Objectives Despite the proven effectiveness of lifestyle interventions and specific medications in the treatment of obesity, little is known about their use in real-world practice. Aims To study the awareness of patients about the problem of overweight/obesity, as well as the clinical practice of non-drug and drug therapy according to the survey. Materials and Methods Eligible patients were recruited from the prospective outpatient registry of patients with cardiovascular diseases. The design of the study was a cross-sectional cohort single-centre. All of the included patients completed a specifically designed questionnaire. The study included 295 patients (mean age 66.8 +/- 11.8 years) with a body mass index (BMI) of >= 25 kg/m2. One hundred eight (36.6%) individuals were overweight, 124 (42.2%) had first-class obesity, 42 (14.2%) had second-class obesity, and 21 (7.1%) patients had third-class obesity. Results 252 patients (85.4%) were informed of being overweight/obese, and all of them received non-drug recommendations for the treatment of obesity. Anti-obesity medications (AOM) were recommended only to 25 (8.5%) patients: 3 - overweight, 11 - obesity class I, 6 obesity class II, and 5 - obesity class III. Twenty-one (7.1%) patients took the prescribed medications (84% adherence). The drugs were more often taken by patients with class II and III disease (40.5% and 57.1% of patients, respectively). Overweight (8.5%) and class I obesity (18.0%) patients took these drugs less often (p < 0.0001). Conclusion The results of the survey have demonstrated good awareness of patients about their obesity/overweight and quite frequent use of non-drug obesity therapy. However, the rate of AOM prescription was extremely low.
Background: To assess the influence of the COVID-19 (Coronavirus Disease 2019) pandemic on treatment adherence by patients with CHF (Chronic heart failure) and to determine the factors associated with changing adherence during home-isolation. Methods: The survey was conducted in patients participating in the COMPLIANCE study (ClinicalTrials.gov. NCT04262583). Thirty-one patients, included into in the COMPLIANCE study before March 1, 2020, were interviewed through phone calls. A modified adherence scale of the National Society for Evidence-Based Pharmacotherapy was used, which permits to assess of overall adherence, adherence to particular drugs and the main causes for non-adherence. Results: In the whole group of patients, only a tendency to reduced overall adherence was registered during the COVID-19 pandemic (р=0,256). Significant differences in the rate of adherence deterioration were revealed for angiotensin-converting enzyme (ACE) inhibitors (p=0.031) and for statins (p=0.002). The reasons for non-adherence were lack of opportunity to contact with a physician, inability to perform investigations necessary for correcting prescribed pharmacotherapy, and side effects. Conclusion: A tendency to deterioration of adherence to prescribed pharmacotherapy was revealed during the COVID-19 pandemic. A significant decline in adherence was registered to ACE inhibitors and statins.
Rationale. Therapy with oral anticoagulants (OACs) in patients with atrial fibrillation (AF) is based on finding the optimal balance of efficacy and safety of these drugs. Data from observational studies are an additional source of information for the adverse events (AEs) of pharmacotherapy. Objective: To investigate pharmacotherapy AEs with OACs in the “ANTEY” prospective observational study in patients with non-valvular atrial fibrillation (AF). Material and Methods: A total of 201 people were enrolled (83 (41.3%) were women). The age of subjects was 71.1 ± 8.7 years (data presented as mean with standard deviation). The study protocol included two face-to-face visits (contacts V0 and V1) and one follow-up (FU) phone contact which were made with the patient at an interval of 6 months. At V0, all patients were recommended to take one of the non-vitamin K antagonist oral anticoagulants (NOACs); starting from V1, warfarin could have been prescribed or NOAC could have been changed. Information about AEs and OACsadministration was collected at V0, V1, and FU. Results. During 1 year of observation, 15 out of 201 patients refused to take OACs, and 186 initiated the recommended drug. Rivaroxaban was initiated in 93 patients, dabigatran in 46, apixaban in 40, and warfarin in 7 patients. There were 55 AEs, 25 of which were serious (SAEs), including 4 deaths. Of the 30 AEs, there were 18 bleedings: eight (8.6%) occurred with the administration of rivaroxaban; four (8.5%) with dabigatran, three (7.5%) with apixaban, and three (42.9%) with warfarin. Differences in the incidence of bleeding events between NOACs and warfarin are statistically significant (p = 0.025). Any AEs increased the chance of nonadherence to treatment nine-fold: OR = 9.2 (CI95%: 3.6–23.5), p < 0.0001. Conclusions. The most typical and common AEs in real-world clinical practice settings treatment with OACs were bleedings, the incidence of which was approximately 8% to 9% in the treatment with NOACs and was much higher with warfarin, bleedings in the treatment with OACs are statistically significantly associated with nonadherence to the use of these drugs in the future.
