Management of older hospitalized patients with type 2 diabetes using linagliptin: Lina-Older study.

BACKGROUND: Older patients managed with intensive antidiabetic therapy are more likely to be harmed. Our study's primary endpoint was to analyze the safety and efficacy of linagliptin in combination with basal insulin versus basal-bolus insulin in patients with 75 years of age or older hospitalized in medicine and surgery departments in real-world clinical practice. METHODS: We retrospectively enrolled non-critically patients ≥75 years with type 2 diabetes admitted to medicine and non-cardiac surgery departments with admission glycated hemoglobin <8%, admission blood glucose <240 mg/dL, and without at-home injectable therapies managed with our hospital's antihyperglycemic protocol (basal-bolus or linagliptin-basal regimens) between January 2016 and December 2018. To match each patient who started on the basal-bolus regimen with a patient who started on the linagliptin-basal regimen, a propensity matching analysis was used. RESULTS: Postmatching, 198 patients were included in each group. There were no significant differences in mean daily blood glucose levels after admission (P=0.203); patients with mean blood glucose 100-140mg/dL (P=0.134), 140-180mg/dL (P=0.109), or >200mg/dL (P=0.299); and number and day of treatment failure (P=0.159 and P=0.175, respectively). The total insulin dose and the number of daily injections were significantly lower in the linagliptin-basal group (both, P<0.001). Patients on the basal-bolus insulin regimen had more total hypoglycemic events than patients on the linagliptin-basal insulin regimen (P<0.001). CONCLUSIONS: The linagliptin-basal insulin regimen was an effective alternative with fewer hypoglycemic events and daily insulin injections than intensive basal-bolus insulin in very old patients with type 2 diabetes with mild-to-moderate hyperglycemia treated at home without injectable therapies.

Clinical benefits of empagliflozin in very old patients with type 2 diabetes hospitalized for acute heart failure.

BACKGROUND: There is little evidence on the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in older patients with heart failure. This work analyzed the clinical efficacy and safety of empagliflozin continuation in very old patients with type 2 diabetes hospitalized for acute decompensated heart failure. METHODS: We conducted a real-world observational study between September 2015 and June 2021. Patients ≥80 years were grouped by antihyperglycemic regimen: (1) continuation of preadmission empagliflozin combined with basal insulin regimen and (2) conventional basal-bolus insulin regimen. A propensity score matching analysis matched patients in both groups in a 1:1 manner. The primary outcome was differences in clinical efficacy measured by the visual analogue scale dyspnea score, NT-proBNP levels, diuretic response, and cumulative urine output. Safety endpoints such as adverse events, worsening heart failure, discontinuation of empagliflozin, length of hospital stay, and in-hospital deaths were also analyzed. RESULTS: After propensity score matching, 79 patients were included in each group. At discharge, the N-terminal pro-brain natriuretic peptide (NT-proBNP) levels were lower in the empagliflozin continuation group than in the insulin group (1699 ± 522 vs. 2303 ± 598 pg/ml, p = 0.021). Both the diuretic response and cumulative urine output were greater in patients treated with empagliflozin than in patients with basal-bolus insulin during the hospitalization (at discharge: -0.14 ± -0.06 vs. -0.24 ± -0.10, p = 0.044; and 16,100 ± 1510 vs. 13,900 ± 1220 ml, p = 0.037, respectively). No differences were observed in safety outcomes. CONCLUSIONS: In very old patients with type 2 diabetes hospitalized for acute heart failure, continuing preadmission empagliflozin reduced NT-proBNP levels and increased diuretic response and urine output compared to a basal-bolus insulin regimen. The empagliflozin regimen also showed a good safety profile.

Efficacy and Safety of Empagliflozin Continuation in Patients with Type 2 Diabetes Hospitalised for Acute Decompensated Heart Failure.

