ЦЕЛЬ ИССЛЕДОВАНИЯ Провести опрос врачей первичного звена здравоохранения о востребованности и применении телемедицинских технологий при диспансерном наблюдении пациентов с хроническими заболеваниями, в частности с артериальной гипертонией, и оценить отношение врачей к дистанционному контролю параметров здоровья, включая факторы риска заболеваний. МАТЕРИАЛ И МЕТОДЫ Проведен медико-социологический опрос врачей первичного звена здравоохранения в двух пилотных регионах по специально разработанной анкете. Статистическая обработка проведена с использованием программного пакета IBM SPSS Statistics 23. РЕЗУЛЬТАТЫ Опрошены 284 врача (средний возраст 47,0±15,8 года) с откликом в двух пилотных регионах 62,4 и 88,9% соответственно. Среди респондентов были участковые врачи-терапевты (84,5%) и врачи общей практики (15,5%). Опрос показал, что врачи широко пользуются телекоммуникационными технологиями, в том числе и в профессиональной деятельности, но недостаточно знакомы с практикой телемедицинской модели «врач — пациент» для дистанционного диспансерного наблюдения (в частности, только 18,1% врачей имели личный опыт проведения такого наблюдения за больными с артериальной гипертонией), а у 1/3 врачей дистанционное наблюдение вызывает сложности. Врачи менее знакомы с применением телемедицинских дистанционных технологий в медицинской профилактике и контроле факторов риска хронических заболеваний. ЗАКЛЮЧЕНИЕ Исследование показало, что повышение информированности, профессиональных знаний и профилактической активности практических врачей следует считать приоритетными мерами успешного внедрения в практику первичного звена здравоохранения новых телемедицинских дистанционных технологий и организационных моделей контроля не только хронических заболеваний, но и профилактики риска их развития.
Aim . To assess in clinical practice the structure of multimorbidity, cardiovascular pharmacotherapy and outcomes in patients with a combination of atrial fibrillation (AF) and chronic heart failure (CHF) based on prospective registries of patients with cardiovascular diseases (CVD). Materials and Methods . The data of 3795 patients with atrial fibrillation (AF) were analyzed within the registries RECVASA (Ryazan), RECVASA FP (Moscow, Kursk, Tula, Yaroslavl), REGION-PO and REGION-LD (Ryazan), REGION-Moscow, REGATA (Ryazan). The comparison groups consisted of 3016 (79.5%) patients with AF in combination with CHF and 779 (29.5%) patients with AF without CHF. The duration of prospective observation is from 2 to 6 years. Results . Patients with a combination of AF and CHF (n=3016, age was 72.0±10.3 years; 41.8% of men) compared with patients with AF without CHF (n=779, age was 70.3±12.0 years; 43.5% of men) had a higher risk of thromboembolic complications (CHA2DS2-VASc – 4.68±1.59 and 3.10±1.50; p<0.001) and hemorrhagic complications (HAS-BLED – 1.59±0.77 and 1.33±0.76; p<0.05). Patients with a combination of AF and CHF significantly more often (p<0.001) than in the absence of CHF were diagnosed with arterial hypertension (93.9% and 83.8%), coronary heart disease (87.9% and 53,5%), myocardial infarction (28.4% and 14.0%), diabetes mellitus (22.4% and 7.7%), chronic kidney disease (24.8% and 16.2%), as well as respiratory diseases (20.1% and 15.3%; p=0.002). Patients with AF in the presence of CHF, compared with patients without CHF, were more often diagnosed with a permanent form of arrhythmia (49.3% and 32.9%; p<0.001) and less often paroxysmal (22.5% and 46.2%; p<0.001) form of arrhythmia. Ejection fraction ≤40% (9.3% and 1.2%; p<0.001), heart rate ≥90/min (23.7% and 19.3%; p=0.008) and blood pressure ≥140/90 mm Hg (59.9% and 52.2%; p<0.001) were recorded with AF in the presence of CHF more often than in the absence of CHF. The frequency of proper cardiovascular pharmacotherapy was higher, albeit insufficient, in the presence of CHF (64.9%) than in the absence of it (56.1%), but anticoagulants were prescribed less frequently when AF and CHF were combined (38.8% and 49, 0%; p<0.001). The frequency of unreasonable prescription of antiplatelet agents instead of anticoagulants was 52.5% and 33.3% (p<0.001) in the combination of AF, CHF and coronary heart disease, as well as in the combination of AF with coronary heart disease but without CHF. Patients with AF and CHF during the observation period compared with those without CHF had higher mortality from all causes (37.6% and 30.3%; p=0.001), the frequency of non-fatal cerebral stroke (8.2% and 5.4%; p=0.032) and myocardial infarction (4.7% and 2.5%; p=0.036), hospitalizations for CVD (22.8% and 15.5%; p<0.001). Conclusion . Patients with a combination of AF and CHF, compared with the group of patients with AF without CHF, were older, had a higher risk of thromboembolic and hemorrhagic complications, they were more often diagnosed with other concomitant cardiovascular and chronic noncardiac diseases, decreased left ventricular ejection fraction, tachysystole, failure to achieve the target blood pressure level in the presence of arterial hypertension. The frequency of prescribing proper cardiovascular pharmacotherapy was higher, albeit insufficient, in the presence of CHF, while the frequency of prescribing anticoagulants was less. The incidence of mortality from all causes, the development of non-fatal myocardial infarction and cerebral stroke, as well as the incidence of hospitalizations for CVDs were higher in AF associated with CHF.
