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Ridker, Paul M

Abstract 23073: Cardiovascular Efficacy of PCSK9 Inhibition Among 1,578 Patients With Familial Hypercholesterolemia: The SPIRE Clinical Trials FH Analysis

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  • Medientyp: E-Artikel
  • Titel: Abstract 23073: Cardiovascular Efficacy of PCSK9 Inhibition Among 1,578 Patients With Familial Hypercholesterolemia: The SPIRE Clinical Trials FH Analysis
  • Beteiligte: Ridker, Paul M
  • Erschienen: Ovid Technologies (Wolters Kluwer Health), 2017
  • Erschienen in: Circulation
  • Sprache: Englisch
  • DOI: 10.1161/circ.136.suppl_1.23073
  • ISSN: 0009-7322; 1524-4539
  • Schlagwörter: Physiology (medical) ; Cardiology and Cardiovascular Medicine
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:p> <jats:bold>Background:</jats:bold> Familial hypercholesterolemia (FH) is a genetic disorder with elevations of low-density lipoprotein cholesterol (LDLC) and premature atherosclerotic events. Therapeutic monoclonal antibodies that inhibit proprotein convertase subtilisin-kexin type 9 (PCSK9) are indicated for the reduction of LDLC in patients with FH, but placebo-controlled outcome data for FH patients are not available. </jats:p> <jats:p> <jats:bold>Objective:</jats:bold> To estimate the efficacy of PCSK9 inhibition with bococizumab on future cardiovascular events among FH and non-FH patients enrolled in the four 1-year SPIRE Lipid Lowering trials or in the two cardiovascular outcomes trials (SPIRE-1 and SPIRE-2). </jats:p> <jats:p> <jats:bold>Design, Setting, and Participants:</jats:bold> Six multinational, randomized, placebo-controlled trials inclusive of 1,578 patients with FH (molecular analysis or Simon Broome criteria) and 15,959 patients without FH and levels of LDLC ≥100 mg/dL or non-HDLC ≥130 mg/dL at trial entry. </jats:p> <jats:p> <jats:bold>Intervention:</jats:bold> Bococizumab 150 mg SC every 2 weeks or matching placebo. The median follow-up period was 49 weeks. </jats:p> <jats:p> <jats:bold>Main Outcomes and Measures:</jats:bold> Incident major adverse cardiovascular events (MACE) including nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. </jats:p> <jats:p> <jats:bold>Results:</jats:bold> Among FH patients, MACE occurred in 18 allocated to bococizumab and 22 to placebo (hazard ratio [HR]=0.83; 95% confidence interval [CI] 0.44-1.54, P=0.55). In the subgroup of 620 FH patients with LDLC ≥160 mg/dL, MACE occurred in 9 allocated to bococizumab and 13 to placebo (HR=0.74; 95% CI 0.31-1.75, P=0.49). For the 1,065 FH patients specifically enrolled in SPIRE-1 or SPIRE-2, MACE occurred in 11 allocated to bococizumab and 18 allocated to placebo (HR=0.64, 95% CI 0.30-1.35, P=0.24). These effect estimates are similar in magnitude to that observed in the 15,959 patients without FH (HR=0.79, 95% CI 0.64-0.97, P=0.023). </jats:p> <jats:p> <jats:bold>Conclusions and Relevance:</jats:bold> Statin-treated FH patients given the PCSK9 inhibitor bococizumab have a similar magnitude of risk reduction for hard cardiovascular events as do patients without FH. These data have importance for clinical practice and guidelines for cardiovascular disease prevention. </jats:p> <jats:p> <jats:bold>Trial Registration:</jats:bold> ClinicalTrials.gov: NCT01968954, NCT01968967, NCT02100514, NCT01968980, NCT01975376, NCT01975389 </jats:p>
  • Zugangsstatus: Freier Zugang