Two years experience of using alirocumab in patients with dyslipidemia

Objective. To evaluate the efficacy and safety of alirocumab in patients with atherogenic dyslipidemia during 2 years of follow-up. Materials and methods. Thirty-seven patients with atherogenic dyslipidemia were followed up: 22 (59.5%) males and 15 (40.5%) females aged 27 to 70 years (mean age 57.03±9.2 years). The very high cardiovascular (CV) risk group included 31 (83.8%) patients, and the high-risk group included 6 (16.2%) patients. The occurrence of the primary endpoints of progressive angina (PA), acute myocardial infarction (AMI), cerebrovascular accident (CVA), as well as the timing of the achievement of the target levels (TL) of low-density lipoproteins (LDL) were evaluated over 2 years. Aspartate and alanine transaminases (AST and ALT), creatinine, and glomerular filtration rate (GFR) were evaluated to assess the safety of drug’s safety. Before treatment, all 37 patients did not reach the target LDL levels during previous therapy. Of these, 25 (67.6%) patients received the maximum tolerated dose (MTD) of statins with ezetimibe (10 mg); 12 (32.4%) patients received ezetimibe only due to statin intolerance. Patients at high CV risk received 75 mg of alirocumab subcutaneously every 2 weeks; patients at very high CV risk received 150 mg of alirocumab with the same regimen. Results. During treatment with alirocumab, LDL TL was achieved in 75.7% of patients; the percentage of patients at very high CV risk with LDL TL gradually increased from 25.8% at 3 months to 71% at 24 months. LDL decreased by 59.2%. There was a significant increase in the level of high-density lipoproteins starting from 3 months of treatment and a decrease in triglycerides after 6 months (p<0.05-0.001), as well as an increase in GFR, a decrease in creatinine and transaminases (ALT, AST) after 6 months (p<0.05). Destabilization of the course of coronary heart disease (CHD) or CVAs were not observed for 2 years. Conclusion. The addition of alirocumab to statin MTD and/or ezetimibe in patients at high and very high CV risk with dyslipidemia decreased LDL by 59.2% and resulted in achievement of LDL TL in 75.7% of patients, contributing to a stable course of coronary artery disease, and was associated with no AMI, PA, or CVA. No adverse events were observed during therapy for 2 years of follow-up. There was also a decrease in transaminases and creatinine and an increase in GFR after 6 months of treatment (p<0.05).