Hospitalization is an opportunity to optimize heart failure (HF) therapy. As optimal treatment for hospitalized HF patients in sinus rhythm with heart rate≥70bpm is unclear, we investigated the ...impact of combined beta-blocker (BB) and ivabradine versus BBs alone on short and longer term mortality and rehospitalization.
A retrospective analysis was performed on 370 hospitalized HF patients with heart rate≥70bpm (150 BB+ivabradine, 220 BB alone) in the Optimize Heart Failure Care Program in Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Russia, Ukraine, and Uzbekistan, from October 2015 to April 2016.
At 1month, 3months, 6months and 12months, there were fewer deaths, HF hospitalizations and overall hospitalizations in patients on BB+ivabradine vs BBs alone. At 12months, all-cause mortality or HF hospitalization was significantly lower with BB+ivabradine than BBs (adjusted hazard ratio HR 0.45 (95% confidence interval CI 0.32–0.64, P<0.0001). Significantly greater improvement was seen in quality of life (QOL) from admission to 12months with BB+ivabradine vs BBs alone (P=0.0001). With BB+ivabradine, significantly more patients achieved ≥50% target doses of BBs at 12months than on admission (82.0% vs 66.6%, P=0.0001), but the effect was non-significant with BBs alone.
Heart rate lowering therapy with BB+ivabradine started in hospitalized HF patients (heart rate≥70bpm) is associated with reduced overall mortality and re-hospitalization over the subsequent 12months. A prospective randomized trial is needed to confirm the advantages of this strategy.
•Hospitalized heart failure patients with heart rate≥70 bpm have a higher mortality risk.•In those patients beta blockers (BB) + ivabradine reduced 12-month mortality/rehospitalization vs BB alone.•A large clinical trial is needed to confirm the advantages of this strategy
The aim: A comparative analysis of the course of pulmonary embolism during the COVID-19 pandemic and the era before pandemia.
Materials and methods: 294 patients with pulmonary embolism (PE) , 1 ...group - 188 with PE before the pandemic, 2 group -106 during the pandemic. Two subgroups were distinguished in 2 group : 1- with laboratory-excluded coronavirus (acute and in anamnesis) and 2 - with a history of COVID-19. The diagnosis of PE was confirmed by CT. Echocardiography and ultrasound Doppler imaging of the veins of the lower extremities were performed.
Results: In 1 group there was a more significant increase in pulmonary artery pressure (44.29 ± 17.04 vs 36.91 ± 16.6, p 0.0023) and a decrease in the E/A ratio of the right ventricle (0.80 ± 0,21 vs 1.28 ± 1.42, p 0.0202). In 2 subgroup of patients with COVID-19 had a significantly higher incidence of Diabetes mellitus (73.7% vs 13.3%, p 0.00001) and significantly lower signs of superficial venous thrombosis of the lower extremities (5.3% vs 33,3%, p 0,0175) and signs of proximal deep vein thrombosis (0% vs 56.7%, p 0.00001) and 3 times less often there was a high risk of adverse disease, right ventricular dysfunction were more pronounced (ratio E/A 0.87 ± 0.25 vs 1.13 ± 0.28, p 0.022).
Conclusions: In patients with coronavirus infection, PE was significantly more common in the presence of diabetes mellitus , right ventricular diastole disorders were more common, and superficial and proximal deep vein thrombosis of the lower extremities were less common.
Hypertrophic cardiomyopathy (HCM) is a common hereditary disease of the myocardium. Sodium-glucose co-transporter 2 inhibitors are recognized as first-line drugs for the treatment of heart failure, ...but at the moment there is little known about their use in HCM. The aim. To assess the possibility of using an acute test with empagliflozin in patients with HCM with echocardiographic assessment of left ventricular outflow tract (LVOT) obstruction. Materials and methods. Twenty-six non-obstructive HCM patients were examined. All the patients underwent an acute test with sodium-glucose co-transporter 2 inhibitor using 10 mg of empagliflozin and echocardiographic examination before and 3 hours after administration. Twenty-four patients were included in the further analysis (2 patients were excluded due to arrhythmia). The patients were divided into two groups: group 1 included subjects with an increase in LVOT pressure after empagliflozin (12 patients), group 2 included those without an increase in the gradient (12 patients). Results. During the acute test, an increase in LVOT gradient occurred in 12 patients, and in 6 patients the gradient increased significantly and reached more than 30 mm Hg. The indicator at rest in patients before the test was 11.2 (10.1-19), after the test it was 12.45 (8.9-17) mm Hg (p = 0.042). The indicator at the height of the Valsalva test also increased from 15 (11-29) to 15.45 (10.4-33) mm Hg (p=0.29). Comparative analysis of clinical and echocardiographic data did not show significant difference between the groups. Conclusions. In some patients with HCM without signs of overt or latent obstruction at the baseline, a significant increase in LVOT pressure was noted after acute test with empagliflozin. Conducting an acute test in patients with HCM is appropriate to determine the possibility of the development of LVOT obstruction while taking the drug.
