Rational Pharmacotherapy in Cardiology

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Vol 10, No 6 (2014)
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584-596 1596

Background. Recently, a greater emphasis is being placed on health-related quality of life (HRQL) in both global and Russian practice. In many countries HRQL in patients with ischemic heart disease (IHD) is assessed by a disease-specific questionnaire – The MacNew Heart Disease HRQL questionnaire (MacNew) – that has been validated in many countries, but not yet in Russia.

Aim. To validate Russian MacNew questionnaire in patients with different clinical types of ICD.

Material and methods. Direct and reverse translation of the MacNew questionnaire was performed in accordance with the protocol of international HeartQol study. The patients (n=322) with angina, myocardial infarction, and heart failure were enrolled into the study and completed the Short-Form 36 (SF-36), the Hospital Anxiety and Depression Scale (HADS) and the Mac-New at the baseline; approximately 20% of the patients were reexamined 2 weeks later. The conceptual framework, reliability and validity of the Russian version of MacNew HRQL questionnaire were assessed.

Results. The Russian version of MacNew questionnaire demonstrated sufficient internal consistency with Cronbach’s α exceeding 0.80. High test-retest reliability of the questionnaire was established in the total sample of ICD patients (0.949; p<0.01). Factor analysis in general substantiated the conceptual model of the Russian version of MacNew and its satisfactory content validity. Convergent validity was confirmed by strong correlations between the subscales of Russian MacNew questionnaire and conceptually similar subscales of the SF-36 survey (in the total sample and in separated clinical groups. Discriminant validity of the Russian version of MacNew was also confirmed differentiating patients with different SF-36 health transition and patients with and without anxiety and depression (HADS questionnaire).

Conclusions. The Russian version of MacNew HRQL questionnaire has demonstrated adequate reliability and validity as compared with the original method. It can be recommended for the assessment of life quality in Russian-speaking patients with various types of ICD in daily clinical practice and research work.

597-605 683

Aim. To study the association of high-sensitivity C-reactive protein (hsCRP) level with socio-demographic, behavioral and traditional risk factors in different regions of the Russian Federation (RF).

Material and methods. Data of the multicenter epidemiological study of cardiovascular disease in different regions of the Russian Federation (ESSE-RF) were used. Representative sample of the unorganized male and female population aged 25-64 from 6 regions of the Russian Federation was drown. 3407 men and 6354 women (n=9761) were included into the study. Standard questionnaire was applied in all subjects. Gender, age, level of education, place of residence and region of residence, traditional risk factors and diseases were analyzed. HsCRP level (level ≥3.0 mg/l was defined as elevated one) was evaluated to detect of indolent inflammation.

Results. HsCRP levels in women was significantly higher compared to males (p<0.005). The average prevalence of elevated hsCRP in the regions was 24.2%, for men - 21.4%, and for women - 25.7% (p<0.005). Significant age-related dynamics of hsCRP (p<0.0001) was found. The average level of hsCRP was significantly lower (p<0.0001) in a cohort of persons with higher education against these with lower level of education. Level of hsCRP as well as prevalence of elevated hsCRP level were higher in villagers than this in the urban population (p<0.05). Prevalence of elevated hsCRP in patients with traditional risk factors after adjustment for sex, age, and region of residence showed that the elevated hsCRP was mostly associated with metabolic factors and diseases that were characterized by systemic inflammation.

Conclusion. Elevated level of hsCRP (≥3.0 mg/l) was significantly associated with female gender, with an older, less educated, and smoking population of Russians. After the multivariate adjustment there remained significant associations (p<0.0001) of elevated hsCRP level with obesity, including abdominal obesity, hyperglycemia and hypertriglyceridemia, low levels of low density cholesterol, rheumatoid arthritis, chronic bronchitis and Parkinson's disease.

606-611 816

Aim. To evaluate the effect of 6-month therapy with combination of amlodipine and bisoprolol on the structural and functional status of the myocardium in hypertensive patients who work in the Far North.

Material and methods. 140 hypertensive patients who live in the Khanty-Mansiysk Autonomous District - Yugra were divided into two groups depending on arrangement of working time. The first group included 72 patients who work only day shift; the second group – 68 patients who work alternate (day/night) shifts. Combination therapy with amlodipine and bisoprolol assigned to all patients. Echocardiography was performed at baseline, after 12 weeks, and after 6 months of therapy.

Results. The target blood pressure (BP) level in group 1 was achieved in 92.9%. A share of patients with normal left ventricular (LV) geometry increased from 37.5 to 44.8%; a share of patients with concentric and eccentric LV hypertrophy (LVH) decreased from 30.6 to 23.9% and 19.4 to 19.2%, respectively. Target BP level in group 2 was achieved in 87.9%. A share of patients with normal LV geometry increased from 23.5 to 33.3%; while share of patients with concentric and eccentric LVH decreased from 45.6 to 38.1% and from 19.1 to 17.4%, respectively. A positive correlation between LV myocardial index and average daily systolic and diastolic BP was found.

