Lipid lowering with inclisiran: a single-center experience from Slovakia

Q: What are the key findings of this study?

Inclisiran significantly reduced LDL-C levels by a median of 57.5% compared to baseline in patients with very high cardiovascular risk in a real-world clinical setting.

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Hyperlipidemia with very high cardiovascular risk (n=36). Intervention: Inclisiran vs. Baseline. Primary outcome: Relative reduction in LDL-C (p=<0.001).

Štefan Tóth; Marianna Vachalcová; Adriana Jarolimkova; Martin Sevcik; Tibor Porubän

doi:10.36290/far.2025.017

April 29, 2025Klinická farmakologie a farmacieOpen Access

Lipid lowering with inclisiran: a single-center experience from Slovakia

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Key result

Inclisiran is linked to ~58% LDL-C reduction in real-world patients with very high cardiovascular risk.

P<0.001
n=36

Why the study?

The study aimed to describe the real-world clinical effects and initial clinical experience with inclisiran in Slovakia.

Does inclisiran reduce LDL-C levels in patients with very high cardiovascular risk on intensive lipid-lowering therapy?

Study Design

Type

Observational (n=36)

Blinding

Open-label

Multicenter

No

Structured PICO

Does inclisiran reduce LDL-C levels in patients with very high cardiovascular risk on intensive lipid-lowering therapy?

P

Population

36 patients with very high cardiovascular risk (75% atherosclerotic coronary artery disease, 25% prior stroke), mean age 60.2 ± 7.1 years, 69.4% male, from Slovakia. Key inclusion: LDL-C > 2.5 mmol/L despite intensive lipid-lowering therapy (maximum tolerated statin + ezetimibe, or statin intolerance) or heterozygous familial hypercholesterolemia with LDL-C > 3.1 mmol/L.

I

Intervention

Inclisiran 284 mg subcutaneous injection initially, followed by a second dose after 3 months, and a third dose after 6 months.

O

Outcome

Efficacy (relative reduction in LDL-C) and safety (adverse effects identified during regular check-ups)surrogate

Main Result

p-value: p=<0.001

In a real-world Slovakian cohort, inclisiran effectively reduced LDL-C by a median of 57.5% in very high-risk cardiovascular patients, with a safety profile consistent with clinical trials.

Limitations

Observational study design relying on patient-reported information
Lack of drug or metabolite concentration measurements
Potential non-adherence to accompanying lipid-lowering therapy
Highly heterogeneous cohort with various diagnoses and baseline therapies
Did not distinguish between statin monotherapy and statin plus ezetimibe combination therapy
Small sample size
Single-center observational design

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Implication

Supports inclisiran in very high-risk patients; extends trial data but leaves practice change open pending RCTs.

Abstract

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Discussion

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Cite This Study

Tóth et al. (2025) conducted an observational in Hyperlipidemia with very high cardiovascular risk (n=36). Inclisiran vs. Baseline was evaluated on Relative reduction in LDL-C (p=<0.001). Inclisiran significantly reduced LDL-C levels by a median of 57.5% compared to baseline in patients with very high cardiovascular risk in a real-world clinical setting.

synapsesocial.com/papers/6a0f97084fb650da4ffe4938 https://doi.org/10.36290/far.2025.017

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Lipid lowering with inclisiran: a single-center experience from Slovakia

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Lipid lowering with inclisiran: a single-center experience from Slovakia

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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