Diego Bellido

Background: Given the increasing prevalence of dyslipidemia and multimorbidity in the older patient population, the lack of safety data on combined statin–fenofibrate therapy in this age group represents a critical gap. The post hoc subgroup analysis of the POSE study addresses this issue. Materials and Methods: The POSE study was a 3-year, real-world, observational, comparative, non-interventional study conducted in Europe. Patients with mixed dyslipidemia treated either by a fixed-dose combination of pravastatin 40 mg/fenofibrate 160 mg or a moderate-intensity statin monotherapy were enrolled. Safety outcomes included the occurrence of renal or urinary disorders, musculoskeletal or connective tissue disorders, hepatobiliary disorders, cholelithiasis, thromboembolic events, pancreatitis, worsening diabetes mellitus, elevated blood homocysteine levels, interstitial pneumopathy, phototoxicity, and fatal or non-fatal cardiovascular events. Laboratory parameters related to lipid control and renal, muscular, and hepatic functions were additionally evaluated. The post hoc analysis focused on a subgroup of patients aged 75 years and older. Results: A total of 458 patients were included in the analysis. The majority had hypertension (79.3%) and diabetes mellitus (55.0%). Over the 3-year study period, the incidence rate of composite safety events was numerically higher with the combination, though this did not reach statistical significance (RR = 2.18 [95% CI = 0.99–4.81]). Renal and urinary disorders were more frequent with the combination (5.5% vs. 0.8%), whereas musculoskeletal disorders, aggravated diabetes mellitus, and cardiovascular events showed no significant difference between groups, as the 95% confidence interval included 1. Globally, there were no significant differences regarding evolution of the hepatic, muscle, and renal biological parameters. From baseline to Year 3, TG levels decreased by 44.3% with pravastatin/fenofibrate and by 10.7% with statin monotherapy, while HDL-C levels increased by 26.5% and 0.4%, respectively. Conclusions: This real-life observational post hoc subgroup analysis suggests that in patients aged 75 years and older with mixed dyslipidemia at high or very high CV risk, pravastatin 40 mg/fenofibrate 160 mg demonstrates an acceptable long-term safety profile. The combination offers additional TG lowering and HDL-C improvement beyond moderate-intensity statin monotherapy, without a significant increase in overall safety events over three years.

Background: Given the increasing prevalence of dyslipidaemia and multimorbidity in the elderly population, the lack of safety data on combined statin–fenofibrate therapy in this age group represents a critical gap. The post hoc subgroup analysis of the Pose study addresses this issue. Materials and methods: The POSE study was a 3-year, real-world, observational, comparative, non-interventional study conducted in Europe. Patients with mixed dyslipidaemia treated either by a fixed-dose combination of pravastatin 40 mg/fenofibrate 160 mg or a moderate-intensity statin monotherapy were enrolled. Safety outcomes included the occurrence of renal or urinary disorders, musculoskeletal or connective tissue disorders, hepatobiliary disorders, cholelithiasis, thromboembolic events, pancreatitis, worsening diabetes mellitus, elevated blood homocysteine levels, interstitial pneumopathy, phototoxicity, and fatal or non-fatal cardiovascular events. Laboratory parameters related to lipid control and renal, muscular, and hepatic functions were additionally evaluated. The post hoc analysis focuses on the subgroup of patients aged 75 years and older. Results: A total of 458 patients were included in the analysis. The majority had hypertension (79.3%) and diabetes mellitus (55.0%). Over the 3-year study period, there was no difference in incidence rate of safety events between groups (RR = 2.18 [95% CI = 0.99–4.81]). Renal and urinary disorders were more frequent with the combination (5.5% vs 0.8%), whereas musculoskeletal disorders, aggravated diabetes mellitus, and cardiovascular events, showed no significant difference between groups, the 95% CI spanning 1. Globally, there were no significant differences regarding the evolution of hepatic, muscle and renal biological parameters. As expected, the pravastatin/fenofibrate combination achieved a more pronounced TG reduction and a modest increase in HDL-C, whereas the statin group showed more modest changes in these parameters. Conclusions: This real-life observational post hoc subgroup analysis suggests that in patients aged 75 years and older with mixed dyslipidaemia at high or very high CV risk, pravastatin 40 mg/fenofibrate 160 mg is well tolerated and can be used with acceptable long‑term safety. The combination offers additional TG lowering and HDL‑C improvement beyond moderate‑intensity statin monotherapy, without a significant increase in overall safety events over three years. The study confirms the positive benefit / risk balance of the fixed-dose combination of pravastatin 40 mg/fenofibrate 160 mg in this growing population of patients aged 75 years and older.