The ANTEY study included 201 patients with non-valvular AF, who had indications and without contraindications for NOAC treatment. The patients had previously been advised to take oral anticoagulants but they did not comply with all medical recommendations. The observation period was 1 year, during which 2 in-person visits were performed: an inclusion visit (V0) and a visit (V1), as well as 1 telephone contact/follow up (FU); the interval between contacts was 6 months. All patients were recommended to take the NOAC by decision of the physician. During the V0, V1 and FU visits, the “National Society for Evidence-Based Pharmacotherapy (NSEPh) Adherence Scale” questionnaire was used to assess overall adherence and associated factors. 15 (7.5%) patients had not started NOAC therapy by the end of the study (primary non-adherent patients). Their characteristics are analysed in this work.
The new coronavirus infection (COVID-19) pandemic and the subsequent quarantine measures, particularly home isolation of the population, could have seriously affected the quality of pharmacotherapy and adherence to it by patients with chronic non-communicable diseases. Aim . To assess the dynamics of adherence to pharmacotherapy by patients with stable coronary artery disease (SCAD) in self-isolation during the COVID-19 pandemic. Material and methods . To accomplish the aim of the study, we selected 39 patients with SCAD who previously completed the ALIGN study, the purpose of which was to align patients’ medical therapies according to current clinical guidelines. From May 05, 2020, to May 14, 2020, a telephone survey was conducted of 39 patients with SCAD (37, 94.8%) males, mean age 67.6±8.5 years). After one year of participation in the ALIGN study, 87.1% of the patients were adherent to their prescribed pharmacotherapy. Adherence (overall and to specific medications) was assessed by means of the original adherence scale, which made it possible to identify violations in taking medications (non-adherence to the intake regime or discontinued intake of medications), and the main reasons for adherence violation were established. Adherence registered during the telephone survey at the time of the COVID-19 pandemic was compared to that obtained during the last time the patient participated in the ALIGN study. Results . During the period of home isolation, a substantial decline in the adherence of patients to pharmacotherapy was revealed. The percentage of adherent patients decreased from 87% to 54% due to an increase in the number of patients who stopped taking several or all of the recommended drugs during home isolation (p=0.024). The overall rate of adherence during the COVID-19 pandemic appeared to be even worse than before the start of the ALIGN study. A comparative analysis of subgroups with and without a decline in adherence revealed a trend suggesting that higher patient education (p=0.067) or previous percutaneous coronary intervention (p=0.063) can be considered a protective factor associated with fewer violations in adherence during the COVID-19 pandemic. Analysis of adherence to specific drugs showed that during self-isolation there was a decrease in adherence to antiplatelet drugs (p=0.047) and to statins (p=0.055). Adherence to beta-blockers, renin-angiotensin-aldosterone system inhibitors and dihydropyridine calcium antagonists remained unchanged. Conclusion . In patients with SCAD during the period of home isolation in the COVID-19 pandemic and associated difficulties in contacting the attending physician, there was a decline in adherence and an increase in the number of patients who stopped taking several or all prescribed drugs.
Takotsubo syndrome is a type of acute reversible heart failure that can involve a form of acute catecholaminergic myocardial stunning. This clinical entity shows a pattern of temporary left ventricular dysfunction in the absence of occlusion of any coronary artery. A midventricular type is a form of Takotsubo syndrome where the atypical morphological variant is Hawk’s beak. The prevalence of this type is estimated to be 10-15% in several series in Asian and Western countries (predominantly Caucasian patients). In Latin America, there are no studies reporting this type of presentation. Two cases are reported in women initially diagnosed with acute myocardial infarction with the finding of the atypical hawk's beak morphology of Takotsubo syndrome, confirmed by left ventriculography. One of them was followed up early, observing recovery in her ventricular function without structural compromise at the level of contractility and with a good response to the outpatient treatment proposed. As there is a low prevalence and few published reports, these 2 cases are presented to promote long-term studies and increase the information regarding the evolution and morbidity/mortality of this type of presentation compared with the classical form of the syndrome.
Aim. Development, testing and validation of the original questionnaire “Adherence Scale” (AS) in the PRIORITY and ANTEY observational studies (OS).Materials and methods. The OS PRIORITY assessed adherence to statins in 298 patients with high and very high cardiovascular risk for 3 months. The OS ANTEY assessed adherence to oral anticoagulants in 201 patients with non-valvular atrial fibrillation for 1 year. Adherence was assessed using the original AS questionnaire, for which external validation was performed (with the calculation of the Cohen's Kappa coefficient). The reference methods were the validated questionnaire and direct medical interview. And internal validation was performed (consistency of questions on the AS using Spearman's correlation analysis). The sensitivity, specificity (ROC analysis) and retest reliability of the adherence scale (Cronbach's alpha) were also determined.Results. In the OS PRIORITY Cohen's kappa for the AS and the reference method of direct medical survey was 0.76 (high consistency), and for the AS and the reference method of the validated questionnaire=0.28 (low consistency). High internal consistency of the questionnaire questions (correlation coefficient=0.78, p<0.0001) confirms the internal validity of the adherence scale. Evaluation of the main characteristics of the modified AS in the OS ANTEY showed high consistency between the results of the AS and the validated questionnaire: Cohen's kappa=0.94 (high external validity of the AS). The retest reliability of the AS was 0.76 (Cronbach's alpha). The internal consistency of the questionnaire was confirmed by a strong and statistically significant correlation between the test questions: Spearman's correlation coefficient=0.80, p<0.0001. The sensitivity of the test, determined using the ROC analysis, was 89%, and the specificity was 62%.Conclusion. The developed and tested new original questionnaire (modified version) – the AS – showed high indicators of reliability, validity and sensitivity. This ensures its reliability and ease of use for assessing various types of adherence and determining the leading factors of non-adherence, and also allows its use in scientific studies and clinical practice.
