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Recent studies showed that patients with glioma can safely participate in early phase clinical trials; however, clinical benefits in this population were limited. We aimed to evaluate the benefit of molecular profiling to guide enrolment in early phase trials for patients with recurrent glioma.Records of patients enrolled in early phase trials of cytotoxic therapies, small molecule inhibitors or monoclonal antibodies from 2008 to 2018 were reviewed for clinico-pathological characteristics, toxicity, response, progression-free survival and overall survival (OS). The primary objective was to evaluate response rates in molecularly-oriented versus non-molecularly-oriented patients.Eighty-eight patients were enrolled, of whom 45 (51.1%) patients were molecularly-oriented. Targets included IDH1/2 (n = 15), BRAF (n = 11), and FGFR1 (n = 3) mutations, FGFR2-3 fusions (n = 9), and mismatch repair deficiency (n = 7). Among patients with high-grade glioma (n = 74), the rate of stable disease ≥6 months and partial or complete response was 25.7% in molecularly-oriented versus 5.1% in non-molecularly-oriented patients (p = 0.02). Upon multivariable adjustment, baseline steroid use ≥20 mg prednisone equivalent per day was associated with shorter OS (OR 3.15 [95% CI 1.62-6.13], p = 0.0008), while molecular enrichment strategy was associated with longer OS (OR 0.40 [95% CI 0.22-0.73], p = 0.003). Nine (10.2%) patients experienced grade 3-4 toxicity and no dose limiting toxicity (DLT) occurred in both cohorts.The use of molecular profiling to guide enrolment in early phase trials is feasible and might provide benefits to selected patients with glioma. Further studies are warranted to confirm these results in larger randomised settings and identify the patients most likely to benefit from this approach.

Acute kidney injury (AKI) is a complication that can occur after cardiac surgery and requires ongoing research in light of the exponential expansion of technological advancements and knowledge in medicine. In this study, we aim to evaluate the outcomes of treated electives of emergency aortic disease with high serum creatinine levels (SCr). Methods: The cohort includes 183 patients, all of whom have an aortic disease and whose SCr levels were checked upon admission on the first day in the intensive care unit (ICU) and upon discharge from the hospital. We examined the correlation of SCr levels with in-hospital mortality and immediate mortality at least six months after discharge as well as with cross-clamp time and bypass time.Results: A high SCr level upon admission is a significant predictive factor of n-hospital mortality (p = 0.001) but not immediate mortality (p = 0.409). A statistically significant correlation was also observed between elevated SCr level on the first day of ICU and aortic disease (p = 0.041) but not immediate mortality (p = 0.119). We observed a significant correlation between aortic disease and in-hospital mortality (p < 0.001), but no correlation was found between high SCr level on the first day of ICU and immediate mortality (p = 0.119). The cross-clamp time is statistically significant correlated with elevated SCr level (p = 0.013) and in-hospital mortality (p = 0.001) but not immediate mortality (p = 0.847). Furthermore, the bypass time is negatively correlated with a high SCr level on the first day of ICU (p = 0.090), in-hospital mortality (p = 0.410), and immediate mortality (p = 0.625). We also found that aortic disease is not correlated with elevated creatinine levels at ICU discharge (p = 0.152) or long-term mortality (p = 0.106). Conclusions: Although this study only included a small portion of the elaborate aspects of surgical and medical management developed around cardiac patients who received invasive treatment, the conclusions reached are nevertheless clearly relevant, as evidenced by the significantly correlations uncovered. In order to manage AKI after AAS and improve the outcome, the SCr level could be used as a marker for renoprotective strategy. Moving forward, these results serve as a first step in motivating us to expand the range of our research, collect newly relevant data, and use it to benefit patients.

Immunotherapy with immune checkpoint blockers (ICB) represents a valid therapeutic option in older patients for several solid cancer types. However, most of the data concerning efficacy and adverse events of ICB available are derived from younger and fitter patients. Reliable biomarkers are needed to better select the population that will benefit from ICB especially in older patients who may be at a higher risk of developing immune-related adverse events (irAEs) with a greater impact on their quality of life. The Lung Immune Prognostic Index (LIPI) is a score that combines pretreatment dNLR (neutrophils/[leukocytes − neutrophils]) and lactate dehydrogenase (LDH) and is correlated with outcomes in patients treated with ICB in non-small-cell lung cancer. We aimed to assess the impact of LIPI in ICB outcomes in a dedicated cohort of older patients. The primary objective was to study the prognostic role of LIPI score in patients aged 70 years or above in a real-life population treated with anti-programmed death-(ligand)1 (anti PD-(L)1). dNLR and LDH were collected in a prospective cohort of patients aged 70 years or above treated with PD-(L)1 inhibitors with metastatic disease between June 2014 and October 2017 at Gustave Roussy. LIPI categorizes the population into three different prognostic groups: good (dNLR ≤ 3 and LDH ≤ ULN—upper normal limit), intermediate (dNLR > 3 or LDH > ULN), and poor (dNLR > 3 and LDH > ULN). Anti PD-(L)1 benefit was analyzed according to overall survival (OS), progression free survival (PFS), and overall response rate (ORR) using RECIST v1.1. criteria. In the 191 older patients treated, most of them (95%) were ICB-naïve, and 160 (84%) had an ECOG performance status of 0–1 with a median age at ICB treatment of 77 (range, 70–93). The most common tumor types were melanoma (66%) and non-small-cell lung cancer (15%). The median follow-up duration was 18.8 months (95% CI 14.7–24.2). LIPI classified the population into three different groups: 38 (23%) patients had a good LIPI score, 84 (51%) had an intermediate LIPI score, and 43 (26%) had a poor LIPI score. The median OS was 20.7 months [95% CI, 12.6–not reached] compared to 11.2 months [95% CI, 8.41–22.2] and 4.7 months [95% CI, 2.2–11.3] in patients with a good, intermediate, and poor LIPI score, respectively (p = 0.0003). The median PFS was 9.2 months [95% CI, 6.2–18.1] in the good LIPI group, 7.2 months [95% CI, 5.4–13] in the intermediate LIPI group, and 3.9 months [95% CI, 2.3–8.2] in the poor LIPI group (p = 0.09). The rate of early death (OS < 3 months) was 37% in the poor LIPI group compared to 5% in the good LIPI group (

