scholarly journals An open-label multicenter observational study (registry) of patients recovered from coronavirus disease 2019 (COVID-19) with involvement of the cardiovascular system or with baseline severe cardiovascular diseases: rationale, design, and implications for clinical practice

2021 ◽  
Vol 26 (1) ◽  
pp. 4287
Author(s):  
A. O. Konradi ◽  
S. V. Villevalde ◽  
D. V. Duplyakov ◽  
A. V. Kozlenok ◽  
O. V. Melnik ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Cardiovascular Diseases ◽  
Cardiovascular System ◽  
Severe Infection ◽  
Cardiovascular Complications ◽  
Open Label ◽  
Multicenter Observational Study ◽  
Cardiovascular Morbidity And Mortality ◽  
International Data

The potential impact on cardiovascular morbidity and mortality have become one of the most important issues of the coronavirus disease 2019 (COVID-19) pandemic. COVID-19 may be associated with more frequent development of acute cardiovascular complications, while patients with established cardiovascular diseases are characterized by a higher risk of severe infection and adverse in-hospital outcomes. Due to the spread scale of the pandemic, understanding the long-term cardiovascular consequences of COVID-19 is of no less importance. Inability to extrapolate available international data to the Russian population has led to the initiation of a national multicenter study (registry) of patients recovered from COVID-19 and with concomitant involvement of the cardiovascular system or with baseline severe cardiovascular diseases. The article presents its rationale, design and implications of the results for clinical practice.

The cardiovascular system during sleep

ESC CardioMed ◽  
2018 ◽  
pp. 146-150
Author(s):  
Naima Covassin ◽  
Virend K. Somers
Keyword(s):  
Physical Activity ◽  
Cardiovascular Diseases ◽  
Cardiovascular System ◽  
Sleep Stage ◽  
Cardiovascular Complications ◽  
Time Dependent ◽  
Diurnal Pattern ◽  
Sleep Period ◽  
Sleep Quantity ◽  
Disturbed Sleep

The majority of molecular, physiological, and behavioural processes undergo substantial variations across a 24 h period. The health implications of such fluctuations, whether they are expressions of an intrinsic circadian rhythmicity or are secondary to changes in physical activity, posture, and/or sleep, are increasingly recognized. Similar to other biological functions, the cardiovascular system exhibits a prominent day–night profile, with profound haemodynamic, autonomic, and hormonal oscillations occurring during the sleep period. These time-dependent and sleep stage-dependent patterns of function have important clinical significance. The cardiovascular downregulation achieved throughout the night while asleep may be restorative and protective against adverse events, while the morning physiological activation coincident with awakening facilitates resumption of daytime activities. Nevertheless, rather than beneficial, these activity configurations may be pathogenic in individuals with a vulnerable substrate and may favour onset and progression of cardiovascular diseases. Cardiovascular complications may also arise as a consequence of abnormal day–night periodicity and disturbed sleep quantity and quality. Hence, consideration of the diurnal pattern of cardiovascular activity is critical in the clinical setting.

scholarly journals Immunovirological parameters and cytokines in HIV infection

2012 ◽  
Vol 45 (6) ◽  
pp. 663-669 ◽  
Author(s):  
Karen Ingrid Tasca ◽  
Sueli Aparecida Calvi ◽  
Lenice do Rosário de Souza
Keyword(s):  
Clinical Practice ◽  
Cardiovascular Diseases ◽  
Hiv Infection ◽  
Immune Activation ◽  
Healthy Individuals ◽  
Antiretroviral Therapies ◽  
The Many ◽  
Lower Morbidity

Although modern combined antiretroviral therapies (cART) result in lower morbidity and mortality and a visible improvement of clinical and laboratory parameters in HIV-infected, it is known that their long-term use contributes to appearance of the many events unrelated to AIDS such as cardiovascular diseases, cancer and osteoporosis, comorbidities which have been proposed as some of the most important that deprive the majority of infected to present an even better prognosis. This is because even with a decrease in inflammation and immune activation after drug intervention to the patient, these parameters remain higher than those shown by healthy individuals and the imbalance of cytokine profiles also persists. Therefore, evaluations of other biomarkers in clinical practice are needed to complement the exams already carried out routinely and allow more effective monitoring of HIV patients. This review aims to investigate the role of cytokines as potential markers showing studies on their behavior in various stages of HIV infection, with or without cART.