Aims: This study evaluated clinical outcomes of oral semaglutide treatment in adults with type 2 diabetes (T2D) in a real‐world setting in Spain as part of the 13‐country PIONEER REAL programme. Materials and Methods: This multicentre, prospective, non‐interventional, single‐arm study (NCT05443334) followed participants for 34–44 weeks. Participants were treated as part of routine clinical practice and were naïve to injectable glucose‐lowering medication. The primary endpoint was the change in glycated haemoglobin (HbA _1c ) from baseline to end of study (EOS). Secondary endpoints included changes in body weight, the proportion of participants with HbA _1c 1c was −1.4%‐points (95%CI −1.5, −1.3; p < 0.0001) and in body weight −6.8% (95%CI −7.4, −6.1; p < 0.0001). In participants using SGLT2is, change in HbA _1c was −1.8%‐points (95%CI −2.1, −1.6; p < 0.0001) versus −1.2%‐points (95%CI −1.3, −1.1; p < 0.0001) in participants without SGLT2is. HbA _1c change was −1.4%‐points (95%CI −1.6, −1.3; p < 0.0001) in participants with T2D duration ≤5 years versus −1.2%‐points (95%CI −1.3, −1.0; p < 0.0001) with T2D duration >5 years. At EOS, 77.4% of participants achieved an HbA _1c level 1c and ≥5% body weight reduction. Treatment satisfaction increased, and no new safety concerns were identified. Conclusions: Oral semaglutide treatment improved glycaemic control and reduced body weight in Spanish clinical practice. Early intervention and SGLT2i co‐treatment were associated with more favourable outcomes.

Background: The prevalence of malnutrition is high in post-intensive care unit (ICU) coronavirus disease 2019 (COVID-19) patients during hospitalization and after hospital discharge. This paper presents prospective results from the NutriEcoMuscle study, a multicenter observational study. The study aimed to evaluate changes in nutritional and functional status in post-ICU COVID-19 patients following nutritional and physical rehabilitation interventions. Secondary aims included assessing adherence to and tolerance of the oral nutritional supplement (ONS) used in the nutritional intervention. Methods: The study enrolled adults who had been admitted to the ICU due to severe COVID-19. At hospital discharge, the patients underwent a nutritional intervention based on oral nutritional supplements (ONSs) with 100% serum lactoprotein enriched with leucine and vitamin D and a physical rehabilitation program. They were followed up during three months. Performed assessments included Subjective Global Assessment (SGA), Global Leadership Initiative on Malnutrition (GLIM) criteria, Barthel index (BI), handgrip strength and Timed Up and Go test, bioelectrical impedance analysis (BIA), nutritional ultrasound (US), and tolerance and adherence to ONS. Sample size was calculated based on handgrip strength, and parametric and non-parametric tests were used to assess differences between the baseline and three-month outcomes. Results: The study included 96 patients (71.9% male, mean age 58.8 years, mean body mass index (BMI) of 28.8 kg/m², 36.5% obese). A total of 85 patients (62 men and 23 women) completed the 90-day follow-up. The mean weight gain after the intervention was 6.8 (SD 5.2) kg (similar in men and women; p = 0.263). The proportion of patients with malnutrition according to the SGA or GLIM criteria decreased from 100% to 11.8% and 36.4%, respectively (p < 0.00001 in both cases). The proportion of patients with functional limitations by BI decreased from 66.7% to 27.0% (p < 0.0001). Handgrip strength increased more than 40% in both men and women (p < 0.00001). The time to perform the Timed Up and Go (TUG) test decreased more than 40% in both men and women (p < 0.00001). According to BIA, the mean fat mass did not increase significantly in either men or women. The mean fat-free mass index (FFMI) increased significantly in both men and women. There were also significant increases in body cell mass, skeletal muscle mass index, and appendicular skeletal muscle mass index. The phase angle (PhA) increased significantly in both men (26.5%) and women (17.4%). In a multivariate analysis, age and baseline PhA were related to the PhA increase (adjusted R² = 0.5573). The US study showed a significant increase in the mean measurements of muscle area, muscle circumference, X-axis, and Y-axis in the rectus femoris. Regarding abdominal fat, there were no significant increases in total, superficial, or preperitoneal adipose tissue by US. Participants engaged in a median interquartile range (IQR) of 70 (0–120) min/week of strength exercise and 60 (0–120) min/week of moderate physical exercise. The supplement was well tolerated, and poor adherence (less than 50%) was low (4% of the participants). Conclusions: A three-month intervention, including ONS and physical rehabilitation, is associated with a significant improvement in nutritional and functional status. Patients gained weight primarily by increasing their muscle mass. There was no significant increase in fat mass, as measured by BIA or US. The intervention was well tolerated and had good adherence.