The aim of the study to evaluate the effect of supplementation of basic therapy by ranolazine in patients with INOCA on exercise test parameters and Holter ECG monitoring.
Materials and methods. 53 ...patients with stable coronary heart disease were examined, including 18 men (33.9 %) and 35 (66 %) women, the average age of patients was 57 (±9.68) years. According to the results of coronary angiography all patients had non-obstructive coronary arteries. In addition to physical and laboratory examination, bicycle ergometry, Holter ECG monitoring and echocardiography were included in the examination of patients. Patients were divided into 2 groups: group I - patients who in addition to standard therapy received ranolazine at a dose of 1000 mg twice a day for 6 months, and group II patients with standard coronary heart disease therapy. After 6 months from the beginning of the observation an objective examination, echocardiography, exercise test, Holter ECG monitoring were repeated.
Results. The study found that patients receiving ranolazine in addition to standard therapy had a statistically significant increase in exercise duration after 6 months compared with baseline and group II. Before treatment in group I, the duration of the exercise test was 356.51±180.24s, and after treatment 414.32±142.10s (p=0.03). In group II, the duration of the test before treatment was 361.4±160.24 c, and after 380.5±152.2 s (p=0.15). It was also found that the duration of the test differed significantly in group I after treatment of patients from group II after treatment of patients with a standard treatment regimen (p=0.04). According to the results of Holter ECG monitoring in group I found a positive effect of ranolazine on the frequency of ventricular arrhythmias: before treatment n=1142 30; 2012, after treatment n=729 23; 1420, while in group II a significant difference between the number of extrasystoles before treatment and after not detected (n=1026 17; 1920, n=985 15; 1680, respectively) p=0.18.
Conclusions. The addition of ranolazine to the basic therapy of patients with non-obstructive coronary arteries disease helps to increase exercise tolerance (according to the loading stress test) and contributes to a significant reduction in the number of ventricular arrhythmias (according to Holter-ECG) compared with both baseline and group II
The aim. To identify features of exercise response in coronary heart disease (CHD) patients depending on coronary artery condition and to identify factors associated with a positive test in patients ...with no obstructive coronary artery disease (INOCA).
Materials and methods. The study included 105 patients diagnosed with stable coronary artery disease (CAD) who were hospitalized at the City Clinical Hospital No. 8 of the Kharkiv City Council. The criteria for diagnosis of ischemia with no obstructive coronary artery disease (INOCA) were met by 53 patients who formed group I. Group II included 52 patients who were consistently hospitalized in the period from June to December 2020, and had obstructive CAD for more than 50 % according to their coronary angiography (CAG).
Results. According to the results of bicycle exercise stress test, a positive test was significantly more often registered in group II – n=30 (57.7 %) patients compared to group I – n=19 (35.8 %) patients (p=0.0249). The duration of the test in patients of group I was significantly longer than 420 seconds 290–540, compared with group II – 300.0 210.0–540.0 (р=0.0352). Also, in patients in group II, the maximum volume of the test performed was probably lower than in group I (p=0.0324). When calculating the double product, it was also found that in group I its value was significantly higher compared to group II (p=0.0292). In group I there was a significantly higher rate of chronotropic reserve (44.0 26.0–60.0), compared with group II (p=0.0168). Elevated total cholesterol (above 5 mmol/l) is a statistically significant and independent factor of a positive exercise test in patients with INOCA (OR, 1.98 0.9992-3.926, p=0.05). A correlation was found between the level of exercise tolerance and smoking in INOCA-patients (r =-0.388975, p=0.010899). Patients who underwent MINOCA also showed reduced tolerance to exercise (r=-0.3104, p=0.042721)
Conclusions. The sensitivity of bicycle exercise stress test in patients with CAD depends on the presence and severity of atherosclerotic lesions of the coronary arteries (63 % in stenotic atherosclerosis, 36 % in no obstructive coronary arteries. It was found that exercise test duration, double product, chronotropic and inotropic reserve of the heart in patients with a positive exercise test with INOCA were significantly higher compared with patients with obstructive CAD. Independent factors associated with a positive exercise test in patients with no obstructive CAD are an increase in total cholesterol (multivariate regression logistic analysis).
At present, biological disease-modifying anti-rheumatic drugs (DMARDs) are the only treatment recommended for patients with ankylosing spondylitis who have not responded to first-line treatment with ...non-steroidal anti-inflammatory drugs (NSAIDs). The TORTUGA trial investigated the efficacy and safety of filgotinib, an oral selective Janus kinase 1 (JAK1) inhibitor, for the treatment of patients with active ankylosing spondylitis.
In this completed, randomised, double-blind, placebo-controlled, phase 2 trial, we enrolled adult patients from 30 sites in seven countries (Belgium, Bulgaria, Czech Republic, Estonia, Poland, Spain, and Ukraine). Eligible patients had active ankylosing spondylitis and an inadequate response or intolerance to two or more NSAIDs. Patients were randomly assigned (1:1) with an interactive web-based response system to receive filgotinib 200 mg or placebo orally once daily for 12 weeks. Randomisation was stratified by current use of conventional synthetic DMARDs and previous receipt of anti-tumour necrosis factor therapy. The patients, study team, and study sponsor were masked to treatment assignment. The primary endpoint was the change from baseline in ankylosing spondylitis disease activity score (ASDAS) at week 12, which was assessed in the full analysis set (ie, all randomised patients who received at least one dose of study drug). Safety was assessed according to actual treatment received. This trial is registered with ClinicalTrials.gov, number NCT03117270.
