Efficacy of statin therapy in primary care — OZIRKA trial: population study on the effectiveness of Ozalex (rosuvastatin) in the treatment of patients with lipid metabolism disorders and hypercholesterolemia in different categories of patients
Keywords:hyperlipidemia, hypercholesterolemia, statins, rosuvastatin
AbstractBackground. In Ukraine, the number of statin prescriptions in recent years remains relatively low. A large-scale Ukrainian study OZIRKA would disprove some of the myths and demonstrate that long-term therapy with one of the most effective statins — rosuvastatin — in moderate and high doses is safe and effective in a large cohort of patients during primary care. The purpose of the study was to demonstrate the effect of Ozalex (rosuvastatin) on lipid and cholesterol levels in patients with lipid metabolism disorders and hypercholesterolemia. Materials and methods. The study was planned as a prospective, open-label, population one. Recruitment of patients was done from March to December 2019. The analysis of the study data was conducted from June to November 2020. All patients had to receive rosuvastatin (Ozalex, Kusum Pharm, Ukraine) at a dose of 10 or 20 mg. Results. A total of 20,000 patients from all over Ukraine were planned to be included in the study. The full follow-up period was completed by 18,100 patients, of whom 17,530 had all the necessary data, so they were included in the final analysis. The mean follow-up period was 2.2 months. During the two months of follow-up, patients on average showed a significant reduction in total cholesterol levels — by 28 % (p < 0.001), low-density lipoprotein cholesterol — by 34 % (p < 0.001), triglycerides — by 25 % (p < 0.001). Increasing the dose of rosuvastatin from 10 to 20 mg after the first visit resulted in an additional reduction in low-density lipoprotein cholesterol by approximately 40 %. The fasting blood glucose level in the patients in this study reduced significantly, from 5.70 ± 0.01 mmol/l to 5.23 ± 0.01 mmol/l (significance of the dynamics of p < 0.001). Conclusions. Ozalex, manufactured by Kusum Pharm (Ukraine), is a highly effective generic drug of rosuvastatin, which has a neutral effect on glucose metabolism and allows achieving good control of blood lipids at the stage of primary care.
Authors/Task Force Members; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2019 ESC/EAS guidelines for the management of dyslipidaemias: Lipid modification to reduce cardiovascular risk. Atherosclerosis. 2019 Nov. 290. 140-205.
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Уніфікований клінічний протокол первинної, екстреної та вторинної (спеціалізованої) медичної допомоги «Артеріальна гіпертензія». Затверджений Наказом Міністерства охорони здоров’я України від 24 травня 2012 року № 384.
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