STUDY OF THE PARAMETERS OF TOLERABILITY AND ADHERENCE TO THERAPY IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND ARTERIAL HYPERTENSION ON THE BACKGROUND OF TREATMENT WITH FIXED COMBINATION OF RAMIPRIL AND AMLODIPINE (ACCORDING TO THE RESULTS OF OBSERVATIONAL STUDY "GRANAT-2")

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

Combination of Atrial Fibrillation and Coronary Heart Disease in Patients in Clinical Practice: Comorbidities, Pharmacotherapy and Outcomes (Data from the REСVASA Registries)

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

Patients with a Combination of Atrial Fibrillation and Chronic Heart Failure in Clinical Practice: Comorbidities, Drug Treatment and Outcomes

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

Features and main problems of treating patients with high and very high cardiovascular risk with statins in real clinical practice (according to the data of the “PRIORITET” research)

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)

STUDY OF PATIENTS ADHERENCE TO TREATMENT IN METABOLIC SYNDROME, WITH THE NOVEL COMBINATION ANTIHYPERTENSION COMPOUND OF RAMIPRIL AND AMLODIPINE BY THE DATA OF OBSERVATIONAL STUDY GRANAT-1

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