Analysis of the effects of combined dyslipidemia therapy with the use of ezetimibe – results of the TEMPO project Original article

Abstract

Background: Dyslipidemia is one of the main risk factors for cardiovascular disease. Due to the continuous tightening of the criteria for correct lipid therapy, the combination usage of statin and ezetimibe is becoming more and more popular.\ However, there is no data on the motivation to implement such a combination and its effectiveness in Poland.

Aim: The purpose of the TEMPO program was the analysis of the used combinations of dyslipidemia therapy in the practice of physicians of various specialties, assessed the motivation to modify treatment and the clinical characteristics of the patient population using combination therapy.

Methode: Multicenter, non-clinical, non-interventional study. Data were obtained on the basis of questionnaires filled in by doctors regarding their practice and concerning the patient. Only patients who have been using ezetimibe for at least 4 weeks were included. Participation of patients in the Program was voluntary, anonymous and did not involve any financial gratification. Among the patients included in the study, a very high cardiovascular risk group was identified, in which patients with known ischemic heart disease (on the basis of medical history, including patients after percutaneous coronary angioplasty, coronary artery bypass graft or myocardial infarction), history of atherosclerosis of peripheral arteries and/or ischemic stroke. Typical statistical methods were used for the analysis of data, assuming a standard value of p < 0.05.

Results: The study involved 246 doctors (55% women, median age – 50 years), almost exclusively family physicians, internists and cardiologists. 80% of practitioners practiced mainly out-patient, 50% worked in cities with > 100,000 residents. The primary reason for the change in treatment was the lack of efficacy or side effects of the earlier treatment regimen. Guidelines and scientific reports as well as the availability of the drug had the slightest influence on the decision of the researchers. The analysis of patient data included results from 636 of the surveys carried out. The mean age of the respondents was 61 years (± 10 years), women constituted 45% of the studied population (n = 291). 38% of respondents came from cities with over 100,000 inhabitants. 82% of respondents were treated for hypertension, 26% for diabetes, 19% had had a myocardial infarction in the past, 2.5% had a stroke. The mean LDL concentration in the study population was 124 mg/dl (± 45 mg/dl). Ezetimibe was the most commonly used simultaneously with rosuvastatin (42%) or atorvastatin (35%). Cardiovascular risk was defined as very high in 46% (294 subjects). These patients were distinguished by older age (63 vs. 58 years; p < 0.01), lower mean concentrations of all lipogram fractions (mean LDL concentration 111 vs. 135 mg/ dl; p < 0.01); they were on significantly higher statin doses, and combination therapy was used significantly longer (4.6 vs. 3.4 months; p < 0.001). The target LDL concentration for very high cardiovascular risk and control group, with values of < 70 mg/dl and < 115 mg/dl, was found only in 19% and 34% of patients, respectively.

Conclusions: The treatment of dyslipidemia in Poland is primarily performed by family physicians, internists and cardiologists. Ezetimibe is most often used in combination with strong statins. Patients with very high cardiovascular risk are treated more aggressively, but LDL targets are still obtained in a low proportion of patients regardless of the risk group. The time when the combination therapy starts seems to be crucial. Perhaps in the case of patients with a very high cardiovascular risk, consideration should be given to starting treatment of dyslipidemia with a combination of a strong statin and ezetimibe.