Risultati per: Standard di cura nel diabete – 2022

Senza DRG, i pazienti non hanno accesso a farmaci e monitoraggio

Senza DRG, i pazienti non hanno accesso a farmaci e monitoraggio

Objective
To assess the effect of goal-directed mobilisation (GDM) on physical functioning in medical inpatients.

Design
Randomised, controlled, single-centre, parallel, superiority trial with a 3-month follow-up and blinded outcome assessment.

Setting
General internal medicine wards of a Swiss tertiary acute hospital, September 2021 to April 2023.

Participants
Adults with expected hospitalisation of ≥5 days, physiotherapy prescription and ability to follow study procedures.

Intervention
GDM during hospitalisation, which includes personal goal setting and a short session of patient education through a physiotherapist (experimental group), versus standard care (control group).

Outcome measures
The primary outcome was the change in physical activity between baseline and day 5 (De Morton Mobility Index (DEMMI)). Secondary outcomes included in-hospital accelerometer-measured mobilisation time; in-hospital falls; delirium; length of stay; change in independence in activities of daily living, concerns of falling and quality of life; falls, readmission and mortality within 3 months.

Results
The study was completed by 123 of 162 (76%) patients enrolled, with the primary outcome collected at day 5 in 126 (78%) participants. DEMMI Score improved by 8.2 (SD 15.1) points in the control group and 9.4 (SD 14.2) in the intervention group, with a mean difference of 0.3 (adjusted for the stratification factors age and initial DEMMI Score, 95% CI –4.1 to 4.8, p=0.88). We did not observe a statistically significant difference in effects of the interventions on any secondary outcome.

Conclusions
The patient’s physical functioning improved during hospitalisation, but the improvement was similar for GDM and standard of care. Improving physical activity during an acute medical hospitalisation remains challenging. Future interventions should target additional barriers that can be implemented without augmenting resources.

Trial registration number
NCT04760392.

I moderni dispositivi permettono di adattare la terapia insulinica alle esigenze individuali di ciascun paziente, migliorando l’efficacia del trattamento

A 5 anni dall’arrivo in Italia trattati oltre 1.400 pazienti

Objective
To generate evidence about changes in the research and development (R&D) investment of Chinese chemical pharmaceutical companies before and after the implementation of the national pooled procurement, to respond to the concerns that significant price reductions might negatively affect R&D investment, and to facilitate the evidence-based decision-making for improvement of the national pooled procurement.

Methods
This retrospective study employed the fixed-effects models with robust SEs to analyse the changes in R&D investment intensities of 76 A-share listed Chinese chemical pharmaceutical companies before and after the procurement implementation in 2019. The analyses were based on a panel data set between 2013 and 2022. Subgroup analyses were conducted to account for the heterogeneity of the target companies. The bootstrap hypothesis test method was employed to assess potential variations across the different subgroups.

Results
Following the procurement implementation, the R&D investment intensity (RDI) of the target companies increased by 1.9% (p

Cherubini (Siedp) “evitabili in oltre 450 bimbi ogni anno”

Circulation, Volume 150, Issue Suppl_1, Page A4120515-A4120515, November 12, 2024. Background:Patients with heart failure (HF) often have difficulty obtaining life-saving medications due to coverage barriers, such as prior authorizations (PA) and high out of pocket (OOP) costs. To promote better insurance coverage of high value therapies, the AHA/ACC/HFSA added Value Statements to HF guidelines to inform policymakers about medication cost effectiveness. We assessed whether these guidelines influenced Medicare drug coverage policies for two life-saving, costly HF medications: angiotensin receptor neprilysin inhibitors (ARNI – guideline “high value”) and sodium glucose cotransporter 2 inhibitors (SGLT2i – guideline “intermediate value”).Methods:We performed an observational study of Medicare drug plans from 4/2020-4/2023 to assess for changes in ARNI and SGLT2i coverage after Value Statement publication (4/2022), and subsequent Medicare plan online update (10/2022). The primary outcome was any barrier to drug coverage (PA, tier ≥ 3 OOP cost-sharing, step therapy, or no coverage). Analysis utilized interrupted time series and difference-in-difference (DiD) approaches. DiD analyses used direct oral anticoagulants as a control due to similar cost and utilization as ARNI and SGLT2i, but with no Value Statement.Results:Among 7,396 Medicare drug plans, 94.3%-97.4% had coverage barriers to ARNI and 93.2%-96.6% to SGLT2i. The majority of barriers were due to tier ≥ 3 OOP cost-sharing requirements (ARNI: 94.3%-95.8%; SGLT2i: 93.2%-95.6%). Coverage barriers remained stable in 4/2022, and declined slightly in 10/2022 (Figure). In DiD analyses, the presence of a Value Statement was associated with a ~1 percentage point decline in coverage barriers for ARNI and SGLT2i.Conclusion:Coverage barriers to ARNI and SGLT2i were common and did not change much in response to Value Statements in HF Guidelines. Increased consideration for Value Statements by Medicare policy-makers is needed to meaningfully improve access to high value therapies.

