scholarly journals Combined therapy with inhaled glucocorticosteroids and long-acting β2-agonists in patients with bronchial asthma: the problem of choice

2021 ◽  
pp. 52-59
Author(s):  
A. I. Sinopalnikov
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Bronchial Asthma ◽  
Randomized Clinical Trials ◽  
Pathological Condition ◽  
New Combination ◽  
Fluticasone Furoate ◽  
Combination Drug ◽  
Optimal Drug ◽  
Long Acting

Bronchial asthma remains one of the most common chronic respiratory diseases. The apparent heterogeneity of BA underlies the concept of phenotype-specific or patient-centered therapy. However, in real clinical practice, BA continues to be regarded as a rather homogeneous pathological condition and its treatment in the vast majority of cases retains an empirical approach, the basis of which are inhaled glucocorticosteroids, usually in combination with long-acting beta2-agonists. Since this group of drugs is very representative, the physician is faced with the question of choosing the optimal drug. The basis of evidence-based medicine is a hierarchical classification, where systematic reviews, meta-analyses, and randomized clinical trials are considered the highest level of evidence. Because randomized clinical trials are conducted in carefully selected highly selected patient populations, they have little relevance to patients encountered in everyday clinical practice. In contrast, pragmatic randomized clinical trials assess the clinical efficacy of the investigational agent in a large, unselected population in which patients with comorbidities are included. In this context, the Salford Lung Study (SLS) is of particular interest. It was conducted before the registration of a new combination drug containing the modern ICS fluticasone furoate and the long-acting beta2-agonist vilanterol. The SLS results indicated not only that the use of fluticasone furoate with vilanterol provides better control of BA compared to continued "conventional therapy" (ICS ± LABAs) in symptomatic patients, but also leads to a consistent improvement in the surrogate parameters of quality of life.

The new prospects of the inhalation therapy for bronchial asthma

2020 ◽  
Vol 30 (4) ◽  
pp. 473-484
Author(s):  
S. N. Avdeev ◽  
Z. R. Aisanov
Keyword(s):  
Clinical Trials ◽  
Bronchial Asthma ◽  
Randomized Clinical Trials ◽  
Inhaled Corticosteroids ◽  
Fixed Combination ◽  
Inhalation Therapy ◽  
International Literature ◽  
Dosing Regimen ◽  
Muscarinic Antagonist ◽  
Long Acting

Based on the latest new international literature data, the article considers the possibilities of fixed combinations of long-acting β2-agonist, long-acting muscarinic antagonist and inhaled corticosteroids in achieving the control of bronchial asthma (BA). Clinical advantages for a fixed combination of indacaterol, glycopyrronium and mometasone furoate one dosing regimen in the therapy of BA are presented based on the results of recently completed randomized clinical trials IRIDIUM and ARGON.

scholarly journals Case Commentary: the Need for Cefiderocol Is Clear, but Are the Supporting Clinical Data?

2020 ◽  
Vol 64 (4) ◽  
Author(s):  
Ryan K. Shields
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Salvage Therapy ◽  
Randomized Clinical Trials ◽  
Treatment Options ◽  
Multidrug Resistant ◽  
Gram Negative Bacteria ◽  
Potential Utility ◽  
Gram Negative

ABSTRACT Cefiderocol is a newly approved siderophore cephalosporin that demonstrates expanded in vitro activity against multidrug-resistant Gram-negative bacteria. In two challenging cases reported here, cefiderocol shows potential utility as salvage therapy against difficult-to-treat pathogens with limited or no treatment options; however, two multicenter, randomized clinical trials have yielded mixed results among cefiderocol-treated patients. Taken together, clinicians must balance a clear need for cefiderocol in clinical practice with the uncertainties that have stemmed from the available data.

