Rational Pharmacotherapy in Cardiology

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Vol 11, No 3 (2015)
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238-246 808

High adherence to blood pressure (BP) medical correction determines clinical and socioeconomic efficacy of antihypertensive treatment. Separate components of adherence are to be studied, including regularity of drugs intake and reasons for non-compliance with medical recommendations in different categories of patients.

Aim. Evaluation of antihypertensive drugs (AHD) intake regularity (as a component of treatment adherence) and factors it is influenced by in hypertensive patients who had for the first time visited a specialized cardiology center during the 6-month follow-up after the primary consultation.

Material and methods. First, a number of hypertensive patients who had visited a cardiologist of one of Moscow’s district cardiology clinics for the first time in 2010 (n=1766) had formed a sample of the study participants. The expert cards were filled out in accordance with the primary medical documentation data. The second step was conducted 6 months after the first visit by a phone survey with the completion of questionnaires (n=1419).

Results. Majority of respondents (74.9%) had been taking AHD regularly 6 months after the primary consultation and 16.2% of the patients had been using them occasionally. 8.9% of the respondents completely refused to control hypertension with drugs. Respondents of male sex (OR=1.4), with poor BP self-control in home settings (OR=2.5), unable to get drugs under the medicine assistance scheme (OR=1.8), those without coronary heart disease (OR=1.9), with hypertension duration less than 5 years (OR=1.9), with changes in antihypertensive therapy regimen as compared to the one recommended by a cardiologist (OR=1.5), those who had 1-2 drugs in the treatment regimen at the moment of the survey (OR=2.4) and patients who had no fixed drug combinations in the treatment scheme (OR=1.4) were shown to have significantly higher probability of irregular AHD intake or complete treatment refusal.

Conclusion. Outpatients of the specialized cardiology center are characterized by rather high treatment adherence by AHD intake regularity. We have revealed a number of factors that significantly correlate with reduced antihypertensive treatment adherence. These factors must be taken into account at treatment regimen selection and patients’ follow-up.

247-252 600

Aim. To study the conformity of preventative therapy prescribed to patients during a hospital stay and at a discharge to clinical guidelines using a special algorithm, and to assess the impact of the results on a long-term mortality based on the LIS-2 register (Lyubertsy study of mortality in patients after cerebral stroke).

Material and methods. The scales to assess the quality of cardiovascular care for the prevention of recurrent stroke along with the prevention of recurrent ischemic attacks index (PRIA index) for this assessment were developed according to current clinical guidelines. Analysis of the therapy was performed using PRIA index on survived hospital patients from LIS-2 register (N=753). The impact of PRIA index results on a long-term mortality (Me=2.3 years) was studied.

Results. Based upon the results of the assessment obtained with PRIA index, higher treatment conformity to clinical guidelines resulted in a significantly better long-term survival. Non-conformity to clinical guidelines was due to the lack of prescription of drugs with proven efficacy and irrational choice of preventive therapy. Median of treatment quality assessment was 44.4% (22.2; 44.4).

Conclusion. Low conformity of preventive therapy to clinical guidelines is found in the LIS-2 register. The algorithm for the assessment of preventive cardiovascular therapy quality allows identifying limitations in the prevention of recurrent stroke, and can serve as an example of implementation of evidence-based medicine in clinical practice.

253-260 1019

Aim. To study the level of total cholesterol in patients at high and very high cardiovascular risk in real clinical practice and the correspondence of their follow-up to current guidelines for the treatment of dyslipidemia issued by European Society of Cardiology and European Atherosclerosis Society (2011), as well as Russian Society of Cardiology and Russian National Society of Atherosclerosis (2012).

Material and methods. Patients aged 30 years and older who visited a general practitioner or a cardiologist in an outpatient clinic in the period from October 2013 to July 2014 were included into the study. Every patient filled out a special questionnaire. The total cholesterol measurement was performed without special preparation of the patient with portable photometric blood analyzer, which allows the evaluation of total cholesterol in 3 minutes.

