Alert-LDL-2: adherence to guidelines and goals attainment in the treatment of diabetic patients with dyslipidemia.

BACKGROUND: Type 2 diabetes mellitus is associated with a cluster of lipid and apolipoprotein abnormalities which increase the risk for atherosclerotic cardiovascular disease. The aim of this study was to evaluate the adherence to guidelines-oriented dyslipidemia treatment in diabetic patients and to assess the efficacy of a territorial goal-oriented program. METHODS: One thousand seventy-one diabetic patients at very high cardiovascular risk were enrolled in this prospective study. They performed a clinical-laboratory follow-up program, received lifestyle recommendations and optimization of their antihyperlipidemic therapies. At the beginning and the 3-month follow-up visit, LDL-c data were collected, and further therapies were prescribed to the patients that did not reach the target. After 12 month follow-up, LDL-c data were collected again. RESULTS: Diabetic patients significantly improved mean LDL cholesterol levels during one-year follow-up (LDLc mean value 135 mg/dL at baseline, 60 mg/dL at the end of the study), obtaining a greater reduction compared to non-diabetic patients participating in the same program. Accordingly, the percentage of patients that reached the lipid target was significantly higher in diabetic patients after 3-months and 12- follow-ups (P<0.05). Diabetic patients assuming statins, both in monotherapy and in combination with ezetimibe, increased during the follow-up (74.1% at the enrolment vs. 88.2% one year later). GLP1ra-treated patients achieved the greatest reduction in cholesterol levels compared to baseline. CONCLUSIONS: The results of the study recommend encouraging strategies and appropriate treatments to achieve a targeted lipid profile in diabetic patients at very high cardiovascular risk.

Exploring Contemporary Data on Lipid-Lowering Therapy Prescribing in Patients Following Discharge for Atherosclerotic Cardiovascular Disease in the South of Italy.

Current international guidelines strongly recommend the use of high-intensity lipid-lowering therapy (LLT) after hospitalization for atherosclerotic cardiovascular disease (ASCVD) events. With this study, our aim was to evaluate LLT prescribing in a large Italian cohort of patients after discharge for an ASCVD event, exploring factors associated with a lower likelihood of receiving any LLT and high-intensity LLT. Individuals aged 18 years and older discharged for an ASCVD event in 2019-2020 were identified using hospital discharge abstracts from two local health units of the Campania region. LLT treatment patterns were analyzed in the 6 months after the index event. Logistic regression models were developed for estimating patient predictors of any LLT prescription and to compare high-intensity and low-to-moderate-intensity LLT. Results: A total of 8705 subjects were identified. In the 6 months post-discharge, 56.7% of patients were prescribed LLT and, of those, 48.7% were high-intensity LLT. Female sex, older age, and stroke/TIA or PAD conditions were associated with a higher likelihood of not receiving high-intensity LLT. Similar predictors were found for LLT prescriptions. LLT utilization and the specific use of high-intensity LLT remain low in patients with ASCVD, suggesting a substantial unmet need among these patients in the contemporary real-world setting.

ALERT-LDL: adherence to guidelines in the treatment of patients with dyslipidemia.

The association between LDL-c levels and cardiovascular outcomes suggests tailoring lipid-lowering therapies according to total cardiovascular risk. We aimed to evaluate the adherence to guidelines-oriented dyslipidaemia's treatment in an outpatient population referring to ARCA cardiologists, and assess the efficacy of treatment's optimization for each specific level of risk. Three thousand seventy-five patients enrolled in this prospective study were classified according to cardiovascular risk category, and their therapies were optimized. At the beginning and the 3 month follow-up visit, LDL-c data were collected, and further therapies were prescribed to the patients that did not reach the target. A significant LDL-c reduction was observed in all subgroups at different cardiovascular risk at the end of the study (p < 0.05). The number of patients assuming statins, both in monotherapy and in combination with ezetimibe, increased during the follow-up (63% at the enrollment vs 89% after 12 months). At the enrollment, only 1.4% of patients were treated with PCSK-9 inhibitors while after 12 months the percentage increased both in high (5.8%) and very high-risk (18.4%) patients. At the beginning of the study, only 698/3075 patients (22.7%) reached lipid targets. At the end of the study, carried out by the referring cardiologists in the pertaining healthcare districts and specifically aimed to control the lipid profile, the percentage of patients on target increased in all risk categories (68.5%). Our results suggest carefully implementing measures that encourage outpatients and their cardiologists to achieve the targeted lipid profile according to cardiovascular risk.

