Financiado en parte por Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca, Sanofi, Gilead Sciences, F. Hoffmann-La Roche, CSL Behring, Boston Scientific Corporation, Regeneron Pharmaceuticals, Ironwood Pharmaceuticals, Incorporated, Ionis Pharmaceuticals, Amarin Corporation, Medicines Company, Kowa Company, Luitpold Pharmaceuticals, Tenax Therapeutics, Regado Biosciences, Belvoir Media Group, Daiichi-Sankyo, Eisai, Novo Nordisk, Astellas Pharma, Servier, Idorsia Pharmaceuticals, HLS Therapeutics, Sirtex Medical, Silence Therapeutics, Esperion Therapeutics, Genentech, St. Jude Medical, American Regent, ODYSSEY OUTCOMES, Sanofi and Regeneron Pharmaceuticals
Lipoprotein(a) lowering by alirocumab reduces the total burden of cardiovascular events independent of low-density lipoprotein cholesterol lowering: ODYSSEY OUTCOMES trial
Szarek M, Bittner VA, Aylward P, Baccara-Dinet M, Bhatt DL, Diaz R, Fras Z, Goodman SG, Halvorsen S, Harrington RA, Jukema JW, Moriarty PM, Pordy R, Ray KK, Sinnaeve P, Tsimikas S, Vogel R, White HD, Zahger D, Zeiher AM, Steg PG, Schwartz GG, ODYSSEY OUTCOMES Investigators
European heart journal · 167 citas
Etiquetas de revisión
Vínculos de autores con la industriaFinanciado por la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiado por la industria
- Organización sin fines de lucro
- American Heart Association
- Empresa
- Amgen
- Empresa
- Bristol-Myers Squibb
- Empresa
- Eli Lilly and Company
- Empresa
- Pfizer
- Empresa
- AstraZeneca
- Empresa
- Sanofi
- Empresa
- Gilead Sciences
- Empresa
- F. Hoffmann-La Roche
- Universidad u hospital
- Cleveland Clinic
- Empresa
- CSL Behring
- Empresa
- Boston Scientific Corporation
- Gobierno
- Boston VA Research Institute
- Empresa
- Regeneron Pharmaceuticals
- Empresa
- Ironwood Pharmaceuticals, Incorporated
- Empresa
- Ionis Pharmaceuticals
- Empresa
- Amarin Corporation
- Empresa
- Medicines Company
- Empresa
- Kowa Company
- Empresa
- Luitpold Pharmaceuticals
- Empresa
- Tenax Therapeutics
- Empresa
- Regado Biosciences
- Empresa
- Belvoir Media Group
- Gobierno
- National Institute for Health and Care Research
- Gobierno
- European Commission
- Organización sin fines de lucro
- European Society of Cardiology
- Empresa
- Daiichi-Sankyo
- Empresa
- Eisai
- Empresa
- Novo Nordisk
- Empresa
- Astellas Pharma
- Empresa
- Servier
- Empresa
- Idorsia Pharmaceuticals
- Empresa
- HLS Therapeutics
- Empresa
- Sirtex Medical
- Empresa
- Silence Therapeutics
- Empresa
- Esperion Therapeutics
- Empresa
- Genentech
- Empresa
- St. Jude Medical
- Empresa
- American Regent
- Universidad u hospital
- NIHR Imperial Biomedical Research Centre
- Gobierno
- National Institute of Diabetes and Digestive and Kidney Diseases
- Universidad u hospital
- Duke Clinical Research Institute
- Empresa
- ODYSSEY OUTCOMES
- Empresa
- Sanofi and Regeneron Pharmaceuticals
- Gobierno
- NIDDK NIH HHS
- Autores
- Al menos un autor declara un vínculo económico con la industria
- Subvenciones
- National Institute of Diabetes and Digestive and Kidney Diseases (P30DK079626)
Según 45 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2020-07-24 · Eur Heart J · vol. 41 · número 44 · págs. 4245–4255
- Editorial
- Oxford University Press
- Citado
- 220 citas · más que el 100% de estudios similares · 24.8× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 17 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY-NC
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Atherosclerosis and Cardiovascular Diseases · Acute Myocardial Infarction Research
- Palabras clave
- lipoprotein(a), alirocumab, PCSK9 inhibitors, acute coronary syndrome, cardiovascular events, LDL cholesterol, cardiovascular risk prediction, treatment goals, ODYSSEY OUTCOMES trial
- MeSH
- humans, cholesterol, lipoprotein(a), anticholesteremic agents, hydroxymethylglutaryl-coa reductase inhibitors, treatment outcome, cholesterol, ldl, antibodies, monoclonal, humanized, proprotein convertase 9
