IN18-MO-01 Neuroethics in daily practice and in clinical trials focused on special populations

Background Clinical trials on the prophylactic effect of propranolol and metoprolol for migraine show that starting this medication leads to a decrease in the use of attack medication of 0.9–8.9 doses per month. However, studies in daily practice are lacking. Methods We compared the number of triptans prescribed in the six months before and the six months after the start of propranolol/metoprolol in a Dutch national representative primary care cohort. Results Of the 168 triptan-using patients who started with propranolol or metoprolol, the number of triptans prescribed before starting was 4.6 doses per month. The number of triptans prescribed six months before compared with six months after starting propranolol/metoprolol decreased with 1.0 dose per month (Wilcoxon rank test; p = 0.000). Conclusion In this primary care population, although the number of triptans prescribed decreased after starting propranolol or metoprolol, the decrease is relatively small compared to data from clinical trials.

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The myth of informed consent: in daily practice and in clinical trials.

Journal of Medical Ethics ◽

10.1136/jme.15.1.6 ◽

1989 ◽

Vol 15 (1) ◽

pp. 6-11 ◽

Cited By ~ 54

Author(s):

W A Silverman

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Daily Practice

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Prediction of individual response to antidepressants and antipsychotics: an integrated concept

Dialogues in Clinical Neuroscience ◽

10.31887/dcns.2014.16.4/spreskorn ◽

2014 ◽

Vol 16 (4) ◽

pp. 545-554 ◽

Cited By ~ 1

Keyword(s):

Clinical Trials ◽

Conceptual Framework ◽

Daily Practice ◽

Intraindividual Variability ◽

Individual Response ◽

Antipsychotic Therapy ◽

Patient Response ◽

Antipsychotic Medications ◽

New Information ◽

Integrated Concept

In both clinical trials and daily practice, there can be substantial inter- and even intraindividual variability in response--whether beneficial or adverse--to antidepressants and antipsychotic medications. So far, no tools have become available to predict the outcome of these treatments in specific patients. This is because the causes of such variability are often not known, and when they are, there is no way of predicting the effects of their various potential combinations in an individual. Given this background, this paper presents a conceptual framework for understanding known factors and their combinations so that eventually clinicians can better predict what medication(s) to select and at what dose they can optimize the outcome for a given individual. This framework is flexible enough to be readily adaptable as new information becomes available. The causes of variation in patient response are grouped into four categories: (i) genetics; (ii) age; (iii) disease; and (iv) environment (internal). Four cases of increasing complexity are used to illustrate the applicability of this framework in a clinically relevant way In addition, this paper reviews tools that the clinician can use to assess for and quantify such inter- and intraindividual variability. With the information gained, treatment can be adjusted to compensate for such variability, in order to optimize outcome. Finally, the limitations of existing antidepressant and antipsychotic therapy and the way they reduce current ability to predict response is discussed.

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An update on the role of daratumumab in the treatment of multiple myeloma

Therapeutic Advances in Hematology ◽

10.1177/2040620716677523 ◽

2016 ◽

Vol 8 (1) ◽

pp. 28-37 ◽

Cited By ~ 16

Author(s):

Caitlin Costello

Keyword(s):

Multiple Myeloma ◽

Clinical Trials ◽

Blood Compatibility ◽

Daily Practice ◽

Combination Strategies ◽

Heavily Pretreated ◽

Pretreated Patients ◽

Phase Ii And Iii ◽

Future Plans

Monoclonal antibodies (mAbs) have emerged as a promising new drug class for the treatment of multiple myeloma (MM). Daratumumab (DARA), a CD38 mAb, has demonstrated safety, tolerability and activity in a range of clinical trials, both as monotherapy and in combination strategies for MM. The favorable efficacy results in heavily pretreated patients with advanced MM have provided the rationale for the investigation of DARA in a number of ongoing and future phase II and III trials. The general tolerability of mAbs has allowed for widespread investigation and use of DARA among a variety of MM patients, however their use requires special consideration. Infusion-related reactions (IRRs), interference with blood compatibility assays and response assessments are all unique factors related to the use of DARA. This review provides an update of the results from the DARA clinical trials conducted to date, its future plans for investigation, and practical management considerations for the use of DARA in daily practice.