There is little evidence on the use of sodium-glucose cotransporter 2 inhibitors in hospitalised patients. This work aims to analyse the glycaemic and clinical efficacy and safety of empagliflozin continuation in patients with type 2 diabetes hospitalised for acute decompensated heart failure. This real-world observational study includes patients treated using our in-hospital antihyperglycaemic regimens (basal-bolus insulin vs. empagliflozin-basal insulin) between 2017 and 2020. A propensity matching analysis was used to match a patient on one regimen with a patient on the other regimen. Our primary endpoints were the differences in glycaemic control, as measured via mean daily blood glucose levels, and differences in the visual analogue scale dyspnoea score, NT-proBNP levels, diuretic response, and cumulative urine output. Safety endpoints were also analysed. After a propensity matching analysis, 91 patients were included in each group. There were no differences in mean blood glucose levels (152.1 ± 17.8 vs. 155.2 ± 19.7 mg/dL, p = 0.289). At discharge, NT-proBNP levels were lower and cumulative urine output greater in the empagliflozin group versus the basal-bolus insulin group (1652 ± 501 vs. 2101 ± 522 pg/mL, p = 0.032 and 16,100 ± 1510 vs. 13,900 ± 1220 mL, p = 0.037, respectively). Patients who continued empagliflozin had a lower total number of hypoglycaemic episodes (36 vs. 64, p < 0.001). No differences were observed in adverse events, length of hospital stay, or in-hospital deaths. For patients with acute heart failure, an in-hospital antihyperglycaemic regimen that includes continuation of empagliflozin achieved effective glycaemic control, lower NT-proBNP, and greater urine output. It was also safer, as it reduced hypoglycaemic episodes without increasing other safety endpoints.

De-Intensification of Antidiabetic Treatment Using Canagliflozin in Patients with Heart Failure and Type 2 Diabetes: Cana-Switch-HF Study.

Canagliflozin is a sodium-glucose co-transporter 2 inhibitor that reduces glycemia as well as the risk of cardiovascular events. Our main objective was to analyze antidiabetic treatment de-intensification and the glycemic efficacy of replacing antidiabetic agents (excluding metformin) with canagliflozin in patients with heart failure and type 2 diabetes with poor glycemic control. In this observational, retrospective, real-world study, we selected patients treated with metformin in combination with ≥2 non-insulin antidiabetic agents or metformin in combination with basal insulin plus ≥1 non-insulin antidiabetic agent. Non-insulin antidiabetic agents were replaced with canagliflozin. Patients were followed-up on at three, six, and 12 months after the switch and a wide range of clinical variables were recorded. A total of 121 patients were included. From baseline to 12 months, the number of antidiabetic agents (3.1 ± 1.0 vs. 2.1 ± 0.8, p < 0.05), basal insulin dose (20.1 ± 9.8 vs. 10.1 ± 6.5 units, p < 0.01), and percentage of patients who used basal insulin (47.9% vs. 31.3%, p < 0.01) decreased. The proportion of patients who used diuretics also declined significantly. In addition, we observed improvement in glycemic control, with an increase in the proportion of patients with glycated hemoglobin <7% from 16.8% at three months to 63.5% at 12 (p < 0.001). Canagliflozin use was also beneficial in terms of body weight, blood pressure, heart failure status, functional class, and cardiovascular-renal risk. There were also reductions in the number of emergency department visits and hospitalizations for heart failure. Moreover, canagliflozin was well-tolerated, with a low rate of drug-related discontinuation. Mounting evidence from randomized controlled trials and real-world studies point to the beneficial profile of sodium-glucose co-transporter type 2 inhibitors such as canagliflozin in patients with heart failure.

Prognostic Implication of Non-Obstructive Coronary Lesions: A New Classification in Different Settings.

The clinical significance of non-obstructive coronary artery disease is the subject of debate. Our objective was to evaluate the long-term cardiovascular prognosis associated with non-obstructive coronary artery disease in patients undergoing coronary angiography, and to conduct a stratification by sex, diabetes, and clinical indication. We designed a multi-centre retrospective longitudinal observational study of 3265 patients that were classified into three groups: normal coronary arteries (lesion <20%, 1426 patients), non-obstructive coronary artery disease (20-50%, 643 patients), and obstructive coronary artery disease (>70%, 1196 patients). During a mean follow-up of 43 months, we evaluated a combined cardiovascular event: acute myocardial infarction, stroke, hospitalization for heart failure, or cardiovascular death. Multivariable-adjusted Cox proportional hazard models showed a worse prognosis in patients with non-obstructive coronary artery disease, in comparison with patients of normal coronary arteries group, in the total population (hazard ratio 1.72, 95% confidence interval 1.23-2.39; p for trend <0.001), in non-diabetics (hazard ratio 2.12, 95% confidence interval: 1.40-3.22), in women (hazard ratio 1.75, 95% confidence interval 1.10-2.77), and after acute coronary syndrome (hazard ratio 2.07, 95% confidence interval 1.25-3.44). In conclusion, non-obstructive coronary artery disease is associated with an impaired long-term cardiovascular prognosis. This association held for non-diabetics, women, and after acute coronary syndrome.

Transcriptional Analysis of FOXO1, C/EBP-α and PPAR-γ2 Genes and Their Association with Obesity-Related Insulin Resistance.