Circulation, Volume 150, Issue Suppl_1, Page A4120131-A4120131, November 12, 2024. Introduction:A growing number of patients develop atherosclerotic cardiovascular disease (ASCVD) despite the absence of standard modifiable risk factors i.e. hypertension (HTN), type 2 diabetes (T2D), dyslipidemia (DSL), and cigarette smoking (SMuRF-less). There is scarcity of studies on prevalence and clinical profiles of SMuRF-less patients in the Middle Ease (ME).Aim:To study the prevalence and clinical features of ME patients with ASCVD who are SMuRF-less vs. those with ≥ 1 SMuRFs, presence of other risk factors and utilization of secondary preventive medications in the 2 groups, and one year survival.Methods:Clinical details of adult patients with ASCVD who participated in 5 previous registries were analyzed according to the absence or presence of ≥ 1 SMuRFs.Results:Of the 5002 patients included in the analysis, 676 (13.5%) were SMuRF-less and 4326 (86.5%) had ≥ 1 SMuRFs. Prevalence of the 4 SMuRFs in the whole cohort was 53.5% HTN, 47.8% T2D, 40.2% smoking, and 37.5% DSL, and the SMuRF group was 61.9%, 55.2%, 46.5%, and 43.4%, respectively. Compared with the SMuRFs group, patients in the SMuRFless group were younger (mean age 52±11.4 years vs. 56.3±11.5 years, respectively, p

Circulation, Volume 150, Issue Suppl_1, Page A4119868-A4119868, November 12, 2024. Introduction:Low-income working-aged adults in the Medicaid program have a high burden of cardiovascular risk factors and disease, but often face barriers accessing necessary therapies. Little is known about contemporary patterns of utilization and spending on lipid-lowering therapies in Medicaid programs.Goal:To evaluate national trends in utilization and spending on statins and proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) in Medicaid.Methods:We performed a serial cross-sectional study using the Medicaid Spending by Drug Database, which contains national-level Medicaid spending data for medications partially or fully reimbursed by Medicaid for the approximately 84 million beneficiaries. We evaluated annual trends in utilization (prescription fills) and total spending for statins and PCSK9i from 2018 to 2022, both overall and by individual drug formulation. Spending was adjusted for inflation and reported in 2022 US dollars.Results:Medicaid beneficiaries filled 20.4 million statin prescriptions in 2018 compared to 20.3 million in 2022, representing a 0.4% decrease. However, Medicaid spending on statins decreased by 7.1%, from $246.2 million to $226.8 million over the same period. Prescription fills for generic Rosuvastatin increased the most (0.79 million to 2.6 million, +224.2%), while fills for brand-name Crestor decreased the most (0.065 million to 0.003 million, -95.2%). Medicaid beneficiaries filled 121,737 prescriptions for PCSK9 inhibitors in 2022 compared to 7,617 in 2018 (+1498%), coinciding with a 640% increase in total spending ($8.9 million to $65.7 million). Repatha Sureclick was the most filled PCSK9i in Medicaid with 80,503 fills in 2022, representing $43.9 million in total Medicaid spending.Conclusions:Despite almost no change in statin utilization between 2018 and 2022, Medicaid spending on statins fell by approximately $20 million, driven by a shift from brand-name to generic formulations. In contrast, spending on PCSK9 inhibitors increased by $57 million as these medications became more widely used. Understanding these trends is critical as Medicaid programs work to ensure access to effective cardiovascular therapies while also identifying opportunities for cost efficiencies nationwide.

