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2020 (1)

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Dissertation
The creation of a training program related to bempedoic acid for the Belgium market

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Abstract

In 2020, a new cholesterol-lowering medicine will receive market authorization from the European medicines agency and in 2019, the European Society of Cardiology (ESC) guidelines were updated. A training program is needed to train the internal staff on this new medicine. The purpose of this training program is to provide an overview of the current medicines against hyperlipidemia, the new ESC guidelines and to discuss the efficacy, safety and positioning of the new medicine bempedoic acid. The development of atherosclerosis is mainly due to hypercholesterolemia. The causal relationship between low density lipoprotein (LDL) and atherosclerosis has been extensively proven and concluded that the lower the LDL value, the lower the risk of cardiovascular events. This was one of the reasons, why the guidelines for the treatment of hyperlipidemia have been updated. The new guidelines have lowered their LDL target values. This will have consequences for the prescribing behaviour of doctors because they will have to evolve from monotherapy to more combination therapy. Statins remain the first line therapy but will be combined with ezetimibe and in some cases with proprotein convertase subtilisin-kexin type 9 (PCSK-9) inhibitors. The use of PCSK-9 inhibitors is therefore more recommended by the new ESC guidelines. This will have a major impact on the healthcare budget and health expenditure of patients, because the price of these medicines is much higher compared to the price of statins and ezetimibe (both generic). The new medicine bempedoic acid, acts on a different enzyme of the same pathway as statins. It can provide added value for patients, who do not reach the new LDL targets and for patients who cannot tolerate daily use of statins. The efficacy and safety of bempedoic acid was extensively tested in these patient populations by several phase 3 studies. CLEAR Tranquility and CLEAR Serenity investigated efficacy and safety in patients, who were statin intolerant. CLEAR Wisdom and CLEAR Harmony investigated efficacy and safety in patients, who were statin tolerant and had a high cardiovascular risk. A fixed dose combination of ezetimibe and bempedoic acid was also investigated. These studies all concluded that the LDL value was reduced by 15.1-36.2% and bempedoic acid was well tolerated. Bempedoic acid has a major advantage over statins because patients report fewer muscle related side effects, what could be a major benefit for statin intolerant patients. The target population for bempedoic acid and fixed dose combination, will be (very) high-risk patients who cannot reach the LDL goals with optimized maximally tolerated statins and ezetimibe. The anticipated place for bempedoic acid in the treatment regimen is between a maximum tolerated doses of statins/ezetimibe and the PCSK-9 inhibitors.

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