BACKGROUND: Obesity is associated with several comorbid disorders, ranging from cardiovascular diseases to insulin resistance. In this context, visceral adipose tissue (VAT) seems to have a close connection with insulin resistance. In our study, we hypothesized that the expression profile of key adipogenic genes, such as proliferator-activated receptor γ type 2 (PPAR-γ2), CCAAT/enhancer-binding protein type α (C/EBP-α), and forkhead box protein class O type 1 (FOXO1) in VAT should shed light on their association with obesity-related insulin resistance. METHODS: To test this idea, we studied the expression profile of C/EBP-α, FOXO1 and PPAR-γ2 in VAT from non-obese individuals, and low insulin (LIR-MO) and high insulin morbidly obese (HIR-MO) subjects, through a combination of RT-qPCR, co-immunoprecipitation, ELISA, Western blot analysis and EMSA assays. RESULTS: Our results show that C/EBP-α and PPAR-γ2 were down-expressed in HIR-MO individuals, while FOXO1 was overexpressed. In addition, the PPAR-γ2-RXR-α heterodimer showed weak activity and bound weakly to the putative IGFBP-2-PPRE promoter sequence in VAT from HIR-MO subjects when compared with LIR-MO individuals. CONCLUSIONS: These results show that PPAR-γ2, C/EBP-α, FOXO1 and IGFBP-2 have a close relationship with insulin resistance in VAT of morbidly obese individuals.

Screening Versus Brief Domain-specific Tests to Assess Long-term Postoperative Cognitive Dysfunction After Concomitant Aortic Valve Replacement and Coronary Artery Bypass Grafting.

BACKGROUND: Although postoperative cognitive dysfunction is a relevant complication after surgery, assessment for the condition is not routine in clinical practice. OBJECTIVE: The aim of this study was to compare the use of screening versus brief domain-specific cognitive tests in assessing long-term cognitive dysfunction after concomitant aortic valve replacement and coronary artery bypass grafting. METHODS: In this observational prospective study, we evaluated 70 patients preoperatively and after 1, 6, and 12 months using 2 screening tests (Mini-Mental State Examination and Clock Drawing Test) and 2 brief domain-specific cognitive tests (Trail Making Test to evaluate attention and executive function, and Semantic and Phonological Tests to evaluate verbal fluency). RESULTS: The brief domain-specific cognitive tests detected significant postoperative worsening in performances (up to 19% on the Trail Making Test and 15.4% on verbal fluency tests at 6 months). Postoperative mild attention/executive dysfunction or inferior normal performance was detected with the maximums being seen at 6 months (44.6%, P < .001). Performances on screening tests did not significantly change during the study period. CONCLUSIONS: A brief domain-specific cognitive evaluation could be routinely implemented in perioperative care practice to detect postoperative cognitive dysfunction.

Impacto de la revascularización coronaria percutánea de lesiones coronarias graves en ramas secundarias / Impact of percutaneous coronary revascularization of severe coronary lesions on secondary branches

Introducción y objetivos: Comparar la estrategia de revascularización percutánea de lesiones graves en ramas coronarias secundarias (RS) (diámetro ≥ 2 mm) de arterias epicárdicas mayores frente al tratamiento conservador. Métodos: Estudio de cohortes retrospectivo en el que se compara a pacientes con lesiones graves en RS de arterias epicárdicas principales tratados con revascularización percutánea o con un tratamiento farmacológico a criterio del operador. Se analizó el porcentaje de eventos relacionados con la rama (muerte cardiovascular, infarto de miocardio atribuible a RS o necesidad de revascularización de la RS). Resultados: Se analizaron 679 lesiones en RS (662 pacientes). Tras un seguimiento medio de 22,2+/-10,5 meses, no hubo diferencias significativas entre ambos grupos de tratamiento en mortalidad de causa cardiovascular (el 1,7 frente al 0,4%; p=0,14), infarto agudo de miocardio (IAM) no fatal (el 1,7 frente al 1,7%; p=0,96) o necesidad de revascularización de la RS (el 4,1 frente al 5,4%; p=0,45) ni en el porcentaje total de eventos (el 5,1 frente al 6,3%; p=0,54). Las variables que mostraron asociación con la ocurrencia de eventos en el análisis multivariable fueron la diabetes (sHR=2,87; IC95%, 1,37-5,47; p=0,004), IAM previo (sHR=3,54; IC95%, 1,77-7,30; p < 0,0001), el diámetro de referencia de la RS (sHR=0,16; IC95%, 0,03-0,97; p=0,047) y la longitud de la lesión (sHR=3,77; IC95%, 1,03-1,13; p < 0,0001). Estos resultados se mantuvieron tras realizar análisis por puntuación de propensión. Conclusiones: En el seguimiento, el porcentaje de eventos relacionados con la RS fue bajo respecto al total de pacientes, sin diferencias significativas entre una y otra estrategia de tratamiento. Las variables que se asociaron con la ocurrencia de eventos en el análisis multivariable fueron la diabetes mellitus, el antecedente de IAM y la mayor longitud de la lesión