Objectives. The present study aims to describe the clinical and biological profile of heart failure patients from central Romania. Material and method. A single centre-based retrospective, observational, descriptive study involving heart failure patients admitted from January 2018 to March 2020 was conducted. Only patients who had echocardiographic data determined by the same examiner were included. Patients were classified according to LVEF at admission in three subgroups: preserved LVEF subgroup (HFpEF, LVEF ≥ 50%), moderate LVEF subgroup (HFmrEF, LVEF 40-49%), reduced LVEF subgroup (HFrEF, LVEF < 40%) and their clinical and biological profile was assessed. Comorbidities were recorded using the Charlson comorbidity index (CCI). Outcomes. A total of 175 patients (57.7% males) were included in our study, with a mean age of 65.3 ± 11.7 years. 44% of patients had more than one hospital admission during the studied timeframe. Mean calculated left ventricular ejection fraction was 47.1% ± 12.1%. According to LVEF 62.8% of patients were in HFpEF group, 20.5% in the HFrEF group and 16.5% in the HFmrEF group. Dyspnoea was the most common presenting symptom in 65.7% of patients, being accompanied by fatigue in majority of cases (63.4%). Charlson comorbidity index mean value for the study population was 4.6 ± 2.1, 4.6 ± 2 in the HFpEF group, 5.2 ± 1.9 in the HFmrEF group and 4.03 ± 2.2 in the HFrEF group. Arterial hypertension was the most frequent comorbid condition and risk factor at the same time, in both men and women. Conclusions. The clinical and biological profile of the heart failure patients is complex, diverse and further research is needed for improving therapeutic and follow-up management of these patients.

New patterns of progression under immune-oncology (IO) antibodies (mAb) have been described such as pseudoprogression. Except for melanoma, variations between studies reveal difficulties to establish their prevalence. This retrospective study enrolled patients participating in IO phase I trials at Gustave Roussy cancer center for solid tumors excluding melanoma. Radiological assessment according to iRECIST was correlated with prospectively registered patient characteristics and outcomes. Pseudoprogression (PsPD) was defined as RECIST-defined progression followed by stabilization or decrease at the next imaging, and dissociated response (DisR) as concomitant decrease in some tumor lesions and increase in others at a same timepoint. Among 360 patients included, 74% received IO mAb combination: 45% with another IO mAb, 20% with targeted therapy and 10% with radiotherapy. The overall response rate was 19.7%. PsPD were observed in 10 (2.8%) patients and DisR in 12 (3.3%) patients. Atypical responses (AR), including PsPD and DisR, were not associated with any patient’s baseline characteristics. Compare with typical responder patients, patients experiencing AR presented a shorter iPFS (HR 0.34; p

The primary cutaneous diffuse large B-cell lymphoma leg type (PCDLBCL-LT) is a rare form of cutaneous lymphoma with aggressive and unpredictable evolution. The patients are often aged and with comorbid conditions so that immunochemotherapy can be poorly tolerated. Despite its complexity, a differential diagnosis is possible in the primary care setting and it is of great importance in guiding further investigation and referral. We present the case of a 70-year-old man with reddish nodular lesions appeared on the anterior region of the right tibia. Anatomopathological subtype identified a PCDLBCL-LT, T2aN1M0 stage. The first line of R-CHOP regimen (rituximab – cyclophosphamide, doxorubicin, vincristine, prednisone) associating intrathecal prophylaxis with methotrexate was prescribed with a good response. An early relapse after first line chemotherapy was noticed. Salvage R-DHAP regimen (rituximab-dexamethasone, high dose cytarabine, cisplatin) with modest response and progression of the disease under chemotherapy was instituted. During targeted therapy, the patient experienced an acute myocardial infarction, heart failure, and acute kidney injury. Thus, comorbid conditions have dramatically reduced systemic therapeutic options. The multidisciplinary approach with the implication of general physician, hematologist, cardiologist and other specialists was necessary for the management of this case.

Background. Increased arterial stiffness assessed by pulse wave velocity (PWV) measurement is a marker of arterial wall dysfunction and has an independent predictive value for adverse cardiovascular outcomes. A positive correlation between the neutrophil-to-lymphocyte ratio (NLR) and PWV has been reported in chronic inflammatory conditions and the general population as well. Furthermore, an association between NLR and PWV has been assumed in hypertensive patients. However, the available data are scarce. The objective of the study was to validate the association between NLR and PWV in a homogenous group of controlled-hypertensive patients without chronic inflammatory conditions. Material and methods. A retrospective observational study was conducted in outpatient cardiology and a general practice. A total number of 25 already on-target treated essential hypertensive, non-diabetic and non-chronic kidney disease (non-CKD) patients were selected. PWV was automatically calculated for each patient using the ABPM BPLab® device. The following laboratory data were collected: complete blood count, fibrinogen, alkaline phosphatase, lactate dehydrogenase, uric acid, serum glucose, total cholesterol, triglycerides, iron, calcium, and creatinine. Neutrophil-to-lymphocyte ratio was calculated. Antihypertensive treatment classes were also assessed. Results. A correlation between increased NLR and PWV in a homogenous group of controlled-hypertensive patients was identified. Conclusions. There is an evident relation between increased NLR and increased PWV in controlled hypertensive patients without evidence of chronic inflammatory conditions.

Atherosclerotic plaque ruptures with subsequent intraluminal thrombosis are the most prevalent causes of acute coronary syndromes, ischemic stroke, acute limb ischemia or cardiovascular death. Hyperlipidemia is no longer considered the primary cause of atherosclerotic disease, as recent data supports the involvement of other triggers such as age, excessive activation of sympathetic nervous system in arterial hypertension, and most importantly, inflammation. Arteriosclerosis is a consequence of interaction between similar mechanisms resulting in arterial stiffening. Furthermore, wall stiffening resulted from the arteriosclerotic process is a risk factor for atherosclerotic disease. This unstructured literature review aimed to present the underlying remodelling processes and mechanisms for atherosclerosis and arteriosclerosis highlighting the common aspects of this two entities and the continuous interrelation that eventually leads to cardiovascular events.