Impact of Peritoneal Dialysis Dose Guidelines on Clinical Outcomes

2005 ◽  
Vol 25 (3_suppl) ◽  
pp. 95-98 ◽  
Author(s):  
David N. Churchill
Keyword(s):  
Clinical Trials ◽  
Peritoneal Dialysis ◽  
Clinical Practice ◽  
Adverse Effects ◽  
Randomized Clinical Trials ◽  
Intervention Group ◽  
The United States ◽  
Dialysis Dose ◽  
Middle Molecules ◽  
The Impact

The objective was to review the rationale for the Kidney Disease Outcomes Quality Initiative (K/DOQI) recommendations for adequacy of peritoneal dialysis and to evaluate the impact of these recommendations on clinical practice and patient survival. The K/DOQI recommendations were based on large observational studies; the target weekly Kt/V value of 2.0 assumed equivalence of peritoneal and renal clearances. This assumption is no longer considered correct. The impact on clinical practice was evaluated by an examination of temporal trends before and after publication of the guidelines in 1997. In the United States and The Netherlands, there had been a trend toward increased delivered total Kt/V prior to 1997, and there was no acceleration in this trend after 1997. Two randomized clinical trials have implemented these guidelines with increased peritoneal Kt/V (or creatinine clearance) used to achieve the K/DOQI target in the intervention group. This was not associated with improved survival, compared to a lower Kt/V, in either of the randomized clinical trials. Among the explanations for the failure to improve outcome are potential adverse effects of increasing the dialysis dose. These include increased intraperitoneal pressure associated with increased exchange volume, failure to increase clearance of middle molecules, and increased exposure to glucose. Strategies that increase peritoneal clearance without exposure to these potential adverse effects include more-frequent exchanges rather than increased exchange volume, and decreased exposure to glucose and glucose degradation products. Pending such studies, current K/DOQI guidelines should be updated in a timely manner.

Treatment-related toxicities in patients with squamous cell carcinoma of the head and neck (SCCHN)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17041-e17041
Author(s):  
M. Ulcickas Yood ◽  
P. Feng Wang ◽  
S. Hensley Alford ◽  
S. Oliveria ◽  
K. Wells ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Health System ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Medical Record ◽  
Squamous Cell ◽  
Real World ◽  
Randomized Clinical Trials

e17041 Background: Although treatment effects and toxicities have been reported from randomized clinical trials of patients with squamous cell carcinoma of the head and neck (SCCHN), little information is available from real-world clinical practice where heterogeneous treatment patterns and patient populations may lead to different estimates than those observed in clinical trials. Methods: Using a population-based tumor registry at a large, Midwestern integrated health system, we identified all cases of stage III or IV SCCHN diagnosed 2000–2006. The incidence/severity of acute and late toxicities associated with SCCHN treatment was obtained from detailed medical record review of health system encounters, including physician notes. Grading of toxicities (using CTCAE3 criteria), distinction between acute and late toxicity, and analyses by treatment are ongoing. The incidence and severity of toxicities will be presented by treatment regimen, tumor location and tumor stage. We presented here an interim analysis. Results: Among the target population of 194 patients that will ultimately be included in this study, 137 medical record reviews have been completed to date. The percentages of patients with toxicities, including 95% confidence intervals are presented in the table , below. Conclusions: Toxicity in patients with advanced SCCHN is common. Data from clinical practice quantifying the incidence are lacking, these data from an observational real-world study provide important baseline information on the incidence of toxicities in patients with advanced SCCHN and also call for safer effective treatment for SCCHN. [Table: see text] [Table: see text]

Primary Stroke Prevention in Nonvalvular Atrial Fibrillation: Implementing the Clinical Trial Findings

1997 ◽  
Vol 31 (10) ◽  
pp. 1187-1196 ◽  
Author(s):  
Patricia A Howard ◽  
Pamela W Duncan
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Cost Effectiveness ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Randomized Clinical Trials ◽  
Nonvalvular Atrial Fibrillation ◽  
Risk Patients

