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V-INITIATE: LEQVIO® in a real-world setting

 

Study Design1

 

A 12-month, randomized, open-label, Phase IIIb study in patients with ASCVD (N=450) evaluated the efficacy and safety of early initiation with LEQVIO® immediately upon failure to reach LDL-C <70 mg/dL on maximally tolerated statin vs usual care in a real-world setting. A prospective, pragmatically designed trial, randomized patients 1:1 to inclisiran (284 mg at days 0, 90, and 270) plus usual care (lipid management at treating physician’s discretion) vs usual care alone.

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Patients with atherosclerotic cardiovascular disease with low-density lipoprotein cholesterol ≥70 mg/dL or non-high-density lipoprotein cholesterol ≥100 mg/dL, and fasting triglycerides <500 mg/dL, receiving maximally tolerated statin therapy (or with documented statin intolerance), were randomized 1:1 to receive inclisiran first or usual care. Syringes represent inclisiran doses. 
aPrimary analysis time point.

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In the V-INITIATE clinical trial, LEQVIO® demonstrated:
 

  • 53% LDL-C reduction difference from usual care.1
  • 82% of patients with ASCVD achieved LDL-C target (<70 mg/dL) vs 22% in usual care.1
  • 71.6% of patients with ASCVD achieved LDL-C target (<55 mg/dL) vs 8.9% in usual care.1
  • The safety profile of LEQVIO® was consistent with pivotal trials.1,2

Primary endpoints: were percentage change in LDL-C from baseline and statin discontinuation rates.1

Early LEQVIO® use after failure to reach LDL-C target on statin1

 

V-INITIATE compared immediate LEQVIO® use after failure to reach LDL-C target with maximally tolerated statin vs usual care, which was physician-determined based on the 2018 AHA/ACC guidelines.1

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Statin Discontinuation in LEQVIO® vs Usual Care1

 

V-INITIATE compared immediate LEQVIO® use after failure to reach LDL-C target with maximally tolerated statin vs usual care,which was physician-determined based on the 2018 AHA/ACC guidelines.1

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In the usual care arm, most patients (73%) remained on statins only, with a minority of patients receiving any additional non statin lipid-lowering therapy, including 4% of patients who received atl east 1 dose of LEQVIO®.1

 

Patients with ASCVD achieved LDL-C target (<70 mg/dL)1

 

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Patients with ASCVD achieved LDL-C target (<55 mg/dL)1

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Safety profile consistent with Phase III trials1,2

Injection site reactions were the most common cause for treatment discontinuation (0.2% of patients taking LEQVIO® vs 0% taking placebo)2
 

In V-INITIATE (N=450), a randomized open-label Phase IIIb study in a real-world setting:

  • The safety profile of LEQVIO® was consistent with pivotal trials1,2
  • No new safety signals1

ASCVD, atherosclerotic cardiovascular disease; LDL-C, low-density lipoprotein cholesterol; EOS, end of study; ACC, American College of Cardiology; AHA, the American Heart Association; CI, Confidence interval.

LEQVIO® NSS -  UAE

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References

  1. Koren MJ, Rodriguez F, East C, et al. An “Inclisiran First” Strategy vs Usual Care in Patients With Atherosclerotic Cardiovascular Disease. J Am Coll Cardiol. 2024 May 21;83(20):1939-1952.

  2. LEQVIO®. Summary of product characteristics. Novartis Europe Limited.