Učinkovitost i sigurnost kombinacije atorvastatina/amlodipina u jednoj tableti kod bolesnika s arterijskom hipertenzijom i dislipidemijom

The aim was to evaluate the efficacy of a single-pill combination of atorvastatin/amlodipine in patients with arterial hypertension, dyslipidemia and moderate to high cardiovascular risk. This prospective study included 243 patients with arterial hypertension, dyslipidemia and moderate to high cardiovascular risk, mean age 63.3±9.8 years. All patients were prescribed a treatment with one of the following doses of a single-pill combination of atorvastatin/amlodipine: 10/5, 10/10, 20/5 or 20/10 mg daily. The follow-up period was 3 months. The mean baseline values of the systolic and diastolic blood pressure were 155.7±16.2 and 92.0±9.2 mm Hg, respectively. At month 3, the respective mean systolic and diastolic blood pressure values were 136.9±26.9 and 80.6±5.1 mm Hg. The mean baseline values of total cholesterol and low-density lipoprotein cholesterol were 6.6±1.2 and 4.4±1.1 mmol/L, respectively. At month 3, the respective mean values of total cholesterol and low-density lipoprotein cholesterol were 5.1±0.9 and 2.9±1.0 mmol/L. Treatment was discontinued in 9 (3.7%) patients due to adverse events. In conclusion, treatment with the single-pill combination of atorvastatin/amlodipine was effective and well tolerated by the patients with arterial hypertension, dyslipidemia and moderate to high cardiovascular risk.Cilj ovoga istraživanja je bio ocijeniti učinkovitost kombinacije atorvastatina/amlodipina u jednoj tableti kod bolesnika s arterijskom hipertenzijom, dislipidemijom i umjerenim do visokim kardiovaskularnim rizikom. Ovo prospektivno istraži­vanje obuhvatilo je 243 bolesnika s arterijskom hipertenzijom, dislipidemijom i umjerenim do visokim kardiovaskularnim rizikom, srednje dobi od 63,3±9,8 godina. Bolesnicima je propisana terapija jednim od sljedećih režima doziranja kombinacije atorvastatina/amlodipina u jednoj tableti: 10/5, 10/10, 20/5 ili 20/10 mg na dan. Razdoblje praćenja bilo je 3 mjeseca. Srednje početne vrijednosti sistoličkog i dijastoličkog tlaka bile su 155,7±16,2 i 92,0±92,0 mm Hg. Krajem 3. mjeseca vrijednosti sistoličkog i dijastoličkog tlaka bile su 136,9±26,9 i 80,6±5,0 mg Hg. Srednje početne vrijednosti ukupnog kolesterola i kolesterola niske gustoće bile su 6,6±1,2 i 4,4±1,1 mmol/L. Krajem 3. mjeseca vrijednosti ukupnog kolesterola i kolesterola niske gustoće bile su 5,1±0,9 i 2,9±1,0 mmol/L. Terapija analiziranom kombinacijom lijekova prekinuta je kod 9 (3,7%) bolesnika zbog neželjenih nuspojava. U zaključku, terapija kombinacijom atorvastatina/amlodipina u jednoj tableti visoko je učinkovita i dobro ju podnose bolesnici s arterijskom hipertenzijom, dislipidemijom i umjerenim do visokim kardiovaskularnim rizikom