23 autores
- Michael J. Szarek🇺🇸 · autor de correspondenciaState University of New York; SUNY Downstate Health Sciences University
- Vera Bittner🇺🇸University of Alabama at Birmingham
- Philip E. Aylward🇦🇺Flinders University; South Australian Health and Medical Research Institute
- Marie T. Baccara‐Dinet🇫🇷Sanofi (France)
- Deepak L. Bhatt🇺🇸Brigham and Women's Hospital; Harvard University
- Rafael Díaz🇦🇷Estudios Clínicos Latinoamérica; Instituto Cardiovascular de Rosario
- Zlatko Fras🇸🇮University of Ljubljana; Ljubljana University Medical Centre
- Shaun G. Goodman🇨🇦St. Michael's Hospital; University of Alberta; Canadian VIGOUR Centre
- Sigrun Halvorsen🇳🇴Oslo University Hospital; University of Oslo
- Robert A. Harrington🇺🇸Stanford Medicine; Stanford University
- J. Wouter Jukema🇳🇱Leiden University Medical Center; Netherlands Heart Institute
- Patrick M. Moriarty🇺🇸University of Kansas Medical Center
- Robert C. Pordy🇺🇸Regeneron (United States)
- Kausik Kumar Ray🇬🇧Imperial College London
- Peter Sinnaeve🇧🇪Universitair Ziekenhuis Leuven
- Sotirios Tsimikas🇺🇸University of California San Diego
- Robert A. Vogel🇺🇸University of Colorado Denver
- Harvey Douglas White🇳🇿Auckland City Hospital
- Doron Zahger🇮🇱Ben-Gurion University of the Negev; Soroka Medical Center
- Andreas Michael Zeiher🇩🇪Goethe University Frankfurt
- Philippe Gabríel Steg🇫🇷🇬🇧Inserm; Université Paris Cité; Royal Brompton Hospital; Assistance Publique – Hôpitaux de Paris; Laboratoire de Recherche Vasculaire Translationnelle; Hôpital Bichat-Claude-Bernard; Imperial College London
- Gregory G. Schwartz🇺🇸University of Colorado Anschutz; University of Colorado Denver
- for the ODYSSEY OUTCOMES Investigators
Resumen
El texto original del estudio, en el idioma en que se publicó.
Aims
Lipoprotein(a) concentration is associated with first cardiovascular events in clinical trials. It is unknown if this relationship holds for total (first and subsequent) events. In the ODYSSEY OUTCOMES trial in patients with recent acute coronary syndrome (ACS), the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab reduced lipoprotein(a), low-density lipoprotein cholesterol (LDL-C), and cardiovascular events compared with placebo. This post hoc analysis determined whether baseline levels and alirocumab-induced changes in lipoprotein(a) and LDL-C [corrected for lipoprotein(a) cholesterol] independently predicted total cardiovascular events.
Methods and results
Cardiovascular events included cardiovascular death, non-fatal myocardial infarction, stroke, hospitalization for unstable angina or heart failure, ischaemia-driven coronary revascularization, peripheral artery disease events, and venous thromboembolism. Proportional hazards models estimated relationships between baseline lipoprotein(a) and total cardiovascular events in the placebo group, effects of alirocumab treatment on total cardiovascular events by baseline lipoprotein(a), and relationships between lipoprotein(a) reduction with alirocumab and subsequent risk of total cardiovascular events. Baseline lipoprotein(a) predicted total cardiovascular events with placebo, while higher baseline lipoprotein(a) levels were associated with greater reduction in total cardiovascular events with alirocumab (hazard ratio Ptrend = 0.045). Alirocumab-induced reductions in lipoprotein(a) (median -5.0 [-13.6, 0] mg/dL) and corrected LDL-C (median -51.3 [-67.1, -34.0] mg/dL) independently predicted lower risk of total cardiovascular events. Each 5-mg/dL reduction in lipoprotein(a) predicted a 2.5% relative reduction in cardiovascular events.
Conclusion
Baseline lipoprotein(a) predicted the risk of total cardiovascular events and risk reduction by alirocumab. Lipoprotein(a) lowering contributed independently to cardiovascular event reduction, supporting the concept of lipoprotein(a) as a treatment target after ACS.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC).
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