Introduction and objectives: To analyze the percutaneous revascularization strategy for severe lesions in the secondary branches (SB) (diameter ≥ 2mm) of major epicardial arteries compared with conservative treatment. Methods: This study analyzed patients with severe SB lesions who underwent percutaneous revascularization treatment compared with patients who received pharmacological treatment. The study examined the percentage of branch-related events (cardiovascular death, myocardial infarction attributable to SB, or the need for revascularization of the SB). Results: We analyzed 679 SB lesions (662 patients). After a mean follow-up of 22.2+/-10.5 months, there were no significant differences between the 2 treatment groups regarding the percentage of death from cardiovascular causes (1.7% vs 0.4%; P=.14), nonfatal acute myocardial infarction (AMI) (1.7% vs 1.7%; P=.96), the need for SB revascularization (4.1% vs 5.4%; P=.45) or in the total percentage of events (5.1% vs 6.3%; P=.54). The variables showing an association with event occurrence on multivariate analysis were diabetes (SHR, 2.87; 95%CI, 1.37-5.47; P=.004), prior AMI (SHR, 3.54; 95%CI, 1.77-7.30; P<.0001), SB reference diameter (SHR, 0.16; 95%CI, 0.03-0.97; P=.047), and lesion length (SHR, 3.77; 95%CI, 1.03-1.13; P<.0001). These results remained the same after the propensity score analysis. Conclusions: The percentage of SB-related events during follow-up is low, with no significant differences between the 2 treatment strategies. The variables associated with event occurrence in the multivariate analysis were the presence of diabetes mellitus, prior AMI, and greater lesion length

Glycaemic efficacy and safety of linagliptin for the management of non-cardiac surgery patients with type 2 diabetes in a real-world setting: Lina-Surg study.

Introduction: The use of dipeptidyl peptidase-4 inhibitors in hospitalized patients is an area of active research. We aimed to compare the efficacy and the safety of the basal-bolus insulin regimen versus linagliptin-basal insulin in non-critically ill non-cardiac surgery patients in a real-world setting. Methods: We enrolled patients with type 2 diabetes hospitalized in non-cardiac surgery departments with admission glycated haemoglobin level < 8%, admission blood glucose concentration < 240 mg/dL, and no at-home injectable treatments who were treated with basal-bolus (n = 347) or linagliptin-basal (n = 190) regimens between January 2016 and December 2017. To match patients on the two regimens, a propensity matching analysis was performed. Results: After matching, 120 patients were included in each group. No differences were noted in mean blood glucose concentration after admission (p = .162), number of patients with a mean blood glucose 100-140 mg/dL (p = .163) and > 200 mg/dL (p = .199), and treatment failures (p = .395). Total daily insulin and number of daily insulin injections were lower in the linagliptin-basal group (both p < .001). Patients on linagliptin-basal insulin had fewer hypoglycaemic events (blood glucose < 70 mg/dL) (p < .001). Conclusion: For type 2 diabetes surgery patients with mild to moderate hyperglycaemia without pre-hospitalization injectable therapies, linagliptin-basal insulin was an effective, safe alternative with fewer hypoglycaemic events in real-world practice. Key messages Treatment with basal-bolus insulin regimens is the standard of care for non-critically ill hospitalized patients with type 2 diabetes. A differentiated treatment protocol that takes into account glycaemic control and clinical factors should be implemented in the hospital setting. Linagliptin-basal insulin is an effective, safe alternative with fewer hypoglycaemic events during the hospitalization of non-critically ill non-cardiac surgery patients with T2D in real-world practice.

Overexpression of scavenger receptor and infiltration of macrophage in epicardial adipose tissue of patients with ischemic heart disease and diabetes.