Background: Malnutrition is a prevalent condition associated with adverse health outcomes, requiring the accurate assessment of muscle composition and fat distribution. Methods: This study presents a novel method for the automatic analysis of ultrasound images to estimate subcutaneous and visceral fat, as well as muscle, in patients with suspected malnutrition. The proposed system utilizes computer vision techniques to segment regions of interest (ROIs), calculate relevant variables, and store data for clinical evaluation. Unlike traditional segmentation methods that rely solely on thresholding or pre-defined masks, our method employs an iterative hierarchical approach to refine contour detection and improve localization accuracy. A dataset of abdominal and leg ultrasound images, captured in both longitudinal and transversal planes, was analyzed. Results: Results showed higher precision for longitudinal scans compared to transversal scans, particularly for length-related variables, with the Y-axis Vastus intermediate achieving a precision of 92.87%. However, area-based measurements demonstrated lower precision due to differences between manual adjustments by experts and automatic geometric approximations. Conclusions: These findings highlight the system’s potential for clinical use while emphasizing the need for further algorithmic refinements to improve precision in area calculations.

Background: A nationwide, prospective, multicenter, cohort study (the Disease-Related caloric-protein malnutrition EChOgraphy (DRECO) study) was designed to assess the usefulness of ultrasound of the rectus femoris for detecting sarcopenia in hospitalized patients at risk of malnutrition and to define cut-off values of ultrasound measures. Methods: Patients at risk of malnutrition according to the Malnutrition Universal Screening Tool (MUST) underwent handgrip dynamometry, bioelectrical impedance analysis (BIA), a Timed Up and Go (TUG) test, and rectus femoris ultrasound studies. European Working Group on Sarcopenia in Older People (EWGSOP2) criteria were used to define categories of sarcopenia (at risk, probable, confirmed, severe). Receiver operating characteristic (ROC) and area under the curve (AUC) analyses were used to determine the optimal diagnostic sensitivity, specificity, and predictive values of cut-off points of the ultrasound measures for the detection of risk of sarcopenia and probable, confirmed, and severe sarcopenia. Results: A total of 1000 subjects were included and 991 of them (58.9% men, mean age 58.5 years) were evaluated. Risk of sarcopenia was detected in 9.6% patients, probable sarcopenia in 14%, confirmed sarcopenia in 9.7%, and severe sarcopenia in 3.9%, with significant differences in the distribution of groups between men and women (p < 0.0001). The cross-sectional area (CSA) of the rectus femoris showed a significantly positive correlation with body cell mass of BIA and handgrip strength, and a significant negative correlation with TUG. Cut-off values were similar within each category of sarcopenia, ranging between 2.40 cm² and 3.66 cm² for CSA, 32.57 mm and 40.21 mm for the X-axis, and 7.85 mm and 10.4 mm for the Y-axis. In general, these cut-off values showed high sensitivities, particularly for the categories of confirmed and severe sarcopenia, with male patients also showing better sensitivities than women. Conclusions: Sarcopenia in hospitalized patients at risk of malnutrition was high. Cut-off values for the better sensitivities and specificities of ultrasound measures of the rectus femoris are established. The use of ultrasound of the rectus femoris could be used for the prediction of sarcopenia and be useful to integrate nutritional study into real clinical practice.