Results. 18.273 patients (58.9% women) were included in the final analysis. Hypercholesterolemia was found in 81.3% women and 78.9% males. In all federal districts the total cholesterol level was significantly above the target and varied from 5.82 to 6.10 mmol/L. At that, statins had not been prescribed to almost half of the patients. Total cholesterol> 5 mmol/L was found in 84.7% of the patients treated with simvastatin, in 75.2% of the patients treated with atorvastatin, in 59% of the patients treated with rosuvastatin. Target level of total cholesterol (<4 mmol/L) was achieved in 2.04-7.38% of the patients at a very high cardiovascular risk.

Conclusion. The situation with the diagnosis and treatment of dyslipidemias in a real clinical practice is far from perfect, despite the availability of information for doctors and patients. The causes of this problem require further investigation.

261-266 988

Aim. To study the prevalence of type D personality and its association with cardiovascular diseases and their risk factors in Russia’s population.

Material and methods. The research was conducted within the framework of multicentre epidemiological study ESSE-RF. The total sample size was 1610 patients (men and women aged 25-64 years). The type D personality was assessed using questionnaire DS-14. The patients were divided into two groups: patients with the presence of type D personality (n=231) and patients without type D personality (n=1379). Arterial hypertension, smoking, diabetes, hypercholesterolemia and obesity were accepted as major cardiovascular risk factors that are well studied and used in the most of the known cardiovascular risk assessment models.

Results. Type D personality was detected in 231 (14.3%) patients. Among patients with the type D personality as compared with those without one arterial hypertension (r=0.033), ischemic heart disease (r=0.053), vascular diseases of a brain (r=0.041) were revealed more often. Type D personality was associated with such risk factors as diabetes, smoking duration, low physical activity, overweight and obesity.

Conclusion. The study results can be useful in the development and carrying out programs of primary and secondary prevention of cardiovascular diseases.


267-271 845

Atrial fibrillation (AF) is a risk factor for thromboembolic complications, requiring administration of vitamin K antagonists (warfarin) or the new oral anticoagulants (apixaban, dabigatran and rivaroxaban).

Aim. To assess the influence of apixaban use on the budget as an alternative to warfarin, dabigatran or rivaroxaban use in patients with non-valvular AF in the Russian Federation (RF).

Material and methods. The analysis was performed with the perspective of the health care budget with 5 year horizon period and by the pharmacoeconomic model developed by Pharmerit International (Rotterdam, Netherlands) and adapted for the RF. The cardiovascular complications rate in the model was in line with the results of comparative clinical trials: ARISTOTLE, AVERROES, RE-LY, ROCKET-AF. The analysis suggested that 100% of patients with atrial fibrillation were transferred on apixaban instead of warfarin, dabigatran or rivaroxaban. The analysis was based on the assumption that patients were fully committed to the therapy over the horizon of the study, ie, refusal of treatment was not considered. The possibility of episodes of ischemic and hemorrhagic strokes, the severity of which corresponded to previously published data for the Russian population, was considered in the study. The present study was performed based on two scenarios. In the first of them the cost of anticoagulation therapy was determined on the basis of the average weighted prices of public procurement for the period from 04.01.2014 to 01.04.2015. The alternative scenario purported to demonstrate potential savings of the budget of the health care system on the inclusion of apixaban in the list of essential drugs. This scenario took into account that the cost of dabigatran and rivaroxaban corresponded to registered maximum selling price including 10% VAT and 10% of the wholesale allowance and the cost of apixaban - presumed maximum selling price which the producer intends to register in case the drug is included in the essential drugs list, subject to 10% VAT and 10% wholesale mark. The cost of complications treatment corresponded to the rate of compulsory health insurance for the city of St. Petersburg for 2015.