Aim. Assess the structure of comorbid conditions, cardiovascular pharmacotherapy and outcomes in patients with atrial fibrillation (AF) and concomitant coronary artery disease (CAD) included in the outpatient and hospital RECVASA registries. Materials and methods . 3169 patients with AF were enrolled in outpatient RECVASA (Ryazan), RECVASA AF-Yaroslavl registries and hospital RECVASA AF (Moscow, Kursk, Tula). 2497 (78.8%) registries of patients with AF had CAD and 703 (28.2%) of them had a previous myocardial infarction (MI). Results. There were 2,497 patients with a combination of AF and CAD (age was 72.2±9.9 years; 43.1% of men; CHA2DS2-VASc – 4.57±1.61 points; HAS-BLED – 1.60±0,75 points), and the group with AF without CAD included 672 patients (age was 66.0±12.3 years; 43.2% of men; CHA2DS2-VASc – 3.26±1.67 points; HAS-BLED – 1,11±0.74 points). Patients with CAD were on average 6.2 years older and had a higher risk of thromboembolic and hemorrhagic complications (p<0.05). 703 patients with a combination of AF and CAD had the previous myocardial infarction (MI; age was 72.3±9.5 years; 55.2% of men; CHA2DS2-VASc – 4.57±1.61; HAS-BLED – 1.65±0.76), and 1794 patients didn't have previous MI (age was 72.2±10.0 years; 38.4% of men; CHA2DS2-VASc – 4.30±1.50; HAS-BLED – 1.58±0.78). The proportion of men was 1.4 times higher among those with the previous MI. Patients with a combination of AF and CAD significantly more often (p <0.0001) than in the absence of CAD received a diagnosis of hypertension (93.8% and 78.6%), chronic heart failure (90.1% and 51.2%), diabetes mellitus (21.4% and 13.8%), chronic kidney disease (24.8% and 17.7%), as well as anemia (7.0% and 3.0%; p=0.001). Patients with and without the previous MI had the only significant difference in the form of a diabetes mellitus higher incidence having the previous MI (27% versus 19.2%, p=0.0008). The frequency of proper cardiovascular pharmacotherapy was insufficient, mainly in the presence of CAD (67.8%) than in its absence (74.5%), especially the prescription of anticoagulants (39.1% and 66.2%; p <0.0001), as well as in the presence of the previous MI (63.3%) than in its absence (74.3%). The presence of CAD and, in particular, the previous MI, was significantly associated with a higher risk of death (risk ratio [RR]=1.58; 95% confidence interval [CI] was 1.33-1.88; p <0.001 and RR=1.59; 95% CI was 1.33-1.90; p <0.001), as well as with a higher risk of developing a combined cardiovascular endpoint (RR=1.88; 95% CI was 1.17-3 , 00; p <0.001 and RR=1.75; 95% CI was 1.44-2.12; p<0.001, respectively). Conclusion . 78.8% of patients from AF registries in 5 regions of Russia were diagnosed with CAD, of which 28.2% had previously suffered myocardial infarction. Patients with a combination of AF and CAD more often than in the absence of CAD had hypertension, chronic heart failure, diabetes, chronic kidney disease and anemia. Patients with the previous MI had higher incidence of diabetes than those without the previous MI. The frequency of proper cardiovascular pharmacotherapy was insufficient, and to a greater extent in the presence of CAD and the previous MI than in their absence. All-cause mortality was recorded in patients with a combination of AF and CAD more often than in the absence of CAD. All-cause mortality and the incidence of nonfatal myocardial infarction were higher in patients with AF and the previous MI than in those without the previous MI. The presence of CAD and, in particular, the previous MI, was significantly associated with a higher risk of death, as well as a higher risk of developing a combined cardiovascular endpoint.
