Risk and time preferences in individuals with lifestyle-related and non-lifestyle-related cardiovascular diseases: a pilot study.

OBJECTIVES: To (1) pilot a study of behavioural characterisation based on risk and time preferences in clinically well-characterised individuals, (2) assess the distribution of preferences in this population and (3) explore differences in preferences between individuals with 'lifestyle-related' (LS) and 'non-lifestyle-related' (NLS) cardiovascular diseases. DESIGN: Cross-sectional study with an economic online experiment to collect risk and time preferences, a detailed clinical characterisation and a sociodemographic and lifestyle survey. A definition of LS and NLS groups was developed. SETTING: Specialist outpatient clinics of the clinic for cardiology and pneumology of the University Hospital Düsseldorf and patients from a cardiology practice in Düsseldorf. PARTICIPANTS: A total of 74 individuals with cardiovascular diseases. OUTCOMES: Risk and time preferences. RESULTS: The implementation of the study process, including participant recruitment and data collection, ran smoothly. The medical checklist, the survey and the time preference instrument were well received. However, the conceptual understanding of the risk preference instrument resulted in inconsistent choices for many participants (47%). The remaining individuals were more risk averse (27%) than risk seeking (16%) and risk neutral (10%). Individuals in our sample were also more impatient (49%) than patient (42%). The participant classification showed that 65% belonged to the LS group, 19% to the NLS group and 16% could not be assigned (unclear allocation to lifestyle (ULS) group). Excluding the ULS group, we show that individuals in the LS group were more risk seeking, and unexpectedly, more patient than those in the NLS group. CONCLUSIONS: The process of the pilot study and its results can be used as a basis for the design of the main study. The differences in risk and time preferences between the LS and NLS groups provide us with a novel hypothesis for unhealthy behaviours: individuals never give up a bad habit, they simply postpone the latter, which can be tested alongside other additional research questions.

A comparison of conventional and advanced 3D imaging techniques for percutaneous left atrial appendage closure.

Background: Understanding complex cardiac anatomy is essential for percutaneous left atrial appendage (LAA) closure. Conventional multi-slice computed tomography (MSCT) and transesophageal echocardiography (TEE) are now supported by advanced 3D printing and virtual reality (VR) techniques for three-dimensional visualization of volumetric data sets. This study aimed to investigate their added value for LAA closure procedures. Methods: Ten patients scheduled for interventional LAA closure were evaluated with MSCT and TEE. Patient-specific 3D printings and VR models were fabricated based on MSCT data. Ten cardiologists then comparatively assessed LAA anatomy and its procedure relevant surrounding structures with all four imaging modalities and rated their procedural utility on a 5-point Likert scale questionnaire (from 1 = strongly agree to 5 = strongly disagree). Results: Device sizing was rated highest in MSCT (MSCT: 1.9 ± 0.8; TEE: 2.6 ± 0.9; 3D printing: 2.5 ± 1.0; VR: 2.5 ± 1.1; p < 0.01); TEE, VR, and 3D printing were superior in the visualization of the Fossa ovalis compared to MSCT (MSCT: 3.3 ± 1.4; TEE: 2.2 ± 1.3; 3D printing: 2.2 ± 1.4; VR: 1.9 ± 1.3; all p < 0.01). The major strength of VR and 3D printing techniques was a superior depth perception (VR: 1.6 ± 0.5; 3D printing: 1.8 ± 0.4; TEE: 2.9 ± 0.7; MSCT: 2.6 ± 0.8; p < 0.01). The visualization of extracardiac structures was rated less accurate in TEE than MSCT (TEE: 2.6 ± 0.9; MSCT: 1.9 ± 0.8, p < 0.01). However, 3D printing and VR insufficiently visualized extracardiac structures in the present study. Conclusion: A true 3D visualization in VR or 3D printing provides an additional value in the evaluation of the LAA for the planning of percutaneous closure. In particular, the superior perception of depth was seen as a strength of a 3D visualization. This may contribute to a better overall understanding of the anatomy. Clinical studies are needed to evaluate whether a more comprehensive understanding through advanced multimodal imaging of patient-specific anatomy using VR may translate into improved procedural outcomes.