Results. The estimated number of patients with non-valvular AF who require anticoagulation therapy in the RF is 1,196,600 people according to the epidemiological data. Treatment with apixaban significantly reduces the incidence of cardiovascular events as compared with warfarin and rivaroxaban. The results of the budget impact analysis, taking into account the price obtained at auction from 01.04.14 through 01.04.15, show a decrease in the load on the budget when the apixaban is included in the therapy regimen of non-valvular atrial fibrillation. Potential savings of resources of the health care system reached 10.9 billion rubles as compared with dabigatran and 39.2 billion rubles as compared with rivaroxaban. This advantage can be explained by both the lower cost of apixaban in comparison with reference drugs, and a reduction of the in-hospital expenses on complications treatment. Switching from warfarin to apixaban increases the budget load in 2.81 times. However, previous data demonstrate the economic feasibility of the additional costs of apixaban, that help to achieve significant advantages from a clinical point of view. The results obtained on the basis of prices, intended to include apixaban in the list of essential drugs, showed that in this case the savings of the budget of the health care system will reach 127-129 bln. rubles for 5 years (average 26%) as compared with dabigatran and rivaroxaban. The comparison of apixaban with warfarin showed an increase in total costs of therapy in 2.72 times.

Conclusion. The inclusion of apixaban in the therapy regimen of non-valvular atrial fibrillation can significantly reduce the burden on the budget of the health care system as compared with dabigatran and rivaroxaban, as well as reduce the incidence of cardiovascular events compared with warfarin. This allows recommending the inclusion of the drug in the federal and regional programs for the prevention of thromboembolic complications in this group of patients.


272-282 609

Own clinical experience in the selection of patients with non-ST elevation acute coronary syndrome for coronary angiography based on clinical guidelines of the European Society of Cardiology (2011) is presented.


283-286 590

Aim. To study the effect of antiviral therapy (AVT) on some cardiac hemodynamic parameters in patients with chronic viral hepatitis (CVH).

Material and methods. Segmental systolic and diastolic functions of the ventricles as well as global diastolic function were evaluated in 25 patients with CVH by pulsed tissue Doppler mapping and by the method of Doppler echocardiography, respectively. The blood flow speed and diameter of blood vessels in liver were determined by ultrasound Doppler. Cardiac hemodynamics was examined in all patients before and after AVT with interferon in combination with ribavirin with formation of persistent virological response. Healthy people (n=19) were included into control group.

Results. Reduction in atrial and ventricular sizes, decrease in left ventricular mass, improvement of systolic function of both ventricles, as well as diastolic function of the left ventricle were found in patients with CVH after specific treatment. Reduction in hepatic arterial and portal blood flow speed and a total number of heart rhythm disorders were also observed. Therefore AVT in patients with CVH shows a positive impact on cardiac hemodynamics. Medium-strength correlation (r=0.31; p<0.05) was identified between Еm speed at fibrous ring of mitral valve and high viral load. Strong correlation (r=0.81; p<0.05) was also found between portal vein diameter and Sm speed at fibrous ring of tricuspid valve.

Conclusion. Patients with CVH that do not receive AVT have worse prognosis and indicators of cardiac hemodynamics in comparison with patients who receive specific AVT.

287-292 585

Venous thromboembolic (VTE) events are a major concern in large joints replacement leading to patients’ death. The prevention of VTE events suggests the prescription of low molecular weight heparin or oral anticoagulants that differ significantly in their efficacy, safety and cost of the therapy.

Aim. To assess the cost-effectiveness of different options for the prevention of VTE events in hip and knee joints replacement.

Material and methods. The model, which allows evaluation of the VTE complications incidence in patients aged 60-65years, was developed based on the results of such clinical trials as ADVANCE-2, ADVANCE-3, RE-MODEL, RE-NOVATE. Analysis was performed on survival period of patients. Weighted average prices of public bidding for the purchase of drugs (enoxaparin, dabigatran and apixaban) during the first quarter of 2015 were the source of the data on the expenses on VTE events prevention. The cost of treatment of VTE events matched for the rate of compulsory health insurance in St. Petersburg for 2015. The costs and life expectancy of patients were discounted at 3.5% per year.

