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In the year 2018, the ODYSSEY OUTCOMES trial was presented that completed a long-term programme with alirocumab. The ODYSSEY programme consists of 9 clinical trials, of which a pooled analysis was performed. The aim of this analysis was to evaluate the data on the efficacy and safety of alirocumab in patients who had DM and concomitant atherosclerotic CV disease. The Odyssey Outcomes trial included 18,924 patients in secondary prevention who had experienced an acute coronary syndrome within the previous 12 months; the mean follow-up duration was 2.8 years and the primary endpoint occurred in 1,955 of them. The primary endpoint occurred in 903 (9.5 %) patients in the active treatment group and in 1,052 (11.1 %) in the placebo group (p = 0.0003). No typical adverse effects were reported, except for puncture site reaction. The greatest benefit was seen in patients with LDL cholesterol above 2.6 mmol/l, where alirocumab reduced the composite endpoint by 24 % and all-cause mortality by 29 %. [ABSTRACT FROM AUTHOR]

PCSK9 inhibitors (inhibitors of proprotein convertase subtilisin/kexin type 9) offer a promising treatment strategy decreasing the concentrations of both atherogenic low density lipoprotein (LDL) and cholesterol contained within LDL. Alirocumab is one of two PCSK9 inhibitors that entered clinical practice so far. Alirocumab is a specific antibody against PCSK9, manufactured using recombinant technique. When the antibody binds to the PCSK9 isoenzyme, no complex encompassing PCSK9 and LDL receptor can be formed, thus enabling further recirculation of the LDL receptor. Increasing the amount of LDL receptors available on the cell membranes leads to higher internalization of LDL within cells and to lowering of LDL cholesterol concentration. It has been shown that alirocumab exerts favorable effect on atherogenic lipoproteins (i.e. decrease of concentrations of LDL cholesterol by more than 50%) both in monotherapy and in combination with statins or other hypolipidemics. Odyssey Outcomes study brought new information into light and changed the guidelines of treating the patients with cardivascular diseases. Alirokumab added to intensive statin therapy reduced significantly the risk of cardiovascular diseases and the post hoc analysis confirmed also the reduction of total death rate. The positive effect of alirocumab is higher in patients with higher initial LDL-C. The therapy with alirokumab is safe, with minimum adverse events.