Assessing the potential for precision medicine in body weight reduction with regard to type 2 diabetes mellitus therapies: A meta-regression analysis of 120 randomized controlled trials.

AIMS: To assess the potential for precision medicine in type 2 diabetes by quantifying the variability of body weight as response to pharmacological treatment and to identify predictors which could explain this variability. METHODS: We used randomized clinical trials (RCTs) comparing glucose-lowering drugs (including but not limited to sodium-glucose cotransporter-2 inhibitors, glucagon-like peptide-1 receptor agonists and thiazolidinediones) to placebo from four recent systematic reviews. RCTs reporting on body weight after treatment to allow for calculation of its logarithmic standard deviation (log[SD], i.e., treatment response heterogeneity) in verum (i.e., treatment) and placebo groups were included. Meta-regression analyses were performed with respect to variability of body weight after treatment and potential predictors. RESULTS: A total of 120 RCTs with a total of 43 663 participants were analysed. A slightly larger treatment response heterogeneity was shown in the verum groups, with a median log(SD) of 2.83 compared to 2.79 from placebo. After full adjustment in the meta-regression model, the difference in body weight log(SD) was -0.026 (95% confidence interval -0.044; 0.008), with greater variability in the placebo groups. Scatterplots did not show any slope divergence (i.e., interaction) between clinical predictors and the respective treatment (verum or placebo). CONCLUSIONS: We found no major treatment response heterogeneity in RCTs of glucose-lowering drugs for body weight reduction in type 2 diabetes. The precision medicine approach may thus be of limited value in this setting.

Sex-specific trends in incidence of first myocardial infarction among people with and without diabetes between 1985 and 2016 in a German region.

BACKGROUND: The reduction of myocardial infarction (MI) and narrowing the gap between the populations with and without diabetes are important goals of diabetes care. We analyzed time trends for sex-specific incidence rates (IR) of first MI (both non-fatal MI and fatal MI) as well as separately for first non-fatal MI and fatal MI in the population with and without diabetes. METHODS: Using data from the KORA myocardial infarction registry (Augsburg, Germany), we estimated age-adjusted IR in people with and without diabetes, corresponding relative risks (RR), and time trends from 1985 to 2016 using Poisson regression. RESULTS: There were 19,683 people with first MI (34% fatal MI, 71% men, 30% with diabetes) between 1985 and 2016. In the entire study population, the IR of first MI decreased from 359 (95% CI: 345-374) to 236 (226-245) per 100,000 person years. In men with diabetes, IR decreased only in 2013-2016. This was due to first non-fatal MI, where IR in men with diabetes increased until 2009-2012, and slightly decreased in 2013-2016. Overall, fatal MI declined stronger than first non-fatal MI corresponding to IRs. The RR of first MI substantially increased among men from 1.40 (1.22-1.61) in 1985-1988 to 2.60 (2.26-2.99) in 1997-2000 and moderately decreased in 2013-2016: RR: 1.75 (1.47-2.09). Among women no consistent time trend for RR was observed. Time trends for RR were similar regarding first non-fatal MI and fatal MI. CONCLUSIONS: Over the study period, we found a decreased incidence of first MI and fatal MI in the entire study population. The initial increase of first non-fatal MI in men with diabetes needs further research. The gap between populations with and without diabetes remained.

Acute and short-term fluctuations in gravity are associated with changes in circulatory plasma protein levels.

Gravitational changes between micro- and hypergravity cause several adaptations and alterations in the human body. Besides muscular atrophy and immune system impairment, effects on the circulatory system have been described, which can be associated with a wide range of blood biomarker changes. This study examined nine individuals (seven males, two females) during a parabolic flight campaign (PFC). Thirty-one parabolas were performed in one flight day, resulting in ~22 s of microgravity during each parabola. Each participant was subjected to a single flight day with a total of 31 parabolas, totaling 11 min of microgravity during one parabolic flight. Before and after (1 hour (h) and 24 h), the flights blood was sampled to examine potential gravity-induced changes of circulating plasma proteins. Proximity Extension Assay (PEA) offers a proteomic solution, enabling the simultaneous analysis of a wide variety of plasma proteins. From 2925 unique proteins analyzed, 251 (8.58%) proteins demonstrated a differential regulation between baseline, 1 h and 24 h post flight. Pathway analysis indicated that parabolic flights led to altered levels of proteins associated with vesicle organization and apoptosis up to 24 h post microgravity exposure. Varying gravity conditions are associated with poorly understood physiological changes, including stress responses and fluid shifts. We provide a publicly available library of gravity-modulated circulating protein levels illustrating numerous changes in cellular pathways relevant for inter-organ function and communication.