Editorial

Редакционен коментар Editoria

Anticoagulant prophylaxis and therapy in patients with COVID-19

В условията на пандемия от COVID-19 продължават проучванията на ранните и късните белодробни и сърдечно-съдови промени, нарушенията в коагулацията и риска от венозен тромбоемболизъм в хода на инфекцията. Особен интерес предизвикват публикуваните данни по тези теми и препоръките за антикоагулантна профилактика и лечение в клиничната практика. В този обзор са представени накратко отговори на някои от най-често задаваните въпроси за COVID-19: честота на тромбоемболични усложнения; необходимо ли е всички пациенти с COVID-19 да получават профилактична доза антикоагулант; кои антикоагуланти се препоръчват за приложение при пациенти, хоспитализирани в общо или интензивно отделение; с какви възможни лекарствени взаимодействия трябва да се съобразяваме при пациенти на антикоагулантна или антитромбоцитна терапия, които приемат и медикаменти за лечение на COVID-19; при кои пациенти с COVID-19 се препоръчва да се продължи антитромбозната профилактика и след изписването им от болница. Надяваме се тази информация да е полезна за всички медицински специалисти, лекуващи пациенти с COVID-19: интернисти, пулмолози, кардиолози, общопрактикуващи лекари During the COVID-19 pandemic, studies of the early and late pulmonary and cardiovascular changes, coagulation disorders and risk of venous thromboembolism in thе course of the infection are ongoing. Of particular interest are the published data on these topics and the recommendations for anticoagulant prophylaxis and treatment in the clinical practice. This review summarizes answers to some of the most commonly asked questions about COVID-19: incidence of thromboembolic complications; should all patients with COVID-19 receive a prophylactic dose of anticoagulant; which anticoagulants are recommended for use in patients hospitalized in a general ward or intensive care unit; what potential drug interactions should be considered in patients on anticoagulant or antiplatelets who are also taking COVID-19 therapies; which patients with COVID-19 are recommended to continue antithrombotic prophylaxis after their hospital discharge. We hope this information will be useful for all medical specialists who are dealing with COVID-19 patients: internists, pulmonologists, cardiologists, general practitioner

Abnormal myocardial performance index in M-mode color tissue Doppler-echocardiography

Индексът на миокардна производителност (myocardial performance index, MPI) е показател, използван за оценка на глобалната систолно-диастолна левокамерна функция и прогнозата при пациентите със сърдечни заболявания, даващ възможност за преценка на моментното състояние на пациента и проследяване на развитието на заболяването. Класическият метод за изчисляването му е пулсовата Doppler-ехокардиография (ЕхоКГ). Целта на проучването е да се оцени корелацията на индекса на миокардна производителност с класическите показатели на систолната и диастолната функция на лявата камера и да се направи преценка на граничните стойности на индекса на миокардна производителност при 1Р цветна тъканна Doppler-ЕхоКГ през аортната и митралната клапа, предсказващи патологичен MPI от пулсова Doppler-ЕхоКГ. Изследвани са 105 лица (30 здрави контроли, 45 човека с артериална хипертония и 30 - с ИБС. При изследваните пациенти е изчислен MPI с помощта на пулсова Doppler-ЕхоКГ (MPIPW) и едноразмерна цветна тъканна Doppler-ЕхоКГ през аортната (MPIAO1 и MPIAO2) и митралната (MPIMV) клапа. Индексът на миокардна производителност за всички изследвани лица показа ниска до умерена негативна корелация с левокамерната фракция на изтласкване, а установената корелация с изследваните показатели на диастолната функция е умерена до висока. При здравите лица установените корелации при почти всички сравнения не са зна-чими. Получените стойности на MPIAO1, MPIAO2 и MPIMV, предсказващи патологичен MPI от пулсов Doppler (MPIPW ≥ 0,50), са MPIAO1 ≥ 0,578, MPIAO2 ≥ 0,446 и MPIMV ≥ 0,552. Получените гранични стойности за MPI при едноразмерна цветна тъканна Doppler-ЕхоКГ през аортната и митралната клапа могат да се използват при оценката на глобалната левокамерна функция на пациентите със сърдечни заболявания. Необходими са по-нататъшни проучвания върху по-голям брой пациенти за преценка на прогностичната стойност на установените параметри. The myocardial performance index (MPI) is used for global systolic-diastolic left ventricular function and prognosis assessment in patients with heart disease, allowing assessment of the patient‘s current condition and disease development follow-up. The classic method of calculation is pulsed Doppler echocardiography. The aim of the study was to evaluate the correlation of myocardial performance index with established left ventricular systolic and diastolic function indices and to determine cut-off values of the myocardial performance index in M-mode color tissue Doppler echocardiography through the aortic and mitral valves predicting abnormal myocardial performance index by pulsed Doppler echocardiography. One hundred and fi ve subjects were studied, including 30 healthy controls, 45 hypertensive patients, and 30 patients with CHD. MPI was calculated using pulsed Doppler (MPIPW) and M-mode color tissue Doppler echocardiography through the aortic (MPIAO1 and MPIAO2) and mitral (MPIMV) valves. In all patients, the myocardial performance index showed a low to moderatenegative correlation with the left ventricular ejection fraction, and the correlation with the diastolic function indices was moderate to high. In healthy persons, the correlations were not signifi cant in almost all comparisons. The MPIAO1, MPIAO2,and MPIMV values predicting abnormal MPI by pulsed Doppler (MPIPW ≥ 0.50) are MPIAO1 ≥ 0.578, MPIAO2 ≥ 0.446, and MPIMV ≥ 0.552. The cut-off values of MPI by M-mode color tissue Doppler echocardiography through the aortic and mitral valve obtained can be used for global left ventricular function assessment in patients with heart disease. Further studies, on a larger number of patients, are necessary to estimate the predictive value of the parameters established

