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Original Research
Inclisiran Lowers LDL-C and PCSK9 Irrespective of Diabetes Status: The ORION-1 Randomized Clinical Trial
Lawrence A. Leiter, Hwee Teoh, David Kallend, R. Scott Wright, Ulf Landmesser, Peter L.J. Wijngaard, John J.P. Kastelein, Kausik K. Ray
Diabetes Care 2018 Nov; dc181491. https://doi.org/10.2337/dc18-1491
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Abstract

OBJECTIVE To evaluate the efficacy and safety of inclisiran by diabetes status.

RESEARCH DESIGN AND METHODS 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.

Footnotes

  • This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc18-1491/-/DC1.

  • Received July 12, 2018.
  • Accepted October 21, 2018.
  • © 2018 by the American Diabetes Association.
http://www.diabetesjournals.org/content/license

Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.

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Inclisiran Lowers LDL-C and PCSK9 Irrespective of Diabetes Status: The ORION-1 Randomized Clinical Trial
Lawrence A. Leiter, Hwee Teoh, David Kallend, R. Scott Wright, Ulf Landmesser, Peter L.J. Wijngaard, John J.P. Kastelein, Kausik K. Ray
Diabetes Care Nov 2018, dc181491; DOI: 10.2337/dc18-1491

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Inclisiran Lowers LDL-C and PCSK9 Irrespective of Diabetes Status: The ORION-1 Randomized Clinical Trial
Lawrence A. Leiter, Hwee Teoh, David Kallend, R. Scott Wright, Ulf Landmesser, Peter L.J. Wijngaard, John J.P. Kastelein, Kausik K. Ray
Diabetes Care Nov 2018, dc181491; DOI: 10.2337/dc18-1491
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