Aim . Based on the data of the TRUST study (Influence of Participation in Randomized Controlled Trials on adheRence to Medicines' Intake and regUlar viSits to the docTor) to assess the quality of drug therapy and patients' awareness of achieving target blood counts and blood pressure (BP) among patients with coronary artery disease (CAD), diabetes mellitus (DM), hypertension. Material and methods . 102 patients are enrolled in the study group of the TRUST study who participated in one or more randomized clinical trials (RCT) in the period from 2011 to 2018. A control group (n=109) included patients who had never participated in an RCT was selected. From January to April 2020, face-to-face or telephone contact was established with patients from both groups. In the study group, the response was 86.3%, in the control group - 81.7%. The adherence to drug therapy accordingly to current clinical guidelines was analyzed in patients with coronary artery disease in both groups. Results . Patients with CAD who previously participated in RCTs take drugs with proven efficacy significantly more often than patients who did not participate in clinical trials. All groups of drugs intake was significantly more frequent in the study group than in the control group: angiotensin-converting-enzyme inhibitors/angiotensin receptor blockers (odds ratio [OR] 7.66, 95% confidence interval [CI] 2.5-22.6; p=0.006), statins (OR 5.12, 95%CI 1.8-14.5; p=0.002), beta-blockers (OR 2.96, 95%CI 1.03-8.5; p=0.038), antiplatelet agents (OR 2.94, 95%CI 1.1-7.7; p=0.026). In the main group, 54.3% of patients with CAD knew about their level of low-density lipoprotein cholesterol (LDL-c), and 68% of them had an LDL level of ≤ 1.8 mmol/l. Patients with DM in 92.9% of cases were aware of their glucose level, and in 76.9% of them had the fasting glucose level <7 mmol/L. Hypertensive patients in 92.8% of cases controlled their blood pressure twice a day and 89.2% of them had a target blood pressure level (<140/90 mm Hg). Conclusion . Patients who participated in RCTs showed better adherence to treatment and health awareness compared to the control group. Partly, the approach to patient management, as it takes place in the RCTs model, can be implemented in real clinical practice to improve the quality of therapy in patients with cardiovascular disease.
Aim. To study the adherence of doctors to the guidelines for the treatment of chronic heart failure (СHF) and the adherence of patients with СHF to the therapy prescribed by doctors.Material and methods. The COMPLIANCE study is an integral part of the PROFILE registry of the specialized cardiology division of the research center. The study includes patients with verified CHF who were previously observed in the PROFILE registry and patients with CHF who have been newly seeking medical care in the period from December 01, 2019 to December 31, 2020. At the first visit, the initial therapy was evaluated, treatment adherence was determined, and treatment was corrected in accordance with current guidelines. The second visit will also assess patient adherence to treatment, assess the factors of non-adherence and complications of diseases during the year of follow-up.Results. The first 30 case-records of patients with CHF included into the study were analyzed. 90% of patients received angiotensin-converting enzyme inhibitors (ACEI)/angiotensin receptor blockers (ARB). Beta-blockers (BB) were prescribed to 96.7% of patients, and mineralocorticoid receptor antagonists (MRAs) – to 76.7% of patients, and some of them received MRAs at ejection fraction >35%. It was found that the overall adherence of patients according to the adherence scale of the Russian National Society of Evidence-Based Pharmacotherapy (NSEPh) was significantly lower than the adherence to specific drugs. The worst was adherence to ACEI (71%) and MRAs (77%), higher – to BB (86%). The most common factors of non-adherence to treatment, according to the first results, are a large number of medications and a complex medication regimen.Conclusion. The first part of the COMPLIANCE study showed a relatively good adherence of doctors to current guidelines. However, the choice of the drug and its doses did not always correspond to evidence-based medicine data, existing guidelines and summary of product characteristics (SmPC) of specific drugs. The patients adherence to the prescribed therapy was not bad (this can be explained by long-term follow-up in specialized centers), but it was different for different drugs. The worst adherence was registered to the ACEI/ARB. This is warning factor, since these drugs make a significant contribution to improving the long-term outcome of CHF.