Results. The best results for the prevention of VTE events are observed at the treatment regimen with apixsaban. Treatment regimens with dabigatran and enoxaparin were less effective and comparable with each other. At that, the prevalence of major bleedings was similar for all treatment regiments. Apixaban reduced the cost of treatment and prevention of VTE events 1.8-2.0 times as compared with enoxaparin and 1.2-1.4 times in comparison with dabigatran.

Conclusion. The new oral anticoagulants are effective and safe alternative to low molecular weight heparins used for the prevention of VTE events in large joints replacement and provide budgetary savings as compared with enoxaparin. Apixaban has a maximum capacity for the reduction of VTE events, lowering the cost of treatment and prevention of VTE events.

293-296 694

Aim. To study the effects of nebivolol on bone mineral density (BMD) in postmenopausal women with mild hypertension (HT) and osteopenia.

Material and methods. Postmenopausal women (n=56) aged 50-65 years with mild HT фтв osteopenia were included into the randomized controlled study and divided in two groups (28 patients in each). During 12 months patients of the main group received treatment with nebivolol (5-7.5 mg/day) and patients of the control group received treatment with atenolol (12.5-25 mg/day). Clinical and anthropometric examinations, blood pressure measurements, ECG registrations were performed in all patients initially and after 12 months of treatment. Quantitative estimation of BMD was performed by dual energy X-ray absorptiometry with osteodensitometry DELPHI W manufactured by HOLOGIC company (USA) in the lumbar spine (L1-L4), femoral neck and proximal femur in the anterior-posterior projection. In addition, calcium and bone metabolism indices were determined: ionized calcium, total alkaline phosphatase, C-telopeptide of type I collagen (CTX).

Results. Therapy of mild HT with nebivolol during 12 months showed increase in BMD in the spine according to the T-test from -1.7±0.4 SD to -1.4±0.53 SD (p<0.001), while in atenolol group this index decreased from -1.5±0.7 SD to -1.6±0.64 SD (p<0.001). When evaluating T-test of the femoral neck the index changed in the main group from - 1.4±0.44 SD to -1.27±0.5 SD (p=0.015), in the control group - from -1.3±0.64 SD to -1.5±0.65 SD (p=0.0005). In the study group T-test of proximal femur changed from -0.58±0.4 SD to -0.49±0.4 SD (p=0.003), and in the control group - from -0.8±0.84 SD to -0.83±0.93 SD (p=0.3). The dynamics of the BMD due to 12 month therapy in all investigated bone segments distinguished significantly between study and control groups. Nebivolol therapy group showed reduction in CTX level from 0.367±0.16 to 0.294±0.12 ng/ml (p<0.001), whereas the control group showed increase in this parameter from 0.369±0.15 to 0.499±0.18 ng/ml (p<0.001). The dynamics of the CTX levels distinguished significantly between groups (p<0.001).

Conclusion. The study demonstrated the positive effect of nebivolol on BMD, whereas atenolol had no effect on bone mass.


297-303 677

Aim. To evaluate the differences between a group of patients treated with ursodeoxycholic acid (UDCA) during the study period and a group of patients not treated with UDCA by pseudo-randomization using Propensity Score Matching.

Material and methods. 262 patients aged 60.1±8.9 years, taking statins for the secondary prevention of cardiovascular complications were included into a 6-month observational cohort study. The UDCA intake was recommended to all the patients due to the presence of liver and/or bile duct diseases. One part of the patients strictly followed medical recommendations and used UDCA, while the other part of the patients wasn’t taking UDCA. This allowed comparing the effect of UDCA in these groups.

