Raul Santos Shares The Results of ORION-16: On The Efficacy and Safety of Inclisiran
Raul Santos, Researcher at ARO Hospital Israelita Albert Einstein, shared on LinkedIn:
”I’m delighted to share the results of ORION-16, which demonstrate the efficacy and safety of Inclisiran, a siRNA inhibitor of PCSK9, in pediatric patients with heterozygous familial hypercholesterolemia (FH) who had elevated LDL-C despite statin therapy.
Overall, LDL-C was reduced by 28-34%, with excellent tolerability.
Results are consistent with those of monoclonal antibodies, a 34-45% reduction that we had demonstrated in recent years.
Apparently, pediatric patients present less intense responses, albeit variable from person to person, than adults, despite similar reductions in circulating PCSK9.
In my opinion, this may result in possible lower adherence to baseline medications that were not disclosed or due to a different biology. Indeed, children and adolescents are not miniature adults.
ORION-16 reinforces the efficacy and safety of PCSK9 inhibitors in pediatric heterozygous FH.
It opens the possibility of a different posology to reduce LDL-C in patients who have severe hypercholesterolemia and remain with very high LDL-C despite statin and or ezetimibe therapy.
I’d like to thank Prof. Albert Wiegman and Novartis for the possibility to participate in this study.”
Read the full article here.
Article: Efficacy and safety of inclisiran in adolescents with heterozygous familial hypercholesterolaemia (ORION-16): a two-part, randomised, multicentre clinical trial
Authors: Albert Wiegman, Amy L. Peterson, Eric Bruckert, Joep C. Defesche, Anja Schweizer, Jean Bergeron, María J. Chueca, Jeanine E. Roeters van Lennep, Raul D. Santos, Karl Otfried Schwab, Anastasia Lesogor, Sijia Zhang, Robert A. Hegele
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