Aim. To study the long-term outcomes of patients who survived after acute myocardial infarction (AMI) in a prospective outpatient registry.Material and methods. Patients (n=160) who applied to one of the outpatient clinics in Moscow after AMI were included in the registry PROFILE-MI. The total follow-up period was 1.5 years. The primary combined endpoint (PCE) included death from any cause, cardiovascular events (nonfatal myocardial infarction, nonfatal cerebral stroke), emergency hospitalizations for cardiovascular diseases, significant cardiac arrhythmias. 1-year observation period was taken in analysis of the factors affecting the development of PCE.Results. During the observation period, 16 patients (10%) died. Life status was not obtained in 4 patients. Most of the deaths were due to cardiovascular complications; in a quarter of patients, repeated AMI was the cause of death. After 12 months of follow-up, the development of PCE was observed in 42 patients. PCE has been identified more often in elderly patients, in patients who had certain complications in the acute period of AMI, in patients who had swelling at the time of the examination in the outpatient clinic, who complained of shortness of breath, and also had a heart rate (HR) more than 70 min-1. Normal blood pressure (within 120/80-139/89 mm Hg) and HR at 60-70 min-1 had a positive prognostic influence. Conclusion. Despite intensive treatment in a hospital and the relatively high quality of secondary pharmacological prevention, the prognosis of life and disease in patients after AMI remains quite serious.
Aim. To study adherence to treatment with new oral anticoagulants (NOAC) and factors associated with it in patients with non-valvular atrial fibrillation (AF) within the outpatient PROFILE registry.Material and methods. ANTEY study included 201 patients with AF from the PROFILE registry (89.3%): 118 males (58.7%) and 83 females (41.3%), aged 71.1Ѓ}8.7 years. The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during all visits with the use of the original questionnaire – National society of evidence-based pharmacotherapy (NSEPh) adherence scale, 8-item Morisky Medical Adherence Scale (MMAS-8) and direct doctors’ questioning.Results. During V0 111 (55.2%) patients were recommended the use of rivaroxaban; 47 (23.4%) – the use of dabigatran and 43 (21.4%) – the use of apixaban. During V1 based on the results of the NSEPh adherence scale 155 (77.5%) patients were completely adherent (strictly followed doctors’ recommendations), 5 patients were partially adherent (violated doctors’ recommendations), 7 patients were partially non-adherent (stopped taking NOACs), and 33 patients were completely non-adherent (did not start taking NOACs). Out of 197 patients who completed MMAS-8 questionnaire 157 (79.7%) patients were partially adherent to treatment and 40 (20.3%) patients were non-adherent. None of the patients were completely adherent to treatment. According to doctors’ questioning, by the time of the PC 15 patients had not started taking the recommended NOAC – were completely non-adherent (CNA). According to the NSEPh adherence scale, by the time of the PC out of 197 patients (4 patients died) 158 patients were completely adherent to treatment, 6 – partially adherent, 18 – partially non-adherent and 15 – CNA. According to MMAS-8, by the time of the PC 153 (77.7%) patients were partially adherent to treatment, and 44 (22.3%) patients – non-adherent (none of the patients were completely adherent). Out of 15 CNA patients MMAS-8 revealed only 4 (27,6%) during B1, and 6 (40%) during the PC. NSEPh adherence scale revealed all CNA patients. The main reason for refusing to start NOAC therapy was their high price. Recently started use of NOACs was stopped mostly due to adverse effects of therapy (bleeding). The most common factors increasing patients’ adherence to NOACs were previous experience of taking this group of drugs and no history of any adverse effects during therapy.Conclusion. The ANTEY study showed relatively high adherence to NOACs prescribed by doctors of the specialized cardiology department of the scientific center. The most common factors associated with early non-adherence to the new drug were high price and adverse effects of therapy, the latter influenced prolonged adherence as well. Previous experience of taking this group of drugs and no history of any adverse effects during therapy increased adherence to NOACs.
Aim. To perform a pharmacoeconomical assessment of the use of generic statin drugs in patients with high and very high cardiovascular risk (CVR) in real clinical practice based on the data of the study PRIORITY.Material and methods. The PRIORITY study included 298 patients with high (29; 9.7%) and very high (269, 90.3%) CVR. All patients were recommended to take the reproduced drugs of atorvastatin and rosuvastatin in an individually prescribed dose. After 1 month (B1), if the target level of lowdensity lipoprotein cholesterol (LDL-C) was not reached, the statin dose was titrated. After 3 months of follow-up (B3), the hypolipidemic effect of statin therapy was evaluated. 295 people completed the study, 285 patients had the results of the lipid profile. To perform a pharmacoeconomic analysis and evaluate the “cost/effectiveness” ratio, we used the prices of generic statins in one of the online pharmacies. The effectiveness of statins was determined by the LDL-C reduction, as well as by the percentage of achieving the target LDL-C level.Results. At the first stage of the pharmacoeconomic analysis, the criterion for the effectiveness of 3-month lipid-lowering therapy was a decrease in LDL-C level by 1 mmol/l. The median and interquartile range of the ratio “cost/effectiveness” indicator for atorvastatin was 658.2 (431.5; 1257.1) RUB/mmol/l, and for rosuvastatin – 621.0 (390.7; 940.6) RUB/mmol/l (p=0.45). The results of a comparative assessment of the “cost/effectiveness” ratio (with the abovementioned effectiveness indicator) in subgroups of patients with high and very high CVR, with the achievement and nonachievement of the target level of LDL-C, adherent and non-adherent to statins, revealed the economic advantage of statins in groups of adherent patients (p=0.35), high-risk patients (p<0.0001) and individuals who reached the target level of LDL-C (p=0.002) when compared with the corresponding comparison groups. Despite the revealed high effectiveness of rosuvastatin at doses of 20-40 mg/day (assessed by the cost/effectiveness of achieving the target values of LDL-C for specific doses of statins), calculation of the “cost/effectiveness” ratio for each reproduced statin, in general, showed a higher economic effectiveness of atorvastatin.Conclusion. Pharmacoeconomic analysis of therapy with generic statin drugs, performed according to the data of the non-randomized uncontrolled study, allows to justify the economic efficiency and advantages of these drugs in various subgroups of patients who need statin therapy.
