9% patients were newly diagnosed, and 3.8% were pregnant women. The mean (SD) total insulin dose pre-index for T1D/T2D was 42.4 (23.4)/40.7 (21.6) U/day, respectively. The mean (SD) insulin dose at initiation of JrKwikPen was 26.6 (16.6) and 22.6 (13.6) U/day for T1D/T2D, respectively. JrKwikPen was first prescribed mainly by endocrinologists (58.7%) or pediatricians (22.6%). This is the first study that describes the profile of patients treated with insulin lispro 100 U/mL JrKwikPen in clinical practice in Spain. JrKwikPen users were mainly women, adults, with T1D, low BMI, and more associated comorbidities.

Impact of the iCODEX tool in routine clinical practice in Spain

Introduction The prognosis of COPD patients can be calculated using multidimensional indexes that improve the predictive capacity of the individual variables. The CODEX index can be calculated using iCODEX, a digital support tool available on the web and in an app. The aim of this study was to evaluate how the usefulness and applicability of iCODEX and its recommendations in routine clinical practice are perceived by specialists in internal medicine, pneumology, and primary care. Methods A cross-sectional study was conducted from November 2019 to February 2020 with the participation of specialists in internal medicine, primary care, and pneumology. All respondents completed a survey consisting of 104 questions on their perception of the iCODEX tool. Results Overall, 335 physicians responded. Of these, 95.2% had no difficulty accessing the tool and 83.1% were quite or very satisfied with it. Regarding the applicability and implementation of iCODEX recommendations in routine clinical practice, respondents reported that the recommendations were generally applicable: most questions obtained a median score of ≥ 4 out of 5. The recommendations with the greatest expected clinical benefit are listed. Conclusions Our study shows that the iCODEX tool is easy for participating specialists to use and identifies the recommendations that have the greatest clinical impact in areas such as lung obstruction, severe exacerbations, exercise, smoking, and patient follow-up.