What is the clinical evidence from this study?

Study design: Observational. Population: Hypercholesterolemia (n=65). Intervention: Inclisiran vs. PCSK9 monoclonal antibodies (for switch group). Primary outcome: Median change in LDL-C levels at 3 months.

What question did this study set out to answer?

To evaluate the real-world efficacy, lipid-lowering potency, and safety profile of inclisiran in clinical practice among treatment-naive patients and those switching from PCSK9 monoclonal antibodies.

September 18, 2023Journal of clinical lipidologyOpen Access

First clinical experiences with inclisiran in a real-world setting

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Key result

Starting inclisiran is linked to ~38% lower LDL-C, but switching from PCSK9 mAbs shows an increase.

n=65

Why the study?

Data on the efficacy and safety of inclisiran in real-world clinical practice are scarce despite proven efficacy in clinical trials.

Does inclisiran reduce LDL-C levels in a real-world clinical setting?

Key Points

To evaluate the real-world efficacy, lipid-lowering potency, and safety profile of inclisiran in clinical practice among treatment-naive patients and those switching from PCSK9 monoclonal antibodies.
Conducted a single-center registry of 65 consecutive patients (median age 63 years; 36 women) initiating inclisiran under reimbursement criteria in the Netherlands.
Categorized patients into group 1 (first-line inclisiran, n=45) or group 2 (switched from PCSK9 monoclonal antibodies to inclisiran, n=20).
Assessed median percentage changes in LDL-C and adverse events at 3-month and 9-month follow-up visits (44 patients completed both visits).
Treatment-naive patients (group 1) achieved a median LDL-C reduction of 38% [25th–75th percentile: -49% to -33%] at 3 months, with greater reductions observed in those receiving concurrent statin therapy (45% vs. 38% without statins).
Patients switching from PCSK9 monoclonal antibodies to inclisiran (group 2) experienced a median LDL-C increase of 38% [25th–75th percentile: +4% to +97%] at 3 months.
Adverse effects were mild, mainly limited to injection-site reactions, with safety remaining consistent and efficacy slightly lower at 9 months.

Study Design

Type

Observational (n=65)

Multicenter

Structured PICO

Does inclisiran reduce LDL-C levels in a real-world clinical setting?

Population

65 patients (36 women, median age 63 years) at a lipid clinic in the Netherlands who started inclisiran as first line (n=45) or switched from PCSK9 monoclonal antibodies (n=20).

Intervention

Inclisiran initiation (either as first-line or switching from PCSK9 monoclonal antibodies).

Outcome

Median change of LDL-C levels at 3 and 9 months after initiation.surrogate

Main Result

Absolute Event Rate: -38% vs 38%

Real-world experience with inclisiran shows a 38% LDL-C reduction in naive patients, which is less than in clinical trials, and an unexpected LDL-C increase in patients switching from PCSK9 monoclonal antibodies.

Discussion

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Implication

Attenuated real-world LDL-C response to inclisiran warrants caution on switching from mAbs; hypothesis-generating for optimal use.

Cite This Study

Mulder et al. (2023) conducted an observational in Hypercholesterolemia (n=65). Inclisiran vs. PCSK9 monoclonal antibodies (for switch group) was evaluated on Median change in LDL-C levels at 3 months. In a real-world registry, newly starting inclisiran reduced LDL-C by 38% at 3 months, whereas switching from PCSK9 mAbs to inclisiran resulted in a 38% increase in LDL-C.

synapsesocial.com/papers/6a155ee15347fbb1739fac6c https://doi.org/10.1016/j.jacl.2023.09.005

Topics

Statin therapy

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First clinical experiences with inclisiran in a real-world setting

Key Points

Study Design

Structured PICO

Main Result

Discussion

Implication

Cite This Study

Topics

First clinical experiences with inclisiran in a real-world setting

Key Points

Study Design

Structured PICO

Main Result

Discussion

Implication

Cite This Study

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Topics

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