Comparative efficacy and safety of statin monotherapy and their combination with ezetimibe (Results of the Russian retrospective observational study UNISON)
DOI:
https://doi.org/10.34687/2219-8202.JAD.2022.04.0003Keywords:
hyperlipidemia, statins, ezetimibe, combined hypolipidemic therapy, effectiveness, safetyAbstract
Objective. Comparative evaluation of the effectiveness of ezetimibe in combination with statins or statin monotherapy in both primary and secondary prevention of CVD.
Materials and Methods. The design was a retrospective post-registration observational multicenter study. Data set for analysis included patients receiving hypolipidemic therapy for both primary and secondary prevention of CVD in real clinical practice, who received statins for ≥3 months as monotherapy or in combination with ezetimibe in steady state, with initiation of therapy not earlier than 2 years before inclusion. The primary endpoint was the frequency of reaching the target LDL cholesterol levels at the time of study inclusion (%).
Results. The population for the analysis (FAS) was composed of 1000 patients (100%), 250 people in the statin monotherapy group and 750 people in the ezetimibe + statin therapy group. The groups did not differ in clinical, demographic, and laboratory variables, except for a higher prevalence of arterial hypertension and higher baseline lipid values in the statin monotherapy group. Against the background of therapy, LDL-С values decreased by -1.10 ± 1.04 mmol/L (change of -27,5 ± 28.5% from baseline) in the statin monotherapy group and by -1.55 ± 1.17 mmol/L (change of -38.2 ± 25.6 % from baseline) in the combination therapy group, p<0.001. The target LDL-С level in the monotherapy group was achieved by 22.4% of patients compared with 28.8% in the combination therapy group, p=0.049.
Conclusion. In real clinical practice, statin/esetimibe combination therapy is accompanied by more frequent achievement of target LDL cholesterol levels than statin monotherapy: 28.8% vs. 22.4% (p=0.049) due to a more pronounced reduction in LDL cholesterol levels compared with baseline. The addition of ezetimibe to statin therapy increases the probability of achieving the target levels of LDL-С by 29% (odds ratio 0.7139 (0.4998- 1.0091), p=0.0493).
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Copyright (c) 2022 И. В. Сергиенко, M. B. Ежов, В. С. Гуревич, В. К. Зафираки, П. А. Баров, О. В. Цыганкова, Е. А. Цыпленкова, Е. П. Приходько, Н. Г. Виноградова, В. Р. Идиятуллина, Е. В. Вырупаева, М. В. Савченко, Ю. Е. Юхина, А. А. Калиновская, Е. С. Тимощенко, А. А. Некрасов, О. Г. Смоленская, К. С. Манько, Е. В. Тимошина
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