Aim . To study comorbidity, drug therapy and outcomes in patients with atrial fibrillation (AF) included in the outpatient and hospital RECVASA registries. Material and methods . Patients with AF (n=3169; age 70.9±10.7 years; 43.1% of men) in whom comorbidity, drug therapy, short-term and longterm outcomes (follow-up period from 2 to 6 years) were included in hospital registers RECVASA AF (Moscow, Kursk, Tula), as well as outpatient registers RECVASA (Ryazan) and RECVASA AF-Yaroslavl. Results . Outpatient registries (n=934), as compared to hospital registries (n=2235), had a higher average age of patients (73.4±10.9 vs 69.9±10.5; p<0.05), the proportion of women ( 66.2% vs 53.0%; p<0.0001) and patients with combination of 3-4 cardiovascular diseases (CVD), including AF (98.0% vs 81.7%, p<0.0001), and also with chronic noncardiac diseases (81.5% vs 63.5%, p<0.0001), the risk of thromboembolic complications (CHA 2 DS 2 -VASc 4.65±1.58 vs 4.15±1.71; p<0.05) and hemorrhagic complications (HAS-BLED 1.69±0.75 vs 1.41±0.77; p<0.05), as well as a lower frequency of prescribing appropriate pharmacotherapy for CVD (55.6% vs 74.6%, p<0.0001). During the observation period, 633 (20.0%) patients died, and in 61.8% of cases - from cardiovascular causes. The mortality rate in one year in Moscow was 3.7%, in Yaroslavl - 9.7%, in Ryazan - 10.7%, in Kursk - 12.5% (on average for four registers - 10.3%). A higher risk of death (1.5-2.7 times) was significantly associated with age, male sex, persistent AF, history of myocardial infarction (MI) and acute cerebrovascular accident (ACVE), diabetes mellitus, chronic obstructive disease lungs (COPD), heart rate>80 bpm, systolic blood pressure <110 mm Hg, decreased hemoglobin level. A lower risk of death (1.2-2.4 times) was associated with the prescription of anticoagulants, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs), betablockers, statins. The number of cases of stroke and MI was, respectively, 5.1 and 9.4 times less than the number of deaths from all causes. The higher risk of stroke in patients with AF during follow-up was significantly associated with female sex (risk ratio [RR]=1.61), permanent AF (RR=1.85), history of MI (RR=1.68) and ACVA (RR=2.69), HR>80 bpm (RR=1.50). Anticoagulant prescription in women was associated with a lower risk of ACVA (if adjusted for age: RR=0.54; p=0.04), in contrast to men (RR=1.11; p=0.79). Conclusion . The majority of patients with AF registries in 5 regions of Russia had a combination of three or more cardiovascular diseases (73.9%), as well as chronic non-cardiac diseases (68.8%). The frequency of proper cardiovascular pharmacotherapy was insufficient (68.6%), especially at the outpatient stage (55.6%). Over the observation period (2-6 years), the average mortality per year was 10.3%, but at the same time it differed significantly in the regions (from 3.7% in Moscow to 9.7-12.5% in Yaroslavl, Ryazan and Kursk). Cardiovascular causes of deaths occurred in 62%. A higher risk of death (1.5-2.7 times) was associated with a history of stroke and MI, diabetes mellitus, COPD, heart rate>80 bpm, systolic blood pressure <110 mm Hg, decreased hemoglobin level. However, the risk of death decreased by 1.2-2.4 times in cases of prescription of anticoagulants, ACE inhibitors / ARBs, beta-blockers and statins. The risk of ACVA and MI was the highest in the presence of the history of this event (2.7 and 2.6 times, respectively). Anticoagulant prescription was significantly associated with a reduced risk of stroke in women.
Aim. To evaluate an incidence of oral anticoagulants (OAC) administration during longterm follow-up period in patients with atrial fibrillation (AF) enrolled in outpatient and hospital RECVASA registries.Material and methods. 3169 patients with AF were enrolled in outpatient registries RECVASA (Ryazan), RECVASA AF-Yaroslavl and hospital registries RECVASA AF (Moscow, Kursk, Tula), age 70.9±10.7 years, 43.1% men. The incidence of OAC administration was evaluated in hospital and outpatient settings, including longterm follow-up period (2-6 years).Results. OAC were administrated only in 42.2% of cases (1335 from 3169 patients; age 69.1±10.4 years, 43% men), including warfarin (817 patients; 26%) and non-vitamin K antagonist oral anticoagulants (NOAC) – 518 (16%). Patients with permanent and persistant types of AF had lower incidence of OAC administration (43% and 40%) than in cases of paroxysmal type (47.6%, p<0.05), despite of the higher СНА2DS2-VASc risk score (4.69±1.66 and 4.23±1.57 vs 3.81±1.69; р<0.05). Patients with and without history of stroke received OAC in 42.5% and 40% of cases that means no significant difference (p>0.05) contrary to the pronounced difference of thromboembolic risk in these groups (6.14±1.34 and 3.77±1.39; р<0.001). The incidence of OAC administration in hospitals (54.1%) was 2.3 times higher than before hospitalization (23.8%) and was 4.1 times higher than in outpatient registries (13.5%). During follow-up period after hospital treatment (2.3±0.9 years) this parameter decreased from 54.1% to 41.2%, but was still 1.8 times higher than before admission to the hospital. After 4 years follow-up in RECVASA (Ryazan) registry we revealed 4.4 times higher incidence of OAC administration compared with enrollment data (4.2% and 18.3%, р<0.0001). This data was confirmed by the information from outpatient medical cards of accidentally generated group (75 from 297 patients survived during follow-up period): 5.3% at baseline and 22.7% six years later.Conclusions. RECVASA registries in 5 regions of Russia revealed low incidence of OAC administration. The risk of thromboembolic events was higher in patients with AF and no OAC administration compared with patients who received OAC. Patients with paroxysmal type of AF received OAC more often than those with permanent type. There were no significant differences of incidence of OAC therapy in patients with and without history of stroke. Both questioning of patients with AF and analysis of medical cards in outpatient clinics revealed higher incidence of OAC administration after 4-6 years of follow-up compared with the stage of enrollment in registries.
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.
