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CC BY-NC-ND 4.0 · Dtsch Med Wochenschr 2023; 148(09): 55-64
DOI: 10.1055/a-2009-5077
Originalarbeit

Behandlung und LDL-Cholesterin-Einstellung von Patienten mit hohem und sehr hohem kardiovaskulärem Risiko in Deutschland und im europäischen Vergleich – Daten des SANTORINI-Registers

Treatment and LDL cholesterol adjustment in patients with high and very high cardiovascular risk in Germany compared with Europe – data from the SANTORINI registry
Paulina Elena Stürzebecher
1   Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Leipzig, Deutschland
,
Adrienn Tünnemann-Tarr
1   Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Leipzig, Deutschland
,
Katja Tuppatsch
2   Daiichi Sankyo Deutschland, München, Deutschland
,
Ulrich Laufs
1   Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Leipzig, Deutschland
› Author AffiliationsDiese Studie wurde finanziert von der Daiichi Sankyo Europe GmbH, München, Deutschland, die das Studiendesign, die Sammlung der Daten und die Datenanalyse definierte. Sechs Auftragsforschungsunternehmen führten die Studie in 14 europäischen Ländern im Auftrag von Daiichi Sankyo Europe durch.
Supported by: ClinicalTrials.gov unter der Identifizierungsnummer NCT04271280
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Zusammenfassung

Einleitung Die ESC/EAS-Leitlinien von 2019 zum Dyslipidämie-Management empfehlen LDL-Cholesterin (LDL-C) Zielwerte gemäß dem kardiovaskulären (CV) Risiko des Patienten. SANTORINI untersucht als erste große europäische Beobachtungsstudie seit Einführung der Leitlinien 2019, ob sich das Lipidmanagement von Patienten mit hohem und sehr hohem CV Risiko verbessert hat.

Methoden SANTORINI ist eine multinationale Registerstudie an 9602 Patienten ≥ 18 Jahre mit hohem und sehr hohem CV Risiko, die eine lipidsenkende Therapie benötigen. Primäres Ziel der Studie ist die Dokumentation der Effektivität aktueller Behandlungsstrategien zum LDL-C-Management in der täglichen Praxis.

Ergebnisse Für diese Analyse lagen vollständige Baselinedaten für 2086 Patienten in Deutschland und 6958 Patienten in Europa vor. Die CV Risikoklassifizierung durch die Behandler erfolgte bei > 50 % der Patienten auf Basis der ESC/EAS-Leitlinien von 2019 und ergab ein hohes CV Risiko für 15,6 % (173/1112) bzw. ein sehr hohes CV Risiko für 84,4 % (939/1112) der Patienten in Deutschland (Europa: 20,7 % [743/3594] hohes, 79,3 % [2851/3594] sehr hohes CV Risiko). Eine unabhängige Nachberechnung, basierend auf diesen Guidelines, ergab dagegen ein hohes bzw. sehr hohes CV Risiko für 4,1 % (46/1112) bzw. 94,5 % (1051/1112) der Patienten in Deutschland. Auch im europäischen Vergleich wurde das CV Risiko in ca. 10 % der Fälle unterschätzt.

Zu Studienbeginn erhielten 59,5 % (1241/2086) der Patienten in Deutschland und 52,6 % (3661/6958) der Patienten in Europa eine lipidsenkende Monotherapie und 19,9 % (416/2086, Deutschland) bzw. 25,2 % (1753/6958, Europa) eine Kombinationstherapie. 78,6 % (1640/2086) der Patienten in Deutschland verfehlten die in den ESC/EAS-Leitlinien empfohlenen LDL-C-Zielwerte (Europa: 71,7 % [4989/6958]).

Fazit Die ESC/EAS Leitlinien-Empfehlungen von 2019 werden nur bei einer Minderheit der Patienten umgesetzt. Die Studie identifiziert Chancen zur Verbesserung der Prävention von CV Erkrankungen in Deutschland.

Abstract

Introduction 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.

Methods 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.

Results 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]).

Discussion 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.

Schlüsselwörter

LDL-C - Leitlinien - kardiovaskuläres Risiko - Dyslipidämie - nichtinterventionelle Studie

Key words

LDL-C - guidelines - cardiovascular risk - dyslipidemia - non-interventional study


Publication History

Article published online:
01 March 2023

© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

Georg Thieme Verlag KG
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