Efficacy, safety and tolerability of long-term therapy with Rosuvastatin and its fixed combination with lisinopril and amlodipine in patients with high and very high cardiovascular risk according to the results of an observational study ANICHKOV

Abstract

The article presents the results of a prospective, observational, multicenter, 12-month study ANICHKOV. Aim: to assess cardiovascular risk in patients undergoing 12 months of follow-up in patients in Moscow and the Moscow Region with hypercholesterolemia and a comparative analysis of adherence, efficacy and safety of various forms of combination therapy in outpatient practice, including the fixed drug lisinopril/amlodipine/rosuvastatin. Materials and methods: persons over 18 years old with a total cholesterol level > 7.5 mmol/l or/and HS-LDL > 5.0 mmol/l (according to results from the Invitro laboratory) were invited to participate in the study. Initially, in the lipid center, those with high and very high cardiovascular risk (n = 702) were recommended to correct risk factors with an emphasis on combination therapy with amlodipine/lisinopril/rosuvastatin (0-12 months). At regular visits, when patients did not reach the target levels of LDL and/or blood pressure, the dose was titrated. Additional therapy with fenofibrate 145 mg/day was recommended for patients with a TG level of more than 2.3 mmol/l. Results: according to the analysis, 659 patients completed the study in accordance with the protocol. At the same time, target levels of cholesterol-LDL less than 2.5 mmol/l and less than 1.8 mmol/l reached 16.6% and 5.6% of patients, respectively. The blood pressure level of less than 140/90 mm Hg when treating fixed combinations of amlodipine/lisinopril/rosuvastatin and amlodipine/lisinopril was in 83.7% and 80.8% of compliant patients, respectively. At the same time, target levels of blood pressure and LDL-LDL of less than 2.5 mmol/l reached 14.5% in the amlodipine/lisinopril/rosuvastatin group and 13.1% of patients in the amlodipine/lisinopril group and less than 1.8 mmol/l in the LDL-LDL group - 5.8% and 5.1%, respectively. Therapy was well tolerated and adherent. Conclusions: despite the high adherence of patients to treatment with a fixed combination of drugs and, as a result, a decrease in the proportion of individuals with an increased risk of SSO, the effectiveness of the simultaneous correction of LDL and BP levels remains insufficient.