Mayo Clinic Principal Investigator Dr. Scott Wright reveals that The Medicines Company ORION-10 clinical trial reveals investigational treatment inclisiran evidenced positive results in lowering LDL-C (bad cholesterol) relative to placebo.
Addressing ASCVD & LDL-C
As WebMD reports ASCVD is a hardening and narrowing of the patient’s arteries. It can put blood flow at risk as the arteries become blocked. It is often the cause of heart attacks, strokes and peripheral vascular disease and hence must be dealt with. The process can be prevented and treated. The earlier the better.
Low-density lipoprotein cholesterol (LDL-C) or bad cholesterol because it can lead to eventual build up within the walls of the blood vessels and narrow the passageways. Sometimes a clot can form and get stuck in the narrowed space, causing a heart attack or stroke.
The ORION-10 Clinical Trial
The ORION-10 clinical trial included a placebo-controlled, double-blind, randomized trial to evaluate the effect of 300 mg of Inclisiran sodium given as subcutaneous injections in patients with atherosclerotic cardiovascular disease (ASCVD) and elevated low-density lipoprotein cholesterol (LDL-C).
Sponsored by The Medicines Company, the trial included 1,561 planned participants and continued for two years from 2017 to 2019. With 145 participating clinical investigational sites, the study principal investigator was Scott Wright with Mayo Clinic.
What is Inclisiran?
Inclisiran is produced by The Medicines Company. It is a small interfering RNA (siRNA) therapy being studied to evaluate its ability to lower low-density lipoprotein (LDL) cholesterol—also known as LDL-C or bad cholesterol. It is designed to prevent the production of proprotein convertase subtilisin/kexin type 9 (PCSK9) at its primary source in the liver. Inclisiran is not yet approved for use by the FDA or any other regulatory authority.
As reported by The Medicines Company, the ORION program includes pivotal Phase III trials (ORION-9, ORION-10 and ORION-11) designed to evaluate the safety and efficacy of inclisiran in people with ASCVD and elevated LDL-C despite maximum tolerate dose of LDL-C lowering therapies, as well as with individuals with familial hypercholesterolemia (FH). In these trials reports the industry sponsor, the patients receive inclisiran or placebo on day one, again at day 90 (three months), then every six months thereafter for a total of four doses over the respective studies’ duration.
ORION-10 was recently summarized by Principal Investigator R. Scott Wright, MD. Follow the link for Dr. Wright’s summary in Professional Heart Daily. They reported that the results were positive. First the investigational drug showed evidence of lowering LDL-C (bad cholesterol) relative to placebo. The study revealed no evidence of liver, kidney, muscle or platelet toxicity. Moreover, there was no difference in serious adverse event between Inclisiran group and placebo. See the source link for primary endpoints.
R. Scott Wright, MD, Division of Structural Heart Disease, Department of Cardiovascular Medicine at The Mayo Clinic