Results. Propensity Score Matching method allowed forming two groups of patients of 52 people each with similar main clinical and demographic characteristics. A more significant decrease in the levels of total cholesterol (TC) and low density lipoprotein cholesterol (LDL-C) (up to 4.0 mmol/L and 1.92 mmol/L, respectively; p<0.001) after 6 months was found in patients treated with lipid-lowering therapy in combination with UDCA as compared with patients without UDCA (up to 4.52 mmol/L and 2.6 mmol/L, respectively; p<0.05). No ALT, AST, CPK, LDH activity deterioration and no bilirubin serum level increase was found. Due to statin treatment the target levels of LDL-C by the end of the study were achieved in 31% of the patients of UDCA-group. Target levels of LDL-C were not achieved in any of the patients of the group without UDCA (p<0.001). There was demonstrated a high adherence to UDCA therapy.

Conclusion. Combined therapy with statins and UDCA is effective and safe in patients with high cardiovascular risk and concomitant liver disease. Co-administration of statins with UDCA is promising in the treatment of hyperlipidemia in patients with low tolerance to statins. However, additional controlled studies are required.


304-308 609

Aim. To study the effect of renal denervation on blood pressure (BP), myocardium function and vegetative status in patients with resistant hypertension (HT).

Material and methods. Patients with a provisional resistant HT diagnosis (n=62; 41.3% male) were included into the study. 17 patients were selected for renal denervation after correction of previous antihypertensive therapy and examination to exclude symptomatic HT. Two patients refused the procedure, 1 patient hadn’t undergone renal denervation due to anatomical features (renal artery diameter <4 mm). Renal denervation was performed in 14 patients. Office and average daily BP, kidney function, the severity of left ventricular hypertrophy and heart rate variability were assessed initially and after the intervention.

Results. Office systolic BP (SBP) decreased from 165 to 150 mm Hg (p=0.016), diastolic BP (DBP) - from 110 to 95 mm Hg (p=0.019) 12 months after the renal denervation. Average daily SBP decreased from 148 to 137 mm Hg (p=0.092), average daily DBP - from 90 to 80 mm Hg (p=0.401). Plasma creatinine level and glomerular filtration rate remained within the reference range at a baseline and in 12 months. Left ventricular hypertrophy measured by echocardiography has not changed significantly. No significant heart rate variability dynamics has been found.

Conclusion. Renal denervation is a promising treatment for resistant HT. The effect of renal denervation on the dynamics of left ventricular hypertrophy and heart rate variability requires updating.


309-316 1128

Efficacy of omega-3 fatty acids in cardiology is so high that in many countries omega-3 fatty acids are included into the treatment protocols for patients with cardiovascular diseases. This therapeutic class slows down oxidative stress and chronic inflammation processes, thereby providing a significant contribution to the complex treatment of hypertension. Besides, omega-3 fatty acids slow down the aging process and prevent the development of age-related diseases affecting the rate of telomere shortening.

317-326 973

Alcohol abuse and particularly extension of alcohol consumption in alcohol diseas increases the risk of cardiac arrhythmias development and aggravates existing arrhythmias. Patients do not always receive the necessary specific treatment due to lack of detection of the ethanol genesis of these arrhythmias. Management of patients with alcohol abuse and alcohol dependence, including its cardiac complications among other cardiac arrhythmias should use both antiarrhythmic and anti-alcohol drugs and antidepressants. Such issues as diagnosis and management of patients with alcohol-induced cardiac arrhythmias are presented.


327-332 42961

Just a small part of hypertensive patients is treated effectively despite the wide variety of antihypertensive drugs. Combined antihypertensive therapy can solve the problem of influence on the various pathogenic mechanisms of hypertension. The combination of an ACE inhibitor and a dihydropyridine calcium channel blocker is one of the most efficient, since both groups of drugs act as vasodilators and have therapeutic synergy in blood pressure reduction. A fixed combination of ramipril with amlodipine is an effective antihypertensive drug with a good tolerability profile. It effectively provides both blood pressure control and positive cardioprotective and nephroprotective effect.

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