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Pharmacists play an essential role in ensuring the medication is dispensed to patients with high atherosclerotic cardiovascular disease risk.
Novartis announced positive topline results from the phase 3 V-MONO (NCT05763875) study, which evaluated twice yearly inclisiran (Leqvio; Novartis Pharmaceuticals) as a monotherapy in patients at low or moderate risk of developing atherosclerotic cardiovascular disease (ASCVD) and not receiving lipid-lowering therapy, according to a news release from the company.1
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The trial met its primary end points, successfully lowering low-density lipoprotein cholesterol (LDL-C) in a clinically meaningful and statistically significant manner compared to both placebo and ezetimibe (Zetia; Merck, Schering-Plough Pharmaceuticals).1
“We are proud that we continue to advance the scientific understanding of using [small interfering RNA] siRNA therapy to tackle one of the world’s biggest health care challenges, as too many people still struggle to reach their cholesterol goals,” Shreeram Aradhye, MD, president of development and chief medical officer of Novartis, said in the news release. “This trial adds to the growing body of evidence for Leqvio across the full spectrum of ASCVD as we strive to help more patients in need.”1
Inclisiran is the first and only siRNA therapy to lower LDL-C. The drug is injected subcutaneously with injections given by a health care provider as an initial dose, a 3-month dose, and then every 6 months. This treatment schedule could help ease the challenges surrounding treatment adherence, which Novartis notes is a common problem in managing cholesterol.1
Trial Name: Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy (V-Mono)
ClinicalTrials.gov ID: NCT05763875
Sponsor: Novartis Pharmaceuticals
Completion Date: June 6, 2024
Beginning in early 2023, V-MONO was a randomized, double-blind, placebo-controlled, multicenter study that enrolled over 300 adult participants. Individuals in the study also had to have a 10-year ASCVD risk of less than 7.5%, and were enrolled to receive either inclisiran (n = 174), ezetimibe (n = 89), or placebo (n = 87).1,2
According to the news release, V-MONO is the first trial evaluating siRNA therapy as a monotherapy to lower LDL-C risk in this patient population. Results from the trial are to be presented by Novartis at an upcoming medical meeting and will be shared with regulatory agencies, including the FDA.1
Pharmacists have a major involvement in the management of inclisiran as they ensure the treatment is received and establishing models of payment for the drug. Luke Gormley, PharmD, BCPS, spoke to the initiatives pharmacists can take to ensure that patients remain on their treatment schedules.3
In his system at Allegheny Health Network, Gormley had his pharmacists “help our clinicians identify candidates, help the teams figure out how to submit for medication approvals and procure the medication,” as well as determine how to properly bill for the medication.3
“We want to make this as easy as possible for our clinicians who may be thinking about using this medication in the near future,” Gormley said, noting the differences from a management perspective that come with this cardiovascular medication. Given the announcement from Novartis, it will likely remain critical that pharmacists are educated on inclisiran and can ensure patients adhere to their treatment.3
ASCVD is a common cause of death from cardiovascular disease, accounting for 85% of deaths. The disease is caused by the development of plaques in the inner lining of arteries, mainly composed of LDL-C that can accumulate over time. Cumulative exposure increases a patient’s risk of CV events such as stroke or heart attack.1
Multiple other studies are currently ongoing to evaluate the possible use of inclisiran across both primary and secondary prevention. One trial, VICTORION-1-PREVENT (NCT05739383), is “the only dedicated study of a non-statin lipid-lowering therapy in a high-risk primary prevention population,” according to Novartis. This trial is expected to complete enrollment later this year.1