Aim . To study the changes in clinical and demographic characteristics, risk factors, treatment tactics, the dynamics of drug therapy at the prehospital stage and prescribed during discharge from the cardiology department over a 4-year period in patients after acute coronary syndrome (ACS) with ST segment elevation and ACS without ST segment elevation. Material and methods . Data from the LIS-3 prospective registry (Lyubertsy mortality study) was used. Patients admitted to the cardiology department of the Lyubertsy district hospital No. 2 for the first 9 months of 2014 (n=104) and for the first 9 months of 2018 (n=223) with a diagnosis of “ACS with ST segment elevation and ACS without ST segment elevation” and with a confirmed diagnosis at discharge “acute myocardial infarction” (AMI) or “unstable angina” (NSA) were included into the study. Comparison of clinical and demographic indicators, risk factors, the frequency of use of acetylsalicylic acid, clopidogrel, statins, beta-blockers, ACE inhibitors, angiotensin II receptor antagonists, anticoagulants at the prehospital stage and during discharge from the hospital were performed. Results . Significant differences in the gender and age composition of patients were not found. The number of working patients increased. Compared to 2014, in 2018 the number of patients with arterial hypertension increased (64.4% and 75.8%, respectively, p=0.047), and with coronary heart disease decreased significantly (39.4% and 22.4%, respectively, p=0.004), however, the incidence of atrial fibrillation, history of AMI, and cerebral stroke did not change over the period under consideration. The frequency of concomitant diseases did not practically change, except for kidney diseases, which have become more common. A significant decrease in the frequency of thrombolysis and a significant (more than 6-fold) increase in angioplasty with stenting were found. Patients before ACS in 2014 received less antiplatelet agents than in 2018, including dual antiplatelet therapy, ACE inhibitors were prescribed more often. The intake of nitrates decreased, and the use of statins increased (6.7% versus 13.9%, respectively, p>0.05). AMI as the outcome of ACS was almost the same in both men and women. A downward trend in myocardial Q-infarction (p>0.05) was found. Taking dual antiplatelet therapy and ACE inhibitors were more often recommended at discharge and taking nitrates and any diuretics was less common. Statins intake did not change. Conclusion . The “portrait” of a hospitalized ACS patient changed somewhat over 4 years: the frequency of the history of coronary heart disease significantly decreased, and the frequency of hypertension increased. The presence and significance of risk factors such as hypercholesterolemia and adverse heredity cannot be assessed as before. The frequency of use of antiplatelet agents and statins increased in prehospital therapy; however, in general, a smaller proportion of patients requiring statins took them. The proportion of AMI patients among ACS ones did not change over the study period.