Aim. To determine the features and main problems of statin therapy, as well as assess the possibility of achieving the target level of lipid pattern in patients with high and very high cardiovascular risk (CVR) in real clinical practice. Material and methods. The design of the “PRIORITET” observational program is an open observational study. Patients with high and very high CVR were divided into 3 groups in accordance with the initial data: (1) not taking statins, (2) taking statins, but not reaching the target low-density lipoprotein cholesterol (LDL-C) level, (3) taking statins with the achievement of the target LDL-C level, which is justified in replacing the statin inside the class — adverse effects (AE), high price, etc. Within 12 weeks 3 visits of patients to hospitals were carried out: baseline visit (B0), visit 1 month after the study initiation (B1) and visit 3 months after the study initiation (B3). The choice of atorvastatin or rosuvastatin was assessed by the doctors. Results. Groups 1, 2 and 3 included 112, 170 and 16 people, respectively. At B0, 145 (48,7%) patients were prescribed atorvastatin, and 153 (51,3%) — rosuvastatin. Three people dropped out of the study to B3, 295 patients completed the program. Lipid pattern of 285 patients were analyzed: 121 (41%) people (101 with very high CVR and 20 with high CVR) achieved the target LDL-C level, the remaining 164 (59%) patients (CVR — 156 and 8, respectively) — no. The most pronounced dynamics of LDL=C level was revealed in group 1, the differences between group 1 and groups 2 and 3 are highly statistically significant (p<0,0001). There were no differences in the frequency of reaching the target LDL-C level between patients taking atorvastatin or rosuvastatin. The target level of LDL-C (p=0,003) in the treatment of rosuvastatin in patients with high CVR was reached significantly more often than in patients with very high CVR. Also 3 non-serious AEs were reported. On average, in 9% of cases, reaching the target level of LDL-С during visits B1 and B3 was wrong interpreted by the attending physicians. Conclusion. The main problems of statin therapy in real clinical practice are the wrong interpretation of reaching the target level of LDL-C, inertness of doctors in titrating of statins doses and achieving the target level of lipid pattern. It may be the cause of reduced efficiency and deterioration of lipid-lowering therapy results in patients with high and very high CVR. The results of the “PRIORITET” study demonstrated the possibility of improving the practice of statins use and its accordance with clinical guidelines. Skibitsky V. V. on behalf of the working group of the “PRIORITET” research Working Group of the “PRIORITET” study: Voronina V. P. (Moscow), Zelenova T. I. (Moscow), Sladkova T.A. (Moscow), Alekseeva A. I. (Tula), Barabanova T. Yu. (Tula), Zotova A. S. (Tula), Kolomeitseva T. M. (Tula), Prikhod’ko T. N. (Tula), Pazelt E. A. (Nizhny Novgorod), Khramushev N. Yu. (Nizhny Novgorod), Skibitsky A. V. (Krasnodar), Alekseeva V. V. (Saratov), Lazareva E. V. (Saratov).
Aim. To determine the features and main problems of statin therapy, as well as assess the possibility of achieving the target level of lipid pattern in patients with high and very high cardiovascular risk (CVR) in real clinical practice.Material and methods. The design of the “PRIORITET” observational program is an open observational study. Patients with high and very high CVR were divided into 3 groups in accordance with the initial data: (1) not taking statins, (2) taking statins, but not reaching the target low-density lipoprotein cholesterol (LDL-C) level, (3) taking statins with the achievement of the target LDL-C level, which is justified in replacing the statin inside the class — adverse effects (AE), high price, etc. Within 12 weeks 3 visits of patients to hospitals were carried out: baseline visit (B0), visit 1 month after the study initiation (B1) and visit 3 months after the study initiation (B3). The choice of atorvastatin or rosuvastatin was assessed by the doctors.Results. Groups 1, 2 and 3 included 112, 170 and 16 people, respectively. At B0, 145 (48,7%) patients were prescribed atorvastatin, and 153 (51,3%) — rosuvastatin. Three people dropped out of the study to B3, 295 patients completed the program. Lipid pattern of 285 patients were analyzed: 121 (41%) people (101 with very high CVR and 20 with high CVR) achieved the target LDL-C level, the remaining 164 (59%) patients (CVR — 156 and 8, respectively) — no. The most pronounced dynamics of LDL=C level was revealed in group 1, the differences between group 1 and groups 2 and 3 are highly statistically significant (p<0,0001). There were no differences in the frequency of reaching the target LDL-C level between patients taking atorvastatin or rosuvastatin. The target level of LDL-C (p=0,003) in the treatment of rosuvastatin in patients with high CVR was reached significantly more often than in patients with very high CVR. Also 3 non-serious AEs were reported. On average, in 9% of cases, reaching the target level of LDL-С during visits B1 and B3 was wrong interpreted by the attending physicians.Conclusion. The main problems of statin therapy in real clinical practice are the wrong interpretation of reaching the target level of LDL-C, inertness of doctors in titrating of statins doses and achieving the target level of lipid pattern. It may be the cause of reduced efficiency and deterioration of lipid-lowering therapy results in patients with high and very high CVR. The results of the “PRIORITET” study demonstrated the possibility of improving the practice of statins use and its accordance with clinical guidelines.Skibitsky V. V. on behalf of the working group of the “PRIORITET” researchWorking Group of the “PRIORITET” study: Voronina V. P. (Moscow), Zelenova T. I. (Moscow), Sladkova T.A. (Moscow), Alekseeva A. I. (Tula), Barabanova T. Yu. (Tula), Zotova A. S. (Tula), Kolomeitseva T. M. (Tula), Prikhod’ko T. N. (Tula), Pazelt E. A. (Nizhny Novgorod), Khramushev N. Yu. (Nizhny Novgorod), Skibitsky A. V. (Krasnodar), Alekseeva V. V. (Saratov), Lazareva E. V. (Saratov).
