Stürzebecher Paulina Elena, Tünnemann-Tarr Adrienn, Tuppatsch Katja, Laufs Ulrich
Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Leipzig, Deutschland.
Daiichi Sankyo Deutschland, München, Deutschland.
Dtsch Med Wochenschr. 2023 Apr;148(9):55-64. doi: 10.1055/a-2009-5077. Epub 2023 Mar 1.
Current 2019 ESC/EAS guidelines for the management of dyslipidemia recommend LDL cholesterol (LDL-C) goals according to the patients' cardiovascular (CV) risk. SANTORINI is the first large European observational study since the 2019 guidelines to assess whether lipid management in patients at high and very high CV risk has improved.
SANTORINI is a multinational, prospective, non-interventional, observational study in 9602 patients ≥ 18 years at high and very high CV risk requiring lipid-lowering therapy. Individual CV risk was assessed by the investigator. The primary study objective is to document, in a real-world setting, the effectiveness of current lipid management regarding LDL-C levels.
For this analysis, complete recruitment data was available for 2086 patients in Germany and 6958 patients Europe. Investigators used the 2019 ESC/EAS guidelines as a basis for CV risk classification in > 50 % of the patients and classified 15.6 % (173/1112) of patients in Germany as high and 84.4 % (939/1112) as very high-risk (Europe: 20.7 % [743/3594] high, 79.3 % [2851/3594] very high CV risk). An independent re-calculation of the CV risk based on these guidelines classified 4.1 % (46/1112) of patients in Germany as high and 94.5 % (1051/1112) as very high-risk. Also in Europe, CV risk was underestimated in around 10 % of patients.At baseline, 59.5 % (1241/2086) patients in Germany and 52.6 % (3661/6958) patients in Europe received lipid-lowering monotherapy; 19.9 % (416/2086) and 25.2 % (1753/6958) of patients in Germany and Europe received combination therapy. 78.6 % (1640/2086) of patients in Germany missed the 2019 ESC/EAS guideline recommended LDL-C treatment goals (Europe: 71.1 % [4989/6958]).
The 2019 ESC/EAS guideline recommendations are only implemented in a minority of patients. The study identifies opportunities for improvements in the prevention of CV diseases in Germany.
2019年欧洲心脏病学会(ESC)/欧洲动脉粥样硬化学会(EAS)血脂异常管理指南根据患者的心血管(CV)风险推荐低密度脂蛋白胆固醇(LDL-C)目标。圣托里尼研究是自2019年指南发布以来,首个评估高心血管风险和极高心血管风险患者血脂管理是否得到改善的大型欧洲观察性研究。
圣托里尼研究是一项针对9602名年龄≥18岁、具有高心血管风险和极高心血管风险且需要降脂治疗的患者的跨国、前瞻性、非干预性观察性研究。研究者评估个体心血管风险。主要研究目标是在现实环境中记录当前血脂管理对LDL-C水平的有效性。
对于本次分析,德国的2086名患者和欧洲的6958名患者有完整的招募数据。超过50%的患者中,研究者以2019年ESC/EAS指南为心血管风险分类的基础,将德国15.6%(173/1112)的患者分类为高风险,84.4%(939/1112)为极高风险(欧洲:20.7%[743/3594]为高风险,79.3%[2851/3594]为极高心血管风险)基于这些指南对心血管风险进行的独立重新计算将德国4.1%(46/1112)的患者分类为高风险,94.5%(1051/1112)为极高风险。在欧洲,约10%的患者心血管风险也被低估。基线时,德国59.5%(1241/2086)的患者和欧洲52.6%(3661/6958)的患者接受了降脂单药治疗;德国和欧洲分别有19.9%(416/2086)和25.2%(1753/6958)的患者接受了联合治疗。德国78.6%(1640/2086)的患者未达到2019年ESC/EAS指南推荐的LDL-C治疗目标(欧洲:71.1%[4989/6958])。
2019年ESC/EAS指南的建议仅在少数患者中得到实施。该研究确定了德国在预防心血管疾病方面有待改进的地方。