Real-World Use of Oral Semaglutide in Adults with Type 2 Diabetes: The PIONEER REAL Switzerland Multicentre, Prospective, Observational Study.

INTRODUCTION: Real-world data provide insight into how medications perform in clinical practice. The PIONEER REAL Switzerland study aimed to understand clinical outcomes with oral semaglutide in adults with type 2 diabetes (T2D). METHODS: PIONEER REAL Switzerland was a 34-44-week, multicentre, prospective, non-interventional, single-arm study of adults with T2D naïve to injectable glucose-lowering medication who were initiated on oral semaglutide in routine clinical practice. The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline (BL) to end of study (EOS); secondary endpoints included change in body weight (BW) from BL to EOS and the proportion of participants achieving HbA1c < 7.0% and the composite endpoints HbA1c reduction ≥ 1%-points with BW reduction ≥ 3% or ≥ 5% at EOS. Safety was assessed in participants who received ≥ 1 dose of oral semaglutide. RESULTS: Of the 185 participants (female/male, n = 67/118) initiating oral semaglutide, 168 (90.8%) completed the study and 143 (77.3%) remained on treatment with oral semaglutide at EOS. At BL, participants had a mean age of 62 years, diabetes duration of 6.4 years, HbA1c of 7.7%, BW of 95.6 kg and body mass index of 33.2 kg/m2; 56.2% of participants were receiving glucose-lowering medications. Significant reductions were observed for HbA1c (estimated change - 0.91%; 95% confidence interval [CI] - 1.10, - 0.71; p < 0.0001) and BW (estimated change - 4.85%; 95% CI - 5.70, - 4.00; p < 0.0001). In total, 139 adverse events (AEs) were reported in 65 (35.1%) participants; most were mild or moderate. The most frequent AEs were gastrointestinal disorders (27.0%); 31 AEs in 20 (10.8%) participants led to discontinuation of oral semaglutide. Six serious AEs were reported; all were considered unlikely to be related to oral semaglutide. CONCLUSION: People living with T2D treated with oral semaglutide in Switzerland achieved clinically significant reductions in HbA1c and BW, with no new safety signals. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT04537624. A graphical abstract is available for this article.

The Italian Society of Cardiology and Working Group on Telecardiology and Informatics 2023 updated position paper on telemedicine and artificial intelligence in cardiovascular disease.

In 2015, the Italian Society of Cardiology and its Working Group on Telemedicine and Informatics issued a position paper on Telecardiology, resuming the most eminent evidence supporting the use of information and communication technology in principal areas of cardiovascular care, ranked by level of evidence. More than 5 years later and after the global shock inflicted by the SARS-CoV-2 pandemic, an update on the topic is warranted. Recent evidence and studies on principal areas of cardiovascular disease will be therefore reported and discussed, with particular focus on telemedicine for cardiovascular care in the COVID-19 context. Novel perspectives and opportunities disclosed by artificial intelligence and its applications in cardiovascular disease will also be discussed. Finally, modalities by which machine learning have realized remote patient monitoring and long-term care in recent years, mainly filtering critical clinical data requiring selective hospital admission, will be provided.

2019 Italian Society of Cardiology Census on telemedicine in cardiovascular disease: a report from the working group on telecardiology and informatics.

Background: The aim of this study was to assess by a census supported by the Italian Society of Cardiology (Società Italiana di Cardiologia, SIC) the present implementation of telemedicine in the field of cardiovascular disease in Italy. Methods: A dedicated questionnaire was sent by email to all the members of the SIC: data on telemedicine providers, service provided, reimbursement, funding and organisational solutions were collected and analysed. Results: Reported telemedicine activities were mostly stable and public hospital based, focused on acute cardiovascular disease and prehospital triage of suspected acute myocardial infarction (prehospital ECG, always interpreted by a cardiologist and not automatically reported by computerised algorithms). Private companies delivering telemedicine services in cardiology (ECGs, ambulatory ECG monitoring) were also present. In 16% of cases, ECGs were also delivered through pharmacies or general practitioners. ICD/CRT-D remote control was performed in 42% of cases, heart failure patient remote monitoring in 37% (21% vital parameters monitoring, 32% nurse telephone monitoring). Telemedicine service was public in 74% of cases, paid by the patient in 26%. About half of telemedicine service received no funding, 17% received State and/or European Union funding. Conclusions: Several telemedicine activities have been reported for the management of acute and chronic cardiovascular disease in Italy. The whole continuum of cardiovascular disease is covered by telemedicine solutions. A periodic census may be useful to assess the implementation of guidelines recommendations on telemedicine.