Circulation, Volume 150, Issue Suppl_1, Page A4147016-A4147016, November 12, 2024. Introduction:One of the main causes of renal disease, in which the kidneys are unable to function properly, is hypertension. Over time, uncontrolled hypertension can harm the fragile blood vessels in the kidneys, resulting in chronic kidney disease (CKD) and eventually end-stage renal disease (ESRD). In this study, we examined the trends of hypertension-related ESRD mortality in the United States from 1999 to 2022 and determined the disparities between various epidemiological groups.Methods:Our study conducted an in-depth search of the Centers for Disease Control and Prevention’s Wide- Ranging Online Data for Epidemiological Research (CDC Wonder) database and retrieved data on hypertension-related end-stage renal disease mortality from 1999 to 2022. Age-adjusted mortality rates (AAMR) per 100,000 individuals and associated annual percent changes (APC) for the overall study population were calculated using Joinpoint Regression Analysis. The data was further stratified into epidemiological groups of age, gender, ethnicity, and census region.Results:A total of 938,095 deaths occurred from hypertension-related end-stage renal disease. It was observed that the overall AAMR for hypertension-related ESRD increased from 1999-2022 with a fixed APC of 9.08. The populations with the highest mortality rates were males, African Americans, non-Hispanics, and the age group of over 85 years. Region-wise analysis gave variable trends in the AAMR (Overall APC: Northeast: 8.42, Midwest: 10.29, West: 9.04, and South: 12.80 from 2011-2022).Conclusion:In the US, the mortality rates from hypertension-related ESRD have shown a constant incline. The need for additional research and action is highlighted by persistent differences in mortality that are related to geography and demographics.

Circulation, Volume 150, Issue Suppl_1, Page A4141352-A4141352, November 12, 2024. Background:Major adverse cardiovascular events (MACE), including myocardial infarction, acute coronary syndrome, ischemic heart disease requiring revascularization, stroke, and heart failure, have been documented as significant contributors to mortality in cancer survivors. Coronary artery calcium (CAC) can predict MACE in non-cancer populations, while calcium in the aorta (CA) has not been evaluated as a prognostic marker. Every patient diagnosed with cancer undergoes a standard-of-care Positron Emission Tomography-Computed Tomography (PET-CT) or a chest CT before the initiation of chemotherapy.Hypothesis:To determine whether the CAC or CA of patients with Hodgkin’s or non-Hodgkin’s lymphoma, derived from standard-of-care PET-CT/chest CT, can predict the incidence of MACE.Methods:Patients treated with anthracycline-based chemotherapy, diagnosed and followed from January 1, 2013, through June 30, 2023, were included. Patients who did not undergo a PET-CT or CT, and/or developed MACE before treatment initiation were excluded. Univariate and multivariate adjusted Cox regression models were employed to assess whether the presence of CAC, CA, or CAC-CA was associated with the development of MACE. Calcium was retrospectively quantified using TeraRecon software (Durham NC) and categorized as: 0, 1-99, and >100. Outcome analyses was estimated using the Kaplan-Meier method.Results:326 patients were included, mean age of 55 years (range: 52-60), predominantly male 201 (61%) and white 314 (96%), CAC was found in 89 patients and CA in 140. In the univariate regression model, a statistically significant association was found with values >100 for CA, CAC and CAC-CA with the risk of MACE. (Fig 1a/b/c). CAC equal to 0 demonstrated a significant protective effect against MACE. (Fig 1a). In the multivariable analysis, these associations persisted even after adjusting for comorbidities. (Table 1).Conclusion:CAC, CA and CAC/CA >100 in the standard-of-care CT/PET CT are predictors of MACE in lymphoma patients undergoing anthracycline treatment, a CAC equal to 0 has protective effect, these relationships remained statistically significant after adjusting for comorbidities.

