Lipid-Lowering Efficiency and Safety of Alirocumab 300 mg Using a 2-mL Autoinjector Device in Real-World Practice: The MARS Study.

IF 1.9 Q3 PHARMACOLOGY & PHARMACY Drugs - Real World Outcomes Pub Date : 2025-03-01 Epub Date: 2025-01-28 DOI:10.1007/s40801-024-00471-w
Klaus G Parhofer, Peter Bramlage, Constanze Gries, Cornelia Harder, Christiane Look, W Dieter Paar, Ursula Rauch-Kröhnert
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Abstract

Background: Alirocumab is a fully human monoclonal antibody to proprotein convertase subtilisin kexin type 9 used for the reduction of low-density lipoprotein cholesterol (LDL-C) in high-risk patients not reaching their LDL-C target. Recently, a 2-mL prefilled autoinjector has been developed to support the monthly 300-mg dosing regimen with a single-injection administration.

Methods and objectives: Monthly application of 300 mg AlirRocumab (Praluent®) using the 2-mL SYDNEY Device (MARS) is a non-interventional, open, prospective, multi-center cohort study conducted in Germany between 2021 and 2023 with an observational period of 12 weeks. Patients included had primary hypercholesterolemia (heterozygous familial or non-familial) or mixed dyslipidemia and confirmed vascular disease and other risk factors or confirmed familial heterozygous hypercholesterolemia. Primary objectives were to assess the effectiveness of the 2-mL SYDNEY autoinjector measured by the lipid-lowering effect of alirocumab and to document therapy satisfaction, patient adherence, and persistence. Secondary objectives were to assess safety (adverse events) and tolerability.

Results: A total of 146 patients were analyzed: 110 (75.3%) patients were proprotein convertase subtilisin kexin type 9 inhibitor naïve and 36 (24.7%) were pre-treated with a proprotein convertase subtilisin kexin type 9 inhibitor. Patient mean age was 65.6 years with a preponderance of male gender (59.6%). At 12 weeks, the LDL-C value had decreased by a median of 59.5 mg/dL (1.5 mmol/L) in naïve patients (median relative decrease: - 52.0%). In the pre-treated group, the LDL-C value remained mainly unchanged (median slight numerical relative increase: 1.6%). Treatment satisfaction was rated similarly in both groups with most patients being satisfied/very satisfied and rating the injection as effective, safe, and easy to handle. Twenty-three adverse events in 13 patients (8.0%) were documented. Three patients experienced one serious adverse event each; for five patients, an adverse drug reaction was observed, although none was serious. The occurrence of adverse events was similar in both groups.

Conclusions: Alirocumab 300 mg administered with the 2-mL SYDNEY autoinjector was safe and effective in lowering LDL-C after 12 weeks in a routine clinical setting in Germany. The treatment schedule was perceived to be beneficial with excellent device acceptance and satisfaction, potentially increasing patient adherence.

Clinical trial registration: Clinicaltrials.gov: NCT05129241.

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来源期刊
Drugs - Real World Outcomes
Drugs - Real World Outcomes PHARMACOLOGY & PHARMACY-
CiteScore
3.60
自引率
5.00%
发文量
49
审稿时长
8 weeks
期刊介绍: Drugs - Real World Outcomes targets original research and definitive reviews regarding the use of real-world data to evaluate health outcomes and inform healthcare decision-making on drugs, devices and other interventions in clinical practice. The journal includes, but is not limited to, the following research areas: Using registries/databases/health records and other non-selected observational datasets to investigate: drug use and treatment outcomes prescription patterns drug safety signals adherence to treatment guidelines benefit : risk profiles comparative effectiveness economic analyses including cost-of-illness Data-driven research methodologies, including the capture, curation, search, sharing, analysis and interpretation of ‘big data’ Techniques and approaches to optimise real-world modelling.
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