Leqvio Shows Effective LDL-C Reduction in ASCVD Risk Patients
Leqvio Demonstrates Significant LDL-C Lowering
Novartis has announced the positive results of the Phase III V-MONO study involving Leqvio (inclisiran), highlighting its potential as a monotherapy for patients at low or moderate risk of developing atherosclerotic cardiovascular disease (ASCVD). This study met its primary endpoints, showcasing the superiority of Leqvio in lowering low-density lipoprotein cholesterol (LDL-C) compared to both placebo and ezetimibe.
Phase III V-MONO Study Overview
The V-MONO study, part of the broader VictORION clinical trial program, included randomized patients not receiving lipid-lowering therapy. It involved 350 participants, split into three groups: one receiving inclisiran, one receiving ezetimibe, and a placebo group. The major objective was to assess the percent change in LDL-C from baseline levels to Day 150.
This trial is notable for being the first to evaluate siRNA therapy as a standalone treatment to effectively lower LDL-C in individuals at low or moderate risk of ASCVD. With its twice-a-year dosing schedule after an initial dose and a follow-up at three months, Leqvio aims to address adherence issues commonly seen with traditional cholesterol management medications.
Implications of V-MONO Results
Following the successful results, Novartis plans to share the findings with regulatory authorities and present them at upcoming medical conferences. As highlighted by Dr. Shreeram Aradhye, President and Chief Medical Officer at Novartis, this trial contributes significantly to the existing research on Leqvio and its application across the spectrum of ASCVD.
Advancement in Cardiovascular Treatments
Leqvio is positioned as a revolutionary option amidst ongoing studies in primary and secondary prevention settings. The VictORION-1-PREVENT study targets a high-risk primary prevention demographic, and enrollment is expected to conclude shortly. In secondary prevention contexts, outcome studies such as ORION-4 and VICTORION-2-PREVENT are set for data disclosures in subsequent years.
Understanding Atherosclerotic Cardiovascular Disease (ASCVD)
Atherosclerotic cardiovascular disease is a leading cause of mortality globally, accounting for 85% of cardiovascular deaths. Risk factors for CVD often lead to plaque buildup in arteries, primarily composed of LDL-C, which can result in severe cardiovascular events, including heart attacks and strokes. Efforts to minimize LDL-C levels through effective medications can significantly reduce the risk of such life-threatening complications.
About Novartis and Its Commitment to CVD
Novartis aims to ensure that preventable cardiovascular deaths are no longer a part of our future. Dedicated to addressing the grave challenges posed by CVD, the company has made significant strides over the past several decades in developing innovative treatment options. By actively engaging in collaboration with various organizations, healthcare professionals, and patients, Novartis strives to improve cardiovascular care beyond traditional medicinal approaches.
Frequently Asked Questions
What is Leqvio and how does it work?
Leqvio (inclisiran) is a novel siRNA therapy designed to lower LDL-C levels through subcutaneous injections, administered by healthcare professionals. Its unique approach allows for biannual dosing after initial treatment.
What were the main findings of the V-MONO study?
The study demonstrated that Leqvio monotherapy significantly reduced LDL-C compared to placebo and ezetimibe in patients at low or moderate ASCVD risk, validating its effectiveness in cholesterol management.
How does Leqvio compare to traditional lipid-lowering therapies?
Unlike conventional therapies that may require daily administration, Leqvio offers a twice-yearly treatment option, potentially enhancing patient adherence and therapeutic outcomes.
What is the VictORION clinical trial program?
The VictORION program encompasses a series of clinical trials aimed at establishing the effectiveness of Leqvio in various patient populations and settings, including studies focused on primary and secondary cardiovascular disease prevention.
How does Novartis contribute to cardiovascular health?
Novartis is committed to tackling cardiovascular disease through innovative research and collaboration. The company's ongoing development of effective therapies seeks to improve patient outcomes and reduce the burden of heart-related conditions globally.
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