{"id":"c3629382a1c9","type":"article","url":"https://hartvaat.nl/2019/07/09/alirocumab-en-mortaliteit-na-acs-odyssey-outcomes-analyse/","title":"Alirocumab en mortaliteit na ACS: ODYSSEY OUTCOMES-analyse","title_en":"Effect of Alirocumab on Mortality After Acute Coronary Syndromes.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.038840","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.038840","authors":["Philippe Gabriel Steg","Michael Szarek","Deepak L Bhatt","Vera A Bittner","Marie-France Brégeault","Anthony J Dalby","Rafael Diaz","Jay M Edelberg","Shaun G Goodman","Corinne Hanotin","Robert A Harrington","J Wouter Jukema","Guillaume Lecorps","Kenneth W Mahaffey","Angèle Moryusef","Petr Ostadal","Alexander Parkhomenko","Robert Pordy","Matthew T Roe","Pierluigi Tricoci","Robert Vogel","Harvey D White","Andreas M Zeiher","Gregory G Schwartz"],"significance":9,"published":"2019-07-09","source_date":"2019-07-09","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/pcsk9-remmers-evolocumab-alirocumab/"],"congress":"","summary_en":"This ODYSSEY OUTCOMES analysis demonstrated that alirocumab reduced all-cause mortality after acute coronary syndrome, particularly in patients with baseline LDL cholesterol ≥100 mg/dL. This was the first PCSK9 inhibitor trial to show a statistically significant mortality reduction.","created":"2026-07-03T10:28:02Z","updated":"2026-07-03T13:27:14Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"ODYSSEY OUTCOMES-analyse die het mortaliteitsvoordeel van alirocumab na ACS kwantificeerde. De eerste PCSK9-remmer die totale mortaliteit significant vermindert.","abstract_original":"BACKGROUND: Previous trials of PCSK9 (proprotein convertase subtilisin-kexin type 9) inhibitors demonstrated reductions in major adverse cardiovascular events, but not death. We assessed the effects of alirocumab on death after index acute coronary syndrome. METHODS: ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) was a double-blind, randomized comparison of alirocumab or placebo in 18 924 patients who had an ACS 1 to 12 months previously and elevated atherogenic lipoproteins despite intensive statin therapy. Alirocumab dose was blindly titrated to target achieved low-density lipoprotein cholesterol (LDL-C) between 25 and 50 mg/dL. We examined the effects of treatment on all-cause death and its components, cardiovascular and noncardiovascular death, with log-rank testing. Joint semiparametric models tested associations between nonfatal cardiovascular events and cardiovascular or noncardiovascular death. RESULTS: Median follow-up was 2.8 years. Death occurred in 334 (3.5%) and 392 (4.1%) patients, respectively, in the alirocumab and placebo groups (hazard ratio [HR], 0.85; 95% CI, 0.73 to 0.98; P=0.03, nominal P value). This resulted from nonsignificantly fewer cardiovascular (240 [2.5%] vs 271 [2.9%]; HR, 0.88; 95% CI, 0.74 to 1.05; P=0.15) and noncardiovascular (94 [1.0%] vs 121 [1.3%]; HR, 0.77; 95% CI, 0.59 to 1.01; P=0.06) deaths with alirocumab. In a prespecified analysis of 8242 patients eligible for ≥3 years follow-up, alirocumab reduced death (HR, 0.78; 95% CI, 0.65 to 0.94; P=0.01). Patients with nonfatal cardiovascular events were at increased risk for cardiovascular and noncardiovascular deaths ( P<0.0001 for the associations). Alirocumab reduced total nonfatal cardiovascular events ( P<0.001) and thereby may have attenuated the number of cardiovascular and noncardiovascular deaths. A post hoc analysis found that, compared to patients with lower LDL-C, patients with baseline LDL-C ≥100 mg/dL (2.59 mmol/L) had a greater absolute risk of death and a larger mortality benefit from alirocumab (HR, 0.71; 95% CI, 0.56 to 0.90; Pinteraction=0.007). In the alirocumab group, all-cause death declined with achieved LDL-C at 4 months of treatment, to a level of approximately 30 mg/dL (adjusted P=0.017 for linear trend). CONCLUSIONS: Alirocumab added to intensive statin therapy has the potential to reduce death after acute coronary syndrome, particularly if treatment is maintained for ≥3 years, if baseline LDL-C is ≥100 mg/dL, or if achieved LDL-C is low. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01663402."}