scholarly journals The Role of MSC Therapy in Attenuating the Damaging Effects of the Cytokine Storm Induced by COVID-19 on the Heart and Cardiovascular System

2020 ◽  
Vol 7 ◽  
Author(s):  
Georgina M. Ellison-Hughes ◽  
Liam Colley ◽  
Katie A. O'Brien ◽  
Kirsty A. Roberts ◽  
Thomas A. Agbaedeng ◽  
...  
Keyword(s):  
Cardiovascular System ◽  
Cardiovascular Complications ◽  
Multiple Organ ◽  
Cytokine Storm ◽  
Cell Therapies ◽  
Tissue Repair And Regeneration ◽  
Global Pandemic ◽  
Organ Systems

The global pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes coronavirus disease 2019 (COVID-19) has led to 47 m infected cases and 1. 2 m (2.6%) deaths. A hallmark of more severe cases of SARS-CoV-2 in patients with acute respiratory distress syndrome (ARDS) appears to be a virally-induced over-activation or unregulated response of the immune system, termed a “cytokine storm,” featuring elevated levels of pro-inflammatory cytokines such as IL-2, IL-6, IL-7, IL-22, CXCL10, and TNFα. Whilst the lungs are the primary site of infection for SARS-CoV-2, in more severe cases its effects can be detected in multiple organ systems. Indeed, many COVID-19 positive patients develop cardiovascular complications, such as myocardial injury, myocarditis, cardiac arrhythmia, and thromboembolism, which are associated with higher mortality. Drug and cell therapies targeting immunosuppression have been suggested to help combat the cytokine storm. In particular, mesenchymal stromal cells (MSCs), owing to their powerful immunomodulatory ability, have shown promise in early clinical studies to avoid, prevent or attenuate the cytokine storm. In this review, we will discuss the mechanistic underpinnings of the cytokine storm on the cardiovascular system, and how MSCs potentially attenuate the damage caused by the cytokine storm induced by COVID-19. We will also address how MSC transplantation could alleviate the long-term complications seen in some COVID-19 patients, such as improving tissue repair and regeneration.

scholarly journals Resolving the Ionotropic P2X4 Receptor Mystery Points towards a New Therapeutic Target for Cardiovascular Diseases

2020 ◽  
Vol 21 (14) ◽  
pp. 5005 ◽  
Author(s):  
Bruno Bragança ◽  
Paulo Correia-de-Sá
Keyword(s):  
Clinical Practice ◽  
Cardiovascular Diseases ◽  
Cardiovascular System ◽  
State Of The Art ◽  
P2x4 Receptor ◽  
Extracellular Milieu ◽  
Intracellular Energy ◽  
Further Development ◽  
Cardiovascular Functions

Adenosine triphosphate (ATP) is a primordial versatile autacoid that changes its role from an intracellular energy saver to a signaling molecule once released to the extracellular milieu. Extracellular ATP and its adenosine metabolite are the main activators of the P2 and P1 purinoceptor families, respectively. Mounting evidence suggests that the ionotropic P2X4 receptor (P2X4R) plays pivotal roles in the regulation of the cardiovascular system, yet further therapeutic advances have been hampered by the lack of selective P2X4R agonists. In this review, we provide the state of the art of the P2X4R activity in the cardiovascular system. We also discuss the role of P2X4R activation in kidney and lungs vis a vis their interplay to control cardiovascular functions and dysfunctions, including putative adverse effects emerging from P2X4R activation. Gathering this information may prompt further development of selective P2X4R agonists and its translation to the clinical practice.

