Physicians' Academy for Cardiovascular Education

Sustained LDL-c lowering up to 360 days with siRNA directed against PCSK9 in phase 2 study

ORION 1: LDL-C Reduction From 6 to 9 Months Following Single or Second Injection of Inclisiran, a Novel siRNA Compound: Primary Efficacy and Safety Outcomes of the ORION 1 Trial

Presented at ACC.17 by Kausik Ray

News - Mar. 16, 2017

Main results

Conclusion

This study shows that 300 mg given twice as a starting regimen, then followed by a 6-monthly regimen, seems to be a safe and effective regimen to lower LDL-c. The unique attributes of inclisiran address multiple unmet needs, since LDL-c variability within individuals is practically eliminated by this approach. Furthermore, it reduces injection burden substantially. A sustained effect between infrequent injections is seen. The dosing regimen provides an opportunity to improve patient adherence.

These results may translate into a considerable reduction of CV endpoints, which will be tested in the ORION-4 outcomes study in patients with high risk and average LDL-c of about 130 mg/dL.

Disclosures

Our coverage of ACC.17 is based on the information provided during the congress.

This study was published today in NEJM

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