Assessment of the global and national market for lipid modifying agents: retrospective and innovation

Abstract

Lipid-lowering therapy is one of the most important aspects in the treatment of patients with cardiovascular disease, which is still the leading cause of death in the adult population. Over the past 10 years, fundamentally new lipid-lowering drugs have appeared such as alipogene tiparvovec, mipomersen, lomitapide, evolocumab, alirocumab, bempedoic acid, inclisiran, evinacumab, volanesorsen. In order to update information on the effectiveness and safety of the use of lipidlowering drugs, their consumption in the pharmaceutical market in retrospect and at the present time, a systematic search was carried out in the scientific databases eLIBRARY.RU, PubMed, Embase, ClinicalTrials.gov, the Cochrane Library, Russian State Register of Medicines from 1980 to 2023. Statins remain the main drugs of choice for regular use in violation of lipid metabolism. Fibrates are the drugs of choice in patients with rare forms of hyperlipidemia associated with high triglyceride level. A group of other lipid-lowering drugs has been characterized from the point of view of the mechanisms of action, indications for use, and the availability of registration certificates in the Russian Federation and in the world. The growing interest in ezetimibe in the Russian pharmaceutical market is confirmed by the high growth in the share of local companies in its production as part of the import substitution strategy. It has been established that the drug causes undesirable effects with a small degree of probability as part of combination therapy. Inhibitors of proprotein convertase subtilisin-kexin type 9 (PCSK9) open up new possibilities for the treatment of patients at very high risk of cardiovascular disease. Lomitapide is not registered in the Russian Federation, but since December 2021 it has been included in the list of medicines purchased by the Krug Dobra Foundation to help children with homozygous familial hypercholesterolemia. Since 2022, inclisiran, a drug inhibiting synthesis of PCSK9 with RNA interference, has been approved for use in Russia and is safe in patients with hyperlipidemia and statin intolerance. Thus, in the 21st century, fundamentally new positions have appeared in the group of lipid-lowering drugs, which are examples of biotechnological and gene therapy drugs.