BACKGROUND: Oxidized low-density lipoproteins and scavenger receptors (SRs) play an important role in the formation and development of atherosclerotic plaques. However, little is known about their presence in epicardial adipose tissue (EAT). The objective of the study was to evaluate the mRNA expression of different SRs in EAT of patients with ischemic heart disease (IHD), stratifying by diabetes status and its association with clinical and biochemical variables. METHODS: We analyzed the mRNA expression of SRs (LOX-1, MSR1, CXCL16, CD36 and CL-P1) and macrophage markers (CD68, CD11c and CD206) in EAT from 45 patients with IHD (23 with type 2 diabetes mellitus (T2DM) and 22 without T2DM) and 23 controls without IHD or T2DM. RESULTS: LOX-1, CL-P1, CD68 and CD11c mRNA expression were significantly higher in diabetic patients with IHD when compared with those without T2DM and control patients. MSR1, CXCL16, CD36 and CD206 showed no significant differences. In IHD patients, LOX-1 (OR 2.9; 95% CI 1.6-6.7; P = 0.019) and CD68 mRNA expression (OR 1.7; 95% CI 0.98-4.5; P = 0.049) were identified as independent risk factors associated with T2DM. Glucose and glycated hemoglobin were also shown to be risk factors. CONCLUSIONS: SRs mRNA expression is found in EAT. LOX-1 and CD68 and were higher in IHD patients with T2DM and were identified as a cardiovascular risk factor of T2DM. This study suggests the importance of EAT in coronary atherosclerosis among patients with T2DM.

Uso de estatinas de alta potencia tras revascularización percutánea / Use of high-potency statins after percutaneous revascularization

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Impact of Percutaneous Coronary Revascularization of Severe Coronary Lesions on Secondary Branches.

INTRODUCTION AND OBJECTIVES: To analyze the percutaneous revascularization strategy for severe lesions in the secondary branches (SB) (diameter ≥ 2mm) of major epicardial arteries compared with conservative treatment. METHODS: This study analyzed patients with severe SB lesions who underwent percutaneous revascularization treatment compared with patients who received pharmacological treatment. The study examined the percentage of branch-related events (cardiovascular death, myocardial infarction attributable to SB, or the need for revascularization of the SB). RESULTS: We analyzed 679 SB lesions (662 patients). After a mean follow-up of 22.2±10.5 months, there were no significant differences between the 2 treatment groups regarding the percentage of death from cardiovascular causes (1.7% vs 0.4%; P=.14), nonfatal acute myocardial infarction (AMI) (1.7% vs 1.7%; P=.96), the need for SB revascularization (4.1% vs 5.4%; P=.45) or in the total percentage of events (5.1% vs 6.3%; P=.54). The variables showing an association with event occurrence on multivariate analysis were diabetes (SHR, 2.87; 95%CI, 1.37-5.47; P=.004), prior AMI (SHR, 3.54; 95%CI, 1.77-7.30; P<.0001), SB reference diameter (SHR, 0.16; 95%CI, 0.03-0.97; P=.047), and lesion length (SHR, 3.77; 95%CI, 1.03-1.13; P<.0001). These results remained the same after the propensity score analysis. CONCLUSIONS: The percentage of SB-related events during follow-up is low, with no significant differences between the 2 treatment strategies. The variables associated with event occurrence in the multivariate analysis were the presence of diabetes mellitus, prior AMI, and greater lesion length.

Use of Linagliptin for the Management of Medicine Department Inpatients with Type 2 Diabetes in Real-World Clinical Practice (Lina-Real-World Study).

The use of noninsulin antihyperglycaemic drugs in the hospital setting has not yet been fully described. This observational study compared the efficacy and safety of the standard basal-bolus insulin regimen versus a dipeptidyl peptidase-4 inhibitor (linagliptin) plus basal insulin in medicine department inpatients in real-world clinical practice. We retrospectively enrolled non-critically ill patients with type 2 diabetes with mild to moderate hyperglycaemia and no injectable treatments at home who were treated with a hospital antihyperglycaemic regimen (basal-bolus insulin, or linagliptin-basal insulin) between January 2016 and December 2017. Propensity score was used to match patients in both treatment groups and a comparative analysis was conducted to test the significance of differences between groups. After matched-pair analysis, 227 patients were included per group. No differences were shown between basal-bolus versus linagliptin-basal regimens for the mean daily blood glucose concentration after admission (standardized difference = 0.011), number of blood glucose readings between 100⁻140 mg/dL (standardized difference = 0.017) and >200 mg/dL (standardized difference = 0.021), or treatment failures (standardized difference = 0.011). Patients on basal-bolus insulin received higher total insulin doses and a higher daily number of injections (standardized differences = 0.298 and 0.301, respectively). Basal and supplemental rapid-acting insulin doses were similar (standardized differences = 0.003 and 0.012, respectively). There were no differences in hospital stay length (standardized difference = 0.003), hypoglycaemic events (standardized difference = 0.018), or hospital complications (standardized difference = 0.010) between groups. This study shows that in real-world clinical practice, the linagliptin-basal insulin regimen was as effective and safe as the standard basal-bolus regimen in non-critical patients with type 2 diabetes with mild to moderate hyperglycaemia treated at home without injectable therapies.