Copyright: © 2025 by the authors. Licensee: Pirogov University.
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OPINION

Ethical and clinical dilemmas of using lipid-lowering therapy in children with hereditary dyslipidemia

Yeregin SY, Klyuyeva PA
About authors

Yaroslavl State Medical University, Yaroslavl, Russia

Correspondence should be addressed: Polina A. Klyueva
Revolutsionnaya str., 5, Yaroslavl, 150000, Russia; ur.liam@anilop_aveyuylk

About paper

Author contribution: the authors contributed equally to the work.

Received: 2025-09-22 Accepted: 2025-10-28 Published online: 2025-11-21
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The article reviews the bioethical concern in providing lipid-lowering therapy to children with hereditary dyslipidemia. The concern is associated with the gap between clinical recommendations and official prescribing information. The purpose of the research was to perform a comparative analysis of regulatory documents, clinical recommendations and prescribing information of 11 medicinal preparations including statins, cholesterol absorption inhibitors, fibrates, omega-3 polyunsaturated fatty acids and PCSK9 inhibitors. The analysis has shown the lack of pediatric-specific data regarding effectiveness and safety of 45% prescribed medications. It imposes direct age restrictions and prevents their use in patients under 18. At the same time, clinical guidelines advocate for early initiation of therapy to reduce the lifetime risk of cardiovascular complications in children with familial hypercholesterolemia. The discovered regulatory inconsistency creates a legal barrier and makes physicians encounter ethical difficulties. The results emphasize the need to update regulatory documents and conduct additional clinical studies to ensure a safe use of lipid-lowering drugs in pediatric practice.

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