Conclusion. Revealed changes in BP and in LV structure and function due to treatment with amlodipine and bisoprolol can be considered as cardioprotective effect of this combination in hypertensive patients who work in the Far North. This effect was more pronounced in hypertensive patients working alternate (day/night) shifts.


612-616 963

Hypercholesterolemia is a proven risk factor for atherosclerotic cardiovascular diseases and for their complications.

Aim. To assess the quality of diagnosis and treatment of patients with severe hypercholesterolemia (total cholesterol >6.2 mmol/L) in the real outpatient practice.

Material and methods. All patients with a diagnosis of arterial hypertension, ischemic heart disease, chronic heart failure, atrial fibrillation applied to primary care physicians or cardiologists in one of the randomly selected out-patient clinic of Ryazan in March-May 2012 and included into the RECVASA registry were enrolled into the study group (n=1642).

Results. The group of patients with severe hypercholesterolemia consisted of 561 (44%) patients at the age of 67 (59-75) years [Me (25% -75%)]. At that, diagnosis of hyperlipidemia was indicated only in 9% of outpatient cards. Data of one or more blood chemistries including low density cholesterol (LDC) levels were presented only in 7% of outpatient cards. 83.7% of patients with severe hypercholesterolemia were classified as patients at high or very high cardiovascular risk, but statins were recommended only to 17.8% of them. Statins were mainly recommended in moderate doses; only one patient took atorvastatin 40 mg per day. Blood LDC levels were examined only in 5% of patients during statins therapy; nobody of them reached target LDC levels.

Conclusion. The study data revealed the presence of a high prevalence of severe hypercholesterolemia in patients with cardiovascular diseases and poor quality of diagnosis and treatment in these patients in the real outpatient practice.

617-624 616

Aim. To analyze pharmacotherapy of cerebral infarction in patients with atrial fibrillation (AF) in real clinical practice of neurological departments of Saratov hospitals.

Material and methods. A retrospective longitudinal pharmacoepidemiologic study was carried out. Medical cards were analyzed in patients with cerebral infarction and atrial fibrillation treated in neurology departments from 01.01.2009 to 31.12.2011.

Results. Acetylsalicylic acid was prescribed to 66.7% of patients, warfarin – 3.9%. At that target level of international normalised ratio was reached only in 40% of patients. It has been shown frequent (96%) prescriptions of metabolic, neuroprotective and vasoactive drugs with low level of efficacy evidence. Beta-blockers (in 39.3% of patients) and their combination with digoxin (18.7%) were prescribed for heart rate control.

Conclusion. Generally, in real clinical practice doctor’s choice of pharmacotherapy of cerebral infarction in patients with AF is not exactly in line with contemporary guidelines. These patients are frequently prescribed drugs with low efficacy and level of evidence.


625-630 1074

Aim. To study in the PROFILE register the rate of new oral anticoagulants (NOAC) taking in patients with atrial fibrillation (AF) and to identify the factors influencing it.

Material and methods. Patients with AF who applied to the Cardiology Center in 2013-2014 (n=111) were included into the study. The oral anticoagulants (OAC) were recommended to patients at the reference visit (n=97). Inquiry in questionnaire format was performed to assess the compliance to recommended therapy at the follow-up visit. Patients were divided into two groups according to taking/not-taking NOAC. Analysis of the facts that influence the compliance to NOAC therapy was performed.

Results. At the reference visit 70 patients desired to receive NOAC. At the follow-up visit 29 (41.4%) patients refused to take NOAC. Leading causes of NOAC refusal were satisfactory with warfarin (32.6%), the high price of these drugs (23.9%), the description of adverse reactions in the patient information leaflet for medicines (15.2%), and withdrawal by physician in outpatient clinic/hospital (8.7%). Preferential provision of medicines and warfarin therapy at the time of reference visit had a negative impact on the taking of NOAC. Patients taking NOAC were more aware of the possible outcomes of their illness, the possible side effects of OAC and were more familiar with patient information leaflet for medicines.

Conclusion. The study assessed NOAC taking rate and the factors influencing patients' compliance to NOAC therapy.

631-633 575

Aim. To study changes in prehospital pharmacotherapy with cardiovascular drugs in patients admitted to hospital with acute coronary syndrome (ACS) in 2005-2014.

Material and methods. The data of the LIS register (Lyubertsy study of mortality in patients undergone acute myocardial infarction) were used. Patients that survived 4 days after admission were included in the analysis.

Results. The positive changes in the prescription of antiplatelet agents (13.5% in 2005 and 27.4% in 2014), statins (1.7% and 16.3%, respectively) and angiotensin receptor blockers (0.6% and 8.8%, respectively) were found. The prescription rate of other cardiovascular drug classes did not change significantly.

Conclusion. Registration of treatment prior to ACS can be an important tool for evaluation of quality of ACS and myocardial infarction drug prevention.


