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dc.contributor.authorSchwartz, GG
dc.contributor.authorSteg, PG
dc.contributor.authorSzarek, M
dc.contributor.authorBhatt, DL
dc.contributor.authorBittner, VA
dc.contributor.authorDiaz, R
dc.contributor.authorEdelberg, JM
dc.contributor.authorGoodman, SG
dc.contributor.authorHanotin, C
dc.contributor.authorHarrington, RA
dc.contributor.authorJukema, JW
dc.contributor.authorLecorps, G
dc.contributor.authorMahaffey, KW
dc.contributor.authorCoverdale, Steven
dc.contributor.authoret al.
dc.date.accessioned2020-12-15T04:31:34Z
dc.date.available2020-12-15T04:31:34Z
dc.date.issued2018
dc.identifier.issn0028-4793en_US
dc.identifier.doi10.1056/NEJMoa1801174en_US
dc.identifier.urihttp://hdl.handle.net/10072/400231
dc.description.abstractBACKGROUND Patients who have had an acute coronary syndrome are at high risk for recurrent ischemic cardiovascular events. We sought to determine whether alirocumab, a human monoclonal antibody to proprotein convertase subtilisin-kexin type 9 (PCSK9), would improve cardiovascular outcomes after an acute coronary syndrome in patients receiving high-intensity statin therapy. METHODS We conducted a multicenter, randomized, double-blind, placebo-controlled trial involving 18,924 patients who had an acute coronary syndrome 1 to 12 months earlier, had a low-density lipoprotein (LDL) cholesterol level of at least 70 mg per deciliter (1.8 mmol per liter), a non-highdensity lipoprotein cholesterol level of at least 100 mg per deciliter (2.6 mmol per liter), or an apolipoprotein B level of at least 80 mg per deciliter, and were receiving statin therapy at a high-intensity dose or at the maximum tolerated dose. Patients were randomly assigned to receive alirocumab subcutaneously at a dose of 75 mg (9462 patients) or matching placebo (9462 patients) every 2 weeks. The dose of alirocumab was adjusted under blinded conditions to target an LDL cholesterol level of 25 to 50 mg per deciliter (0.6 to 1.3 mmol per liter). The primary end point was a composite of death from coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization. RESULTS The median duration of follow-up was 2.8 years. A composite primary end-point event occurred in 903 patients (9.5%) in the alirocumab group and in 1052 patients (11.1%) in the placebo group (hazard ratio, 0.85; 95% confidence interval [CI], 0.78 to 0.93; P<0.001). A total of 334 patients (3.5%) in the alirocumab group and 392 patients (4.1%) in the placebo group died (hazard ratio, 0.85; 95% CI, 0.73 to 0.98). The absolute benefit of alirocumab with respect to the composite primary end point was greater among patients who had a baseline LDL cholesterol level of 100 mg or more per deciliter than among patients who had a lower baseline level. The incidence of adverse events was similar in the two groups, with the exception of local injection-site reactions (3.8% in the alirocumab group vs. 2.1% in the placebo group). CONCLUSIONS Among patients who had a previous acute coronary syndrome and who were receiving highintensity statin therapy, the risk of recurrent ischemic cardiovascular events was lower among those who received alirocumab than among those who received placebo.en_US
dc.description.peerreviewedYesen_US
dc.languageEnglish
dc.language.isoeng
dc.publisherMassachusetts Medical Societyen_US
dc.relation.ispartofpagefrom2097en_US
dc.relation.ispartofpageto2107en_US
dc.relation.ispartofissue22en_US
dc.relation.ispartofjournalNew England Journal of Medicineen_US
dc.relation.ispartofvolume379en_US
dc.subject.fieldofresearchMedical and Health Sciencesen_US
dc.subject.fieldofresearchcode11en_US
dc.titleAlirocumab and cardiovascular outcomes after acute coronary syndromeen_US
dc.typeJournal articleen_US
dc.type.descriptionC1 - Articlesen_US
dcterms.bibliographicCitationSchwartz, GG; Steg, PG; Szarek, M; Bhatt, DL; Bittner, VA; Diaz, R; Edelberg, JM; Goodman, SG; Hanotin, C; Harrington, RA; Jukema, JW; Lecorps, G; Mahaffey, KW; Coverdale, S; et al, Alirocumab and cardiovascular outcomes after acute coronary syndrome, New England Journal of Medicine, 2018, 379 (22), pp. 2097-2107en_US
dc.date.updated2020-12-15T04:22:26Z
dc.description.versionVersion of Record (VoR)en_US
gro.rights.copyright© 2018 Massachusetts Medical Society. The attached file is reproduced here in accordance with the copyright policy of the publisher. Please refer to the journal's website for access to the definitive, published version.en_US
gro.hasfulltextFull Text
gro.griffith.authorCoverdale, Steven


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