Aim. To assess the quality of therapy in stable coronary heart disease (CHD) patients, who first sought consultation in the specialized cardiology department of the research center, and try to adjust the therapy in accordance with current clinical guidelines, paying special attention to achieving the target levels of blood pressure, low-density lipoprotein cholesterol (LDL), and glycosylated hemoglobin (in patients with diabetes mellitus), increasing exercise tolerance and improving the quality of life (QL).Material and methods. The ALIGN study is an integral part of the PROFILE outpatient registry. ALIGN study included all patients with verified coronary heart disease who came for consultation to the specialized institution for the first time or for the first time in more than the last 3 years. Patients have been recruited from December 01, 2017 to December 31, 2019. The study consisted of 4 visits: the first-time visit – inclusion in the study (V0), when drug therapy, QL, and adherence were evaluated, and therapy correction was made in accordance with clinical guidelines. In 3 months (V1) the target values of clinical and laboratory parameters were estimated. The third visit (V2) was planned to take place 1 year after the first visit with reevaluation of QL and patients' adherence to treatment, and effectiveness of the therapy. The fourth visit (V3)/telephone contact was planned in 2 years after the first visit to assess life status, get information about complications and therapy.Results. 389 people were included in the PROFILE registry for the specified period of time, 79 had a verified diagnosis of CHD, and 71 patients were included in the ALIGN study: 55 men (aged of 68.7±8.96 years) and 16 women (aged of 67.5±8.08 years). Arterial hypertension was registered in 90.1% of patients, stable angina class I-III – in 62%, 47.9% of patients had a history of acute myocardial infarction (AMI), 52.1% had percutaneous coronary intervention, 15.5% of patients had coronary artery bypass graft, chronic heart failure was detected in 40.8%, diabetes mellitus – in 21.1%, atrial fibrillation – in 15.5% of patients. Lipid-lowering drugs were taken by 53 (74.6%) patients, but only 21 (29.6%) achieved the target values of LDL cholesterol. Angiotensin-converting enzyme inhibitors were taken by 34 patients (47.9%), and angiotensin receptor blockers by 15 (21%) of patients, 47 (66.2%) patients took beta-blockers, antiplatelet agents were taken by 61 people, and anticoagulants by 10 patients. Patients who had a history of AMI had been prescribed BB in 88%, statins – in 90%, and renin-angiotensin-aldosterone system (RAAS) blockers – in 80% of cases.Conclusions. Initial quality of therapy for patients with stable CHD did not fully match the clinical guidelines: a quarter of patients did not receive lipidlowering therapy, and target levels of LDL cholesterol were achieved only in one third of patients. Among patients who had a history of AMI, every fifth patient did not receive RAAS blockers.
The article focuses on the problem of low adherence to treatment among patients, in general, and provides data on the high adherence among patients in randomized controlled trials. Low adherence remains one of the most debated and difficult problems to solve nowadays. Poor medication adherence of the patient can significantly worsen the effectiveness of treatment and leads to increased health care costs. And although the factors that improve adherence are varied, and include the skills of the doctor, the patient's personal characteristics, the external environment, an individual approach to each patient and etc., the absence of a "gold standard" for assessing adherence in clinical practice makes it difficult to predict and significantly improve it among patients. Nevertheless, the article discusses the existing doctor-patient interaction model, which strictly regulates the algorithms and technical means to achieve the best medication adherence. Randomized clinical trials (RCT) are the basis of evidence-based medicine, the results obtained in RCT form the basis of existing clinical guidelines. While participating in RCT patients can receive comprehensive information about the disease, the effectiveness of drug therapy, possible side effects of the therapy being conducted, the research objectives and prognosis from their attending physician; patients are trained to be disciplined and adhere to the recommendations of the doctor. The RCT, for a number of objective reasons, uses a variety of methods for assessing adherence and ways to improve it, which leads to higher patient adherence then among patients in general.
Aim. To assess the influence of addition of nicorandil on long-term cardiovascular complications in patients with chronic coronary artery disease (CAD) in the framework of a prospective observational study.Material and methods. Prospective observational multicenter NIKEA study included 590 patients with stable CAD. All patients were recommended to add nicorandil to their baseline therapy. After 21 months, 547 telephone contacts were made, the life status of 524 people was specified, 23 patients were lost to follow-up. The following complications were registered: death from any cause; non-fatal myocardial infarction (MI); non-fatal stroke; urgent myocardial revascularization; hospitalization due to deterioration of CAD, chronic heart failure (CHF) or atrial fibrillation (AF). In 479 patients, a telephone survey was performed to identify adherence (persistence) to nicorandil– i.e. to verify the continuing the treatment for the prescribed duration.Results. During the follow-up period, 15 deaths were recorded, the causes of which were as follows: 3 CAD (2 MI, 1 left ventricular aneurysm), 1 pulmonary embolism, 2 CHF; 1 stroke, 1 oncology, 1 bilateral pneumonia. In the remaining 6 cases, the causes of death were not known. Cardiovascular (CV) complications were MI (8 cases in 7 patients, 1 patient had 2 MI in the follow-up period, 3 patients from this group died), stroke in 6 patients (7 cases, 1 patient had 2 strokes, 1 patient died). Urgent percutaneous coronary intervention was performed in 3 patients (in 2 patients due to acute MI, in 1 patient due to unstable angina). During the observation period, 21 people were urgently hospitalized due to deterioration of clinical condition. According to the results of a medical survey, by the end of the follow-up period, 237 people were not adherent to prescribed nicorandil, and 242 patients took the recommended medication (adherent patients). The main cardiovascular complications and death from any cause (р<0.001) as well as the number of urgent hospitalizations (р=0.017) were significantly more common in non-adherent to nicorandil patients in comparison with adherent patients.Conclusion. The overall rate of CAD complications in NIKEA study was typical for patients with stable CAD receiving contemporary medical therapy. Addition of nicorandil significantly reduced the rate of CV complications in adherent patients in comparison with non-adherent patients.
