ODYSSEY OUTCOMES is registered with, number NCT01663402.Īt study baseline, 5444 patients (28♸%) had diabetes, 8246 (43♶%) had prediabetes, and 5234 (27♷%) had normoglycaemia.

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. 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 HbA 1c or fasting serum glucose-and risk of new-onset diabetes among those without diabetes at baseline. Alirocumab was titrated to target LDL cholesterol concentrations of 0♶5-1♳0 mmol/L.

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. 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. 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. 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. A reduction in mean LDL cholesterol to 1♴-1♸ mmol/L with ezetimibe or statins reduces cardiovascular events in patients with an acute coronary syndrome and diabetes. After acute coronary syndrome, diabetes conveys an excess risk of ischaemic cardiovascular events.

Loving Leonardo by Rose Anderson