A new type of cholesterol-lowering drug can reduce “bad cholesterol” levels by 60%

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A new type of cholesterol-lowering drug can reduce “bad cholesterol” levels by 60%

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A new type of cholesterol-lowering drug can reduce “bad cholesterol” levels by 60%

Lowering levels of low-density lipoprotein cholesterol (LDL-C, known as “bad cholesterol”) helps reduce the risk of atherosclerotic cardiovascular disease (ASCVD). However, most ASCVD patients fail to achieve the LDL-C target recommended by guidelines. Currently, statins are considered the first-line treatment for lowering cholesterol. For those patients who still have high cholesterol levels after statin treatment or cannot tolerate statin treatment, the use of new cholesterol-lowering drugs is crucial.

Drugs that inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9) have been proven to be an effective and well-tolerated treatment for hypercholesterolemia. In different patient groups, this type of therapy can continuously reduce LDL-C levels by 50% to 70%, and improve cardiovascular outcomes. Inclisiran, a novel small interfering RNA (siRNA) therapy targeting PCSK9, inhibits the synthesis of PCSK9, has a long duration of action, and is administered conveniently (subcutaneous injection twice a year).

The 73rd American College of Cardiology Scientific Session (ACC 2024) is currently underway, and during the conference, a study on this therapy (VICTORION-INITIATE) was presented.

The results showed that, compared to conventional treatment, the “inclisiran-first” strategy (adding inclisiran treatment immediately in patients receiving maximum tolerated statin therapy who failed to achieve LDL-C <70 mg/dL) can significantly reduce LDL-C levels (percentage change in LDL-C at 330 days: -60.0% vs. -7.0%; P<0.001). This study was also selected as a Featured Clinical Research (FCR) and the results were simultaneously published in JACC.

This prospective, randomized, multicenter, open-label phase 3b trial aimed to evaluate the effectiveness of the “inclisiran-first” strategy compared to conventional treatment (other lipid-lowering treatments at the discretion of the researchers) in achieving adequate lipid lowering in patients with ASCVD who were either receiving maximum tolerated statin therapy or were intolerant to statins.

The study included ASCVD patients aged ≥18 years who had previously received maximum tolerated statin therapy alone, with LDL-C ≥70 mg/dL or high-density lipoprotein cholesterol (HDL-C) ≥100 mg/dL, and randomly assigned 450 patients in a 1:1 ratio to the “inclisiran-first” group (inclisiran + conventional treatment; n=225) or the conventional treatment group (n=225). The median age of the patients was 67 years, with 30.9% being female. The baseline mean LDL-C level was 97.4 mg/dL. The follow-up time was 330 days. The primary endpoints were the percentage change in LDL-C from baseline and the statin discontinuation rate (the proportion of patients who discontinued statins for ≥30 days without previous statin intolerance).

Compared to conventional treatment, the “inclisiran-first” strategy significantly reduced LDL-C from baseline to day 330 (percentage change in LDL-C: -60.0% vs. -7.0%; P<0.001). Additionally, the statin discontinuation rate in the “inclisiran-first” group was non-inferior to that in the conventional treatment group (6.0% vs. 16.7%; treatment difference -10.6%, 97.5% CI -18.3% to -3.0%) (non-inferiority CI threshold +15.0%).

In terms of secondary outcomes at 330 days, compared to the conventional treatment group, more patients in the “inclisiran-first” group achieved LDL-C targets, and the safety profiles were similar between the two groups:

LDL-C reduction ≥50%: 69.8% vs. 5.3% (P<0.001).

LDL-C <70 mg/dL: 81.8% vs. 22.2% (P<0.001).

LDL-C <55 mg/dL: 71.6% vs. 8.9% (P<0.001).

Composite major adverse cardiovascular events (MACE): 2.7% vs. 2.2%.

The incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs was similar between the two groups (62.8% vs. 53.7% and 11.5% vs. 13.4%, respectively).

In summary, in ASCVD patients receiving maximum tolerated statin therapy with poor blood lipid control, the “inclisiran-first” strategy resulted in lower LDL-C levels compared to conventional treatment, without hindering the use of statins or causing new safety issues.

A new type of cholesterol-lowering drug can reduce “bad cholesterol” levels by 60%

References: 

[1] 403-08 – Comparison Of An “Inclisiran First” Strategy With Usual Care In Patients With Atherosclerotic Cardiovascular Disease: Results From The VICTORION-INITIATE Randomized Trial. Retrieved Apr 06, 2024 from https://www.abstractsonline.com/pp8/#!/10973/presentation/22715

[2] Michael J. Koren, et al., (2024). An Inclisiran First Strategy vs Usual Care in Patients with Atherosclerosis. J Am Coll Cardiol, DOI: 10.1016/j.jacc.2024.03.382

(source:internet, reference only)

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