Am. To study in the RECVASA registers the availability of data about the international normalized ratio (INR) indicator and achievement of its target values in outpatient and hospital practice in patients with atrial fibrillation (AF) receiving anticoagulant therapy with warfarin.Material and methods. Data about the INR control and the frequency of achievement of its target values at the outpatient and hospital stages were analyzed in RECVASA (Ryazan) and RECVASA FP – Yaroslavl outpatient registries, as well as in the hospital registers RECVASA FP (Moscow, Kursk, Tula) in 817 patients (46.9% of men, age 68.5±9.6 years) with AF and the prescribed anticoagulant therapy with warfarin.Results. INR was determined in 689 (84.3%) of 817 patients. The values of INR were monitored during therapy with warfarin in RECVASA (Ryazan) and RECVASA FP –Yaroslavl outpatient registries in 73.7% and 77.7% of patients, respectively, and in RECVASA FP hospital registers: 95.8% (Moscow); 81.3% (Tula) and 93.5% (Kursk). The target level of INR (2.0-3.0) was achieved in a minority of patients with AF during treatment with warfarin: inRyazan – in 26.3% of cases;Yaroslavl – 38.3%;Kursk – 34.8%;Moscow – 39.5%; Tule – 26.3%. Control of INR in hospital registries during warfarin therapy in patients with AF significantly more often (p<0.05) was performed at the hospital stage, compared with prehospital (in Kursk –2.3 times more often in Moscow – 2.6 times, in Tula – in 1,8 times). The target level of INR in the hospital was achieved significantly more often (p<0.05) than before hospitalization (Moscow andKursk), but no significant differences were found in the RECVASA FP –Tula register (p=0.08). The INR was monitored by 94.9% of the patients; however, the target values of this indicator were achieved only in 33% of cases in the sample study in the RECVASA FP –Moscow registry according to a survey of 39 patients with AF who continued to receive warfarin after 2.6±0.8 years after discharge from the hospital.Conclusion. INR was monitored in 74-96% of patients with AF treated with warfarin and included in the RECVASA and RECVASA FP registries. Target levels of INR were achieved only in 26-39% of patients. INR was monitored with achievement of its target levels more often at the hospital stage of treatment than before hospitalization and more often than in outpatient registries. In practical public health in patients with AF treated with warfarin, it is fundamentally important to monitor INR and increase the frequency of achieving its target values, at which the risk of cardioembolic stroke and other thromboembolic complications is proven to be reduced.
Aim. To assess quality of life (QoL) and its dynamics during nicorandil treatment in patients with stable ischemic heart disease, to study the relationship of treatment adherence and QoL indicators when treated with nicorandil. Material and methods. Observational program NIKEA included 590 patients with angina pectoris. Seattle Angina Questionnaire (SAQ) was used to assess QoL. Patients completed SAQ at the visit of inclusion (V0) and at the visit after 3 months of observation (V3). Potential and actual adherence to therapy was assessed by medical interviews at visits V0, V1 (1 month of observation) and V3. During the visit V0 417 people (from 590 ones enrolled into the study) completed SAQ (71% response); after 3 months (V3) SAQ was filled in by 454 of 552 people who came to this visit (82% response). According to the results of medical interviews, potential adherence (visit V0) was determined in all 590 patients, actual adherence to nicorandil (visits V1 and V3) was assessed in 552 patients who came to these visits. In accordance with the degree of adherence, all patients were divided into 3 groups: (1) adherent to treatment (taking nicorandil for the first three months), (2) non-adherent (who refused to take nicorandil), and (3) partially non-adherent (who started nicorandil, but for various reasons stopped taking the drug). Results. In all patients, regardless of their adherence to the recommended drug, there was an increase in QoL according to all five scales of the SAQ after 3 months of follow-up. Statistically significant positive dynamics of all SAQ indicators was found only in adherent patients (p< 0.0001 for all aspects). Patients, who showed good adherence to nicorandil at V1, had more severe angina at the beginning of treatment (according to " Angina Stability" and "Angina Frequency" indicators). These patients also had lower QoL "Disease Perception" score and more confidence in the doctor ("Treatment Satisfaction" score) than non-adherent patients (p< 0.05). In non-adherent patients a mild degree of angina was determined 2 times more often according to "Angina Frequency" indicator (p= 0.03). Conclusion. The results of the study confirm the interrelation and mutual influence of the QoL indicators and treatment adherence to nicorandil. Effective treatment with nicorandil in patients with lower health-related QoL indicators could increase treatment adherence. On the other hand, the mild degree of angina, the low level of confidence in the treating doctor, the side effects of the new drug reduce medication adherence of patients, which, as a result, negatively affects the QoL of these patients.