Aim. To study adherence to treatment with generic statins prescribed to patients with high and very high cardiovascular risk in routine clinical practice, as well as the possible impact of educational training of doctors on compliance with clinical guidelines and changes in patient adherence to treatment. Material and methods. The study was prospective, with educational training for physicians on the main provisions of current clinical guidelines prior to the program. It included 3 visits over 12 weeks: inclusion visit (V0), and visits after 1 and 3 months of follow-up (V1 and V3). The use of generic atorvastatin or rosuvastatin was recommended for all patients. To assess adherence the following surveys were used: medical survey (all visits), the original questionnaire to assess the potential and the actual commitment to taking statins and the causes of non-adherence, and the Morisky-Green 8-question test (visits V0 and V3) to evaluate overall adherence to drug treatment. The patients who started the drug taking according to the medical recommendations and continued it during the study were considered as adherents. Patients who started but stopped taking the drug for 12 weeks were considered as partially non-adherent. Patients who refused to take the recommended statin were considered as non-adherents. The prescribed doses of statins and medical tactics in the titration of doses, as well as the achievement of the target level of low-density lipoprotein cholesterol (LDL cholesterol) were evaluated. Results. 112 (37.5%) of the 298 patients with baseline indications for taking statins did not take these drugs. According to the medical survey at V0 a total of 286 (96%) patients were potential adherents to medical recommendations; at V3 262 (88%) patients were adherent to statin treatment; 34 patients were partially non-adherent, 1 – was non-adherent, and 1 – dropped out of the study immediately after V0. According to the original questionnaire, potential adherence was assessed in 281 patients: 244 (86.8%) were potentially adherent, 37 (13.2%) – partially non-adherent. At V3, out of 294 patients who filled in the original questionnaire, 260 (88.5%) were adherent, 26 (8.8%) – partly non-adherent, 8 (2.7%) – nonadherent. The Morisky-Green questionnaire was filled in by 292 patients: at V0, 106 patients (36.3%) had treatment adherence, non-adherence – 186 patients (63.7%). By V3, an increase in total adherence was found: 159 patients (54.5%) were adherent, and 133 (45.5%) – non-adherent. The lipid profile was evaluated in 231 patients in V1 and in 285 ones – in V3. The target LDL cholesterol level was reached by V1 in 47 (20.3%) patients, and in 184 (79.7%) patients – was not. Dose titration occurred in 56 patients. By V3, 121 (42.4%) patients reached the target level of LDL cholesterol, and 164 – did not. The results of the lipid profile analysis were erroneously interpreted in 21 patients. Conclusion The results of the medical survey and the original questionnaire for assessing adherence predominantly coincided. The Morisky-Green test does not accurately reflect patients' commitment to taking a particular drug. Clinical inertness of doctors in the titration of statin doses and achievement of target LDL cholesterol levels were found as well as erroneous interpretation of the LDL cholesterol level. Educational trainings for doctors had a positive effect on the implementation of clinical guidelines, and also contributed to increasing patient adherence to medical recommendations.
Working Group of the NIKEA Study. Yekaterinburg: Akulina E.N., Reznik I.I.; Izhevsk: Grebnev S.A., Yezhov A., Shinkareva S.E.; Krasnodar: Kudryashov E.A., Skibitsky A.V., Skibitsky V.V., Fendrikova A.V.; Krasnoyarsk: Altayev V.D., Matyushin G.V., Nemik D.B., Pitaev R.R., Samokhvalov E.V., Stolbikov Yu.Yu.; Moscow: Balashov I.S., Voronina V.P., Gaisenok O.V., Dmitrieva N.A., Zagrebelny A.V., Zakharova A.V., Zelenova T.I., Kolganova E.V., Leonov A.S., Lerman O.V., Maximova M.A., Sladkova T.A., Shestakova G.N.; Novosibirsk: Kuimov A.D., Shurkevich A.A.; Omsk: Goodilin V.A., Loginova E.N., Nechaeva G.I.; Orel: Zhuravleva L.L., Lobanova G.N., Luneva M.M., Mitroshina T.N.; Orenburg: Kondratenko V.Yu., Libis R.A.; Rostov-on-Don: Dubishcheva N.F., Kalacheva N.M., Kolomatskaya O.E., Romadina G., Skarzhinskaya N.S., Chesnikova A.I., Chugunova I.B.; Ryazan: Dobrynina N.V., Nikolaev A.S., Trofimova Ya.M., Yakushin S.S.; Tula: Berberfish L.D., Gomova T.A., Gorina G.I., Dabizha V.G., Zubareva L.A., Nadezhkina K.N., Nikitina V.F., Renko I.E., Soin I.A., Yunusova K.N. Background. Nicorandil is an antianginal drug for which, the ability to positively influence the prognosis of patients (pts) with stable ischemic heart disease (IHD) was confirmed in a randomized controlled trial (RCT) of IONA (the Impact Of Nicorandil in Angina). To study whether the results of RCTs are reproduced in real clinical practice seems to be an actual scientific and practical task. Aim . To compare the data on the effectiveness and safety of nicorandil in pts with stable IHD obtained in the NIKEA observational study (OS) and in the IONA randomized study. Material and methods . 590 pts with IHD and stable angina pectoris were included in the OS NIKEA. All pts were recommended to take nicorandil in addition to the standard antiischemic therapy. 