The different role of sex hormones on female cardiovascular physiology and function: not only oestrogens.

Human response to different physiologic stimuli and cardiovascular (CV) adaptation to various pathologies seem to be gender specific. Sex-steroid hormones have been postulated as the major contributors towards these sex-related differences. This review will discuss current evidence on gender differences in CV function and remodelling, and will present the different role of the principal sex-steroid hormones on female heart. Starting from a review of sex hormones synthesis, receptors and CV signalling, we will summarize the current knowledge concerning the role of sex hormones on the regulation of our daily activities throughout the life, via the modulation of autonomic nervous system, excitation-contraction coupling pathway and ion channels activity. Many unresolved questions remain even if oestrogen effects on myocardial remodelling and function have been extensively studied. So this work will focus attention also on the controversial and complex relationship existing between androgens, progesterone and female heart.

Telemedicine for cardiovascular disease continuum: A position paper from the Italian Society of Cardiology Working Group on Telecardiology and Informatics.

Telemedicine is the provision of health care services, through the use of information and communication technology, in situations where the health care professional and the patient, or 2 health care professionals, are not in the same location. It involves the secure transmission of medical data and information, through text, sound, images, or other forms needed for the prevention, diagnosis, treatment, and follow-up of a patient. First data on implementation of telemedicine for the diagnosis and treatment of acute myocardial infarction date from more than 10 years ago. Telemedicine has a potential broad application to the cardiovascular disease continuum and in many branches of cardiology, at least including heart failure, ischemic heart disease and arrhythmias. Telemedicine might have an important role as part of a strategy for the delivery of effective health care for patients with cardiovascular disease. In this document the Working Group on Telecardiology and Informatics of the Italian Society of Cardiology intends to remark some key-points regarding potential benefit achievable with the implementation of telemedicine support in the continuum of cardiovascular disease.

Endoscopic treatment of superficial colorectal neoplasms. Retrospective analysis of a single center technique and results.

Endoscopic Submucosal Dissection (ESD) is a technique developed in Japan for "en bloc" resection of larger superficial neoplasms of the gastrointestinal tract as an alternative to the traditional Endoscopic Mucosal Resection (EMR), with removal of the lesion in multiple fragments ("piecemeal"). ESD offers a lower recurrence rate and allows a more accurate histopathological examination. This procedure is however considered technically difficult and therefore requires an adequate learning curve, it is time consuming with more discomfort for the patient, it has a higher complication rate, it is more expensive. To overcome these disadvantages, in the Western countries a hybrid technique called Circumferential Submucosal Incision - Endoscopic Mucosal Resection (CSI-EMR) has been developed and is especially employed for colonic lesions. This article analyzes retrospectively the results obtained in a single centre by a single operator in the treatment of 23 patients (12 men and 11 women, average age 65,6 years), all suffering from superficial, larger than ≥ 20 mm colorectal neoplasms: 9 were treated with ESD for rectal lesions and 14 were treated with CSI-EMR for colonic lesions. Findings show a technical success rate of 66,6% for ESD and 78,5% for CSI-EM, and a 0% recurrence rate during follow-up, 4,3% bleeding and 13% perforation complications. The histology of the removed lesions showed 13 (56,5%) low grade dysplasia adenomas, 8 (34,7%) high grade dysplasia adenomas, one grade 1 sigmoid colon adenocarcinoma infiltrating the submucosal layer without lymphovascular invasion, with free margins (R0), treated conservatively, and one grade 1 cecum adenocarcinoma, infiltrating the submucosal layer, with lymphovascular invasion and involved excision margin, treated surgically with no residual neoplastic disease in the surgical specimen. These data are in line with the most significant ones in literature, except for the higher complication rate, which the authors ascribe to the "learning curve" and the smaller number of treated patients.