Aging is an important risk factor for cancers and is associated with poor prognosis. Weakness of the immune system, also called immunosenescence may occur with older age. The impact of aging on efficacy and safety of immune checkpoint blockers, such as anti-programmed death (ligand) PD-(L)1, remains undetermined. This study aims to evaluate the incidence of immune-related adverse events (irAEs) in patients aged 70 years or older than their younger counterparts.Patients with advanced solid tumors treated at Gustave Roussy with an anti-PD-(L)1 monotherapy between June 2014 and October 2017 were prospectively included within the dedicated irAEs pharmacovigilance registry REISAMIC (Registre des Effets Indésirables Sévères des Anticorps Monoclonaux Immunomodulateurs en Cancérologie). The incidence of irAEs of grade ≥II was compared between patients aged ≥70 (old patients, OP) versus patients aged 70 years (young patients, YP) using a chi-squared test. Survivals were estimated using the Kaplan-Meier method.Among the 603 patients treated by anti-PD(L)1, 191 were ≥70 y.o (OP) and 424 70 y.o (YP). The median (range) age of OP and YP were respectively 77 (70-93) and 59 years old (17-69). A total of 165 irAEs occurred in these patients (103 grade II and 58 grade III-IV). The overall incidence of grade ≥II irAEs was higher in OP than in YP (33% versus 25%, p = 0.03). In addition, OP were more prone of having multiples irAEs compared with YP (p = 0.037). Skin toxicities were more frequent in OP than in YP (p = 0.007) but endocrine toxicities were less frequent in OP than in YP (p = 0.044). This higher level of irAEs seems to be responsible for a higher rate of treatment discontinuation in OP (p = 0.2). There was no statistical difference in median time to toxicity, exposure to steroids or survival between the two groups.Although anti-PD-(L)1 immunotherapies remain an acceptable treatment option for older patients, prescribers should be aware that irAEs are more frequent in the elderly. Further translational studies are warranted to better understand the relationship between aging and irAEs.

Purpose: Although the role of epigenetic alterations in oncogenesis has been well studied, their prevalence in metastatic solid tumors is still poorly described. We therefore aimed at: (i) describing the presence of epigenetic gene alterations (EGA) - defined by an alteration in a gene encoding an epigenetic regulator; and (ii) evaluating their relationship with clinical characteristics and outcome in patients (pts) included in prospective molecular profiling trials.Patients and methods: On-purpose tumor biopsies from pts with metastatic solid tumors enrolled in the Gustave Roussy-sponsored MOSCATO (NCT01566019) and MATCHR (NCT02517892) trials were molecularly profiled using Whole Exome Sequencing (WES). Alterations in 176 epigenetic genes were assessed and classified as pathogenic variants (PV) or non-pathogenic variants by a molecular tumor board. Clinical characteristics and outcome were collected.Results: Between Dec 2011 and Oct 2016, WES was successfully performed in 292 pts presenting various solid tumors. We found 496 epigenetic gene alterations in 134 patients (49%), including 237 pathogenic variants in 86 patients; 63 tumor samples (47%) presented ≥3 EGAs. The median number of previous treatment lines was 3 (1 – 10). The most frequently altered genes were KMT2D and KMT2C (16% each), ARID1A and SETD2 (10% each) and KMT2A (8%).; 31% of EGA co-occurred with a driver gene alteration (p < 0.001). Outcome was not correlated with the presence of EGA.Conclusions: Epigenetic alterations occur frequently in metastatic solid tumors. With the current development of epigenetic modifiers, they increasingly represent actionable targets. Such genes should now be systematically analyzed in molecular profiling studies.

Background We aimed to determine the safety and efficacy of nintedanib, an oral anti-angiogenic tyrosine kinase inhibitor, in combination with pembrolizumab, an anti-PD1 immunotherapy, in patients with advanced solid tumors (PEMBIB trial; NCT02856425). Methods In this monocentric phase Ib dose escalation cohort, we evaluated escalating doses of nintedanib (Dose level 1 (DL1) = 150 mg bid [bis in die, as twice a day]; DL2 = 200 mg bid, oral delivery) in combination with pembrolizumab (200 mg Q3W, IV). Patients received a 1-week lead-in dose of nintedanib monotherapy prior starting pembrolizumab. The primary objective was to establish the maximum tolerated dose (MTD) of the combination based on dose limiting toxicity (DLT) occurrence during the first 4 weeks. Secondary objectives were to assess the anti-tumor efficacy and to identify the associated immune and angiogenic parameters in order to establish the recommended nintedanib dose for expansion cohorts. Flow cytometry (FC), Immuno-Histo-Chemistry (IHC) and electrochemiluminescence multi-arrays were prospectively performed on baseline & on-treatment tumor and blood samples to identify immune correlates of efficacy. Results A total of 12/13 patients enrolled were evaluable for DLT (1 patient withdrew consent prior receiving pembrolizumab). Three patients at 200 mg bid experienced a DLT (grade 3 liver enzymes increase). Four patients developed grade 1–2 immune related adverse events (irAE). Eight patients died because of cancer progression. Median follow-up was 23.7 months (95%CI: 5.55–40.5). Three patients developed a partial response (PR) (ORR = 25%) and five patients (42%) had durable clinical benefit (DCB), defined as PR or stable disease (SD) ≥ 6 months. At baseline, patients with DCB had higher plasma levels of Tie2, CXCL10, CCL22 and circulating CD4+ PD1+ OX40+ T cells than patients without DCB. Patients with DCB presented also with more DC-LAMP+ dendritic cells, CD3+ T cells and FOXP3+ Tregs in baseline tumor biopsies. For DCB patients, the nintedanib lead-in monotherapy resulted in higher blood CCL3, Tregs and CCR4+ CXCR3+ CXCR5− memory CD4 T cells. After the first pembrolizumab infusion, patients with DCB showed lower IL-6, IL-8, IL-27 plasma levels. Conclusion Nintedanib 150 mg bid is the recommended dose for combination with pembrolizumab and is currently investigated in multiple expansion cohorts. Early tumoral and circulating immune factors were associated with cancer outcome under nintedanib & pembrolizumab therapy. Trial registration ClinicalTrials.gov, NCT02856425. Registered August 4, 2016 — Prospectively registered.

Diabetes mellitus (DM) represents a major public health problem, with yearly increasing prevalence. DM is considered a progressive vascular disease that develops macro and microvascular complications, with a great impact on the quality of life of diabetic patients. Over time, DM has become one of the most studied diseases; indeed, finding new pharmacological ways to control it is the main purpose of the research involved in this issue. Sodium–glucose cotransporter 2 inhibitors (SGLT-2i) are a modern drug class of glucose-lowering agents, whose use in DM patients has increased in the past few years. Besides the positive outcomes regarding glycemic control and cardiovascular protection in DM patients, SGLT-2i have also been associated with metabolic benefits, blood pressure reduction, and improved kidney function. The recent perception and understanding of SGLT-2i pathophysiological pathways place this class of drugs towards a particularized patient-centered approach, moving away from the well-known glycemic control strategy. SGLT-2i have been shown not only to reduce death from cardiovascular causes, but also to reduce the risk of stroke and heart failure hospitalization. This article aims to review and highlight the existing literature on the effects of SGLT-2i, emphasizing their role as oral antihyperglycemic agents in type 2 DM, with important cardiovascular and metabolic benefits.