Absolute treatment effects of novel antidiabetic drugs on a composite renal outcome: meta-analysis of digitalized individual patient data.

BACKGROUND: Absolute treatment benefits-expressed as numbers needed to treat-of the glucose lowering and cardiovascular drugs, glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose transporter 2 (SGLT2) inhibitors on renal outcomes remain uncertain. With the present meta-analysis of digitalized individual patient data, we aimed to display and compare numbers needed to treat of both drugs on a composite renal outcome. METHODS: From Kaplan-Meier plots of major cardiovascular outcome trials of GLP-1 receptor agonists and SGLT2 inhibitors vs. placebo, we digitalized individual patient time-to-event information on composite renal outcomes with WebPlotDigitizer 4.2; numbers needed to treat from individual cardiovascular outcome trials were estimated using parametric Weibull regression models and compared to original data. Random-effects meta-analysis generated meta-numbers needed to treat with 95% confidence intervals (CI). RESULTS: Twelve cardiovascular outcome trials (three for GLP-1 receptor agonists, nine for SGLT2 inhibitors) comprising 90,865 participants were included. Eight trials were conducted in primary type 2 diabetes populations, two in a primary heart failure and two in a primary chronic kidney disease population. Mean estimated glomerular filtration rate at baseline ranged between 37.3 and 85.3 ml/min/1.73 m2. Meta-analyses estimated meta-numbers needed to treat of 85 (95% CI 60; 145) for GLP-1 receptor agonists and 104 (95% CI 81; 147) for SGLT2 inhibitors for the composite renal outcome at the overall median follow-up time of 36 months. CONCLUSION: The present meta-analysis of digitalized individual patient data revealed moderate and similar absolute treatment benefits of GLP-1 receptor agonists and SGLT2 inhibitors compared to placebo for a composite renal outcome.

Prevalence and prognostic value of neurological affections in hospitalized patients with moderate to severe COVID-19 based on objective assessments.

Neurological manifestations of coronavirus disease 2019 (COVID-19) have been frequently described. In this prospective study of hospitalized COVID-19 patients without a history of neurological conditions, we aimed to analyze their prevalence and prognostic value based on established, standardized and objective methods. Patients were investigated using a multimodal electrophysiological approach, accompanied by neuropsychological and neurological examinations. Prevalence rates of central (CNS) and peripheral (PNS) nervous system affections were calculated and the relationship between neurological affections and mortality was analyzed using Firth logistic regression models. 184 patients without a history of neurological diseases could be enrolled. High rates of PNS affections were observed (66% of 138 patients receiving electrophysiological PNS examination). CNS affections were less common but still highly prevalent (33% of 139 examined patients). 63% of patients who underwent neuropsychological testing (n = 155) presented cognitive impairment. Logistic regression models revealed pathology in somatosensory evoked potentials as an independent risk factor of mortality (Odds Ratio: 6.10 [1.01-65.13], p = 0.049). We conclude that hospitalized patients with moderate to severe COVID-19 display high rates of PNS and CNS affection, which can be objectively assessed by electrophysiological examination. Electrophysiological assessment may have a prognostic value and could thus be helpful to identify patients at risk for deterioration.

Virtual and augmented reality in intensive care medicine: a systematic review.

