scholarly journals Statin-Associated Myopathy: From Genetic Predisposition to Clinical Management

2014 ◽  
pp. S327-S334 ◽  
Author(s):  
M. VRABLIK ◽  
L. ZLATOHLAVEK ◽  
T. STULC ◽  
V. ADAMKOVA ◽  
M. PRUSIKOVA ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Energy Metabolism ◽  
Broad Spectrum ◽  
Genetic Predisposition ◽  
Coenzyme Q10 ◽  
Current Data ◽  
Membrane Transporters ◽  
Pharmacological Properties ◽  
Everyday Clinical Practice

Statin-associated myopathy (SAM) represents a broad spectrum of disorders from insignificant myalgia to fatal rhabdomyolysis. Its frequency ranges from 1-5 % in clinical trials to 15-20 % in everyday clinical practice. To a large extent, these variations can be explained by the definition used. Thus, we propose a scoring system to classify statin-induced myopathy according to clinical and biochemical criteria as 1) possible, 2) probable or 3) definite. The etiology of this disorder remains poorly understood. Most probably, an underlying genetic cause is necessary for overt SAM to develop. Variants in a few gene groups that encode proteins involved in: i) statin metabolism and distribution (e.g. membrane transporters and enzymes; OATP1B1, ABCA1, MRP, CYP3A4), ii) coenzyme Q10 production (e.g. COQ10A and B), iii) energy metabolism of muscle tissue (e.g. PYGM, GAA, CPT2) and several others have been proposed as candidates which can predispose to SAM. Pharmacological properties of individual statin molecules (e.g. lipophilicity, excretion pathways) and patients´ characteristics influence the likelihood of SAM development. This review summarizes current data as well as our own results.

Generalisability of recent clinical trials in idiopathic pulmonary fibrosis to everyday clinical practice

2015 ◽  
Author(s):  
Lisa Nicol ◽  
Pauline McFarlane ◽  
Catriona Graham ◽  
David McAllister ◽  
William Wallace ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Everyday Clinical Practice

How to assess response to immune therapy

2016 ◽  
Vol 4 (3) ◽  
pp. 47-51
Author(s):  
Judith Michels ◽  
Emilie Lanoy ◽  
Caroline Caramella ◽  
Christian Marth
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Tumor Microenvironment ◽  
Renal Cancer ◽  
Immune Therapy ◽  
Treatment Decisions ◽  
Response Criteria ◽  
Everyday Clinical Practice ◽  
Biological Analysis

Immunotherapy is already a mainstay in treating melanoma, lung cancer and renal cancer and shows compelling promise in many different tumors. However, responses to immunotherapy may be present despite apparent initial progression of the tumor. This underlines the importance of defining accurate tumor assessments and response criteria for immunotherapy. The RECIST criteria have therefore been modified to adhere to requirements of immunotherapy. In line with that, this review will focus on the current imaging tools, the statistical evaluations in clinical trials and the biological analysis of the tumor microenvironment that will in the future effectively guide treatment decisions in everyday clinical practice.

Methotrexate in rheumatology – efficacy and safety of the therapy

2020 ◽  
Vol 13 (3) ◽  
pp. 314-319
Author(s):  
Tomasz Kosakowski
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Time Frame ◽  
Chronic Arthritis ◽  
Gastrointestinal Disorders ◽  
Efficacy And Safety ◽  
Everyday Clinical Practice ◽  
Elevated Transaminase ◽  
Health Complications ◽  
Significant Health

Methotrexate is currently the safe and effective drug used in chronic arthritis and other rheumatic diseases. Avoiding the use of methotrexate in everyday rheumatic treatment can lead to significant health complications. There is no time frame for the use of methotrexate, the drug can be used successfully for many years. The therapeutic dose of the drug is usually 25–30 mg/week. The most common side effects are gastrointestinal disorders and elevated transaminase levels. The efficacy and safety of methotrexate have been confirmed in many clinical trials and in everyday clinical practice.

scholarly journals Evaluation of Minimally Invasive, Ultrasound-guided Synovial Biopsy Techniques by the OMERACT Filter — Determining Validation Requirements

