Background Sodium-glucose co-transporter 2 inhibitors (SGLT2-I) currently receive intense clinical interest in patients with and without diabetes mellitus (DM) with pleiotropic beneficial effects. Nowadays, the inflammation response in the setting of acute myocardial infarction (AMI) has been proposed as a potential pharmacological intervention target. In this setting, we tested the hypothesis that the SGLT2-I displays anti-inflammatory effect along with glucose-lowering properties. We investigated the relationship between stress hyperglycemia, inflammation burden and infarct size in a cohort of type 2 diabetic AMI patients treated with SGLT2-I versus other oral anti-diabetic (OAD) agents alone. Methods In this multicenter international registry, all diabetic patients with AMI treated with percutaneous coronary intervention (PCI) between 2018 and 2021 were enrolled. Based on the admission anti-diabetic therapy, patients were divided into those receiving SGLT2-I versus other OAD agents alone. Patients on insulin therapy alone or combined with OAD agents were excluded from the study. The following inflammatory markers were evaluated at different time points: total white blood cell, neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and neutrophil-to-platelet ratio (NPR), C-reactive protein. Infarct size was assessed by peak troponin levels and echocardiographic parameters. Results The final study population consisted of 583 patients hospitalized for AMI (both STEMI and NSTEMI) classified as SGLT2-I users (n=98) versus other OAD agents alone (n=485). Admission hyperglycemia was more prevalent among the other OAD agents group. Reduced infarct size was detected in patients treated with SGLT2-I compared to those treated with other OAD agents alone. Both at admission, and after 24 hours, inflammatory indices were significantly higher in patients treated with other OAD agents alone, with a significant increase in neutrophils levels at 24 hours, compared to the SGLT2-I group. In multivariate analysis, SGLT2-I emerged as a significant predictor of reduced inflammatory response (OR 0.45, 95% CI 0.27–0.75, p=0.002), together with peak troponin values, independently of age, admission creatinine values and admission glycemia. Conclusions Type 2 Diabetic patients hospitalized for AMI and receiving SGLT2-I exhibited modest inflammatory response and myocardial damage/infarct size compared to other OAD agents alone, independently of glucose-metabolic control. Our findings pave the way for new pathophysiological and therapeutic insights regarding the cardioprotective effect of SGLT2-I in the setting of coronary artery disease. Funding Acknowledgement Type of funding sources: None.
Introduction Hypercholesterolemia is a major risk factor for the development of atherosclerotic cardiovascular disease (ASCVD). Proprotein Convertase Subtilisin/Kexin type 9 inhibitors (PCSK9i) are recommended in patients with documented ASCVD or Familial Hypercholesterolaemia (FH), not achieving LDL-C target while treated with maximally tolerated dose of lipid-lowering therapy (LLTs). In this conext, single country real-life data, reporting use of PCSK9i in clinical practice are needed. Purpose AT-TARGET-IT is an observational, retrospective, IV phase registry, involving 10 Italian sites, designed to study adherence and persistence of PCSK9i (either Evolocumab or Alirocumab) in patients with ASCVD or FH. Methods All clinical and demographic characteristics were recorded at the time of first prescription and at the latest observation preceding inclusion in the study. Adherence was calculated as Medical Possession Ratio (MPR), defined as the ratio between the drug units dispensed during the treatment period and the duration of the treatment period itself. Persistence was defined as therapeutic continuity from the start of treatment upon enrollment and was assessed at the time points of 6, 12 and 18 months from prescription. Results 798 patients were enrolled. In the overall population, mean age was 62 years (±7.8) and the majority were male (66%). Patients were followed for a median time of 19.33 months. 760 patients (95.2%) showed high adherence to therapy, 13 (1.6%) partial adherence, and 25 (3.1%) no adherence. At 6 month 99.7% of patients enrolled in the study remained on therapy; there were 519 and 423 patients in the study with a follow up of at least 12 and 18 months respectively. Persistence in these groups was 98.1% and 97.5%, respectively. Overall, 28 patients (3.5%) discontinued therapy. No differences in adherence and persistence were found between patients on Alirocumab or Evolocumab. Conclusion The AT-TARGET-IT registry study demonstrated that, in a large single-country real-world population, PCSK9i therapy is extremely successful in routine clinical practice, very high adherence and persistence.