Management of patients with chronic heart failure and type 2 diabetes mellitus: the SCODIAC-II study.

SCODIAC was a pilot study which revealed an increasing use of SGLT2i in 123 outpatients affected with Heart Failure (HF) and Type 2 Diabetes Mellitus. SCODIAC-II study, the second phase of the program, has been carried out to determine diagnostic and therapeutic pathways in a larger group of patients and to verify whether the use of innovative antidiabetic therapies could modify echocardiographic parameters and cardiovascular therapies. 406 HF-diabetic patients, referred to Cardiologists and Diabetologists of pertaining healthcare districts in Campania, were enrolled in this retrospective study and divided in Group A, composed of 136 patients with preserved Ejection Fraction (HF-pEF)(> 45%) and Group B, formed of 270 patients with reduced EF (HF-rEF)(≤ 45%). All patients had performed periodic clinical and echocardiographic evaluations. The antidiabetic therapies resulted modified after 1 year with a greater use of GLP1-AR, gliptins and SGLT2i. Cardiovascular therapies resulted also modified with a greater use of sacubitril/valsartan and a reduction of ACEi and ARBs in HF-rEF patients. Echocardiography E velocity, A velocity and E/e' ratio resulted markedly reduced in 25 HF-pEF and in 60 HF-rEF patients treated with SGLT2i, in respect to both the whole sample of subjects at beginning and the other diabetic patients. LAVi resulted reduced only in HF-pEF patients and EF increased only in HF-rEF patients. The approach to the patients with HF and diabetes must necessarily take place in the healthcare districts, be multidisciplinary and integrated. SGLT2i could improve left ventricular function in HF-rEF patients and modify cardiovascular therapies, almost in this setting of patients.Trial registration The protocol was approved by the University of Naples Federico II Ethics Committee and registered at ClinicalTrial.gov (CT04375943). The principles outlined in the Declaration of Helsinki were followed.

Adherence to guidelines in the management of patients with chronic heart failure follow-up: role of periodic echocardiographic examinations.

BACKGROUND AND AIM: The Adherence to Guidelines in the Treatment of patients with Chronic Heart Failure trial showed a poor adherence to the current therapeutic guidelines in 660 chronic heart failure (CHF) patients. The second phase, Adherence to Guidelines in the Treatment of patients with Chronic Heart Failure follow-up, was aimed to determine if periodic echocardiographic evaluations could improve the prognosis of CHF patients and/or increase the adherence to the guidelines. MATERIAL AND METHODS: Among 528 CHF patients with reduced ejection fraction from the ALERT registry, 436 patients accepted to participate in the second phase of the study between February and September 2013 and completed the 3-year follow-up phase between February and September 2016. They were randomized into two groups: Group A (n = 218) followed by clinical evaluation and ECG every 3 months, and echocardiography every 6 months and Group B (n = 218) monitored only with clinical evaluation and ECG every 3 months. RESULTS: The number of vascular events that occurred resulted as similar in both the groups: there were 78 hospitalizations (37 in Group A vs. 41 in Group B); 9 home-treated vascular events (4 in Group A and five in Group B); and 16 cardiovascular deaths (9 and 7, respectively). The adherence to the guidelines at the end of the trial resulted as significantly improved in both the groups in comparison with the basal evaluation, without differences between the two groups. CONCLUSION: A strict follow-up of CHF patients was associated with a lower number of events and an improvement in the adherence to the guidelines. Periodic echocardiography does not modify these results.

Awareness and appropriateness of the management of preclinical heart failure in outpatient clinics in Italy: Insights from the VASTISSIMO study - EValuation of the AppropriateneSs of The preclInical phase (Stage A and Stage B) of Heart FaIlure Management in Outpatient Clinics in Italy.