BACKGROUND: Virtual reality (VR) and augmented reality (AR) are rapidly developing technologies that offer a wide range of applications and enable users to experience digitally rendered content in both physical and virtual space. Although the number of studies about the different use of VR and AR increases year by year, a systematic overview of the applications of these innovative technologies in intensive care medicine is lacking. The aim of this systematic review was to provide a detailed summary of how VR and AR are currently being used in various areas of intensive care medicine. METHODS: We systematically searched PubMed until 1st March 2023 to identify the currently existing evidence for different applications of VR and AR for both health care providers in the intensive care unit and children or adults, who were in an intensive care unit because of a critical illness. RESULTS: After screening the literature, a total of 59 studies were included. Of note, a substantial number of publications consists of case reports, study plans or are lacking a control group. Furthermore, study designs are seldom comparable. However, there have been a variety of use cases for VR and AR that researchers have explored. They can help intensive care unit (ICU) personnel train, plan, and perform difficult procedures such as cardiopulmonary resuscitation, vascular punctures, endotracheal intubation or percutaneous dilatational tracheostomy. Patients might benefit from VR during invasive interventions and ICU stay by alleviating stress or pain. Furthermore, it enables contact with relatives and can also assist patients in their rehabilitation programs. CONCLUSION: Both, VR and AR, offer multiple possibilities to improve current care, both from the perspective of the healthcare professional and the patient. It can be assumed that VR and AR will develop further and their application in health care will increase.

Left atrial appendage sizing for percutaneous closure in virtual reality-a feasibility study.

Background and aims: The complex and highly variable three-dimensional anatomy of the left atrial appendage (LAA) makes planning and device sizing for interventional occlusion procedures (LAAC) challenging. Several imaging modalities [e.g. echocardiography, multi-slice computed tomography (MSCT)] are used for this purpose. Virtual reality (VR) is an emerging imaging technique to immerse into a three-dimensional left atrium and appendage, offering unprecedented options of visualization and measurement. This study aimed to investigate the feasibility, accuracy and reproducibility of visualizing the LAA in VR for preprocedural planning of LAAC. Methods and results: Twenty-one patients (79 ± 7 years, 62% male) who underwent LAAC at University Hospital Düsseldorf were included in our study. A dedicated software generated three-dimensional VR models from preprocedural MSCT imaging data. Conventional measurements of LAA dimensions (ostium, landing zone and depth) using a commercially available software were compared to measurements in VR: MSCT and VR ostium min. (r = 0.93), max. (r = 0.80) and mean (r = 0.88, all p < 0.001) diameters as well as landing zone (LZ) min. (r = 0.84), max. (r = 0.86) and mean diameters (r = 0.90, all p < 0.001) showed strong correlations. Three-dimensional orientation was judged superior by physicians in VR compared to MSCT (p < 0.05). Conclusion: Virtual reality visualization of the left atrium and appendage based on MSCT data is feasible and allows precise and reproducible measurements in planning of LAA occlusion procedures with enhanced 3D orientation. Further studies need to explore additional benefits of three-dimensional visualization for operators in preprocedural planning.

Risk-adjusted management in catheterization procedures for non-ST-segment elevation myocardial infarction: A standard operating procedure pilot study.

BACKGROUND: The effects of standardized risk-adjusted periprocedural management of cardiac catheterization procedures in Non-ST segment elevation myocardial infarction (NSTEMI) remain unknown. We implemented a standard operating procedure (SOP) specifying risk assessment (RA, using National Cardiovascular Data Registry (NCDR) risk models) and risk-adjusted management (RM, e.g. intensified monitoring) in 2018 and aimed to investigate staff SOP adherence and associations with patient outcomes. METHODS AND RESULTS: All 430 invasively managed NSTEMI patients (mean age 72y; 70.9% male) in 2018 were analyzed for staff SOP adherence and in-hospital clinical outcomes. 207 patients (48.1%; RM+) received both RA and RM; 92 patients (21.4%; RM-) received RA but no RM; 131 patients (30.5%; RA-) received neither RA nor RM. Lower staff adherence to RA was associated with emergency settings (51.9% (RA-) vs. 22.1% (RA+); p<0.01), presentation in cardiogenic shock (17.6% (RA-) vs. 6.4% (RA+); p<0.01) and invasive mechanical ventilation (12.2% (RA-) vs. 3.3% (RA+); p<0.01). Early sheath removal (87.9% (RM+) vs. 56.5% (RM-); p<0.01) and intensified monitoring (p<0.01) were more frequent in the RM+ group. All-cause mortality was not different (1.4% (RM+) vs. 4.3% (RM-); p=0.13), but there were fewer major bleeding events with associated with RM (2.4% (RM+) vs. 12% (RM-); p<0.01), which remained independently associated with RM in a multivariate logistic regression model correcting for confounders (p<0.01). CONCLUSION: In an all-comer patient cohort with NSTEMI, staff adherence to risk-adjusted periprocedural management was independently associated with fewer major bleeding events. Staff adherence to SOP-specified risk assessment was frequently neglected in more critical clinical situations.