Circulation, Volume 150, Issue Suppl_1, Page A4141704-A4141704, November 12, 2024. Background:The multiple electrodes needed to generate a 12-lead electrocardiogram (12L ECG) limits its use to traditional health care settings. An innovative credit-card sized unit (HeartBeam, Santa Clara, CA, USA) when placed on the chest without cables captures a vectorcardiogram (VCG). A personalized transformation matrix (PTM) then converts the signals into a 12L ECG.Objective:This is the first quantitative (standard intervals and amplitudes) and qualitative (rhythm diagnosis) accuracy assessment of a synthesized 12L ECG (Syn 12L) compared to a simultaneously recorded standard 12L ECG (Std 12L) on patients in sinus rhythm (SR) or in a non-life-threatening arrhythmia.Methods:The 80 patients, who were enrolled at a single center (Dedinje Cardiovascular Research Institute, Belgrade, Serbia), first underwent recording of a Std 12L and VCG to create a unique PTM, which was used to create the Syn 12L from the VCG. Then a simultaneous Std 12L and VCG were recorded. The quantitative endpoint was the calculated difference (mean and standard deviation [SD]) between the Syn 12L and Std 12L in a series of intervals (RR, PQ, QJ, and QT) and amplitudes (P wave, R wave, and T wave). For the qualitative endpoint, 2 blinded electrophysiology physicians (EP) classified the Syn 12L and Std 12L arrhythmia status.Results:Of the 80 patients, 41 were in SR and 39 in another rhythm (3:SR with PACs, 5:SR with PVCs, 1:SR with pre-excitation, 16:atrial fibrillation, 3:atrial flutter, 2:atrial pacing, and 9:ventricular pacing). The interval and amplitude differences are listed in the table. Rhythm classification by the blinded EPs demonstrated a sensitivity of 94.9% (95% CI: 82.7-99.4%) and specificity of 100% (95% CI: 91.4-100%) compared to Std 12L.Conclusion:In this first study comparing the performance of a 12L ECG created from a credit card sized VCG recorder, the 12L Syn demonstrated clinically equivalent interval and amplitude accuracy and excellent agreement in arrhythmia classification when compared to a simultaneously recorded 12L Std. This approach holds significant promise, potentially permitting patients to obtain a 12L ECG outside of a health care setting with a compact, easy to use device.

Circulation, Volume 150, Issue Suppl_1, Page A4136889-A4136889, November 12, 2024. Background:In patients with acute myocardial infarction (AMI), recent studies have intriguingly reported that up to a quarter of AMI patients have none of the 4 main standard modifiable cardiovascular (CV) risk factors (SMuRFs) (i.e. hypertension (HTN), diabetes mellitus (DM), hypercholesterolemia (HC), and smoking) and have worse mortality.Hypothesis:We tested the hypothesis that the prevalence and prognosis of SMuRF-less patients varies with the definition of risk factors.Aim:Using a French nationwide MI cohort, we aimed to compare SMuRF-less ST-segment elevation MI (STEMI) patients according to 2 HC definitions, given the possibility of using several HC criteria.Methods:The French Cohort of Myocardial Infarction Evaluation (FRENCHIE) is a large ongoing AMI cohort, collecting data from all patients hospitalized for AMI < 48 h of symptom onset in 21 French centers. STEMI patients without prior CAD admitted in 2019 to 2022 were studied. DM was defined as prior DM diagnosis, HbA1c >7% or anti-diabetic medications, ongoing or at discharge, HTN was defined as treated or previous HTN diagnosis and smoking was defined as current smoking within the past month. Restrictive HC (RHC) was defined as either a previous diagnosis of HC or statin therapy. Permissive HC (PHC) was defined as previous diagnosis of HC or lipid-lowering therapy, or LDL-C > 135 mg/dL or total Cholesterol > 213 mg/dL.Results:Among 8008 patients (mean age 61.5± 12.9y, 22.6% women), 41.4% were smokers, 17.4% had diabetes, and 38.5% HTN. According to HC definitions, the prevalence of HC almost doubled, ranging from 30.3% for RHC to 61.0% for PHC. Consequently, the prevalence of SMuRF-less was divided by ≈ two (21.1% vs 11.3%, respectively), depending on the definition of HC used. Age and sex-adjusted logistic regression analysis showed that PHC, but not RHC, was associated with lower odds of in-hospital death (figure). Moreover, having multiple SMuRFs was associated with higher risk of mortality than no SMuRF when using RHC, but not with PHC definition.Conclusion:The prevalence and impact on acute mortality of being SMURFless varies largely with the definition of HC. More research is needed, using HC standardized definitions to explore these patients.Frenchie:was supported in part by the RHU iVASC grant ANR-16-RHUS-00010 from the French National Research Agency (ANR) as part of the Investissements d’Avenir program. The FRENCHIE cohort is registered with ClinicalTrials.gov, NCT04050956.

