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2016 - 2022年德国降脂治疗的治疗途径

Treatment pathways of lipid-lowering therapies in Germany 2016-2022.

作者信息

Katzmann Julius L, Grellmann Claudia, Leppert Beate, Müller-Kozarez Irina, Schulz Martin, Laufs Ulrich

机构信息

Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstraße 20, 04103, Leipzig, Germany.

inav - privates Institut für angewandte Versorgungsforschung GmbH, Berlin, Germany.

出版信息

Clin Res Cardiol. 2025 May 28. doi: 10.1007/s00392-025-02686-5.


DOI:10.1007/s00392-025-02686-5
PMID:40434561
Abstract

BACKGROUND: Despite the availability of effective LDL cholesterol (LDL-C)-lowering drugs, only a minority of patients achieves the guideline-recommended treatment targets. This analysis describes treatment pathways of lipid-lowering therapy (LLT) in Germany. METHODS: Health claims data were used to identify patients at high or very-high cardiovascular risk who received a LLT prescription 2016-2022. Treatment pathways and the time to switch or discontinue LLT were analysed for statins, ezetimibe, bempedoic acid (BA), and PCSK9 inhibitors (PCSK9i). RESULTS: Out of 3,487,827 insured persons, 247,529 met the inclusion criteria. The most frequent first-line LLT were statins in 96.3%. Ezetimibe, BA, and PCSK9i were first-line LLT in only 0.9%, 0.061%, and 0.046%, respectively. Only few patients experienced a change in their treatment regimen following LLT initiation. Prescriptions of BA and PCSK9i were mainly second-, third-, or fourth-line add-on treatment. Termination of treatment with BA and PCSK9i was less frequent compared to statins and ezetimibe. The median time to treatment discontinuation was 1.45, 1.04, 0.60, and 2.45 years for statins, ezetimibe, BA, and PCSK9i, respectively, and the median time to switch therapy was 4.81 and 4.87 years for ezetimibe and PCSK9i, respectively (median not reached for statins and BA). CONCLUSIONS: Changes in LLT were only observed in a minority of patients. BA and PCSK9i were switched more frequently than statins and ezetimibe. BA was discontinued earlier, and PCSK9i later than the other agents. Continued efforts to maintain long-term adherence and overcome therapeutic inertia are needed to realise the potential of available LLT with proven cardiovascular benefit.

摘要

背景:尽管有有效的降低低密度脂蛋白胆固醇(LDL-C)的药物,但只有少数患者达到指南推荐的治疗目标。本分析描述了德国降脂治疗(LLT)的治疗途径。 方法:利用健康声明数据识别2016年至2022年期间接受LLT处方的心血管风险高或非常高的患者。分析了他汀类药物、依折麦布、贝派地酸(BA)和前蛋白转化酶枯草溶菌素9抑制剂(PCSK9i)的治疗途径以及换药或停药的时间。 结果:在3487827名被保险人中,247529人符合纳入标准。最常见的一线LLT是他汀类药物,占96.3%。依折麦布、BA和PCSK9i作为一线LLT的比例分别仅为0.9%、0.061%和0.046%。只有少数患者在开始LLT后改变了治疗方案。BA和PCSK9i的处方主要是二线、三线或四线附加治疗。与他汀类药物和依折麦布相比,BA和PCSK9i停药的频率较低。他汀类药物、依折麦布、BA和PCSK9i停药的中位时间分别为1.45年、1.04年、0.60年和2.45年,依折麦布和PCSK9i换药的中位时间分别为4.81年和4.87年(他汀类药物和BA未达到中位时间)。 结论:仅在少数患者中观察到LLT的变化。BA和PCSK9i比他汀类药物和依折麦布更频繁地换药。BA停药较早,PCSK9i停药比其他药物晚。需要持续努力维持长期依从性并克服治疗惰性,以实现具有已证实心血管益处的现有LLT的潜力。

相似文献

[1]
Treatment pathways of lipid-lowering therapies in Germany 2016-2022.

Clin Res Cardiol. 2025-5-28

[2]
Guideline LDL-C Threshold Achievement in Acute Myocardial Infarction Patients: A Real-World Evidence Study Demonstrating the Impact of Treatment Intensification with PCSK9i.

Cardiol Ther. 2023-6

[3]
Prescriber Uptake and Use of Novel Lipid-Lowering Therapies.

J Am Heart Assoc. 2025-5-6

[4]
Simulation of Lipid-Lowering Therapy Intensification in a Population With Atherosclerotic Cardiovascular Disease.

JAMA Cardiol. 2017-9-1

[5]
Lipid lowering with bempedoic acid added to a proprotein convertase subtilisin/kexin type 9 inhibitor therapy: A randomized, controlled trial.

J Clin Lipidol. 2021

[6]
Use of Lipid-Lowering Therapies Over 2 Years in GOULD, a Registry of Patients With Atherosclerotic Cardiovascular Disease in the US.

JAMA Cardiol. 2021-9-1

[7]
Non-statin lipid-lowering therapy over time in very-high-risk patients: effectiveness of fixed-dose statin/ezetimibe compared to separate pill combination on LDL-C.

Clin Res Cardiol. 2022-3

[8]
Lipid-lowering treatment among older patients with atherosclerotic cardiovascular disease.

J Am Geriatr Soc. 2023-4

[9]
Use of negative control outcomes to assess the comparability of patients initiating lipid-lowering therapies.

Pharmacoepidemiol Drug Saf. 2022-4

[10]
Clinical characteristics and lipid lowering treatment of patients initiated on proprotein convertase subtilisin-kexin type 9 inhibitors: a nationwide cohort study.

BMJ Open. 2019-4-1

本文引用的文献

[1]
Prevalence, incidence, and treatment of dyslipidemia in patients with high or very high cardiovascular risk in Germany.

J Clin Lipidol. 2024-10-19

[2]
Variation in secondary prevention of coronary heart disease: the INTERASPIRE study.

Eur Heart J. 2024-10-14

[3]
Trends in atherosclerotic cardiovascular disease and lipid management: a population-level observational cohort study in Wales.

Eur J Prev Cardiol. 2024-11-11

[4]
Persistence and Adherence to PCSK9 Inhibitor Monoclonal Antibodies Versus Ezetimibe in Real-World Settings.

Adv Ther. 2024-6

[5]
Real-World Effectiveness of PCSK9 Inhibitors in Reducing LDL-C in Patients With Familial Hypercholesterolemia in Italy: A Retrospective Cohort Study Based on the AIFA Monitoring Registries.

J Am Heart Assoc. 2023-11-7

[6]
Retrospective real-world analysis of adherence and persistence to lipid-lowering therapy in Germany.

Clin Res Cardiol. 2024-6

[7]
Optimal implementation of the 2019 ESC/EAS dyslipidaemia guidelines in patients with and without atherosclerotic cardiovascular disease across Europe: a simulation based on the DA VINCI study.

Lancet Reg Health Eur. 2023-6-8

[8]
Gaps in Guideline-Based Lipid-Lowering Therapy for Secondary Prevention in the United States: A Retrospective Cohort Study of 322 153 Patients.

Circ Cardiovasc Qual Outcomes. 2023-8

[9]
Lipid Profile and Lipoprotein(a) Testing.

Dtsch Arztebl Int. 2023-9-4

[10]
Treatment gaps in the implementation of LDL cholesterol control among high- and very high-risk patients in Europe between 2020 and 2021: the multinational observational SANTORINI study.

Lancet Reg Health Eur. 2023-4-5

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