Physicians’ Perceptions of Their Patients’ Attitude and Knowledge of Long-Term Oral Anticoagulant Therapy in Bulgaria

Background and Objectives: Oral anticoagulation (OAC) is widely used in daily clinical practice worldwide for various indications. We aimed to explore the perception of Bulgarian clinicians about their patients’ attitude and knowledge of long-term OAC, prescribed for atrial fibrillation (AF) and/or known deep venous thrombosis (DVT)/pulmonary embolism (PE). Materials and Methods: We performed a cross-sectional study that involved 226 specialists: 187 (82.7%) cardiologists, 23 (10.2%) neurologists, and 16 (7.1%) vascular surgeons. They filled in a questionnaire, specially designed for our study, answering various questions regarding OAC treatment in their daily clinical practice. Results: The mean prescription rate of OACs in AF patients was 80.3% and in DVT/PE—88.6%. One hundred and eighty-seven (82.7%) of the participants stated they see their patients on OAC at least once per month. According to more than one-third of the inquired clinicians, the patients did not understand well enough the provided information concerning net clinical benefit of OAC treatment. About 68% of the clinicians declared that their patients would prefer a “mutual” approach, discussing with the physician the OAC options and taking together the final decision, whereas according to 43 (19.0%), the patients preferred the physician to take a decision for them. Patients’ OAC treatment had been interrupted at least once within the last year due to a physician’s decision by 178 (78.8%) of the participants and the most common reason was elective surgery. The most influential factors for a patient’s choice of OAC were the need of a specific diet to be kept, intake frequency, and possible adverse reactions. Conclusions: Our results suggest that a clinician’s continuous medical education, shared decision-making, and appropriate local strategies for improved awareness of AF/DVT/PE patients are key factors for improvement of OAC management

Efficacy and Safety of a Single-Pill Combination of Atorvastatin/Amlodipine in Patients with Arterial Hypertension and Dyslipidemia