An Open-Label, Multicenter, Observational Study of The Effectiveness of The Cefepime/Sulbactam Antibiotic (Maxictam®-AF) In Patients With Intra Abdominal Infection, Nosocomial Pneumonia or Ventilator-Associated Pneumonia (Study MAXI-2019)

2021 ◽  
Vol 65 (11-12) ◽  
pp. 49-58
Author(s):  
S. V. Yakovlev ◽  
M. P. Suvorova ◽  
A. O. Bykov ◽  
S. V. Zhuravel ◽  
K. A. Popugaev ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Observational Study ◽  
Nosocomial Pneumonia ◽  
Intraabdominal Infection ◽  
Apache Ii ◽  
Ventilator Associated Pneumonia ◽  
Open Label ◽  
Multicenter Observational Study ◽  
Abdominal Infection ◽  
Intra Abdominal Infection

The aim of the study was to evaluate the effectiveness of cefepime/sulbactam in patients with intra-abdominal infection, nosocomial pneumonia (NP) or ventilator-associated pneumonia (VAP) in actual clinical practice. Material and methods. The study was conducted in 14 Russian Clinics from October 2019 to March 2020. Study design: an open-label, prospective, non-comparative, multicenter, observational study. The study included patients who met the inclusion/exclusion criteria and signed a written informed consent. The studied antibiotic: cefepime/sulbactam (Maxictam®-AF). The primary parameter for effectiveness evaluation was the clinical effect after the conclusion of cefepime/sulbactam therapy — recovery/improvement or no effect. Results. The study included 140 patients (average age — 60.8 years) who received at least one dose of cefepime/sulbactam; 37 of them had intraabdominal infection, 72 — NP, and 31 — VAP. Most of the included patients were in the ICU department (82.1%) and their condition was severe: the average APACHE II score was 15.5 points, SOFA — 5.4 points, the Mannheim peritonitis index value in patients with intra-abdominal infection was from 14 to 35 points, with an average of 24.3 points. The majority of patients treated with cefepime/sulbactam (68.6%) had one or more risk factors for multi-resistant pathogens upon hospital or ICU admission. Cefepime/sulbactam was prescribed as the 1st or 2nd line of empirical therapy at a daily dose of 4 g (in 68.3%), 6 g (2.9%) or 8 g (28.8%); most patients were prescribed cefepime/sulbactam in monotherapy (72.3%). The average duration of therapy with cefepime/sulbactam was 9.6±3.5 days. The final assessment of treatment effectiveness was carried out in 132 patients: recovery or improvement was noted in 80.6% of patients with intra-abdominal infection, the effectiveness in NP and VAP was slightly higher — 95.6 and 89.3%. The effect was absent in 5.3% of patients, relapse or superinfection was noted in 3.0 and 1.5%. The majority of patients (81.3%) treated with cefepime/sulbactam were discharged from the hospital. No serious side effects were observed. In patients with a positive effect, age and values of APACHE II were significantly lower (59.58 years and 14.79 points) compared to those with no effect (67.95 years and 18.39 points). A multivariate analysis found that the probability of recovery of patients treated with cefepime/sulbactam did not depend on the diagnosis of infection, ICU admission, the presence of sepsis or septic shock. Conclusion. The multicenter study has established a high clinical efficacy of cefepime/sulbactam in real clinical practice in the treatment of patients with severe intraabdominal infection, nosocomial pneumonia or ventilator-associated pneumonia.

scholarly journals 35 Long-term Improvements in Site-Rated Outcomes with Deutetrabenazine Treatment in Patients with Tardive Dyskinesia

CNS Spectrums ◽  
2019 ◽  
Vol 24 (1) ◽  
pp. 193-194
Author(s):  
Karen E. Anderson ◽  
David Stamler ◽  
Mat D. Davis ◽  
Nicholas Gross ◽  
Robert A. Hauser ◽  
...  
Keyword(s):  
New York ◽  
Clinical Practice ◽  
Tardive Dyskinesia ◽  
Real World ◽  
Treatment Success ◽  
Open Label ◽  
Double Blind ◽  
Abnormal Movements ◽  
Global Impression Of Change