Given their endemic prevalence in the past decades, obesity and type 2 diabetes mellitus (T2DM) have become a major sanitary burden with an important economic impact. Novel treatment options have been designed with the aim of reducing the numerous complications associated with these metabolic disorders, as well as reducing morbidity and mortality and improving the quality of life of those who suffer from these disorders. Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are among the most modern therapeutics that target ‘diabesity’, a term used to describe the pathophysiological link between obesity and T2DM. Their glucose-lowering effects are mainly attributed to glucose-dependent insulin secretion, glucagon inhibition and decreased gastric emptying. Given the effects on the central nervous system, GLP-1 RA usage may lead to body weight reduction. GLP-1 RAs are classified based on their pharmacokinetic properties as short- and long-acting agents, with both types being administered by subcutaneous injection. The latest agent from this drug class approved for use in T2DM is semaglutide, a long-acting compound that is the only GLP-1 RA available as an oral pill. The present narrative review highlights the most recently published data on the effects and safety of semaglutide in diabetic obesity, also emphasizing its cardiovascular benefits and potential side effects. In addition, an overview of the role of semaglutide in the treatment of non-diabetic obesity is provided.

Objective: Our study aimed to validate the neutrophil-to-lymphocyte ratio (NLR) as a marker for aortic arch calcification in hypertensive patients with less advanced chronic kidney disease (CKD). Methods: A number of forty-four hypertensive patients with chronic kidney disease (categories G3a and G3b – 2012 KDIGO nomenclature) were included in the study. Considering the presence of aortic arch calcification (AAC) on chest X-ray, the study population was divided into two groups: 27 patients AAC present and seventeen without aortic arch calcification. Laboratory data were collected for each patient and NLR was computed. Comorbidities were also recorded: stable coronary artery disease, lower extremity arterial disease and hypertensive heart disease. Results: A positive correlation between neutrophil-to-lymphocyte ratio and aortic arch calcification in hypertensive CKD patients was identified. Furthermore, advanced age, increased alkaline phosphatase and increased erythrocyte sedimentation rate had a positive association with aortic arch calcification. We found no statistical correlation between neutrophil-to-lymphocyte ratio and other laboratory features in both groups of patients. Conclusions: Neutrophil-to-lymphocyte ratio may be viewed as a potential risk factor for vascular calcification in patients with moderate chronic kidney disease; nevertheless, future extensive studies are necessary. In the management of hypertensive patients, general medicine might particularly benefit of this simple, readily available inflammatory marker.

The aim of this study was to establish the correlation between the value of serum cystatin C (Cys C) and carotid atherosclerosis in patients without chronic kidney disease and to determine the serum Cys C cut-off level for carotid atherosclerosis diagnosis. The study was performed between October 2014 and June 2018, and included 256 patients from 20 family medicine offices of Timis County, both from urban and rural areas. The patients completed a socio-demographic questionnaire, and were clinically examined by their general practitioner and investigated by laboratory tests and carotid ultrasound. The mean age of the patients with high serum Cys C (study group 1) was 74 years (82% male), while in study group 2 (with low serum Cys C values) the mean age was 56 years old (63% male). Cys C levels were significantly correlated with serum creatinine and estimated glomerular filtration rate. In the group with elevated levels of Cys C we found an increased incidence of obesity, hypertension, diabetes and carotid atherosclerosis. Multivariate analysis showed that the increased levels of Cys C were associated with a maximum carotid plaque thickness (MCPT) �2 mm (OR: 2.86, 95% C.I.: 1.13-7.97). The serum Cys C cut-off level for the diagnosis of atherosclerosis determined by ROC (receiver operating characteristic) curve was 0.73 mg/dL.

Obesity and type 2 diabetes mellitus have become a significant public health problem in the past decades. Their prevalence is increasing worldwide each year, greatly impacting the economic and personal aspects, mainly because they frequently coexist, where the term “diabesity” may be used. The drug class of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) is one of the most modern therapy options in managing these metabolic disorders. This review focuses on the effects of liraglutide, a long-acting GLP-1 RA, in diabesity and non-diabetic excess weight. This drug class improves glycemic control by enhancing insulin secretion from the beta-pancreatic cells and inhibiting glucagon release. Furthermore, other effects include slowing gastric emptying, increasing postprandial satiety, and reducing the appetite and food consumption by influencing the central nervous system, with weight reduction effects. It also reduces cardiovascular events and has positive effects on blood pressure and lipid profile. A lower-dose liraglutide (1.2 or 1.8 mg/day) is used in patients with diabetes, while the higher dose (3.0 mg/day) is approved as an anti-obesity drug. In this review, we have summarized the role of liraglutide in clinical practice, highlighting its safety and efficacy as a glucose-lowering agent and a weight-reduction drug in patients with and without diabetes.

Despite important advancements in acute myocardial infarction (AMI) management, it continues to represent a leading cause of mortality worldwide. Fast and reliable AMI diagnosis can significantly reduce mortality in this high-risk population. Diagnosis of AMI has relied on biomarker evaluation for more than 50 years. The upturn of high-sensitivity cardiac troponin testing provided extremely sensitive means to detect cardiac myocyte necrosis, but this increased sensitivity came at the cost of a decrease in diagnostic specificity. In addition, although cardiac troponins increase relatively early after the onset of AMI, they still leave a time gap between the onset of myocardial ischemia and our ability to detect it, thus precluding very early management of AMI. Newer biomarkers detected in processes such as inflammation, neurohormonal activation, or myocardial stress occur much earlier than myocyte necrosis and the diagnostic rise of cardiac troponins, allowing us to expand biomarker research in these areas. Increased understanding of the complex AMI pathophysiology has spurred the search of new biomarkers that could overcome these shortcomings, whereas multi-omic and multi-biomarker approaches promise to be game changers in AMI biomarker assessment. In this review, we discuss the evolution, current application, and emerging blood biomarkers for the diagnosis of AMI; we address their advantages and promises to improve patient care, as well as their challenges, limitations, and technical and diagnostic pitfalls. Questions that remain to be answered and hotspots for future research are also emphasized.

