Abstract
Coinciding in time with the expiration of the patent of enoxaparin and clopidogrel, a number of new antithrombotics (anticoagulants and antiplatelets with new mechanisms of action) have been developed or are still under development for both venous and arterial thromboembolic complications. The effect of antithrombotic drugs is a continuum where a fine tune assessment of the ischemic events that are intended to be prevented and bleeding complications derived naturally from the own mechanism of action of the administered agent is essential. This paper discusses relevant aspects of pivotal studies aimed to support the marketing authorisation application of new antithrombotics for the prophylaxis or treatment of venous thromboembolism on one hand, and arterial thromboembolism on the other hand (acute coronary syndromes and stroke and systemic embolic events in patients with atrial fibrillation). General methodological issues and tools to assess efficacy and safety parameters and problems encountered in the way they are measured and classified are discussed.
Keywords: Antithrombotics, clinical trials, guidelines, methodology, thromboembolism
Current Drug Discovery Technologies
Title:Clinical Drug Development in Thromboembolic Diseases: Regulatory and Methodological Approach
Volume: 9 Issue: 2
Author(s): Gonzalo Calvo-Rojas and Antonio Gomez-Outes
Affiliation:
Keywords: Antithrombotics, clinical trials, guidelines, methodology, thromboembolism
Abstract: Coinciding in time with the expiration of the patent of enoxaparin and clopidogrel, a number of new antithrombotics (anticoagulants and antiplatelets with new mechanisms of action) have been developed or are still under development for both venous and arterial thromboembolic complications. The effect of antithrombotic drugs is a continuum where a fine tune assessment of the ischemic events that are intended to be prevented and bleeding complications derived naturally from the own mechanism of action of the administered agent is essential. This paper discusses relevant aspects of pivotal studies aimed to support the marketing authorisation application of new antithrombotics for the prophylaxis or treatment of venous thromboembolism on one hand, and arterial thromboembolism on the other hand (acute coronary syndromes and stroke and systemic embolic events in patients with atrial fibrillation). General methodological issues and tools to assess efficacy and safety parameters and problems encountered in the way they are measured and classified are discussed.
Export Options
About this article
Cite this article as:
Calvo-Rojas Gonzalo and Gomez-Outes Antonio, Clinical Drug Development in Thromboembolic Diseases: Regulatory and Methodological Approach, Current Drug Discovery Technologies 2012; 9 (2) . https://dx.doi.org/10.2174/1570163811209020105
DOI https://dx.doi.org/10.2174/1570163811209020105 |
Print ISSN 1570-1638 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-6220 |
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
- Announcements
Related Articles
-
Silica Sulfuric Acid and Related Solid-supported Catalysts as Versatile Materials for Greener Organic Synthesis
Current Organic Synthesis Screening of Candidate Pathogenic Genes for Spontaneous Abortion Using Whole Exome Sequencing
Combinatorial Chemistry & High Throughput Screening Treating Depression in Coronary Artery Disease and Chronic Heart Failure: What’s new in using Selective Serotonin Re-Uptake Inhibitors?
Cardiovascular & Hematological Agents in Medicinal Chemistry Canagliflozin : A New Hope in the Antidiabetic Armamentarium
Recent Patents on Cardiovascular Drug Discovery In Vivo Bacterial Imaging without Engineering; A Novel Probe-Based Strategy Facilitated by Endogenous Nitroreductase Enzymes
Current Gene Therapy Hemodynamic Forces Regulate Embryonic Stem Cell Commitment to Vascular Progenitors
Current Cardiology Reviews Imaging Epigenetics in Alzheimer’s Disease
Current Pharmaceutical Design Menopause and Non-Alcoholic Fatty Liver Disease: A Review Focusing on Therapeutic Perspectives
Current Vascular Pharmacology Treatment of Disability in Peripheral Arterial Disease: New Drugs
Current Drug Targets - Cardiovascular & Hematological Disorders COX-2 in Brain and Spinal Cord - Implications for Therapeutic Use.
Current Medicinal Chemistry G Protein-Coupled Receptors – Potential Roles in Clinical Pharmacology
Cardiovascular & Hematological Agents in Medicinal Chemistry Nanomedicines for Brain Targeting: A Patent Review
Recent Patents on Nanomedicine Therapeutic Strategies in Pulmonary Hypertension of the Newborn: Where Are We Now?
Current Medicinal Chemistry Assessing the Performance of 3D Pharmacophore Models in Virtual Screening: How Good are They?
Current Topics in Medicinal Chemistry Anderson-Fabry Disease in Children
Current Pharmaceutical Design Stroke Outcomes in Mice Lacking the Genes for Neuronal Heme Oxygenase-2 and Nitric Oxide Synthase
Current Neurovascular Research Exercise-Induced Cardioprotection via eNOS: A Putative Role of Red Blood Cell Signaling
Current Medicinal Chemistry A Review of Statistical and Machine Learning Techniques for Microvascular Complications in Type 2 Diabetes
Current Diabetes Reviews Regulatory Effects of N-3 PUFAs on Pancreatic β-cells and Insulin-sensitive Tissues
Current Drug Metabolism Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9): Impact of PCSK9 on Major Adverse Cardiac and Cerebrovascular Events
Cardiovascular & Hematological Agents in Medicinal Chemistry