Working Group of the NIKEA Program. Ekaterinburg: Akulina E.N.; Izhevsk: Shinkareva S. E., Grebnev S.A.; Krasnodar: Kudryashov E.A., Fendrikova A.V.; Krasnoyarsk: Nemik D.B., Pitaev R.R., Altaev V.D., Samokhvalov E.V., Stolbikov Y.Y.; Moscow: Dmitrieva N.A., Zagrebelnyy A.D., Zakharova A.V., Balashov I.S., Leonov A.S., Sladkova T.A., Zelenova T.I., Shestakova G.N., Kolganova E.V., Maksimova M.A.; Novosibirsk: Moskalenko I.V., Shurkevich A.A.; Omsk: Loginova E.N., Gudilin V.A.; Orel: Zhuravleva L.L., Lobanova G.N., Luneva M.M.; Orenburg: Kondratenko V.Y.; Rostov-on-Don: Kalacheva N.M., Kolomatskaia O.E., Dubishcheva N.F., Romadina G.V., Chugunova I.B., Skarzhinskaia N.S.; Ryazan: Bulanov A.V., Trofimova Y.M., Nikolaeva A.S.; St. Petersburg: Savinova E.B., Ievskaia E.V., Vasileva L.B.; Tula: Zubareva L.A., Berberfish L.D., Gorina G.I., Nadezhkina K.N., Iunusova K.N., Nikitina V.F., Dabizha V.G., Renko I.E., Soin I.A.Aim. To study the adherence to treatment and the factors that affect it in patients with stable coronary heart disease during the treatment with nicorandil. Material and methods. The use of nicorandil in addition to standard antianginal therapy was recommended to patients (n=590) in a prospective, observational, multicenter NIKEA study. Patients completed original questionnaires on adherence, including a Morisky-Green test at the enroll visit. The questionnaires were filled by 423 patients (73% response). The factors that influence adherence were studied.Results. All patients were divided into 3 groups, depending on the adherence to the use of nicorandil: immediately refused to take the drug (n=150; group 1); started, but stopped taking nicorandil in the first 3 months of observation (n=75; group 2); who took nicorandil for 3 months (n=327; group 3). Potentially adherents (intention to treat) were 582 out of 590 (98.6%) patients, and actually adherents – only 327 of 552 (59.2%) patients. The main reason for non-adherence to the beginning of therapy is polypharmacy; to the continuation of the treatment that had just started – adverse events; for termination of long-term therapy – polypharmacy, adverse events and insufficient effectiveness of treatment. Group 3 had initially more severe angina pectoris: more number of angina attacks (p=0.014) and the need of short-acting nitrates (p<0.0001). Patients of the group 1 compared to the patients of group 3 did not visit the doctors more often or attended them only when necessary, violated the medical prescriptions for taking medications (p<0.05). According to the results of the Morisky-Green test, 150 patients (36.2%) were not are committed to medical recommendations, 264 (63.8%) – are committed. Women were more adherent than men (p=0.47); patients with class I angina were more adherent than patients with class III angina (p=0.027), and patients who regularly attended the treating physician (more often than once a month) were more committed to medical recommendations than patients, not visiting the treating physician (p=0.004).Сonclusion. The levels of overall adherence according to Morisky-Green test, the potential adherence according to the survey and the actual adherence of patients to treatment vary considerably. The leading cause of non-adherence at the beginning of therapy is polypharmacy, for the continuation of the recently started treatment – the adverse events; for long-term sustained treatment – equally polypharmacy, drug adverse events and the lack of treatment efficacy.
Working group of the “GRANAT-2” study: Tula - Trubitsyn G.I., Ivanov Yu.V., Mirenkova O.K., Eskova R.A., Simonova R.P., Milon M.E., Telegina E.V., Kuznetsov A.M., Zhukova N.A., Zainullina I.K.; Rostov-on-Don - Budanov O.V., London E.M., Minosyan L.V., Nedashkovskaya N.G., Ter-Ananyants Ye.A.; Tomsk - Proskokova I.Yu., Permyakova O.V., Politova L.V., Maneeva I.D., Ivanova S.Yu.; Nizhny Novgorod - Larina O.V., Pokrovskaya I.N., Patselt E.A.; Moscow - Sladkova T.A., Zelenova Т.V. Aim. To study the tolerability and adherence to antihypertensive therapy in patients with hypertension and chronic obstructive pulmonary disease (COPD) using the fixed combination of ramipril and amlodipine in the observational program for patients with arterial hypertension and COPD (GRANAT-2). Material and methods. Patients with hypertension and COPD (n=52) with all inclusion criteria and without exclusion criteria who signed informed consent to participate in the GRANAT-2 program were included into the study. The use of a fixed combination of ramipril and amlodipine was recommended in all patients. The doses were determined by the treating physicians in accordance with the official drug instruction. The patients had 4 visits, and the duration of the study was 5 months. The Morisky-Green test was used to assess an adherence of patients to treatment. Assessments of blood pressure, adverse events were performed at all visits. Results. 50 of 52 patients completed the study: 45 patients used the studied fixed combination in the recommended doses, and 5 patients used other antihypertensive drugs, 2 patients withdrew from the study. Systolic blood pressure after 1 month of treatment decreased by an average of 20 mm Hg from the baseline, and diastolic blood pressure – by 10 mmHg. These rates after 5 months of therapy were 29 mm Hg and 15 mm Hg, respectively. Target blood pressure level was achieved in all patients. Increase in adherence of patients to treatment (according to the Morisky-Green test from 21.1% to 65.1%) was found. 2 cases of adverse events (dry cough) were registered. The discrepancy in adherence assessment was revealed between the results from the Morisky-Green test and the data from program case report forms. Conclusion. Regular patient visits to the doctor and the rapid achievement of an antihypertensive effect with good tolerability of a fixed combination of ramipril and amlodipine contributed to the increase in adherence of patients to treatment. Undesirable effects of the drug therapy are significant, but not leading factors that have a negative impact on the patient adherence to treatment.