Between March 7, 2017, and July 2, 2018, 263 patients were screened and 116 randomly assigned to filgotinib (n=58) or placebo (n=58). 55 (95%) patients in the filgotinib group and 52 (90%) in the placebo group completed the study; three (5%) patients in the filgotinib group and six (10%) in the placebo group discontinued treatment. The mean ASDAS change from baseline to week 12 was −1·47 (SD 1·04) in the filgotinib group and −0·57 (0·82) in the placebo group, with a least squares mean difference between groups of −0·85 (95% CI −1·17 to −0·53; p<0·0001). Treatment-emergent adverse events were reported in 18 patients in each group, the most common being nasopharyngitis (in two patients in the filgotinib group and in four patients in the placebo group). Treatment-emergent adverse events led to permanent treatment discontinuation in two patients (a case of grade 3 pneumonia in the filgotinib group and of high creatine kinase in the placebo group). No deaths were reported during the study.
Filgotinib is efficacious and safe for the treatment of patients with active ankylosing spondylitis who have not responded to first-line pharmacological therapy with NSAIDs. Further investigation of filgotinib for ankylosing spondylitis is warranted.
Galapagos and Gilead Sciences.
To compare the efficacy and safety of SB4 (an etanercept biosimilar) with reference product etanercept (ETN) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) ...therapy.
This is a phase III, randomised, double-blind, parallel-group, multicentre study with a 24-week primary endpoint. Patients with moderate to severe RA despite MTX treatment were randomised to receive weekly dose of 50 mg of subcutaneous SB4 or ETN. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 24. Other efficacy endpoints as well as safety, immunogenicity and pharmacokinetic parameters were also measured.
596 patients were randomised to either SB4 (N=299) or ETN (N=297). The ACR20 response rate at week 24 in the per-protocol set was 78.1% for SB4 and 80.3% for ETN. The 95% CI of the adjusted treatment difference was -9.41% to 4.98%, which is completely contained within the predefined equivalence margin of -15% to 15%, indicating therapeutic equivalence between SB4 and ETN. Other efficacy endpoints and pharmacokinetic endpoints were comparable. The incidence of treatment-emergent adverse events was comparable (55.2% vs 58.2%), and the incidence of antidrug antibody development up to week 24 was lower in SB4 compared with ETN (0.7% vs 13.1%).
SB4 was shown to be equivalent with ETN in terms of efficacy at week 24. SB4 was well tolerated with a lower immunogenicity profile. The safety profile of SB4 was comparable with that of ETN.
NCT01895309, EudraCT 2012-005026-30.
АНОТАЦІЯ. Гіпертрофічна кардіоміопатія – це одне із розповсюджених генетично обумовлених захворювань міокарда, яке супроводжується розвитком діастолічної, а згодом і систолічної дисфункції міокарда. ...Метою нашого дослідження стало вивчити клініко-інструментальні особливості хворих на гіпертрофічну кардіоміопатію із порушеними показниками глобального поздовжнього стрейну лівого шлуночка та оцінити його прогностичне значення на розвиток серцево-судинних подій в українській популяції хворих на гіпертрофічну кардіоміопатію. Матеріали та методи. Було ретроспективно проаналізовано дані 35 хворих на гіпертрофічну кардіоміопатію, яким проведене комплексне клініко-інструментальне обстеження з визначенням абсолютного показника GLS на спекл-трекінг-ехокардіографії. Хворі були поділені на дві групи: І група (показник глобального стрейну < 14,5) та ІІ група (показник глобального стрейну ≥ 14,5). Результати. Зниження GLS асоціювалося із більшою тривалістю захворювання (8 (5-11) і 3 (2-5) років, р=0,003), збільшенням кількості скарг на перебої в роботі серця (66,7% і 23,5%, р=0,018) та слабкість (61,1% і 23,5%, р=0,04), підвищенням систолічного артеріального тиску (130 (120-140) проти 110 (100-120) мм рт ст, р=0,009), відсутністю хворих без ознак СН (0 і 29,4%, р=0,019), збільшенням IVRT (106,19±28,62 і 84,57±27,54 мс, р=0,044) та більшою кількістю шлуночкових екстрасистол (17 (4-69) і 2 (0,5-3), з=0,014). За даними аналізу виживання Каплана-Мейера відносно фатальних та нефатальних серцево-судинних подій або комбінації їх з госпіталізацією з приводу СН у них було виявлено достовірно гірші показники виживання (Log-Rank, р=0,016 та р=0,003). Висновки Хворі на гіпертрофічну кардіоміопатію з поганими показниками GLS характеризувалися гіршими клініко-інструментальними даними та несприятливим серцево-судинним прогнозом.
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