AbstractBackgroundTardive dyskinesia (TD) is an often-irreversible movement disorder that may intensify the stigma of patients with psychiatric disorders and worsen quality of life. In two randomized, double-blind, placebo (PBO)-controlled, 12-week trials, ARM-TD and AIM-TD (‘parent studies’), deutetrabenazine (DTB) demonstrated statistically significant improvements in centrally read Abnormal Involuntary Movement Scale (AIMS) scores at Week 12 compared with PBO and was generally well tolerated.Study ObjectiveTo evaluate the long-term efficacy of DTB in an open-label safety study following double-blind treatment using site-rated efficacy measures: AIMS, the Clinical Global Impression of Change (CGIC) and the Patient Global Impression of Change (PGIC), which may be used in real-world clinical practice settings.MethodPatients with TD who completed the parent studies were eligible to enter this open-label, long-term extension (OLE) after completing the 1-week washout period and final evaluation in the blinded portion of the trial. This extension comprised a 6-week titration period followed by a long-term maintenance phase. Patients began DTB at 12mg/day, titrating up to a maximum total dose of 48mg/day based on dyskinesia control and tolerability. Efficacy endpoints included in this analysis are the change in site-rated AIMS score (items 1–7) from parent study baseline, and the proportion of patients who were “Much Improved” or “Very Much Improved” (treatment success) on the CGIC and PGIC from OLE baseline.ResultsAt the end of the parent studies (Week 12), patients treated with DTB had experienced greater mean (standard error) improvements in site-rated AIMS score (–5.0[0.40]) than patients given PBO (–3.2[0.47]). With long-term DTB treatment, both groups experienced improvements in site-rated AIMS scores (prior DTB, –7.9[0.62]; prior placebo, –6.6[0.64]) compared with parent study baseline. Similarly, at the end of the parent studies, a greater proportion of patients treated with DTB had treatment success on the CGIC (DTB, 51%; PBO, 32%) and the PGIC (DTB, 46%; PBO: 33%); whereas at Week 54 of the OLE study, treatment success on CGIC and PGIC were similar in both the CGIC (prior DTB: 66%; prior PBO: 68%) and PGIC (prior DTB: 62%; prior PBO: 62%) groups. DTB was generally well tolerated.ConclusionsPatients treated with DTB showed improvements in abnormal movements, as measured by site-rated AIMS, CGIC, and PGIC scores, which may be used in real-world clinical practice settings. These results corroborate the previously reported efficacy of DTB as observed in the 12-week, double-blind ARM-TD and AIM-TD trials, in which central raters were used to evaluate AIMS scores.Presented at: American Psychiatric Association Annual Meeting; May 5–9, 2018, New York, New York, USAFunding Acknowledgements: Funding: This study was supported by Teva Pharmaceuticals, Petach Tikva, Israel.

scholarly journals A Randomized Open Clinical Study of the Atherosclerosis Treatment Information Video Effect on Adherence to Long-Term Therapy in Patients with Cardiovascular Diseases

2021 ◽  
Vol 17 (5) ◽  
pp. 683-687
Author(s):  
Yu. V. Bulaeva ◽  
E. A. Naumova ◽  
O. N. Semenova ◽  
T. V. Kanaeva ◽  
K. A. Popov ◽  
...  
Keyword(s):  
Cardiovascular Diseases ◽  
Patient Adherence ◽  
Intervention Group ◽  
Cardiovascular Complications ◽  
The Body ◽  
Term Therapy ◽  
Control Group ◽  
Treatment Information ◽  
Long Term Therapy