The aim was to evaluate the efficacy of a single-pill combination of atorvastatin/amlodipine in patients with arterial hypertension, dyslipidemia and moderate to high cardiovascular risk. This prospective study included 243 patients with arterial hypertension, dyslipidemia and moderate to high cardiovascular risk, mean age 63.3±9.8 years. All patients were prescribed a treatment with one of the following doses of a single-pill combination of atorvastatin/amlodipine: 10/5, 10/10, 20/5 or 20/10 mg daily. The follow-up period was 3 months. The mean baseline values of the systolic and diastolic blood pressure were 155.7±16.2 and 92.0±9.2 mm Hg, respectively. At month 3, the respective mean systolic and diastolic blood pressure values were 136.9±26.9 and 80.6±5.1 mm Hg. The mean baseline values of total cholesterol and low-density lipoprotein cholesterol were 6.6±1.2 and 4.4±1.1 mmol/L, respectively. At month 3, the respective mean values of total cholesterol and low-density lipoprotein cholesterol were 5.1±0.9 and 2.9±1.0 mmol/L. Treatment was discontinued in 9 (3.7%) patients due to adverse events. In conclusion, treatment with the single-pill combination of atorvastatin/amlodipine was effective and well tolerated by the patients with arterial hypertension, dyslipidemia and moderate to high cardiovascular risk

Pericardial Effusion in Obstructive Sleep Apnea without Pulmonary Arterial Hypertension and Daily Hypoxemia - is it Unusual?

Background: Pericardial effusion in chronic hypoxemic lung diseases, such as Obstructive Sleep Apnea syndrome, usually occurs after the development of severe pulmonary arterial hypertension. However, data about the frequency of pericardial effusions in Obstructive Sleep Apnea syndrome without pulmonary arterial hypertension and/or daytime hypoxemia are still scarce, and their pathogenesis is unclear. Aims: To assess the prevalence of pericardial effusions and their volume and location in patients with obesity and Obstructive Sleep Apnea syndrome without pulmonary arterial hypertension and/or hypoxemia. Study Design: Cross-sectional study. Methods: We included 279 consecutive patients (162 males) with newly diagnosed Obstructive Sleep Apnea syndrome having a mean age of 42.8±12.4 years and a mean body mass index of 37.3±7.8 kg/m2. Obstructive Sleep Apnea syndrome was confirmed by polysomnography. Main exclusion criteria were concomitant inflammatory diseases, thyroid dysfunction, daytime hypoxemia, nephrotic syndrome, left ventricular systolic dysfunction and pulmonary arterial hypertension. Results: Pericardial effusion was found in 102 (36.56%) -all of them with moderate to severe obstructive Sleep Apnea syndrome. The mean effusion volume was mild to moderate (up to 250 mL). In 36 patients (35.3%) the pericardial effusion was diffuse, in 42 (41.2%), the pericardial effusion was located in front of the right atrium and the right ventricle, and in 24 (23.5%) the pericardial effusion was situated in front of the right cardiac cavities and the left atrium. We found a significant positive correlation between the presence of pericardial effusion and apnea-hypopnea index (r=0.374, p<0.001), body mass index (r=0.473, p<0.001), and desaturation time during sleep (r=0.289, p<0.001). Conclusion: Pericardial effusion in patients with obesity and moderate to severe Obstructive Sleep Apnea syndrome without daily hypoxemia and/or pulmonary hypertension is a relatively common finding. The occurrence of pericardial effusions is dependent mostly on the grade of Obstructive Sleep Apnea syndrome, degree of obesity, and duration of sleep desaturation

Evaluation of lipoprotein(a) in the prevention and management of atherosclerotic cardiovascular disease: A survey among the Lipid Clinics Network

Background and aims: The European Atherosclerosis Society (EAS) Lipid Clinics Network promoted a survey in order to identify and understand how and when lipoprotein(a) [Lp(a)] is tested and clinically evaluated in lipid clinics throughout Europe, and the challenges that may prevent evaluation from being carried out. Methods: This survey was divided into three areas of inquiry: background and clinical setting information of clinicians, questions for doctors who claimed not to measure Lp(a), in order to understand what were the reasons for not ordering the test, and questions for doctors who measure Lp(a), to investigate the use of this value in the management of patients.Results: A total of 151 centres clinicians filled in the survey, out of 226 invited. The proportion of clinicians who declare to routinely measure Lp(a) in clinical practice was 75.5%. The most common reasons for not ordering the Lp(a) test were the lack of reimbursement or of treatment options, the non-availability of Lp(a) test, and the high cost of performing the laboratory test. The availability of therapies targeting this lipoprotein would result in a greater propensity of clinicians to start testing Lp(a). Among those who declared to routinely measure Lp(a), the Lp(a) measurement is mostly requested to further stratify patients' cardiovascular risk, and half of them recognized 50 mg/dL (approx. 110 nmol/L) as the threshold for increased cardiovascular risk due.Conclusions: These results warrant for a great deal of effort from scientific societies to address the barriers that limit the routine use of the measurement of Lp(a) concentration and to recognise the importance of Lp(a) as a risk factor

Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI) : a phase 3, placebo-controlled, randomised trial

Background: Patients with stable coronary artery disease and diabetes with previous percutaneous coronary intervention (PCI), particularly those with previous stenting, are at high risk of ischaemic events. These patients are generally treated with aspirin. In this trial, we aimed to investigate if these patients would benefit from treatment with aspirin plus ticagrelor. Methods: The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) was a phase 3 randomised, double-blinded, placebo-controlled trial, done in 1315 sites in 42 countries. Patients were eligible if 50 years or older, with type 2 diabetes, receiving anti-hyperglycaemic drugs for at least 6 months, with stable coronary artery disease, and one of three other mutually non-exclusive criteria: a history of previous PCI or of coronary artery bypass grafting, or documentation of angiographic stenosis of 50% or more in at least one coronary artery. Eligible patients were randomly assigned (1:1) to either ticagrelor or placebo, by use of an interactive voice-response or web-response system. The THEMIS-PCI trial comprised a prespecified subgroup of patients with previous PCI. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, or stroke (measured in the intention-to-treat population). Findings: Between Feb 17, 2014, and May 24, 2016, 11 154 patients (58% of the overall THEMIS trial) with a history of previous PCI were enrolled in the THEMIS-PCI trial. Median follow-up was 3·3 years (IQR 2·8–3·8). In the previous PCI group, fewer patients receiving ticagrelor had a primary efficacy outcome event than in the placebo group (404 [7·3%] of 5558 vs 480 [8·6%] of 5596; HR 0·85 [95% CI 0·74–0·97], p=0·013). The same effect was not observed in patients without PCI (p=0·76, p interaction=0·16). The proportion of patients with cardiovascular death was similar in both treatment groups (174 [3·1%] with ticagrelor vs 183 (3·3%) with placebo; HR 0·96 [95% CI 0·78–1·18], p=0·68), as well as all-cause death (282 [5·1%] vs 323 [5·8%]; 0·88 [0·75–1·03], p=0·11). TIMI major bleeding occurred in 111 (2·0%) of 5536 patients receiving ticagrelor and 62 (1·1%) of 5564 patients receiving placebo (HR 2·03 [95% CI 1·48–2·76], p<0·0001), and fatal bleeding in 6 (0·1%) of 5536 patients with ticagrelor and 6 (0·1%) of 5564 with placebo (1·13 [0·36–3·50], p=0·83). Intracranial haemorrhage occurred in 33 (0·6%) and 31 (0·6%) patients (1·21 [0·74–1·97], p=0·45). Ticagrelor improved net clinical benefit: 519/5558 (9·3%) versus 617/5596 (11·0%), HR=0·85, 95% CI 0·75–0·95, p=0·005, in contrast to patients without PCI where it did not, p interaction=0·012. Benefit was present irrespective of time from most recent PCI. Interpretation: In patients with diabetes, stable coronary artery disease, and previous PCI, ticagrelor added to aspirin reduced cardiovascular death, myocardial infarction, and stroke, although with increased major bleeding. In that large, easily identified population, ticagrelor provided a favourable net clinical benefit (more than in patients without history of PCI). This effect shows that long-term therapy with ticagrelor in addition to aspirin should be considered in patients with diabetes and a history of PCI who have tolerated antiplatelet therapy, have high ischaemic risk, and low bleeding risk