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Can Clinicians Start Prescribing Inclisiran for Hypercholesterolemia Today? A Review of Clinical Studies for Internal Medicine Physicians and Endocrinologists

The safety profile and efficacy margin of inclisiran as a lipid-lowering drug have been assessed in clinical trials and are underway in subgroups with relevant co-morbidities. This systematic review looks at the clinical trials that have been conducted to comment on its safety and efficacy. The conc...

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Detalles Bibliográficos
Autores principales: Jahangir, Abdullah, Sahra, Syeda, Krzyzak, Michael
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cureus 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8388613/
https://www.ncbi.nlm.nih.gov/pubmed/34462692
http://dx.doi.org/10.7759/cureus.16664
Descripción
Sumario:The safety profile and efficacy margin of inclisiran as a lipid-lowering drug have been assessed in clinical trials and are underway in subgroups with relevant co-morbidities. This systematic review looks at the clinical trials that have been conducted to comment on its safety and efficacy. The conclusions can serve as a guide for practicing physicians and researchers for following current and future cohorts of patients. PubMed, Cochrane, Embase, Scopus, CINAHL, Web of Science, and Clinicaltrials.gov were searched comprehensively using the terms “Inclisiran”, “ALN-PCSsc”, and “ALN-PCS” using the Boolean operator “OR” with data cut-off date of June 28, 2020. The outcomes of safety and efficacy were collected and charted for the systematic review. In our study, eight clinical trials were included in the final study: the ORION (1,2,7,9-11) trials and two clinical trials (phase 1 randomized clinical trials) done before ORION trials. Favourable efficacy in terms of LDL levels and PSCK9 levels was observed across all eight clinical trials. No severe adverse effects, safety concerns, or fatalities attributable directly to inclisiran were reported. Therefore, our study results suggest a positive efficacy and safety profile of inclisiran as a lipid-lowering drug in clinical trials.