Circulation, Volume 150, Issue Suppl_1, Page A4140901-A4140901, November 12, 2024. Background:This meta-analysis aims to compare chest compression-only cardiopulmonary resuscitation (CO-CPR) with standard CPR (sCPR), which includes mouth-to-mouth ventilation, as potential strategies for managing out-of-hospital cardiac arrest (OHCA).Methods:We systematically searched various databases and registries such as MEDLINE, Embase, The Cochrane Library, and Clinicaltrials.gov to retrieve relevant studies. We used the revised Cochrane “Risk of bias” tool for randomized trials (RoB 2.0) to assess the risk of bias in included studies. Revman 5.4 was used to pool dichotomous outcomes under a random effects model.Results:A total of 4 RCTs were included in our meta-analysis. Our results indicate that CO-CPR was associated with a significantly increased survival to hospital discharge compared to sCPR (RR 1.22, 95% CI: 1.01 to 1.46) with minimal heterogeneity (I2= 0%). No significant difference was observed between the two groups regarding 1-day survival (RR 1.07, 95% CI: 0.94 to 1.23), survival to hospital admission with a good neurological outcome (CPC 1 or 2) (RR 1.10, 95% CI: 0.80 to 1.51), return of spontaneous circulation (RR 1.05, 95% CI: 0.95 to 1.17), and survival to hospital admission (RR 1.08, 95% CI: 0.93 to 1.25).Conclusion:This meta-analysis found that chest compression-only CPR (CO-CPR) significantly improves survival to hospital discharge compared to standard CPR for managing OHCA while yielding comparable results for other resuscitation outcomes.

Circulation, Volume 150, Issue Suppl_1, Page A4146278-A4146278, November 12, 2024. Background:Cardiovascular disease (CVD) is a leading cause of mortality worldwide and is inextricably linked to obesity, which is a modifiable risk factor for the pathology. In this study, we aimed to analyze the trends of obesity-related cardiovascular disease mortality in the United States from a period of 1999-2022 and also explored the incongruities between various epidemiological groups.Methods:Our study involved accessing multiple cause of mortality records obtained from the Centers for Disease Control and Prevention’s Wide-Ranging Online Data for Epidemiological Research (CDC Wonder) database, specifically focusing on obesity-related cardiovascular mortality, from 1999 to 2022. Age-adjusted mortality rates (AAMR) per 100,000 individuals and associated annual percent changes (APC) for the overall study population were calculated. We further analyzed the data by dividing it into epidemiological groups of age, race, gender, and ethnicity. We further stratified the cardiovascular disease mortality into heart failure, hypertension, ischemic heart disease, and cerebrovascular disease. We used Joinpoint Regression Program to analyze trends in AAMR.Results:A total of 33,359 deaths occurred from obesity-related cardiovascular disease in the US from 1999 to 2022. The overall AAMR for obesity-related cardiovascular mortality increased from 1999-2018 with an APC of 5.26, but following this, almost tripled from 2018-2022 with an APC of 14.69. The populations with the highest mortality rates were those in Males, African Americans, non-Hispanics, and the age group of 65-74 years. Among the stratification for the causes of CVD mortality, the highest increase in obesity-related AAMR was observed in hypertensive diseases (APC of 7.56 from 1999-2018, and 15.91 from 2018-2022).Conclusion:Obesity-related CVD mortality experienced a moderate incline in the United States. However, since COVID-19, there has been a significant increase in mortality. Persistent demographic and geographic disparities in mortality underscore the need for further investigation and intervention.