Aim. Study the effect of a study video, which was created by researchers and devoted to the atherosclerosis development and the effect of statin therapy on atherosclerotic plaque, on adherence to long-term therapy in patients with high or very high risk of cardiovascular complications.Material and methods. 120 patients admitted to hospital with cardiovascular diseases were included in the study. Patients were randomized into 2 groups: in the main group (n=60), the information video edited by the researchers was shown to patients on the eve of discharge, in addition to a printed brochure on lifestyle and diet modification, and in the control group (n=60), patients were given only a standard brochure. The motivating video shows the damage to the cardiovascular system by the atherosclerotic process and the beneficial effect on the body of constant intake of statins. After 1 and 3 months after discharge from the hospital, telephone calls were made, after which the patients had to visit the center for an objective examination by a researcher and control of laboratory parameters. After 1 month, 110 patients visited the center, after 3 months, 98 respondents visited the center.Results. The group with the information video demonstration noted more frequent adherence to medical recommendations compared to the control: after 1 month, 52 (96%) patients continued treatment versus 48 (86%) patients, 3 months after discharge 48 (96%) patients continued treatment versus 38 (79%) patients (p<0.05). After 1 month, 38 (70%) patients in the intervention group continued taking statins versus 29 (43%) respondents in the control group (p<0.05), 3 months after discharge, 40 (80%) patients in the intervention group continued to take statins versus 33 (69%) control patients (p<0.09).Conclusion. Demonstration of a motivating video about the effect of statins on the atherosclerosis course increases patient adherence to medicinal therapy, including adherence to statins.

scholarly journals Long-term safety and effectiveness of tocilizumab in patients with rheumatoid arthritis and inadequate responses to csDMARDs and/or TNF inhibitors: an open-label study close to clinical practice

2019 ◽  
Vol 38 (9) ◽  
pp. 2411-2421 ◽  
Author(s):  
Vivian P. Bykerk ◽  
Andrew J. K. Östör ◽  
José Alvaro-Gracia ◽  
Karel Pavelka ◽  
José Andrés Román Ivorra ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Practice ◽  
Tnf Inhibitors ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

Survey of Safety and Efficacy of Long-acting Injectable Risperidone in Daily Practice: An Open-label, Non-interventional Prospective Study

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1 ◽  
Author(s):  
E. Parellada ◽  
F. Kouniakis ◽  
A. Siurkute ◽  
A. Schreiner ◽  
L. Don
Keyword(s):  
Clinical Practice ◽  
Paranoid Schizophrenia ◽  
Daily Practice ◽  
Routine Clinical Practice ◽  
Open Label ◽  
Antipsychotic Therapy ◽  
Patient Functioning ◽  
Insufficient Response ◽  
Long Acting

Objective:This post-authorization safety survey evaluated the long-term safety, tolerability, and efficacy of risperidone long-acting injectable (RLAI) in routine clinical practice.Methods:In this 6-month, multicenter, European, naturalistic survey, patients were included if, during routine clinical practice, long-term antipsychotic therapy with RLAI was deemed necessary by the treating physician. Efficacy measures (at baseline and after 1, 3, 6 months) included Clinical Global Impression-Severity (CGI-S) and Global Assessment of Functioning (GAF). Safety was evaluated by recording treatment-emergent adverse events (TEAEs) at every visit.Results:RLAI was initiated in 5,134 predominantly male (58.6%) patients (aged 14-94 years) with a diagnosis of paranoid schizophrenia (69.8%). RLAI initial doses were 25 mg every-two-weeks in 37.0%, or 50 mg in 44.4% of patients. at endpoint, RLAI dosages were 50 mg in 49.3% of patients, 25 mg in 27.0%, and 37.5 mg in 22.1%. Six-month treatment with RLAI was completed by 4,314 patients (84.0%). RLAI was discontinued due to loss to follow-up (n=346;6.7%), insufficient response (n=116;2.3%), and AEs (n=106;2.1%). CGI-S significantly improved from baseline to endpoint (p< 0.001). Patient functioning in the GAF scale also significantly improved from baseline to endpoint (45.4±16.0 versus 62.4±17.7, respectively, p< 0.001). TEAEs were recorded by 20% of patients. AEs occurring in ≥5% of patients were akathisia, extrapyramidal disorders, depression, psychotic disorder, anxiety, and weight gain. Serious AEs were reported by 384 (8%) patients.Conclusions:This large prospective survey confirms the good safety, tolerability, and efficacy of RLAI as reported in previous controlled clinical trials when used in routine clinical practice.

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