In this explorative study analyzing patients with severe CKD treated with edoxaban 30 mg once daily, no major bleeding or thrombotic events were observed. Some minor bleedings were observed. While additional studies are necessary to confirm the results of this exploratory study, edoxaban 30 mg once daily appears to be safe in patients with severe CKD.
The SANTORINI study is an observational study that enrolled 9602 adult individuals at high or very high cardiovascular (CV) risk across Europe, aimed at providing information on the current status of the management of dyslipidaemias, in light of the most recent 2019 EAS/ESC guidelines. Italy participated in the study with 1977 patients, 1531 (77.4%) of whom were classified at very high CV risk and 446 (22.6%) at high CV risk. Overall, in the Italian population, 79.31% of the patients had a history of atherosclerotic cardiovascular disease (ASCVD). At enrolment, the mean level of LDL-C in the total population was 98.4 mg/dL. LDL-C levels were lower in the very high-risk group (94.6 mg/dL) than in the high-risk group (111.4 mg/dL). Considering the therapeutic goals recommended by the most recent 2019 ESC/EAS guidelines (LDL-C <55 mg/dL or <70 mg/dL respectively in very high or high-risk patients, respectively), only 20.3% of the overall study population achieved such goals (19.9% of very high-risk patients and 21.8% of high-risk patients). About one-third of the patients included in the study (32.6%) were not prescribed any therapy, one-third received statin monotherapy (34.4%), and only one-third (33%) were taking combination therapy; these percentages were comparable in the two risk subgroups. Based on the most recent 2019 ESC/EAS guidelines, the use of cholesterol-lowering therapies is not always optimal to achieve the therapeutic goals even in patients with very high CV risk. This means that about 80% of patients are far from the recommended therapeutic goals for their risk category.
The management of severe hypercholesterolemia (sHC) (LDL–C >160 mg/dL) represents a clinical challenge in routine practice, mainly in the setting of high cardiovascular (CV) risk. The aim of the present analysis was to assess the characteristics and management at baseline examination of patients with sHC enrolled in the Italian cohort of SANTORINI study. The SANTORINI study (NCT04271280) is a multinational, observational, prospective study evaluating the use of lipid–lowering therapies (LLTs) in 9044 adult patients with high– and very–high CV risk enrolled from 14 European countries between March 2020 and February 2021, with a 12–month follow–up period per patient. The Italian cohort comprised 1977 patients, 229 (11.6%) of whom were classified with sHC. Their mean age was 59.4 years, 56% were male, BMI was 27.2 kg/m2 and mean LDL–C levels were 196.7 mg/dL. In 7% of cases sHC was reported to be associated with a clinical diagnosis of familial hypercholesterolemia. By investigators, 150 (65.5%) patients were classified at very–high and 79 (34.5%) at high CV risk, mainly (74.2%) based upon ESC/EAS European guidelines criteria. Atherosclerotic cardiovascular disease was actually present in 68.4% of patients, while 40.6% were on primary prevention. Despite sHC was associated with high CV risk, 64.6% of patients had no documented LLTs at baseline, 15.3% was receiving lipid–lowering monotherapy including 9.2% on statins (6.1 % moderate and 2.6% high–intensity), 1.7% were on ezetimibe, 1.6% on PCSK9i and 0.5% on other oral LLTs, and 20.1% was receiving combination therapy (10.9% were on statin + ezetimibe, 4.8% on PCSK9i + oral LLT, and 4.4% other oral combination therapy). Based on present findings, it is therefore concluded that, although the clinicians mostly follow current guidelines to determine CV risk in hypercholesterolemia, there is a low utilisation of LLTs, especially combination therapies, in the subgroup of patients with sHC at high and very–high CV risk. This means that further measures are needed to improve the therapeutic management of these patients in order to minimise the risk of adverse cardiovascular events.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.