Ioan Tilea,1,2 Dorina Nastasia Petra,3,4 Razvan Constantin Serban,5 Manuela Rozalia Gabor,6 Mariana Cornelia Tilinca,1 Leonard Azamfirei,7,8 Andreea Varga2,3 1Department of Internal Medicine, “George Emil Palade” University of Medicine, Pharmacy, Science and Technology of Targu Mures, Targu Mures, 540142, Romania; 2Department of Cardiology II, County Emergency Clinical Hospital, Targu Mures, 540042, Romania; 3Department of Family Medicine, “George Emil Palade” University of Medicine, Pharmacy, Science and Technology of Targu Mures, Targu Mures, 540142, Romania; 4Department of Internal Medicine II, County Emergency Clinical Hospital, Targu Mures, 540042, Romania; 5Cardiac Catheterization Laboratory, The Emergency Institute for Cardiovascular Diseases and Transplantation, Targu Mures, 540136, Romania; 6Department of Economics and Law, “George Emil Palade” University of Medicine, Pharmacy, Science and Technology of Targu Mures, Targu Mures, 540142, Romania; 7Department of Anesthesiology and Intensive Care, “George Emil Palade” University of Medicine, Pharmacy, Science and Technology of Targu Mures, Targu Mures, 540142, Romania; 8Department of Anesthesiology and Intensive Care, County Emergency Clinical Hospital, Targu Mures, 540042, RomaniaCorrespondence: Dorina Nastasia PetraDepartment of Family Medicine, “George Emil Palade” University of Medicine, Pharmacy, Science and Technology of Targu Mures, Targu Mures, 540142, RomaniaTel +40 740 194 122Email dorina.petra@umfst.roBackground: Over the last few decades, interest in the role of iron status in pulmonary hypertension (PH) has grown considerably due to its potential impact on symptoms, exercise capacity (as assessed by the 6-minute walk distance [6MWD]), prognosis, and mortality. The aim of the present study was to identify iron deficiency (ID) prevalence in specific precapillary PH subgroups of Romanian patients and its short-term impact on 6MWD.Patients and Methods: Complete datasets from 25 precapillary PH adults were examined and included in the analysis. Data were collected at baseline and after continuous follow-up of an average of 13.5 months. Enrolled patients were assigned to group 1 (pulmonary arterial hypertension) or subgroup 4.1 (chronic thromboembolic pulmonary hypertension), and individualized targeted therapy was prescribed. General characteristics, World Health Organization functional class, 6MWD, pulse oximetry, laboratory parameters, and echocardiographic and hemodynamic parameters were recorded. Ferritin values and transferrin saturation were used to assess ID.Results: At baseline, 16 out of 25 patients were iron deficient. The univariate linear regression analysis did not show a statistically significant impact of ID on 6MWD (p=0.428). In multivariate regression analysis, possible predictors of 6MWD, including ID, were not statistically significant at baseline or after an average of 13.5 months follow-up (p=0.438, 0.361, respectively) and ID indicates a negative impact on 6MWD independent of applied corrections.Conclusion: The results of this study demonstrate that 1.4.1 subgroup PAH patients have an increased prevalence of ID compared with other etiologies. ID has a negative impact on the functional status (assessed by 6MWD), in specific groups and subgroups of patients with precapillary PH, albeit not independently nor significant to other known predictors such as age, gender, oxygen saturation, and hemoglobin value. These data can be integrated with global research and are consistent with phenotypes of patients diagnosed with PH of different etiologies.Keywords: pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension, ferritin, iron replenishment, six-minute walk distance

Background: Pseudoaneurysm of the mitral-aortic intervalvular fibrosa (P-MAIVF) is an unusual complication related to various injuries or conditions which involve the mitro-aortic region; it communicates with the left ventricular outflow tract and is associated with a high-risk of redoubtable complications or sudden death. The cerebral and splenic localizations are frequently seen as manifestations of systemic embolism in infective endocarditis. Currently, there are no specific recommendations related to the diagnosis, management, treatment, or further evolution of patients with P-MAIVF and concomitant splenic infarction. This paper presents the case of a 43-year-old Caucasian woman with a late diagnosis of mixed bicuspid aortic valve disease, affected by an under-detected and undertreated episode of infective endocarditis leading to asymptomatic P-MAIVF. Prime clinical and imagistic diagnosis of splenic infarction indicated further extended investigations were required to clarify the source of embolism. Methods: Integrated multimodality imaging techniques confirmed the unexpected diagnosis of P-MAIVF. Results: The case had a fatal outcome following an uncomplicated yet laborious cardiac surgery. Patient death was attributed to a malignant ventricular arrhythmia. Conclusion: The present case raises awareness by highlighting an unexplained and unexpected splenic infarction association with P-MAIVF as a result of infective endocarditis related to mixed bicuspid aortic valve disease.

TPS3153 Background: ADCs are a class of anti-cancer agents that leverage the selectivity of monoclonal antibodies to preferentially target and deliver chemotherapeutic agents to cancer cells. AZD8205 is an ADC, administered by IV infusion, that consists of a human anti-B7-H4 antibody conjugated via a cleavable linker to a topoisomerase I inhibitor (TOP1i) warhead. B7-H4 is a transmembrane protein that binds to an unknown receptor on activated T cells, inhibiting their function. It is highly expressed by a wide variety of tumors including cholangiocarcinoma (CCA) and breast, ovarian and endometrial cancers, and is associated with poor prognosis. AZD8205 specifically binds to B7-H4 expressing tumor cells and is internalized. The TOP1i warhead is released, interfering with TOP1 during DNA replication leading to transcription-mediated DNA damage and cell death. TOP1i ADCs have shown clinical activity in several tumor types including breast cancer. In preclinical studies, AZD8205 has shown promising antitumor activity in various patient-derived xenograft models and an acceptable toxicity profile. This first-in-human study (NCT05123482) is evaluating AZD8205 for the treatment of selected advanced/metastatic tumors. Methods: This phase I/IIa, open-label, dose-escalation and dose-expansion study is currently investigating AZD8205 monotherapy in patients ≥18 years old (≥20 years for Japan) with CCA, breast, ovarian or endometrial cancers. Eligibility criteria include relapsed/metastatic disease following standard of care treatment, measurable disease per RECIST v1.1, and ECOG PS 0–1. Key exclusion criteria include spinal cord compression or leptomeningeal carcinomatosis, symptomatic brain metastases, and history of interstitial lung disease/pneumonitis. Expression of B7-H4 will be evaluated using a validated central laboratory immunohistochemistry assay on tumor samples collected before, during, and when feasible, after AZD8205 treatment. In the escalation phase, patients will receive AZD8205 followed by 21 days of observation for dose-limiting toxicities. Patients will be enrolled in escalating dose cohorts using the modified toxicity probability interval-2 model with at least 3 evaluable patients per dose level. Patients will continue on study treatment until disease progression, initiation of alternate anticancer therapy, unacceptable toxicity, or withdrawal of consent. Primary objectives are to determine the safety and tolerability of AZD8205 and identify the maximum tolerated dose and/or recommended phase 2 dose. Secondary objectives include assessing initial activity (objective response and progression-free survival by RECIST v1.1, and overall survival), pharmacodynamics, pharmacokinetics, and immunogenicity. The trial is currently recruiting and will enroll patients globally. Clinical trial information: NCT05123482.