This paper presents baseline results from the NutriEcoMuscle study, a multicenter observational study conducted in Spain which focused on changes in nutritional status, body composition, and functionality in post-intensive care unit (ICU) COVID-19 patients following a nutritional intervention. Assessments at hospital discharge included Subjective Global Assessment (SGA), Global Leadership Initiative on Malnutrition (GLIM) criteria, the Barthel index, handgrip strength (HGS) and the Timed Up-and-Go test, bioelectrical impedance analysis (BIA), and nutritional ultrasound (US). The study involved 96 patients (71.9% male, mean age 58.8 years, mean BMI 28.8 kg/m², 36.5% obese). All patients were malnourished at discharge according to GLIM and SGA. Functional status declined from admission up to hospital discharge. A total of 33.3% of patients had a low fat-free mass index (FFMI) and 29.5% had a low phase angle (PhA). Myosteatosis was observed in 83.7% of the population. There was a positive correlation between rectus femoris cross-sectional area, PhA, FFMI, and HGS. In conclusion, post-critically ill COVID-19 patients commonly suffer from malnutrition and reduced muscle mass, causing a loss of independence at hospital discharge. BIA and US could be valuable tools for assessing body composition in these patients. The NutriEcoMuscle study highlights the need for a thorough nutritional and morphofunctional status assessment of post-ICU patients.

Introduction Nutritional ultrasound (US) is an emerging technique in clinical nutrition for the morphological and structural study of muscle mass. Currently, all definitions of malnutrition include the measurement of muscle mass; however, there is no single way to assess it. It is necessary to develop new techniques to identify muscle involvement in malnutrition that are valid, standardised, reliable, accurate and profitable. Objective To value the new muscle US techniques aimed to measure muscle and functional status, to make a more accurate diagnosis and a better prediction of complications and morbidity and mortality in patients at nutritional risk. Primary outcome: to assess the feasibility of US or muscle US techniques in both nutritional diagnosis and follow-up in a nutritional intervention programme. Methods and analysis Disease-Related caloric-protein malnutrition EChOgraphy (DRECO) is a prospective, multicentre (25 Spanish hospitals), uncontrolled clinical study in standard clinical practice to value the usefulness of nutritional US (muscle US) in the nutritional diagnosis and follow-up, over 3–6 months, after standard nutritional clinical practice intervention and physical activity, to control their disease-related malnutrition. 1000 patients are expected to be included in. Discussion This study will standardise nutritional US measures. It will validate and define specific cut-off values for nutritional US and correlate it with already well-known nutritional tools such as Subjective Global Assessment or Global Leadership Initiative on Malnutrition criteria. Thus, muscle US will become not only a tool to diagnose malnutrition, but it will also be integrated in the daily practice to evaluate nutritional interventions. Ethics and dissemination All DRECO study materials have been approved by each of the IRB/IEC of all the sites enrolled (either approval of the own IRB/IEC or validating the approval of the IRB/IEC of another hospital). The study has been registered with ClinicalTrials.gov, on 27 June 2022. The results from this study will be presented at scientific conferences and in peer-reviewed scientific journals. Trial registration number NCT05433831.