Martin Čaprnda, Ján Farkašovský, Oliver Tlčimuka
Introduction: Dyslipidemia is one of the most significant risk factors for cardiovascular diseases. Its diagnosis and
treatment is managed by general practitioners as well as specialists. Atorvastatin (ATST) at 80 mg dose is used primarily
in patients high and very high cardiovascular risk in both primary and secondary prevention. However, some
patients require statin dose reduction, most frequently due to adverse effects. The aim of this study (project ATORNOVA
60 – Phase 2) was to identify patients treated for dyslipidemia using ATST 80 mg, who required statin dose
reduction, and to compare the efficacy and safety of ATST doses reduced to 40 mg and 60 mg.
Methodology: The ATORNOVA 60 project was conducted in the form of a prospective, non-randomized, open-label
trial of 6-month duration. Phase 2 of the project included a total of 449 patients aged 33–88 (222 men, and 227
women), who required statin dose reduction. The patients received ATST doses reduced to 40 mg or 60 mg at the
discretion of their attending physicians. The patients were educated about the need to adhere to both non-pharmacological
and pharmacological hypolipidemic treatment. Three and six month later, lipid level and safety parameters
were checked (creatine kinase – CK, alanine aminotransferase – ALT). The project was supported by KRKA’s
research grant.
Results: At the beginning of the trial, patients in the ATST40 group manifested slightly lower level of total cholesterol
(Tot-C) (4.72 ± 1.51 vs. 5.07 ± 2.06; p = 0.040), LDL cholesterol (LDL-C) (2.64 ± 1.19 vs. 2.94 ± 1.65; p < 0.024),
and non-HDL cholesterol (nonHDL-C) (3.47 ± 1.53 vs. 3.83 ± 2.09; p = 0.035). There were no differences in TAG
levels (1.79 ± 1.12 vs. 1.74 ± 0.83; p = NS) and HDL-C (1.25 ± 0.38 vs. 1.24 ± 0.39; p = NS). The most common
reason for dose reduction were adverse effects of ATST: myalgia, gastrointestinal problems, hepatopathy, elevated
CK. After 6 months of treatment we surprisingly recorded a slight decrease in the levels of Tot-C, LDL-C and non-
HDL-C (statistically significant only in the ATST60 group), and a slight increase in HDL-C (statistically significant in
both groups). When evaluating the safety parameters, we observed a decrease in absolute CK values in both monitored
groups, and a decrease in ALT in the ATST60 group. There was also a decrease in the percentage of patients
who exceeded 1-fold and 3-fold the normal CK and ALT values.
102 Kardiológia pre prax 2/2018
Conclusion: In this group of patients treated with ATST 80 mg, who required statin dose reduction, there was
a slight decrease in the levels of total, LDL and nonHDL cholesterol despite dose reduction, with lower levels being
achieved in the group of patients receiving ATST 60 mg. In most patients, dose reduction led to a decrease, respectively
normalization, of elevated values of monitored safety parameters (CK, ALT).