2015 ◽  
Vol 43 (1) ◽  
pp. 208-213 ◽  
Author(s):  
Frances Humby ◽  
Stephen Kelly ◽  
Serena Bugatti ◽  
Antonio Manzo ◽  
Andrew Filer ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Minimally Invasive ◽  
Synovial Tissue ◽  
Working Group ◽  
Current Data ◽  
Synovial Biopsy ◽  
Limited Data ◽  
Global Consensus ◽  
Robust Techniques

Objective.Because limited data currently support the clinical utility of peripherally expressed biomarkers in guiding treatment decisions for patients with rheumatoid arthritis, the search has turned to the disease tissue. The strategic aim of the Outcome Measures in Rheumatology (OMERACT) synovitis working group over the years has been to develop novel diagnostic and prognostic synovial biomarkers. A critical step in this process is to refine and validate minimally invasive, technically simple, robust techniques to sample synovial tissue, for use both in clinical trials and routine clinical practice. The objective of the synovitis working group (SWG) at OMERACT 12 (2014) was to examine whether recently developed ultrasound (US)-guided synovial biopsy techniques could be validated according to the OMERACT filter for future clinical use recommendation.MethodsThe SWG examined whether current data reporting US-guided synovial biopsy of both large and small joints addressed the OMERACT filters of truth, discrimination, and feasibility.Results.There are currently limited data examining the performance of US-guided synovial biopsy, mainly from observational studies. Thus, it remains critical to evaluate its performance, within the clinical trials context, against the current gold standard of arthroscopic biopsy, with particular reference to: (1) synovial tissue yield, (2) capacity to determine treatment response as measured by a validated synovial biomarker, and (3) tolerability of the procedure.Conclusion.We summarize the discrete work packages agreed to as requirements to validate US-guided synovial biopsy and therefore lead to a global consensus on the use of synovial biopsy for research and clinical practice.

scholarly journals Results of the expert forum on the use of perampanel in adolescents with epilepsy in everyday clinical practice

2021 ◽  
Vol 12 (4) ◽  
pp. 248-261
Author(s):  
Article Editorial
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Diagnostic Errors ◽  
Current Data ◽  
Social Aspects ◽  
Online Forum ◽  
Everyday Clinical Practice ◽  
Antiepileptic Therapy ◽  
Juvenile Population

In June 2020, an online forum of experts on the use of perampanel in adolescents with epilepsy in everyday clinical practice was held. The main goal was to discuss the features of juvenile epilepsy, its diagnosis, the possibilities of using perampanel in this category of patients, and the effectiveness of using the drug in everyday clinical practice. The forum was attended by leading experts in neurology and epileptology. Current data on the epidemiology of epilepsy in the child and juvenile population were presented; the issues of difficulties and diagnostic errors were considered, as well as features of managing adolescents with epilepsy, adverse events of antiepileptic therapy, results of studies on the effectiveness of perampanel, and many social aspects of the life of patients in this category.

Statin treatment after a recent TIA or stroke: is effectiveness shown in randomized clinical trials also observed in everyday clinical practice?

2009 ◽  
Vol 122 (1) ◽  
pp. 15-20 ◽  
Author(s):  
H. F. Lingsma ◽  
E. W. Steyerberg ◽  
W. J. M. Scholte op Reimer ◽  
R. Van Domburg ◽  
D. W. J. Dippel ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Randomized Clinical Trials ◽  
Statin Treatment ◽  
Everyday Clinical Practice

“Bridging Gaps – Improving Outcomes”: Problem domains in schizophrenia research, treatment and policy

2016 ◽  
Vol 13 (03) ◽  
pp. 118-120
Author(s):  
W. Wölwer ◽  
W. Gaebel ◽  
V. Toeller
Keyword(s):  
Clinical Practice ◽  
Mental Healthcare ◽  
Knowledge Gaps ◽  
Everyday Clinical Practice ◽  
Treatment Gaps ◽  
Different Types

Summary Background: The provision of mental healthcare for patients with schizophrenia is still characterized both by knowledge gaps and by treatment gaps in everyday clinical practice. Aim: This article discusses the different types of treatment gaps in schizophrenia and describes actions taken to overcome these gaps especially in Europe.

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