1052 Background: Dysregulating mutations in PIK3CA, encoding the PI3K p110α subunit, occur in ̃40% of HR+/HER2– BCs. Inavolisib is a PI3Kα-specific inhibitor that also promotes degradation of mutant p110α. It has demonstrated encouraging preliminary antitumor activity in pts with PIK3CA-mutated HR+ BC as a monotherapy, and in combo with other anticancer agents. Methods: We included pts from NCT03006172 on treatment ≥1 year with inavolisib alone (Arm A), or in combo with palbo + letrozole (letro) (B), letro (C), fulvestrant (fulv) (D), or palbo + fulv (E; + metformin in Arm F for pts with body mass index ≥30 and/or HbA1c ≥5.7%). Inavolisib was administered orally daily (PO QD) at 3, 6, 9, or 12 mg (3+3 dose-escalation design); letro at 2.5 mg PO QD; palbo at 125 mg PO QD for 21/28 days; and fulv at 500 mg intramuscularly every 4 weeks, in 28-day cycles until intolerable toxicity/disease progression. Safety was assessed by NCI-CTCAE v4. Results: 57 female pts were included (cutoff 07/26/21; N = 1, 18, 6, 12, 15, 5 in Arms A–F); median age: 57 years (range 33–80); median lines of prior therapy: 2 (1–7). All but 2 pts, both in Arm B (3 mg), were assigned the 9 mg inavolisib recommended phase 3 dose. Overall median treatment duration: 19 months (range 12–45); median inavolisib cumulative dose intensity, 95%. The most frequent treatment-related adverse events (AEs; in ≥20 pts/35%) were hyperglycemia (68%), stomatitis (68%; grouped terms), neutropenia (58%), diarrhea (51%), nausea (39%), alopecia (35%), and rash (35%; grouped terms). The most frequent treatment-related Grade (G) 3–4 AEs (≥2 pts/4%) were neutropenia (47%), hyperglycemia (16%), leukopenia (9%), thrombocytopenia (9%), lymphopenia (7%), weight decreased, and hypokalemia (4% each). G3–4 neutropenia, leukopenia, thrombocytopenia, and lymphopenia were all reported in palbo arms. One G5 AE of pleural effusion was reported (disease progression-related). 39 pts (68%) had ≥1 AE resulting in study treatment modification (drug interruption/dose reduction/treatment withdrawal); 11 (19%) had an inavolisib dose reduction and 2 (4%) discontinued treatment due to an AE (1 related G2 diarrhea, 1 unrelated G3 cerebrovascular disorder). AEs typically occurred during the first 6 months and tended to be less frequent in later cycles. No new safety signals were observed with long-term inavolisib use. Conclusions: These data indicate acceptable long-term tolerability. The safety profile of pts on study treatment with inavolisib alone or in combo with endocrine-based anticancer therapies for ≥1 year was similar to that reported for the overall study population. Updated data will be presented. A phase 3 study of inavolisib + palbo + fulv is enrolling (NCT04191499; INAVO120). Clinical trial information: NCT03006172.

Diabetic individuals are considered a vulnerable population during the COVID-19 Pandemic, and several studies noted worse outcomes, including death, among those who get infected. Diabetic emergencies, such as ketoacidosis (DKA), are common and potentially life-threatening conditions in uncontrolled patients. While the pathophysiological background of the relationship between COVID-19 and DKA is not fully understood, early reports available so far indicate that patients with pre-existing diabetes who get infected with the SARS-CoV 2 virus are at higher risk of DKA. It was also suggested that DKA is a poor prognostic sign for infected patients, these being at higher risk of developing worse forms of COVID-19 disease and having high mortality. Therefore, healthcare personnel dealing with such patients face a considerable challenge, as the correct and safe emergency management of such cases is far from established. This article aimed to conduct a study that reviews the current published data available about patients with DKA and COVID-19.

Introduction. Cardiovascular risk factors, pre-existing comorbidities, molecular factors, and the direct effects of second- and third-generation BCR-ABL1 tyrosine kinase inhibitors on the vascular endothelium contribute to the progression of cardiovascular (CV) events, especially atherothrombotic conditions. The study objective was to evaluate comorbidities, the cardiovascular risk profile, and events throughout the chronic myeloid leukaemia disease course. Methods. Retrospective data from adults who experienced haematology treatment at a single centre were continuously updated and followed throughout the disease course. A total of 43 subjects conforming with the inclusion and exclusion criteria of the study protocol were finally recruited. The median disease course was 77.0 &plusmn, 17.5 months. Statistical analyses were performed. Results. More than three CV risk factors were identified in 41.9% of cases. Almost half of the cases had relevant comorbidities (Charlson Comorbidity Index (CCI) &ge, 4), and no statistically significant comorbidities were found when comparing the tyrosine kinase inhibitor (TKI) treatment subgroups (p = 0.53). The patients at high and very high CV risk, according to Systematic Coronary Risk Evaluation (SCORE) risk classification, had 75.0% CV events (12/22 patients), p = 0.45. Throughout the disease course, 19 cardiovascular events were reported in 37.2% patients (13 males/3 females, p &lt, 0.03). Conclusion. To the best of our knowledge, this is the first study exploring cardiovascular risk factors in Romanian chronic myeloid leukaemia patients. This study reinforces the need for close long-term follow-up that should be performed by a multidisciplinary team. The target should be not only the disease and specific drug-related toxicities but, also, the identification of cardiovascular and metabolic risk factors before the commencement of and throughout TKI therapy.

