Evolocumab-Based LDL-C Management in High and Very High Cardiovascular Risk Patients in German Clinical Practice : The HEYMANS Study
© 2024. The Author(s)..
INTRODUCTION: Low-density lipoprotein cholesterol (LDL-C) is among the most important modifiable risk factors for cardiovascular disease. In very high-risk patients, the European Society of Cardiology/European Atherosclerosis Society guidelines recommend attaining LDL-C < 55 mg/dL. In the German cohort of the observational HEYMANS study, we aimed to describe the clinical characteristics and LDL-C control among patients initiating evolocumab.
METHODS: Data was collected between 09/2016 and 05/2021 for ≤ 6 months before (retrospectively) and ≤ 30 months after evolocumab initiation (prospectively). Patient characteristics, lipid-lowering therapy (LLT), lipid values, evolocumab use, and safety were collected.
RESULTS: Of 380 enrolled patients, 93% received evolocumab in secondary prevention and 69% had a history of statin intolerance. At study baseline, 49% did not receive any statins and LDL-C was very high (145 mg/dL). Use of evolocumab decreased LDL-C by a median of 53% within 3 months and remained stable thereafter, despite mainly unchanged background LLT. Overall, 59% attained an LDL-C level < 55 mg/dL (69% with, 49% without LLT). Persistence to evolocumab was 90.6% in months 1-12 and 93.5% in months 13-30. Adverse drug reactions were reported in 8% of patients.
CONCLUSION: Data from the German HEYMANS cohort corroborate previous reports on evolocumab effectiveness and safety in clinical practice. Evolocumab initiation was associated with a rapid and sustained LDL-C reduction. Persistence with evolocumab was high. Our finding that patients receiving an evolocumab/LLT combination are more likely to attain the LDL-C goal than those receiving evolocumab alone corroborates previous data showing the importance of using highly intensive therapy. Graphical abstract available for this article.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02770131 (registration date 27 April 2016).
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:41 |
|---|---|
| Enthalten in: |
Advances in therapy - 41(2024), 3 vom: 01. März, Seite 1184-1200 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Lehrke, Michael [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 22.02.2024 Date Revised 06.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT02770131 Citation Status MEDLINE |
|---|
| doi: |
10.1007/s12325-023-02757-x |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM367773015 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM367773015 | ||
| 003 | DE-627 | ||
| 005 | 20240306232804.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240130s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1007/s12325-023-02757-x |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1318.xml |
| 035 | |a (DE-627)NLM367773015 | ||
| 035 | |a (NLM)38286961 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Lehrke, Michael |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Evolocumab-Based LDL-C Management in High and Very High Cardiovascular Risk Patients in German Clinical Practice |b The HEYMANS Study |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 22.02.2024 | ||
| 500 | |a Date Revised 06.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02770131 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2024. The Author(s). | ||
| 520 | |a INTRODUCTION: Low-density lipoprotein cholesterol (LDL-C) is among the most important modifiable risk factors for cardiovascular disease. In very high-risk patients, the European Society of Cardiology/European Atherosclerosis Society guidelines recommend attaining LDL-C < 55 mg/dL. In the German cohort of the observational HEYMANS study, we aimed to describe the clinical characteristics and LDL-C control among patients initiating evolocumab | ||
| 520 | |a METHODS: Data was collected between 09/2016 and 05/2021 for ≤ 6 months before (retrospectively) and ≤ 30 months after evolocumab initiation (prospectively). Patient characteristics, lipid-lowering therapy (LLT), lipid values, evolocumab use, and safety were collected | ||
| 520 | |a RESULTS: Of 380 enrolled patients, 93% received evolocumab in secondary prevention and 69% had a history of statin intolerance. At study baseline, 49% did not receive any statins and LDL-C was very high (145 mg/dL). Use of evolocumab decreased LDL-C by a median of 53% within 3 months and remained stable thereafter, despite mainly unchanged background LLT. Overall, 59% attained an LDL-C level < 55 mg/dL (69% with, 49% without LLT). Persistence to evolocumab was 90.6% in months 1-12 and 93.5% in months 13-30. Adverse drug reactions were reported in 8% of patients | ||
| 520 | |a CONCLUSION: Data from the German HEYMANS cohort corroborate previous reports on evolocumab effectiveness and safety in clinical practice. Evolocumab initiation was associated with a rapid and sustained LDL-C reduction. Persistence with evolocumab was high. Our finding that patients receiving an evolocumab/LLT combination are more likely to attain the LDL-C goal than those receiving evolocumab alone corroborates previous data showing the importance of using highly intensive therapy. Graphical abstract available for this article | ||
| 520 | |a TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02770131 (registration date 27 April 2016) | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Observational Study | |
| 650 | 4 | |a Cardiovascular risk | |
| 650 | 4 | |a Evolocumab | |
| 650 | 4 | |a Guidelines | |
| 650 | 4 | |a LDL-C | |
| 650 | 4 | |a PCSK9 inhibitors | |
| 650 | 4 | |a Registry | |
| 650 | 7 | |a Antibodies, Monoclonal, Humanized |2 NLM | |
| 650 | 7 | |a Anticholesteremic Agents |2 NLM | |
| 650 | 7 | |a Cholesterol, LDL |2 NLM | |
| 650 | 7 | |a evolocumab |2 NLM | |
| 650 | 7 | |a LKC0U3A8NJ |2 NLM | |
| 650 | 7 | |a Hydroxymethylglutaryl-CoA Reductase Inhibitors |2 NLM | |
| 700 | 1 | |a Vogt, Anja |e verfasserin |4 aut | |
| 700 | 1 | |a Schettler, Volker |e verfasserin |4 aut | |
| 700 | 1 | |a Girndt, Matthias |e verfasserin |4 aut | |
| 700 | 1 | |a Fraass, Uwe |e verfasserin |4 aut | |
| 700 | 1 | |a Tabbert-Zitzler, Anja |e verfasserin |4 aut | |
| 700 | 1 | |a Bridges, Ian |e verfasserin |4 aut | |
| 700 | 1 | |a Dhalwani, Nafeesa N |e verfasserin |4 aut | |
| 700 | 1 | |a Ray, Kausik K |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Advances in therapy |d 1990 |g 41(2024), 3 vom: 01. März, Seite 1184-1200 |w (DE-627)NLM085859427 |x 1865-8652 |7 nnns |
| 773 | 1 | 8 | |g volume:41 |g year:2024 |g number:3 |g day:01 |g month:03 |g pages:1184-1200 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1007/s12325-023-02757-x |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 41 |j 2024 |e 3 |b 01 |c 03 |h 1184-1200 | ||