A key factor in cardiovascular prevention is the detection and appropriate management of preclinical heart failure (HF), but information on the subject is scarce. We designed VASTISSIMO as a prospective, observational study to investigate Outpatient Clinic Cardiologists' skills in detecting and managing preclinical HF in Italy. Quality scores were used to assess the appropriateness of clinical management according to guideline recommendations. The feasibility of making a diagnosis of preclinical HF in a cardiology outpatient clinical setting, cardiologists' awareness of preclinical HF and consistency between physician's perceived risk of HF and the patient's classification into the preclinical HF Stages A [(SAHF) or B (SBHF)] have been investigated. Consistency was defined acceptable if the concordance between perceived risk and actual risk was >70%. Out of 3322 patients included in the study data necessary for identifying SBHF were collected in 2106 (63.4%). Many SBHF patients had their risk underestimated: 16.2% of those with previous acute myocardial infarction (AMI), 23.1% with left ventricular hypertrophy (LVH) at ECG/echocardiography, 30% with systolic/diastolic dysfunction, and 14.3% with valve disease. Cardiologists' awareness of preclinical HF in the outpatient setting should be improved. This is a critical area of cardiovascular prevention that requires attention to improve good clinical practice and adherence to guidelines.

Evaluation of the appropriateness of the preclinical phase (stage A and stage B) of heart failure Management in Outpatient clinics in Italy rationale and design of the 'VASTISSIMO' study.

Early detection of heart failure, when still preclinical, is fundamental. Therefore, it is important to assess whether preclinical heart failure management by cardiologists is adequate. The VASTISSIMO study ('EValuation of the AppropriateneSs of The preclInical phase (Stage A and Stage B) of heart failure Management in Outpatient clinics in Italy') is a prospective nationwide study aimed to evaluate the appropriateness of diagnosis and management of preclinical heart failure (stages A and B) by cardiologists working in outpatient clinics in Italy. Secondary goals are to verify if an online educational course for cardiologists can improve management of preclinical heart failure, and evaluate how well cardiologists are aware of patients' adherence to medications. The study involves 80 outpatient cardiology clinics distributed throughout Italy, affiliated either to the Hospital Cardiologists Association or to the Regional Association of Outpatient Cardiologists, and is designed with two phases of consecutive outpatient enrolment each lasting 1 month. In phase 1, physicians' awareness of the risk of heart failure and their decision-making process are recorded. Subsequently, half of the cardiologists are randomized to undergo an online educational course aimed to improve preclinical heart failure management through implementation of guideline recommendations. At the end of the course, all cardiologists are evaluated (phase 2) to see whether changes in clinical management have occurred in those who underwent the educational program versus those who did not. Patients' adherence to prescribed medications will be assessed through the Morisky Self-report Questionnaire. This study should provide valuable information about cardiologists' awareness of preclinical heart failure and the appropriateness of clinical practice in outpatient cardiology clinics in Italy.

Management of chronic heart failure: Role of home echocardiography in monitoring care programs.

AIM: To identify a possible role of home echocardiography for monitoring chronic heart failure (CHF) patients. METHODS: We prospectively investigated 118 patients hospitalized during the last year for CHF who could not easily reach the pertaining District Healthcare Center. The patients were followed up with 2 home management programs: one including clinical and electrocardiographic evaluations and also periodic home echocardiographic examinations (group A), the other including clinical and electrocardiographic evaluations only (group B). RESULTS: At the end of the 18-mo follow-up no signi-ficant differences were observed between the 2 groups as regards the primary endpoint: rehospitalization occurred in 4 patients of the group A and in 6 patients of the group B; major cardiovascular events occurred in 2 and in 3 patients, respectively. No significant differences were observed with respect to the secondary endpoints: one vascular event appeared in both the groups, 3 cardiovascular deaths occurred in group A and 2 in group B. No significant differences were observed between the 2 groups as regards the composite endpoint of death plus hospitalization. CONCLUSION: Home echocardiography for monitoring of CHF patients does not improve the cardiovascular endpoints. In our CHF patients, a low incidence of vascular events was observed.