Aim. In the circumstances of real clinical practice, to evaluate the changes in life quality (LQ) parameters of the patients with coronary heart disease and stable angina with addition of nicorandil to standard treatment. Material and methods. Study design — prospective, observational, multicenter. In the trial, the physicians participated, from 14 institutions in a range ofRussia regions. Totally, 590 included: 261 (44,2%) females, 329 (55,8%) males. All patients, in addition to the standard antianginal treatment, were prescribed with nicorandil. At the visits V0 (baseline) and V3 (3 months of therapy) they completedSeattle questionnaire (SAQ) of LQ assessment. Five parameters were assessed: exercise intolerance, attacks frequency, stability, attitudes toward disease, treatment satisfaction. At the visit V0 417 questionnaires were completed (response 71%), at V3 — 454 (response 82%). Results. The significant increase was demonstrated, for parameters by SAQ in 3 months of observation, the highest parameters, except the scale exercise intolerance, were found in the group taking nicorandil during 3 months of follow-up (p<0,05 for all scale SAQ comparing to the group refused taking nicorandil at baseline or stopped at various stages of the study). By 3 months of follow-up, 3 times increase was noted of the patients with minimal number of angina attacks or absence, and the part of patients found that their life quality is “excellent”. Almost 4 times the part of patients raised by the stability parameter, and the amount by the score “treatment satisfaction” increased to 50,2%. Comparison of ranged SAQ parameters at V0 and V3 visits with Wilcoxon criteria, showed significant differences by all the scales of SAQ (р<0,0001). Conclusion. Under the real practice circumstances there was significant increase of all LQ parameters by SAQ in 3 months of observation. Most prominent positive changes were noted in patients taking nicorandil during whole follow-up period, comparing to those not taking nicorandil or discontinued at various stages of the study.
Aim. To determine the proportion of patients with atrial fibrillation (AF) among hospitalized patients in the departments of the multidisciplinary hospital and to study the structure of the associated cardiovascular diseases (CVD) and drug therapy within the RECVAZA AF-Tula hospital registry.Material and methods. All patients with a diagnosis of AF in the patient's chart (n=1225) were included into the RECVAZA AF-Tula registry; that is 4.2% of 29018 patients hospitalized to the Tula Regional Clinical Hospital in 2013. The structure of the associated cardiovascular diseases, as well as drug therapy, was evaluated on the basis of data in the medical documentation.Results. The mean age of patients with AF was 69.6±9.9 years, men was 47.8%. 87.5% of patients had a combination of AF with hypertension, 75.1% – with ischemic heart disease, and 81.4% – with chronic heart failure. The average number of diagnoses was 3.4 per patient. The proportion of patients with permanent, persistent and paroxysmal forms of AF was 46.4%, 20%, and 29%, respectively. The risk score according to the CHA2DS2-VASc and HAS-BLED scales was higher in patients of therapeutic profile (4.27±1.66 and 1.48±0.95) than this in patients of surgical profile (3.57±1.70 and 1.06±0.74, p<0.05). Average number of medicines for the treatment of cardiovascular diseases was 4.8. The frequency of prognostically significant drug prescriptions for CVD increased in hospital, in comparison with the outpatient stage, by an average of 1.2 times. Frequency of prescribing prognostically significant medications at discharge was higher in the therapeutic departments than this in the surgical departments (77.0% vs 57.1%, p<0.0001), including anticoagulants (65.8% vs 48.3%, p<0.0001). The frequency of compliance of drug prescriptions with clinical guidelines in the hospital was insufficient (on average 67.6%); whereas in the cardiology group of departments it was significantly higher than this in departments of other profiles.Conclusion. Patients with AF accounted for 4.2% of all hospitalized patients in a multidisciplinary hospital. The proportion of patients with AF in the therapeutical departments was 4 times more than that in the surgical departments. Most patients enrolled in the registry had associated CVD. The compliance of drug therapy of CVD to clinical guidelines was insufficient, especially at the outpatient stage, as well as in the surgical departments of the hospital.