21 months after being included in the study, 524 pts received a phone call. During the telephone contact with pts or their relatives, the life status of pts was determined. According to these results of the survey data were obtained, that 15 people died and 509 pts were alive. The events included in the primary combined endpoint (PCEP) were also determined: death from all causes, new cases of acute myocardial infarction and acute cerebrovascular accident, unscheduled operations of myocardial revascularization, hospitalization for decompensation of chronic heart failure, atrial fibrillation, unstable angina, information on taking nicorandil and other drug therapy, adverse events of drug treatment have been reported. A comparative analysis of the results of the OS NIKEA and RCT IONA was carried out. The results of the IONA study were taken according to the publication in the Lancet 2002. A comparative analysis of the results of the effectiveness of nicorandil in real practice (according to the OS results) was performed with the data obtained in the RCT: the nicorandil/placebo groups in the RCT were compared with the adherent/non-adherent nicorandil groups in the OS. Results . The follow-up duration in both studies was similar and averaged 1.6±0.5 years at RCT IONA and 1.8±0.4 years at NIKEA study. The average age of pts was 67,0±8,0 years in RCT and 65.1±9.6 years in OS. In pts of OS more pronounced comorbidity was noted (cardiovascular diseases, diabetes mellitus). Drugs that favorably affect the prognosis in pts with IHD were more often prescribed to NIKEA study pts (p<0.05). In both RCTs and OS, the antianginal effectiveness of nicorandil was confirmed. According to the OS results, a reduction in the number of angina attacks and a decrease in the need for short-acting nitrates were demonstrated. The frequency of PCEP components was higher in RCT. Conclusion . Long-term outcomes according to the NIKEA observational program for various components of the PCEP turned out to be similar to the results of RCT IONA. It is demonstrated the efficacy of nicorandil in real clinical practice.
Assessment of treatment specifics in patients with obesity and patients' adherence to doctors’ recommendations within the outpatient registry PROFILE. The registry PROFILE included patients with chronic cardiovascular diseases (CVD) or/and CVD risk factors, attending specialized cardiology department of a scientific medical center. During the period from April 19, 2017 to January 30, 2018 520 patients from the PROFILE registry have attended the department. Obesity was diagnosed in 347 patients. Out of 347 patients, 305 (88%) were interviewed using specifically designed questionnaire: 167 females, 138 males, mean age of patients was 63.9 ± 11.3. Only 81 out of 305 patients (26.6%) with diagnosed obesity accepted having this disease, 189 patients (62%) considered themselves overweight and 35 patients (11.5%) considered themselves normal weight. Primary-care doctors had paid attention to the problem of obesity only in 255 out of 305 cases (83.6%). Analysis of doctors’ recommendations showed that 242 out of 305 patients (79.3%) had been recommended reducing calorie intake, 194 (63.6%) – increasing physical activity, 37 patients (12.1%) had been prescribed medications, three patients (1%) had been recommended surgical treatment. Interviewing of patients revealed patients' underestimation of their condition and doctors’ low attention to the problem of obesity treatment.
Aim. To assess long-term outcomes in patients after acute stroke within LIS-2 registry.Material and methods. 960 patients hospitalized in 2009-2011 due to acute stroke in one of the district hospitals of Lyubertsy town were included into analysis. The first assessment of the life status was carried out in 2012-2013 through 2.8 [2.1; 3.5] years after discharge, and a reassessment was in 2017 through 7-8 years after discharge, median follow-up 6.1 [6.9; 7.7] years. The primary endpoint was total mortality. Survival was assessed using the Kaplan-Meier curves.Results. Only 300 patients were alive by the end of the follow-up, 543 patients died, and life status of 117 patients were unknown. Kaplan-Mayer curves showed that mortality was the highest during the first year after stroke, and then it stabilized and remained unchanged till the end of the followup. Less than a third of patients were alive after 8 years of follow-up. The identification of causes of death was difficult in a significant number of cases (in 52% of cases the cause was unknown). Acute stroke and other cerebrovascular diseases, as causes of death, were found in 15% of deaths, other cardiovascular diseases – in 18%, oncological diseases – in 7%, injuries – in 4%. Such causes of death as acute myocardial infarction, pulmonary disease or pulmonary embolism accounted for only 2% in the structure of deaths. A trend towards decrease in the proportion of recurrent stroke as the cause of death was observed as the follow-up period increases.Conclusion. Mortality rate of patients after acute stroke remains stably high throughout the follow-up period: after 8 years less than a third of patients were alive. Death from acute stroke and cardiovascular diseases prevailed among the main causes of death at a distant stage of observation. It is necessary to analyze the factors determining the long-term outcomes at different periods after the stroke.