Effect of Carvedilol, Ivabradine or their combination on exercise capacity in patients with Heart Failure (the CARVIVA HF trial).

AIM: Patients with heart failure (HF) have reduced exercise capacity. The beneficial effect of beta-blocker on prognosis is not matched by an impact on exercise capacity and quality of life. We performed a randomised open blinded endpoint study to assess the effect of heart rate reduction with carvedilol, ivabradine, and their combination on exercise capacity in HF patients receiving maximal dose of ACE inhibitor. METHODS AND RESULTS: After a run-in phase patients were randomly allocated to 3 groups: carvedilol up to 25mg bid (n=38); ivabradine up to 7.5mg bid (n=41); and carvedilol/ivabradine up to 12.5/7.5mg bid (n=42). The maximal dose of study treatment was more frequently tolerated in patients receiving ivabradine (36/41) than in those receiving carvedilol (18/38) or combination therapy (32/42) (P<0.01 ivabradine versus carvedilol). Heart rate was reduced in all three groups, but to a greater extent by the combination. The distance walked on the 6-min walking test and the exercise time on MVO(2) test significantly improved in the ivabradine and combination groups (both P<0.01 versus baseline), as did peak VO(2) and VAT (P<0.01 for ivabradine and P<0.03 for combination versus carvedilol, respectively). No changes in these parameters were found with carvedilol. The patients receiving ivabradine or the combination had better quality of life (P<0.01 versus baseline for ivabradine and P<0.02 for combination), versus no change with carvedilol. CONCLUSION: Ivabradine alone or in combination with carvedilol is more effective than carvedilol alone at improving exercise tolerance and quality of life in HF patients.

[The walking test: use in clinical practice]. / Il test del cammino: utilizzo nella pratica clinica.

Exercise Capacity is the expression of the cardiovascular and of metabolic organic efficiency and represents a important prognostic marker. The Six Minute Walking Test is adopted in the practice for exercise capacity evaluation in the normal subject as in pneumologic or cardiac rehabilitation programs, and in both pediatric and elderly ages. The aim of the work is to present a practical summary of the application of the six minutes walking test, according to the American Thoracic Society statement. We reviewed the various experiences of its application, and reported the indications, clinical interpretation parameters, relationship and correlation between functional and clinical parameters (hospitalization, quality of life, therapy and exercise control response and compliance), the basic and advanced protocol, the application modality, the reporting models, and the educational checklist.

Awareness of cardiovascular risk factors in ischaemic heart disease: implications during the projection of secondary prevention interventions.

OBJECTIVES: Changing lifestyles and monitoring risk factors are two of the goals of secondary prevention programmes. To do this, it is necessary to investigate the level of patient's awareness regarding such factors. The purpose of this study was to investigate which factors the patients attribute as the cause of their ischemic disease and the level of their awareness. MATERIALS AND METHODS: One hundred and fifty-one patients from the Cardiology Rehabilitation Ward, who had undergone coronary bypass surgery, were enlisted (average age: 63.25 +/- 9.01 years; 85.4% men). During the psychological clinical interview, they were asked about the cause of their own coronary disease; their answers were then compared to the risk factors really present, to evaluate the index of awareness. RESULTS: The factors mainly indicated as linked to coronopathy are stress, smoking habits, dyslipidemia, and unbalanced eating habits ( 32, 30, 23, and 21%, respectively). The spontaneous indication of each of these factors was present only in individuals with the mentioned risk factors, and it varied on the basis of some sociological variables (chi, P < 0.05). CONCLUSION: Interventions of cardiovascular education must consider the personal data of the recipient individuals to increase the efficacy through the selection of targeted strategies.