The value of statins to achieve target levels of total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides is emphasized in current international guidelines.1 The relationship between LDL level and frequency of cardiovascular events has been confirmed in large studies.2–7 However, clinicians do not always follow the recommendations.8 The situation with regard to the use of lipid-lowering drugs in Russia is particularly difficult. A study of statin use in Moscow obtained the following results: only 30% of patients with coronary heart disease (CHD) took statins; 80% of prescriptions were for simvastatin or lovastatin at initial doses; and mean duration of treatment was five months.9 However, this study investigated selective samples of patients. Data that are more relevant to clinical practice are obtained from studies conducted using the principles of consistent inclusion of patients, i.e. under registry rules.10 Analysis of the drugs taken as outpatients by high-risk patients before a reference myocardial infarction in the LIS study enrolled in the hospital's registry showed that the frequency of statin use was only 2%.11 With modern cardiovascular disease registries it is possible not only to determine the frequency of drug prescriptions but also to assess the factors that influence compliance with medication.

The aim of this study was to analyze the quality of lipid-lowering therapy in a cohort of patients with cardiovascular disease enrolled in a Moscow-based registry, and to analyze the factors affecting the regularity of statin administration in this patient category.

The PROFILE registry is a outpatient registry compiled by the Preventive Pharmacotherapy Department of the National Research Center for Preventive Medicine (NRCPM) of the Ministry of Healthcare of the Russian Federation. NRCPM is a federal medical center to which patients from other medical institutions (including municipal) are referred to seek medical advice. The PROFILE registry includes all patients presenting to the department for consultations on cardiovascular disease.

This study included all patients who sought medical advice in the Preventive Pharmacotherapy Department between May 1 and December 31, 2011. Each patient was given a specially designed questionnaire in order to assess compliance with the prescribed treatment. Patients were required to answer the following questions: (1) if they knew, according to the results of previous exams, that they had elevated cholesterol levels (yes, no, don’t know); (2) what method of hypercholesterolemia correction they used (diet, medication, physical exercise, or other); (3) if they were taking any statins (regularly, no, irregularly); and (4) if yes, what statin preparation and what dose they were taking. Compliance with statin therapy was assessed on the basis of the responses received and the regularity of statin intake. A registration card was completed for each patient observed during this period. The questionnaire and the registration card were developed by the researchers. The questionnaire was filled in directly by the patient, while the registration card (including anthropometric, clinical, laboratory and test data, and previous history) was filled in by a physician.

Patients were divided into three age groups: <50 years old, 50–70 years old, and >70 years old. In addition, the following factors were taken into account: (a) alcohol consumption (according to the questionnaire data) – none, occasional (once or twice a week or less), regularly (three or more times a week); (b) smoking status: current smoker, non-smoker, former smoker; (c) education: higher education or not; (d) statin dose: low (rosuvastatin <10 mg, atorvastatin <20 mg, simvastatin <20 mg), medium/standard (rosuvastatin 10–20 mg, atorvastatin 20–40 mg, simvastatin 20–40 mg), high (rosuvastatin >20 mg; atorvastatin >40 mg; simvastatin >40 mg). On the basis of these data patients’ compliance with treatment and its effectiveness as shown by the results of further analysis were assessed.

All patients gave their written informed consent for participation in the study and the questionnaire was approved by the Independent Ethics Committee of NRCPM. Blood tests for cholesterol and its fractions were performed in the laboratory of NRCPM on the day of each patient's enrollment.

The present study included consecutive patients seen in the Preventive Pharmacotherapy Department between May 1 and December 31, 2011. During this period 274 patients were recorded in the registry. Their main demographic and clinical characteristics are presented in Table 1.

Patients were divided into three groups according to how regularly they were taking statins: regularly, irregularly, or none. These groups were compared in terms of lipid profile (Table 2).

There were significant differences in total cholesterol and LDL cholesterol levels between patients regularly taking statins and patients not taking or irregularly taking statins (Figures 1 and 2).

Figure 1.

Differences between groups by total cholesterol level. 1: taking statins regularly; 2 not taking statins; 3: taking statins irregularly.

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Figure 2.

Differences between groups by LDL level. 1: taking statins regularly; 2 not taking statins; 3: taking statins irregularly.

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Odds ratios (OR) and their 95% confidence intervals (CI) were calculated to determine the influence of various factors on regularity of statin intake (Table 3).

The question of patients’ compliance with prescribed therapy is extremely important, especially concerning statins, given their possible side effects that require dynamic control by biochemical blood tests.

This study addresses these issues. Certain limitations should be noted, particularly the selectivity of the study population; this was not an epidemiological study, but an analysis of clinical practice that assessed ordinary patients.

The criteria for statin use in this study were based on current guidelines: patients with TC >5 mmol/l and LDL >3 mmol/l and high-risk patients with documented CHD, previous MI or stroke or associated clinical conditions, as well as with additional risk factors including TC >4.5 mmol/l and LDL >2.5 mmol/l.

The study is relevant to the issue, which has also been analyzed in other studies carried out in recent years.12–16 It is striking that our study, which was small but governed strictly by guidelines for registries, revealed such interesting data. In our analysis of the factors affecting regularity of statin intake in patients with cardiovascular disease enrolled in the PROFILE registry, those that were most likely to increase the chances that the patient would take statins regularly were the presence of CHD and a history of MI and PCI (Table 3). At the same time it should be noted that a history of stroke and the presence of diabetes did not motivate these patients to take statins on a regular basis.

This can probably be explained by the fact that cardiologists are more likely to adhere to current international guidelines for the management of their patients and to prescribe statins, in contrast to neurologists and endocrinologists, who also often see patients with a history of stroke and diabetes, respectively.

The authors have no conflicts of interest to declare.