634-639 655

Despite large number of known risk factors of venous thromboembolism (VTE) in cancer patients existing prediction models do not allow definite identification of cancer patients that have indications for anticoagulant prevention. Besides, heparin and warfarin use for VTE prevention in cancer is accompanied by some problems. New oral anticoagulants (NOAC) are promising drugs for use in oncology practice; however their use is complicated by the lack of data on efficacy and safety in these patients, potential drug interactions and the possibility of unpredictable changes in effect during chemotherapy. Widespread use of NOAC for the prevention and treatment of tumor-associated VTE prior to phase III trials is not recommended. However, the criteria for selection of patients for whom the study of the efficacy and safety of NOAC is a priority can now be developed.


640-645 645

Aim. To compare prognostic impact of community-acquired and hospital-acquired hyponatremia in hospitalized patients with decompensated heart failure Material and methods. Data of 120 patients with decompensated heart failure were analyzed. Hyponatremia was defined as serum sodium concentration of 135 mmol/l or less. Several outcomes were analyzed: mortality, transfer to intensive care unit (ICU), resistance to loop diuretics and worsening renal function.

Results. 13.0% of patients had community-acquired hyponatremia, 9.6% - hospital-acquired hyponatremia. Community-acquired hyponatremia was associated with increased mortality [odds ratio (OR)=7.8], admission to ICU (OR=19.1) and resistance to loop diuretics (OR=4.8). Hospital-acquired hyponatremia was associated with worsening renal function (OR=12.4).

Conclusion. Both, community-acquired and hospital hyponatremia have negative impact in hospitalized patients with decompensated heart failure.

646-650 733

Aim. To study what cardiac drugs currently have any comments on biomarkers and what information can be obtained by pharmacogenetic testing using data exome sequencing in patients with cardiac diseases.

Material and methods. Exome sequencing in random participant of the ATEROGEN IVANOVO study and bioinformatics analysis of the data were performed. Point mutations were annotated using ANNOVAR program, as well as comparison with a number of specialized databases was done on the basis of user protocols.

Results. 11 cardiac drugs and 7 genes which variants can influence cardiac drug metabolism were analyzed. According to exome sequencing of the participant we did not reveal allelic variants that require dose regime correction and careful efficacy control.

Conclusion. The exome sequencing application is the next step to a wide range of personalized therapy. Future opportunities for improvement of the risk-benefit ratio in each patient are the main purpose of the collection and analysis of pharmacogenetic data.


651-658 1771

Data on the epidemiology and pathogenesis of alcoholic cardiomyopathy (ACMP) are presented. Special aspects of clinical manifestations as well as management of these patients are considered. Psychotropic therapy aimed at reduction in motivation to alcohol consumption in patients with ACMP is discussed separately.


659-664 754

Only few hypertensive patients are treated effectively despite of the variety of antihypertensive drugs. There is a linear relationship between blood pressure levels and the risk of complications (myocardial infarction, stroke, chronic heart and renal failure). Angiotensin receptor blockers are the first-line drugs for initial therapy of uncomplicated hypertension. Irbesartan is one of the most studied angiotensin receptor blockers. Data supporting the high antihypertensive and nephroprotection efficacy of irbesartan as well as its ability to reduce cardiovascular risk in hypertensive patients are presented.

665-671 633

Concomitant administration of clopidogrel and proton pump inhibitors (PPI), the possible influence of PPI on the effectiveness of clopidogrel often raises questions among practitioners. Massive antithrombotic therapy increases the risk of upper gastrointestinal tract lesions. Concomitant administration of these drugs is studied in a large number of trials. Results of the most significant of these trials are considered. Safety of concomitant administration of clopidogrel and PPI, its impact on long-term outcomes of cardiovascular diseases, and a choice of particular PPI are also discussed.

672-678 562

The significance of verapamil in the treatment of patients with ischemic heart disease (IHD) and hypertension (HT) is considered. Data on the limited role of beta-blockers in the improvement of patient’s status in stable IHD, data about negative effect of heart rate (HR) reduction on the central aortic pressure, as well as the relationship between HR and risk of complications in the INVEST trial are presented. Verapamil therapy in patients with HT and IHD without heart failure/systolic dysfunction and/or recent myocardial infarction may have advantages due to achievement of the sufficient antiischemic effect with less HR reduction.


679-687 685

Conclusion of Interdisciplinary Expert Council of Russian Association of Angiologists and Vascular Surgeons, Russian Scientific Society of Endovascular Surgeons and Interventional Radiologists, National Stroke Association, National Scientific Inflammation Society The Conclusion of Interdisciplinary Expert Council on the significance of testing of platelet functional activity in the prevention of cardiovascular complications in patients receiving antiplatelet therapy is presented. Indications for antiplatelet therapy, relation of platelet reactivity with the risk of adverse events, as well as factors that contribute to high residual platelet reactivity in patients receiving antiplatelet therapy are considered. The results of studies on the correction of antiplatelet therapy based on aggregometry data, indications for its implementation in clinical practice, as well as methods for evaluation of residual platelet reactivity are discussed separately.

688-691 428

On the subject of pharmacovigilance.

694-695 375

Index of the papers published in the “Rational Pharmacotherapy in Cardiology” journal in 2014.

696-697 397
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700 619

Nexium. Prevention of gastroduodenal ulcer associated with nonsteroidal anti-inflammatory drugs.

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