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Direct Oral Anticoagulants in the Treatment of Venous Thromboembolism: Use in Patients with Advanced Renal Impairment, Obesity, or Other Weight-Related Special Populations

Seminars in Respiratory and Critical Care Medicine ◽

10.1055/s-0041-1723952 ◽

2021 ◽

Author(s):

Paul P. Dobesh ◽

Molly M. Kernan ◽

Jenni J. Lueshen

Keyword(s):

Clinical Trials ◽

Venous Thromboembolism ◽

Renal Impairment ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Safety Data ◽

Special Populations ◽

Dose Selection ◽

Phase 3 ◽

Optimal Drug

AbstractThere are currently more than 7 million patients taking a direct oral anticoagulant (DOAC), with more new prescriptions per year than warfarin. Despite impressive efficacy and safety data for the treatment of venous thromboembolism, patients with obesity or advanced renal impairment represented a small portion of the patients enrolled in the phase 3 clinical trials. Therefore, to evaluate the potential use of DOACs in these special populations, clinicians need to have an understanding of the pharmacokinetics and pharmacodynamics of these agents in these settings. Since data from randomized controlled trials are limited, data from observational trials are helpful in gaining comfort with the use of DOACs in these special populations. Selecting the appropriate dose for each agent is imperative in achieving optimal patient outcomes. We provide an extensive review of the pharmacokinetics, pharmacodynamics, phase 3 clinical trials, and observational studies on the use of DOACs in patients with advanced renal impairment, obesity, or other weight-related special populations to provide clinicians with a comprehensive understanding of the data for optimal drug and dose selection.

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Precision medicine for gastrointestinal cancers: a conference report

Future Science OA ◽

10.2144/fsoa-2020-0061 ◽

2020 ◽

Vol 6 (6) ◽

pp. FSO478

Author(s):

Ibrahim Halil Sahin

Keyword(s):

Clinical Trials ◽

Precision Medicine ◽

Conference Report ◽

Daily Practice ◽

Future Perspective ◽

Gastrointestinal Cancers ◽

Therapeutic Approaches ◽

Important Data ◽

Cancer Management ◽

Novel Therapeutic

As cancer management evolves into precision medicine national/international cancer meetings bring novel therapeutic approaches and potentially practice-changing results of clinical studies are presented. This year, the ASCO GI Symposium 2020 had also several updates from ongoing and finalized clinical trials. Although there were no groundbreaking results that impact the daily practice directly, several highly important data from ongoing studies were shared with the audience. In this report, the highlights of the ASCO GI Symposium 2020 are presented with a future perspective.

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Immunotherapy of brain metastases: breaking a “dogma”

Journal of Experimental & Clinical Cancer Research ◽

10.1186/s13046-019-1426-2 ◽

2019 ◽

Vol 38 (1) ◽

Cited By ~ 10

Author(s):

Anna Maria Di Giacomo ◽

Monica Valente ◽

Alfonso Cerase ◽

Maria Fortunata Lofiego ◽

Francesca Piazzini ◽

...

Keyword(s):

Clinical Trials ◽

Brain Metastases ◽

Case Series ◽

Daily Practice ◽

Clinical Activity ◽

Check Point ◽

Wide Range ◽

Check Point Inhibitors ◽

Clinical Responses ◽

The Central Nervous System

Abstract Until very few years ago, the oncology community dogmatically excluded any clinical potential for immunotherapy in controlling brain metastases. Therefore, despite the significant therapeutic efficacy of monoclonal antibodies to immune check-point(s) across a wide range of tumor types, patients with brain disease were invariably excluded from clinical trials with these agents. Recent insights on the immune landscape of the central nervous system, as well as of the brain tumor microenvironment, are shedding light on the immune-biology of brain metastases. Interestingly, retrospective analyses, case series, and initial prospective clinical trials have recently investigated the role of different immune check-point inhibitors in brain metastases, reporting a significant clinical activity also in this subset of patients. These findings, and their swift translation in the daily practice, are driving fundamental changes in the clinical management of patients with brain metastases, and raise important neuroradiologic challenges. Along this line, neuro-oncology undoubtedly represents an additional area of active investigation and of growing interest to support medical oncologists in the evaluation of clinical responses of brain metastases to ICI treatment, and in the management of neurologic immune-related adverse events. Aim of this review is to summarize the most recent findings on brain metastases immunobiology, on the evolving scenario of clinical efficacy of ICI therapy in patients with brain metastases, as well as on the increasing relevance of neuroradiology in this therapeutic setting.

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