Aim. In the circumstances of real clinical practice, to evaluate the changes in life quality (LQ) parameters of the patients with coronary heart disease and stable angina with addition of nicorandil to standard treatment.Material and methods. Study design — prospective, observational, multicenter. In the trial, the physicians participated, from 14 institutions in a range ofRussia regions. Totally, 590 included: 261 (44,2%) females, 329 (55,8%) males. All patients, in addition to the standard antianginal treatment, were prescribed with nicorandil. At the visits V0 (baseline) and V3 (3 months of therapy) they completedSeattle questionnaire (SAQ) of LQ assessment. Five parameters were assessed: exercise intolerance, attacks frequency, stability, attitudes toward disease, treatment satisfaction. At the visit V0 417 questionnaires were completed (response 71%), at V3 — 454 (response 82%).Results. The significant increase was demonstrated, for parameters by SAQ in 3 months of observation, the highest parameters, except the scale exercise intolerance, were found in the group taking nicorandil during 3 months of follow-up (p<0,05 for all scale SAQ comparing to the group refused taking nicorandil at baseline or stopped at various stages of the study). By 3 months of follow-up, 3 times increase was noted of the patients with minimal number of angina attacks or absence, and the part of patients found that their life quality is “excellent”. Almost 4 times the part of patients raised by the stability parameter, and the amount by the score “treatment satisfaction” increased to 50,2%. Comparison of ranged SAQ parameters at V0 and V3 visits with Wilcoxon criteria, showed significant differences by all the scales of SAQ (р<0,0001).Conclusion. Under the real practice circumstances there was significant increase of all LQ parameters by SAQ in 3 months of observation. Most prominent positive changes were noted in patients taking nicorandil during whole follow-up period, comparing to those not taking nicorandil or discontinued at various stages of the study.
Aim. To study some aspects of antihypertension therapy (AHT) adherence in patients with arterial hypertension (AH) and metabolic syndrome (MS) by an example of fixed combination of ramipril and amlodipine, under the framework of GRANAT-1 trial (Observational Program for Patients with Arterial Hypertension and Metabolic Syndrome).Material and methods. Totally, 101 patient included, having had confirmed AH and MS. All participants completed the study. All patients consented to participate, had been recommended the combination drug AHT — fixed combination of ramipril and amlodipine (Egipres) in various dosages selected by clinician in routine assessment. Every patient was invited to clinic for 4 visits during 5 months with interval 1-2-2 months (visits 1-4). For assessment of the general adherence to clinician recommendations (CR) during the first and final visits, all patients filled the Moriskos-Green test (MG) including 4 questions. In all visits, patients were assessed BP level, heart rate, and during visits 2-4 there was adverse events evaluation (AE). Also, the real adherence was evaluated by the intake of Egipres, and activeness of clinicians towards the achievement of target BP levels in participants.Results. The recommended AHT started taking 95 patients, by the end Egipres was being taken by 92 participants, 9 of them took other AHT. 90 patients achieved target BP (81 taking Egipres). Effect of the prescribed at visit 1 AHT in most patients appeared by 1 month (visit 2): in every third patient the target BP was reached, and mean systolic BP decreased by 17,2 mmHg and diastolic BP by 7,7 mmHg (visit 2), and 31,0 mmHg and 16,1 mmHg, resp. — by visit 4. Totally, 3 AE registered, probably amlodipine-related. A significant improvement of total adherence was found: if at the beginning of study, by MG test only 22 (21,8%) adhered, by the end — 70 (69%) of patients. In three cases there was lack of clinician activity to help achieve target BP.Conclusion. Single-time usage of the fixed combination of amlodipine and ramipril, its high efficacy and safety with regular visiting of physician help to increase general adherence of patients to treatment.
Aim. To assess the results of addition of nicorandil to the treatment of ischemic heart disease: clinical course and long-term outcomes, and to evaluate life quality and treatment adherence in stable angina patients. The article provides data on the NIKEA study design and results of antianginal efficacy of the drug.Material and methods. The design is prospective multicenter observational study. Totally, 14 institutions participated, from different Russia regions. Included 590 patients: 261 women (44,2%) and 329 men (55,8%). Mean age 65,1±9,6 y.o. All patients had inclusion criteria and no exclusion criteria. All participants, in addition to standard antianginal therapy, were recommended to take nicorandil dosage 20 mg daily with titration up to 40 mg daily in 1 month of the observation. By the protocol, three office visits were set (inclusion, in 1 month and in 3 months): V0, V1, V3. During the visits, physical examination was done, anthropometry, hemodynamics measurement. Antianginal efficacy was assessed with patients diaries on angina attacks and demand of short-acting nitrates (SAN). At the visits V0 and V3 patients completed Seattle life quality questionnaire in CHD, and at V0 also an original questionnaire was completed for adherence evaluation.Results. Among 590 patients included in NIKEA, 582 (98,6%) confirmed their intention to take nicorandil and 6 refused to buy additional medication. On the planned visits V1 and V3552 patients came: of them 402 started taking nicorandil, and in 1 month 383 continued; in 3 months — 327 patients continued. During the visits V1 and V3 a statistically significant decrease in angina attacks frequency and in demand of SAN was noted (p<0,05). In comparison analysis of dynamics of these parameters with those refused or having stopped taking the medication (controls) it was found that these parameters declined in both groups, and in nicorandil group — more seriously; in 3 months the difference between groups became significant (p<0,05). During the first 3 months of the observation there was almost triple increase of those having 1st functional class of angina: from 4% to 11,6%, and decrease of the 3rd class angina patients almost 1,5 times: from 32% to 20%.Conclusion. The results of observational program demonstrated good antianginal efficacy of the added nicorandil — antianginal medication with proven positive prognostic influence: decrease of angina attacks, decrease of the demand in SAN, increase of the 1st functional class patients and decrease — of the 3rd, respectively