Inclisiran Lowers LDL-C and PCSK9 Irrespective of Diabetes Status: The ORION-1 Randomized Clinical Trial.
Diabetes Care
; 42(1): 173-176, 2019 01.
Article
em En
| MEDLINE
| ID: mdl-30487231
ABSTRACT
OBJECTIVE:
To evaluate the efficacy and safety of inclisiran by diabetes status. RESEARCH DESIGN ANDMETHODS:
ORION-1 (ClinicalTrials.gov, NCT02597127) randomized 501 subjects with atherosclerotic cardiovascular disease (ASCVD) or ASCVD risk equivalents and high LDL cholesterol (LDL-C), despite maximally tolerated LDL-C-lowering therapies, to one or two doses of placebo or inclisiran. Levels of lipids and proprotein convertase subtilisin/kexin type 9 (PCSK9) at baseline and day 180 were compared.RESULTS:
Inclisiran was associated with marked declines in LDL-C (median -28% to -52%, P < 0.0001 and -28% to -55%, P < 0.005 for all doses in the without- and with-diabetes groups, respectively) and PCSK9. The inclisiran-treated groups also had lower apolipoprotein B, non-HDL cholesterol, and lipoprotein(a) but higher HDL cholesterol. Inclisiran had an adverse profile similar to that of placebo, and adverse events were proportionally balanced in the baseline with- and without-diabetes groups.CONCLUSIONS:
PCSK9-targeted siRNA-driven strategies may provide a novel therapeutic option for managing dyslipidemia in the presence and absence of diabetes.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
RNA Interferente Pequeno
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Dislipidemias
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Pró-Proteína Convertase 9
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LDL-Colesterol
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article