Background Sodium-glucose co-transporter 2 inhibitors (SGLT2-I) currently receive intense clinical interest in patients with and without diabetes mellitus (DM) with pleiotropic beneficial effects. Nowadays, the inflammation response in the setting of acute myocardial infarction (AMI) has been proposed as a potential pharmacological intervention target. In this setting, we tested the hypothesis that the SGLT2-I displays anti-inflammatory effect along with glucose-lowering properties. We investigated the relationship between stress hyperglycemia, inflammation burden and infarct size in a cohort of type 2 diabetic AMI patients treated with SGLT2-I versus other oral anti-diabetic (OAD) agents alone. Methods In this multicenter international registry, all diabetic patients with AMI treated with percutaneous coronary intervention (PCI) between 2018 and 2021 were enrolled. Based on the admission anti-diabetic therapy, patients were divided into those receiving SGLT2-I versus other OAD agents alone. Patients on insulin therapy alone or combined with OAD agents or with unavailable admission medical therapy were excluded from the study. Further exclusion criteria encompassed AMI (mostly NSTEMI) treated with coronary artery bypass grafting (CABG) after the CAG, severe valvular heart disease, prosthetic heart valves, severe anemia, major acute bleeding, pulmonary embolism, fever (38° C), chronic renal failure (glomerular filtration rate < 30 mL/min/1.73 m2), autoimmune diseases, malignancies and congenital heart disease. The following inflammatory markers were evaluated at different time points: total white blood cell, neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and neutrophil-to-platelet ratio (NPR), C-reactive protein. Infarct size was assessed by peak troponin levels and echocardiographic parameters. Results The final study population consisted of 583 patients hospitalized for AMI (both STEMI and NSTEMI) classified as SGLT2-I users (n = 98) versus other OAD agents alone (n = 485). Admission hyperglycemia was more prevalent among the other OAD agents group. Reduced infarct size was detected in patients treated with SGLT2-I compared to those treated with other OAD agents alone. Both at admission, and after 24 hours, inflammatory indices were significantly higher in patients treated with other OAD agents alone, with a significant increase in neutrophils levels at 24 hours, compared to the SGLT2-I group. In multivariate analysis, SGLT2-I emerged as a significant predictor of reduced inflammatory response (OR 0.45, 95%CI 0.27–0.75, p = 0.002), together with peak troponin values, independently of age, admission creatinine values and admission glycemia. Conclusions Type 2 Diabetic patients hospitalized for AMI and receiving SGLT2-I exhibited modest inflammatory response and myocardial damage/infarct size compared to other OAD agents alone, independently of glucose-metabolic control. Our findings pave the way for new pathophysiological and therapeutic insights regarding the cardioprotective effect of SGLT2-I in the setting of coronary artery disease.
The SANTORINI registry is an observational study that aims to evaluate the management of patients with high and very high cardiovascular (CV) risk in clinical practice, collecting data at enrolment and after 12 months. Italy participated in this study with 1531 patients at very high risk and 446 at high risk. The scope of the present analysis was to investigate low-density lipoprotein cholesterol (LDL-C) goal attainment in patients who do not qualify for PCSK9 inhibitors (PCSK9i) (according to Italian reimbursement regulations) in Italian cohort, with focus on patients in secondary prevention. The current indications for PCKS9i charged to the National Health System in Italy in secondary prevention, are for patients aged ≤ 80 years with LDL-c levels ≥ 70 mg/dl in at least three detections despite therapy for at least 6 months with high intensity statin at the highest tolerated dose and ezetimibe or after a single LDL-C detection for recent myocardial infarction or multiple cardiovascular events or with demonstrated intolerance to statins and/or ezetimibe. At enrolment, a total of 509 (33.2%) of 1531 patients at very-high risk had an LDL-C level of less than 70 mg/dl. Of them, about half do not reach the LDL-C target. In particular, 34.4% takes statin monotherapy, and 50.3% of them do not reach the target. Even patients taking high-intensity statins as monotherapy reach the target in only 47.9% of cases, leaving more than half of patients with LDL-C levels between 55 and 70 mg/dl. Regarding combination therapy, statin and ezetimibe, patients taking this combination account for 26.9%, of these those taking the combination of moderate-intensity statin and ezetimibe reach the target in 56.7% of cases while those taking high-intensity statins and ezetimibe reach the target in 51.4% of cases. Our findings show that there is a proportion of patients with LDL-C below 70 mg/dl who do not qualify for PCSK9i who are not at target for LDL-C levels despite maximal therapy with statins and ezetimibe.
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