Lactate versus Phosphate as Biomarkers to Aid Mechanical Circulatory Support Decisions in Patients with Out-of-Hospital Cardiac Arrest and Return of Spontaneous Circulation.

AIMS: Identifying patients who may benefit from mechanical circulatory support (MCS) after out-of-hospital cardiac arrest (OHCA) and return of spontaneous circulation (ROSC) remains challenging; thus, a search for helpful biomarkers is warranted. We aimed to evaluate phosphate and lactate levels on admission regarding their associations with survival with and without MCS. METHODS: In 224 OHCA patients who achieved ROSC, the initial phosphate and lactate levels were investigated to discriminate in-hospital mortality by receiver operating characteristic (ROC) curves. According to the Youden Index (YI) from the respective ROC, the groups were risk stratified by both biomarkers, and 30-day mortality was analyzed in patients with and without MCS. RESULTS: Within the entire collective, MCS was not associated with a better chance of survival. Both phosphate and lactate level elevations showed good yet comparable discriminations to predict mortality (areas under the curve: 0.80 vs. 0.79, p = 0.74). In patients with initial phosphate values > 2.2 mmol/L (>YI), 30-day mortality within the MCS cohort was lower (HR 2.3, 95% CI: 1.4-3.7; p = 0.0037). In patients with lower phosphate levels and groups stratified by lactate, 30-day mortality was similar in patients with and without MCS. CONCLUSIONS: We found a significant association between survival and MCS therapy in patients with phosphate levels above 2.2 mmol/L (Youden Index), and a similar discrimination of patient overall survival by lactate and phosphate. Prospective studies should assess the possible independent prognostic value of phosphate and its clearance for MCS efficiency.

Associations of anemia and blood transfusions with mortality in old, critically ill COVID-19 patients - Results from the prospective COVIP Study.

AIMS: Anemia is common in the old and often observed in critically ill patients. Increased age is associated with higher mortality following a COVID-19 infection, making old patients prone to poor outcomes. We investigated whether anemia at admission to the ICU or the need for blood transfusion was associated with 90-day mortality in older, critically ill COVID-19 patients. METHODS: In this prospective multicenter study, the 90-day mortality of COVID-19 patients≥70 years treated in 138 intensive care units (ICU) was analyzed. Associations between anemia (WHO definition) at admission and discharge from ICU and the use of red blood cell (RBC) transfusions with mortality were assessed. Hemoglobin thresholds of RBC transfusions in old, critically ill COVID-19 patients were recorded. RESULTS: In 493 patients (350 anemic, 143 non-anemic), anemia (WHO definition) at the time of ICU admission was not associated with impaired overall survival. Transfusion and severe anemia (hemoglobin≤10 g/dL) at ICU discharge were independently associated with a higher risk of 90-day mortality. CONCLUSION: The need for red blood cell transfusions and severe anemia at ICU discharge, but not at the timepoint of admission, were independently associated with 90-day mortality in critically-ill old COVID-19 patients.

The Clinical Frailty Scale for mortality prediction of old acutely admitted intensive care patients: a meta-analysis of individual patient-level data.

