2005

JACC March 24, 2020

Volume 75, Issue 11

Prevention
EVALUATION OF LDL-C REDUCTIONS BY SIRNA TREATMENT WITH INCLISIRAN IN PATIENTS WITH
DIABETES MELLITUS, METABOLIC SYNDROME OR NEITHER
Poster Contributions
Posters Hall_Hall A
Sunday, March 29, 2020, 3:45 p.m.-4:30 p.m.

Session Title: Prevention: Clinical 6

Abstract Category: 32. Prevention: Clinical
Presentation Number: 1360-102

Authors: R. Scott Wright, David Kallend, Kausik Kumar Ray, Lawrence Leiter, Wolfgang Koenig, Frederick Raal, Peter Wijngaard, John
J.P. Kastelein, Mayo Clinic, Rochester, MN, USA
Background: Patients with diabetes (DM) and metabolic syndrome (MS) have elevated risks for atherosclerotic cardiovascular disease.
Aggressive LDL-C lowering reduces risks. Inclisiran, a new siRNA, lowers LDL-C and was evaluated in patients with type 2 diabetes (DM),
metabolic syndrome (MS) without DM or neither (N) in the ORION-10 trial.
Methods: ORION -10 was a double-blind, randomized, placebo controlled trial evaluating inclisiran in 1561 patients with ASCVD on
maximally tolerated therapy for lowering LDL-C. 781 inclisiran (INC) participants and 780 placebo (P) patients received 1.5 ml SQ tx at
days 1, 90, then every six months until day 540. We evaluated the time adjusted change in LDL-C from baseline after day 90 to 540 in DM
(n=702), MS (n=455) and N participants (n=404).
Results: There were no differences in baseline demographics and background therapies between INC and P. Statins were utilized in
89.8% INC and 88.7% of P. High intensity statins were utilized in 67.2% of INC and 68.8% of P; ezetimibe in 10.2% of INC and 9.5% of P
participants. INC reduced LDL-C by -54.4% (-58.3, -50.6 95% CI) in DM, (P<0.001), -58.6 % (-62.3, -54.8), P<0.001 in MS and -56.0 %
(-60.2, -51.7), in N subjects p<0.001 (see Figure).
Conclusion: Inclisiran potently and durably reduces LDL-C across patients with DM, MS and those with neither, demonstrating potent
efficacy and durability across glycemic categories. Inclisiran may also represent a potent LDL-C lowering treatment for those with DM and
MS.

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