PURPOSE Anaplastic thyroid carcinoma is an aggressive malignancy that is almost always fatal and lacks effective systemic treatment options for patients with BRAF-wild type disease. As part of a phase I/II study in patients with advanced/metastatic solid tumors, patients with anaplastic thyroid carcinoma were treated with spartalizumab, a humanized monoclonal antibody against the programmed death-1 (PD-1) receptor. METHODS We enrolled patients with locally advanced and/or metastatic anaplastic thyroid carcinoma in a phase II cohort of the study. Patients received 400 mg spartalizumab intravenously, once every 4 weeks. The overall response rate was determined according to RECIST v1.1. RESULTS Forty-two patients were enrolled. Adverse events were consistent with those previously observed with PD-1 blockade. Most common treatment-related adverse events were diarrhea (12%), pruritus (12%), fatigue (7%), and pyrexia (7%). The overall response rate was 19%, including three patients with a complete response and five with a partial response. Most patients had baseline tumor biopsies positive for PD-L1 expression (n = 28/40 evaluable), and response rates were higher in PD-L1–positive (8/28; 29%) versus PD-L1–negative (0/12; 0%) patients. The highest rate of response was observed in the subset of patients with PD-L1 ≥ 50% (6/17; 35%). Responses were seen in both BRAF-nonmutant and BRAF-mutant patients and were durable, with a 1-year survival of 52.1% in the PD-L1–positive population. CONCLUSION To our knowledge, this is the first clinical trial to show responsiveness of anaplastic thyroid carcinoma to PD-1 blockade.

Background Immune checkpoint inhibitors (ICIs) alone or in combination with chemotherapy (CT) are the current standard of therapy in several cancer types. Patients (pts) with lung cancer display higher response rates to CT when given after ICIs. Although ICIs have failed to demonstrate antitumour activity in microsatellite stable (MSS) metastatic colorectal cancer (mCRC), little is known about CT effect after ICIs. We aimed to assess whether sequential ICIs followed by CT may be an alternative therapeutic approach in a population of pts with mCRC. Material and methods We retrospectively assessed CT after ICI (CAICI) failure in pts with mCRC. The ICI regimen consisted of anti-PD(L)1 alone or in combination. The primary end-point was objective response rate. Progression-free survival (PFS) and overall survival (OS) were secondary end-points. Results Between 2014 and 2018, 29 pts with mCRC received CAICI (MSS tumours, 27 pts [86%]). The median number of previous lines was 4 (range, 2–7). Regimens included TAS-102 (n = 14), FOLFIRI (irinotecan, leucovorin, and fluorouracil; n = 6) or FOLFOX (oxaliplatin, leucovorin, and fluorouracil; n = 4), regorafenib (n = 3) and carboplatin (1 pt with BRCA mutation). Partial response and stable disease were observed in 4 (19%) and 9 (43%) pts, respectively (disease control rate, 62%). The median PFS and OS were 3.8 months (95% confidence interval [CI] = 1.5–5.4) and 8.0 months (95% CI = 4.2–14.0), respectively. Conclusion ICIs administered before CT might enhance cytotoxic effects even in pts with immunorefractory MSS mCRC. The results of this small cohort need to be validated in independent prospective cohorts. The role of ICIs as modifiers of both tumour cells and microenvironment in mCRC deserves further research.

Funding Acknowledgements This work was supported by the University of Medicine, Pharmacy, Science and Technology of Targu Mures Research Grant number 615/13/17.01.2019 Background An early appearance of cardiac masses after valve replacement raises differential diagnosis problems. The specific therapeutic approach of autoimmune comorbidities enhances the risk of infective endocarditis or inflammatory reactions. Among systemic disorders leading to cardiac complications, rheumatoid arthritis is cited. Leflunomide is a synthetic disease-modifying antirheumatic drug (DMARD) with immunomodulatory actions as it inhibits the de novo synthesis of pyrimidine, hence suppressing T cell activation and proliferation. It is used as first line treatment strategy for rheumatoid arthritis (RA) patients, with contraindication or non-tolerance of Methotrexate. Case presentation We present the case of a 63-year old Caucasian male with seropositive RA, treated with Leflunomide 20 mg od, with history of severe calcified aortic stenosis and permanent atrial fibrillation. The patient underwent an aortic valve replacement with a St. Jude Regent 25 mechanical valve and ascending aorta replacement with a Dacron 30mm graft. Leflunomide was forthwith discontinued before surgery. Five months after surgery, in a routine check-up, including proper adherence to the anticoagulation regimen (regular INR 2.6-3.2), and stable hemodynamic status, a right atrial mass was identified by transthoracic echocardiography (figure). The mobile hyperechogenic mass appeared to be attached by a narrow stalk to the atrial septum, presenting a quasi-parallel movement to the septal cusp. The haemodynamic of the tricuspid valve was not affected. A suspicion of early infective endocarditis was ruled out. Cardiac CT identified a well-defined, pedunculated, mobile mass measuring 2.8x3.1 cm originating above the tricuspid annulus, attached to the atrial septum without hemodynamic impact. An inflammatory pseudotumor was identified and a granulomatous mass was diagnosed. Consecutively, Leflunomide 20 mg od along with adjusted doses of corticosteroids were initiated with progressively diminished dimensions of the tumour three months after the ultrasound and CT diagnosis. One year after complete resolution of the mass, the patient continues his immunosuppressive and cardiac pharmacological regimen. Repeated echocardiograms showed standard functionality of the aortic prosthesis, without recurrent intracardiac mass. Conclusion Management of an intracardiac mass after cardiac surgery in patients with systemic inflammatory diseases may be challenging. Cardiac imaging is mandatory to differentiate among thrombi, vegetations, primary or metastatic cardiac tumours. In RA patients DMARD and immunosuppressive therapy should not be discontinuing during perioperative procedures as they do not increase the risk of infectious complications. Sequential imaging studies in patients presenting systemic inflammatory comorbidities should be used to assess and identify the immunological responses in the absence of targeted therapy. Abstract P1454 Figure.

Osimertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), specifically designed to inhibit EGFR sensitizing and T790M acquired mutations, minimizing exposure in EGFR-wild-type tissues. Areas covered: Osimertinib use in EGFR-mutated non-small cell lung cancer patients is described, focusing on safety and tolerability from studies supporting its approval. Expert opinion: Osimertinib demonstrated greater efficacy, including CNS activity, compared to chemotherapy, with a manageable safety profile in pretreated T790M+ EGFR-mutated patients, leading to FDA approval in 2015 within record time in the oncology field. However, the therapeutic strategy in the EGFR-mutated population is changing, following the FLAURA study in untreated EGFR-mutated patients, in which osimertinib improved progression-free survival compared to other TKIs, with a similar toxicity profile but a lower serious adverse event rate. In April 2018, the FDA and EMA approved osimertinib as first-line therapy for EGFR-mutated patients. Long-term survival data will ultimately establish the true benefit of upfront versus sequential strategies guided by T790M status. These studies favor osimertinib for tolerability and safety, except for the slightly higher rate of interstitial lung disease, but which was nonetheless manageable. In the coming years, osimertinib will be consolidated as standard therapy in the EGFR population and in naïve and pretreated patients, based on mature survival data and the toxicity profile.

Resume Cibler le systeme immunitaire de l’hote dans le traitement antitumoral a maintenant fait ses preuves dans de nombreux types tumoraux. Cependant le role de cette approche reste plus controverse dans les glioblastomes et de nombreux essais sont en cours pour determiner l’efficacite de l’immunotherapie dans cette indication. Le systeme nerveux central a longtemps ete considere comme un sanctuaire immunitaire mais de recents travaux ont montre la presence de reponses immunitaires meme en l’absence d’effractions au niveau de la barriere hemato-encephalique. Mieux comprendre le fonctionnement du systeme immunitaire permettra de developper des strategies therapeutiques efficaces. Les objectifs de cette revue sont de decrire le systeme immunitaire au sein du systeme nerveux central et d’evaluer les strategies therapeutiques en cours dans les glioblastomes.

The objectives of the present study were to evaluate the prevalence of resistant hypertension (RH) in primary care setting and to analyse its biochemical and clinical characteristics. After 3 months of treatment and evaluation, 721 (14.01%) of 5,146 patients with hypertension did not reach target office blood pressure of [ 140/90 mmHg. After exclusion of �white-coat effect� with ambulatory blood pressure, of secondary and pseudo- resistant hypertension, prevalence of RH was 6.74%. Lifestyle factors associated with RH were physical inactivity, obesity, high salt intake, smoking and excessive alcohol ingestion. Compared to controlled hypertension, RH patients presented higher incidence of family history of cardiovascular disease (38.90% vs 25.94%), diabetes mellitus (34.87% vs 19.01%), impaired fasting glucose (21.91% vs 19.07%), target organ damage (29.1% vs 15.95%), and cardiovascular disease (27.09% vs 17.06%). Dyslipidaemia (52.90% vs 42.03%), fasting plasma glucose (116.10�38.9 vs 107.80�37.2), HbA1c (6.41�1.42 vs 5.96�0.94), serum creatinine (1.09�0.27 vs 1.03�0.24) and microalbuminuria (21.90% vs 10.95%) were significantly higher in RH. Predictors of RH, determined by a multivariate logistic regression analysis were left ventricular hypertrophy (OD 2.14, 95% CI 1.32-3.69), renal impairment expressed as eGFR [ 60 ml/min/1.73m2 (OD 1.62, 95% CI 1.21-2.21) and the presence of cardiovascular disease (OD 1.48, 95% CI 1.02-2.16).

The present cross-sectional observational study was made in family medicine offices of Timi� County, Romania. The aim of the study was to investigate the prevalence of urinary microalbumin excretion (MAU) in resistant systemic arterial hypertension (RH), to analyze patients� biochemical and clinical characteristics, and the predictive factors for MAU. From a total number of 347 patients, MAU was detected in 76 cases (21.9%). The microalbuminuria positive patients were older, with significant higher office systolic blood pressure (BP) (155 � 13.50 vs 148 � 12.40 mmHg, p [ 0.0001) and diastolic blood pressure (94 � 12.20 vs 88 � 14.6 mmHg, p = 0.0013), higher prevalence of left ventricular hypertrophy, diabetes mellitus, obesity, ischemic and peripheral arterial disease. MAU positive patients presented statistical significant differences in biochemical data concerning: fasting plasma glucose (FPG) (118.80 � 32.02 vs 108.01 � 26.01 mg/dL, p = 0.003), impaired glucose tolerance (IGT) (10.52 % vs 4.94 %), glycated hemoglobin (HbA1c) (6.56 � 0.98% vs 5.96 � 0.91%, p [ 0.001), reduced estimated glomerular filtration rate (eGFR) (56.10 � 15.4 vs 69.30 � 17.5 ml/min/1.73m2, p [ 0.001) and higher potassium levels (4.71 � 0.43 vs 4.59 � 0.44 mg/dL, p = 0.0378). No significant differences were noticed regarding LDL- and HDL-cholesterol, triglycerides, uric acid and serum creatinine. In a logistic multivariate analysis independent predictors for MAU were: systolic BP (odds ratio, OR = 1.024, 95% confidence interval, CI:1.011-1.039, p [ 0.001), HbA1c (OR = 1.324, 95% CI: 1.078-1.724, p = 0.008) and eGFR (OR = 0.989, 95% CI: 0.977-0.999, p = 0.01). Our findings suggest that an important part of RH patients have microalbuminuria and highlight the importance of controlling its predictors, in order to improve patients� outcome.

The aim of this study was to assess the basic biochemical and clinical characteristics of patients with hypertension and type 2 diabetes mellitus (T2DM), office blood pressure (BP) and 24-h BP profile, their risk factors and associated comorbidities. Compared with non-diabetics, hypertensive patients with T2DM were older, with a longer duration of hypertension (5.9 vs. 4.7 years), greater office blood pressure and ambulatory BP values, increased incidence of multiple risk factors, target organ damage and cardiovascular disease. Biochemical data in hypertension with T2DM revealed significantly high levels of LDL cholesterol, triglycerides, creatinine, micro- and macro-albuminuria and a reduced estimated glomerular filtration rate. The presence of diabetes was associated with obesity, represented by a BMI ]30 kg/m2 (OR 2.08 [95% CI 1.26-3.45], p = 0.004), abdominal obesity (OR 1.85 [95% CI 1.11-3.04], p = 0.016), high LDL cholesterol (OR 2.02 [95% CI 1.22-3.35], p = 0.006) and high triglycerides (OR 1.86 [95% CI 1.11-3.11], p = 0.017).