BACKGROUND: This large-scale analysis pools individual data about the Clinical Frailty Scale (CFS) to predict outcome in the intensive care unit (ICU). METHODS: A systematic search identified all clinical trials that used the CFS in the ICU (PubMed searched until 24th June 2020). All patients who were electively admitted were excluded. The primary outcome was ICU mortality. Regression models were estimated on the complete data set, and for missing data, multiple imputations were utilised. Cox models were adjusted for age, sex, and illness acuity score (SOFA, SAPS II or APACHE II). RESULTS: 12 studies from 30 countries with anonymised individualised patient data were included (n = 23,989 patients). In the univariate analysis for all patients, being frail (CFS ≥ 5) was associated with an increased risk of ICU mortality, but not after adjustment. In older patients (≥ 65 years) there was an independent association with ICU mortality both in the complete case analysis (HR 1.34 (95% CI 1.25-1.44), p < 0.0001) and in the multiple imputation analysis (HR 1.35 (95% CI 1.26-1.45), p < 0.0001, adjusted for SOFA). In older patients, being vulnerable (CFS 4) alone did not significantly differ from being frail. After adjustment, a CFS of 4-5, 6, and ≥ 7 was associated with a significantly worse outcome compared to CFS of 1-3. CONCLUSIONS: Being frail is associated with a significantly increased risk for ICU mortality in older patients, while being vulnerable alone did not significantly differ. New Frailty categories might reflect its "continuum" better and predict ICU outcome more accurately. TRIAL REGISTRATION: Open Science Framework (OSF: https://osf.io/8buwk/ ).

Resuscitation room management of patients with non-traumatic critical illness in the emergency department (OBSERvE-DUS-study).

BACKGROUND: Few studies address the care of critically ill non-traumatic patients in the emergency department (ED). The aim of this study was to assess the epidemiology, management, and outcome of these patients. METHODS: In this retrospective study, we identified and analyzed data from all consecutive adult critically ill non-traumatic ED patients treated from March 2018 to February 2019. Patient characteristics, major complaint leading to admission, out-of-hospital, and in-hospital interventions and 30-day mortality were extracted from medical records of the electronic patient data management system. RESULTS: During the study period, we analyzed 40,764 patients admitted to the ED. Of these, 621 (1.5%) critically ill non-traumatic patients were admitted for life-threatening emergencies to the resuscitation room (age: 70 ± 16 years, 52% male). Leading problem on admission was disability/unconsciousness (D), shock (C), respiratory failure (B), airway obstruction (A), and environment problems (E) in 41%, 31%, 25%, 2%, and 1%, respectively. Out-of-hospital and in-hospital measures included: intravenous access (61% vs. 99%), 12-lead ECG (55% vs. 87%), invasive airway management (21% vs. 34%) invasive ventilation (21% vs. 34%), catecholamines (9% vs. 30%), arterial access (0% vs. 52%), and cardiopulmonary resuscitation (11% vs. 6%). The underlying diagnoses were mainly neurological (29%), followed by cardiological (28%), and pulmonological (20%) emergencies. The mean length of stay (LOS) in the resuscitation room and ED was 123 ± 122 and 415 ± 479 min, respectively. The 30-day mortality was 18.5%. CONCLUSION: The data describe the care of critically ill non-traumatic patients in the resuscitation room. Based on these data, algorithms for the structured care of critically ill non-traumatic patients need to be developed.

Rational and design of the REMOTE trial: An exploratory, pilot study to analyze REtinal MicrOcirculaTion in wEightlessness.

BACKGROUND: "Spaceflight associated neuro-ocular syndrome" (SANS) represents a challenging health condition in modern space medicine. Forty-eight percent of astronauts are diagnosed with SANS after long-term space missions. The pathophysiological mechanism seems to be multifactorial, and yet remains unknown. In this proof-of-concept study we plan to investigate retinal microcirculatory changes in weightlessness and aim to identify their role in the development of SANS. METHODS AND DESIGN: Healthy individuals will take part in a parabolic flight campaign, which recreates fractioned total weightlessness periods. The airplane is specifically equipped, and designed for the execution of parabolic flight maneuvers and scientific research in microgravity. Retinal microcirculation will be assessed with a modified fundus camera, which allows dynamic vessel analysis. We will additionally measure intra-ocular pressure and hemodynamic changes during each phase of the flight. Blood samples will be analyzed at baseline, one hour and 24 hours after exposure to weightlessness. CONCLUSIONS: This pilot study aims to investigate the feasibility of retinal microcirculation assessment during varying gravity. Results of this study may generate insights whether venous stasis in the eye, surrogated by the dilatation of retinal vessels and increase in intraocular pressure as signs of venous insufficiency, may potentially contribute to the development of SANS.

