[Efficacy and safety of ezetimibe in vascular risk units]

Abstract

Objectives: This study was intended to assess the efficacy and safety of ezetimibe when taken alone or combined with statins in a specialized care setting and under standard clinical practice conditions.

Patients and methods: A multicenter, retrospective study in patients with dyslipidemia seen in a specialized outpatient clinic and treated with ezetimibe for at least 12 weeks. Patients were divided into three groups: monotherapy, add-on ezetimibe, and initial coadministration.

Results: A total of 217 patients (mean age 59 years; 37% ≥65 years) were enrolled. Of these, 61% were women, 21% had type 2 diabetes and 20% had had a previous cardiovascular event so that the lipid lower drug treatment should satisfy the objectives of secondary prevention. Mean change in the monotherapy group (n = 92; mean 41 weeks) included: decrease of LDLc of 28% (P <.001). In the group where ezetimibe was added on to different ongoing statins (n = 94, mean 73 weeks), mean changes was as follows: LDLc -34%, significant change as compared to monotherapy (P < .001). In the group with initial coadministration of ezetimibe with different statins (n = 31; mean 118 weeks), mean change included: LDLc -53% (P < .001). Overall, 64% of patients reached the thereapeutic objective proposed for the Adult Treatment Panel III (ATPIII) for cLDL. In patients with low risk (LDLc < 160 mg/dL), moderate risk (LDLc < 130 mg/dL) and high-very high risk (LDLc < 100-70 mg/dL), the percentage of patients who reached the therapeutic objective was 81%, 64% and 44%, respectively.

Conclusions: Under standard clinical practice conditions, ezetimibe appears to be effective and safe for the control LDLc, thus making it possible to reach the therapeutic objectives proposed by the ATP-III in a high number of patients, especially when associated to statins.