OBJECTIVE: To review the clinical trials evaluating warfarin for primary stroke prophylaxis in nonvalvular atrial fibrillation (NVAF), to discuss the relative benefits and risks of warfarin versus aspirin therapy, and to review the clinical practice guidelines and identify potential barriers to their implementation in clinical practice. DATA SOURCES: A MEDLINE literature search was performed to identify clinical trials of antithrombotic therapy for NVAF, clinical practice guidelines, studies evaluating physician practices and attitudes, cost-effectiveness studies, and pertinent review articles. Key search terms included atrial fibrillation, stroke, antithrombotic, warfarin, aspirin, and cost-effectiveness. DATA EXTRACTION: Prospective, randomized clinical trials were selected for analysis. Clinical practice guidelines from recognized panels of experts were reviewed. Comprehensive review articles were selected. DATA SYNTHESIS: NVAF is a common arrhythmia that is associated with a substantial risk for stroke. Seven prospective, randomized, clinical trials have conclusively demonstrated the efficacy of warfarin for stroke prevention. The greatest benefits are achieved in older patients and those with comorbidities that increase their risk for stroke. The potential benefits of preventing a devastating stroke, however, must be weighed against the potential for bleeding complications. Warfarin has been shown to be cost-effective in high-risk patients, provided the rate of complications is minimized. Nonetheless, many physicians remain hesitant to implement warfarin therapy in older, high-risk patients. The clinical data on aspirin are less consistent than those observed with warfarin. Aspirin appears to be most effective in younger individuals or those considered to be at low risk for stroke. CONCLUSIONS: In patients with NVAF, the personal, social, and economic consequences of stroke are often devastating. Clinical trials have provided definitive proof that the risks of stroke can be significantly reduced through the use of appropriate antithrombotic therapy. Despite this evidence and the recommendations of a number of clinical practice guidelines, variations in care exist that continue to place patients at risk. Additional outcomes research is needed to evaluate the impact of the clinical trial findings and practice guidelines on clinical practice and to develop methods for overcoming barriers to implementation.

scholarly journals Approaches to Assessing the Quality of Observational Studies of Clinical Practice Based on the Big Data Analysis

2021 ◽  
Vol 17 (4) ◽  
pp. 584-593
Author(s):  
S. R. Gilyarevsky
Keyword(s):  
Clinical Trials ◽  
Big Data ◽  
Clinical Practice ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Real Life ◽  
Hierarchy Of Evidence

The article is devoted to the discussion of the problems of assessing the quality of observational studies in real clinical practice and determining their place in the hierarchy of evidence-based information. The concept of “big data” and the acceptability of using such a term to refer to large observational studies is being discussed. Data on the limitations of administrative and claims databases when performing observational studies to assess the effects of interventions are presented. The concept of confounding factors influencing the results of observational studies is discussed. Modern approaches to reducing the severity of bias in real-life clinical practice studies are presented. The criteria for assessing the quality of observational pharmacoepidemiological studies and the fundamental differences between such studies and randomized clinical trials are presented. The results of systematic reviews of real-life clinical trials to assess the effects of direct oral anticoagulants are discussed. 

scholarly journals Cardioprotective Properties Of Xenon

2020 ◽  
Vol 9 (2) ◽  
pp. 264-272
Author(s):  
A. I. Shpichko ◽  
O. A. Grebenchikov ◽  
I. V. Molchanov ◽  
A. K. Shabanov ◽  
N. P. Shpichko ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Randomized Clinical Trials ◽  
Protective Action ◽  
Experimental Studies ◽  
Molecular Targets ◽  
Cardiac Complications ◽  
Ischemia And Reperfusion

Abstract The review presents the main aspects of the cardioprotective properties of the xenon inhalation anesthetic. Based on the analysis of publications, the article discusses modern views on the mechanisms of the protective action of xenon, realized using pre- and post-conditioning mechanisms, shows major molecular targets and their effects. The article presents the results of experimental studies in vivo and in vitro, which showed the protective effect of xenon on the myocardium and the results of recent randomized clinical trials. The analysis of studies demonstrates the ability of xenon to increase myocardial resistance to ischemia and reperfusion and opens up good prospects for its use in clinical practice in patients with a high risk of cardiac complications.

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