Knowledge of HbA1c and LDL-C treatment goals, subjective level of disease-related information and information needs in patients with atherosclerotic cardiovascular disease.

BACKGROUND/HYPOTHESIS: Risk factor control of diabetes mellitus (DM) and especially dyslipidemia remains unsatisfactory in patients with atherosclerotic cardiovascular disease (ASCVD). We aimed to analyze the knowledge of low-density lipoprotein cholesterol (LDL-C) and glycated hemoglobin (HbA1c) treatment goals, subjective level of information, and information needs in very high-risk patients with ASCVD. METHODS: ASCVD patients (n = 210; 75 ± 9 years; 71.4% male; 89.5% coronary disease) with DM (96.7% type 2) completed a questionnaire assessing knowledge of HbA1c and LDL-C treatment goals and subjective level of information and information needs on disease-related topics of DM and ASCVD. Serum LDL-C and HbA1c were measured. RESULTS: HbA1c goal (<7.0% in 60.6%) was attained more frequently than LDL-C goal (<70 mg/dl in 39.9%; p < .01). Significantly more participants named the correct goal for HbA1c compared to LDL-C (52.9% vs. 2.4%; p < .01). Subjective levels of information were higher and information needs were lower for DM than for ASCVD (p < .01 for all topics). No associations of knowledge of treatment goals and level of information with the attainment of treatment goals for HbA1c and LDL-C were found. However, in multivariate regression, higher levels of education were associated with knowledge of treatment goals (HbA1c: odds ratio [OR] 1.32, 95% confidence interval [CI] 1.01-1.72, p = .04; LDL-C: OR 2.32, 95% CI 1.07-5.03; p = .03). CONCLUSION: In very high-risk patients with ASCVD, a deficit of knowledge of treatment goals to control dyslipidemia exists when compared to DM, patients felt significantly better informed for topics of DM than for ASCVD and display higher information needs for topics of ASCVD.

Meta-analysed numbers needed to treat of novel antidiabetic drugs for cardiovascular outcomes.

AIMS: Absolute treatment effects-i.e. numbers needed to treat (NNTs)-of novel antidiabetic drugs for cardiovascular outcomes have not been comprehensively evaluated. We aimed to perform a meta-analysis of digitalized individual patient outcomes to display and compare absolute treatment effects. METHODS AND RESULTS: Individual patient time-to-event information from Kaplan-Meier plots of cardiovascular mortality (CM) and/or hospitalization for heart failure (HHF) endpoints from cardiovascular outcome trials (CVOTs) evaluating dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, and sodium glucose transporter 2 (SGLT2) inhibitors vs. placebo were digitalized using WebPlotDigitizer 4.2 and the R code of Guyot et al.; Weibull regression models were generated, validated, and used to estimate NNT for individual trials; random-effects meta-analysis generated Meta-NNT with 95% confidence intervals. Sixteen CVOTs reported time-to-event information (14 in primary diabetes and 2 in primary heart failure populations). Thirteen studies including 96 860 patients were meta-analysed for CM: At the median follow-up of 30 months, Meta-NNTs were 178 (64 to ∞ to -223) for DPP-4 inhibitors, 261 (158 to 745) for GLP-1 receptor agonists, and 118 (68 to 435) for SGLT2 inhibitors. Ten studies including 96 128 patients were meta-analysed for HHF: At the median follow-up of 29 months, estimated Meta-NNTs were -644 (229 to ∞ to -134) for DPP-4 inhibitors, 441 (184 to ∞ to -1100) for GLP-1 receptor agonists, and 126 (91 to 208) for SGLT2 inhibitors. SGLT2 inhibitors were especially effective for HHF in primary heart failure populations [Meta-NNT 25 (19 to 39)] vs. primary diabetes populations [Meta-NNT 233 (167 to 385)] at 16 months of follow-up. CONCLUSIONS: We found only modest treatment benefits of GLP-1 receptor agonists and SGLT2 inhibitors for CM and HHF in primary type 2 diabetes mellitus populations. In primary heart failure populations, SGLT2 inhibitor benefits were substantial and comparable in efficacy to established heart failure medication.