| Title: |
Effects of alirocumab on cardiovascular and metabolic outcomes after acute coronary syndrome in patients with or without diabetes: a prespecified analysis of the ODYSSEY OUTCOMES randomised controlled trial |
| Authors: |
Ray, KK; Colhoun, HM; Szarek, M; Baccara-Dinet, M; Bhatt, DL; Bittner, VA; Budaj, AJ; Diaz, R; Goodman, SG; Hanotin, C; Harrington, RA; Jukema, JW; Loizeau, V; Lopes, RD; Moryusef, A; Murin, J; Pordy, R; Ristic, AD; Roe, MT; Tunon, J; White, HD; Zeiher, AM; Schwartz, GS; Steg, PG |
| Source: |
628 ; 618 |
| Publisher Information: |
Elsevier |
| Publication Year: |
2019 |
| Collection: |
Imperial College London: Spiral |
| Subject Terms: |
Science & Technology; Life Sciences & Biomedicine; Endocrinology & Metabolism; MYOCARDIAL-INFARCTION; GENETIC-VARIANTS; STATIN THERAPY; BLOOD-GLUCOSE; RISK; PCSK9; ASSOCIATION; LIRAGLUTIDE; GUIDELINES; EVOLOCUMAB; ODYSSEY OUTCOMES Committees and Investigators |
| Description: |
Background After acute coronary syndrome, diabetes conveys an excess risk of ischaemic cardiovascular events. A reduction in mean LDL cholesterol to 1·4–1·8 mmol/L with ezetimibe or statins reduces cardiovascular events in patients with an acute coronary syndrome and diabetes. However, the efficacy and safety of further reduction in LDL cholesterol with an inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9) after acute coronary syndrome is unknown. We aimed to explore this issue in a prespecified analysis of the ODYSSEY OUTCOMES trial of the PCSK9 inhibitor alirocumab, assessing its effects on cardiovascular outcomes by baseline glycaemic status, while also assessing its effects on glycaemic measures including risk of new-onset diabetes. Methods ODYSSEY OUTCOMES was a randomised, double-blind, placebo-controlled trial, done at 1315 sites in 57 countries, that compared alirocumab with placebo in patients who had been admitted to hospital with an acute coronary syndrome (myocardial infarction or unstable angina) 1–12 months before randomisation and who had raised concentrations of atherogenic lipoproteins despite use of high-intensity statins. Patients were randomly assigned (1:1) to receive alirocumab or placebo every 2 weeks; randomisation was stratified by country and was done centrally with an interactive voice-response or web-response system. Alirocumab was titrated to target LDL cholesterol concentrations of 0·65–1·30 mmol/L. In this prespecified analysis, we investigated the effect of alirocumab on cardiovascular events by glycaemic status at baseline (diabetes, prediabetes, or normoglycaemia)—defined on the basis of patient history, review of medical records, or baseline HbA1c or fasting serum glucose—and risk of new-onset diabetes among those without diabetes at baseline. The primary endpoint was a composite of death from coronary heart disease, non-fatal myocardial infarction, fatal or non-fatal ischaemic stroke, or unstable angina requiring hospital admission. ODYSSEY OUTCOMES is ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
Lancet Diabetes and Endocrinology; http://hdl.handle.net/10044/1/72695 |
| DOI: |
10.1016/S2213-8587(19)30158-5 |
| Availability: |
http://hdl.handle.net/10044/1/72695; https://doi.org/10.1016/S2213-8587(19)30158-5 |
| Rights: |
© 2019 Elsevier Ltd. All rights reserved. This manuscript is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International Licence http://creativecommons.org/licenses/by-nc-nd/4.0/. |
| Accession Number: |
edsbas.A49C6199 |
| Database: |
BASE |