MAIN RESULTS OF RANDOMIZED TRIAL "FREGAT"1: EFFECT OF SHORT-TERM INTENSIVE ROSUVASTATIN THERAPY ON CAROTID ATHEROSCLEROSIS IN PATIENTS AT VERY HIGH CARDIOVASCULAR RISK


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Abstract

The purpose of the study was to assess the possibility of regression/stabilization of carotid atherosclerosis (CA) under the influence of short-term intensive lipid-lowering therapy with statins in patients at very high cardiovascular risk (VHCVR) according to the threedimensional ultrasound. After a preliminary screening, the study included 80 VHCVR patients with dyslipidemia and the presence of atherosclerosis in CA (presence of atherosclerotic plaques in CA narrowing the lumen of the vessel by 20 to 70%). Patients were randomized into two groups of 40 people: the first group was assigned to receive rosuvastatin at the dose of 40 mg/day (Group A), the second group continued to receive statins at standard doses (Group B, simvastatin 20-40 mg/day or other statins at equivalent doses). The study lasted 12 weeks. In Group A, there was a significant decrease in total cholesterol (TC) and low density lipoprotein cholesterol (LDL-C) levels by 35.5 and 47.9%, respectively. In Group B, decrease in total cholesterol and LDL-C levels was also significant and amounted to 26.0 and 36.3%. In group A, recommended target LDL-C level <1.8 mmol/L was achieved in 65% of patients, which was significantly higher than in the standard therapy group - 35% (p<0.007). Patients in Group A had marked decrease in total atheroma volume from 85.0 [54.5; 196.0] mmз to 83.5 [56.0; 192.0] mmз(p=0.045), in group B - from 51.0 [22.0; 133.5] to 50 [21.5; 132.0] mmз (p<0.0001). Thus, short-term intensive therapy with rosuvastatin at the dose of 40 mg/day and a standard statin therapy in VHCVR patients accompanied by a significant reduction in the median of the total volume of atherosclerotic plaques in CA along with a marked decrease in the level of lipid parameters; there were no significant differences in the effect on dynamics of atheroma volume between the groups. Both groups had a good tolerability and safety of statin therapy.

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About the authors

Z. G Luginova

Federal State Budget-Funded Organization “Russian Cardiological Research and Production Complex" of RMH

Institute of Clinical Cardiology n.a. A.L. Myasnikov Moscow

O. A Pogorelova

Federal State Budget-Funded Organization “Russian Cardiological Research and Production Complex" of RMH

Institute of Clinical Cardiology n.a. A.L. Myasnikov Moscow

M. I Tripoten

Federal State Budget-Funded Organization “Russian Cardiological Research and Production Complex" of RMH

Institute of Clinical Cardiology n.a. A.L. Myasnikov Moscow

M. V Koshurnikova

Federal State Budget-Funded Organization “Russian Cardiological Research and Production Complex" of RMH

Institute of Clinical Cardiology n.a. A.L. Myasnikov Moscow

T. V Kuznetsova

Federal State Budget-Funded Organization “Russian Cardiological Research and Production Complex" of RMH

Institute of Clinical Cardiology n.a. A.L. Myasnikov Moscow

V. P Masenko

Federal State Budget-Funded Organization “Russian Cardiological Research and Production Complex" of RMH

Institute of Clinical Cardiology n.a. A.L. Myasnikov Moscow

Yu. G Matchin

Federal State Budget-Funded Organization “Russian Cardiological Research and Production Complex" of RMH

Institute of Clinical Cardiology n.a. A.L. Myasnikov Moscow

T. V Balakhonova

Federal State Budget-Funded Organization “Russian Cardiological Research and Production Complex" of RMH

Institute of Clinical Cardiology n.a. A.L. Myasnikov Moscow

A. V Susekov

FSBEI FPE“Russian Medical Academy of Postgraduate Education» of RMH

Email: asus99@mail.ru
MD, Prof. at the Department of Clinical Pharmacology and Therapy, Leading Researcher Moscow

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