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
-
The Gut Microbiota-Brain Axis in Acute Neurological Disease: Focus on
Stroke
Reviews on Recent Clinical Trials Heart Rate Lowering by Inhibition of the Pacemaker Current: A New Therapeutic Perspective in Cardiovascular Disease
Cardiovascular & Hematological Agents in Medicinal Chemistry The Two fACEs of the Tissue Renin-Angiotensin Systems: Implication in Cardiovascular Diseases
Current Pharmaceutical Design VNTR Variant of the <i>eNOS</i> Gene and its Relationship with Osteoporosis in Postmenopausal Turkish Women
Endocrine, Metabolic & Immune Disorders - Drug Targets Is there a Rational Approach for Increasing Drug Specificity? Considerations on CNS Target Choice and Validation
Recent Patents on CNS Drug Discovery (Discontinued) Asymptomatic Alzheimers Disease: A Prodrome or a State of Resilience?
Current Alzheimer Research Patent Perspective for Potential Antioxidant Compounds-Rutin and Quercetin
Recent Patents on Nanomedicine Sleep Duration as a Risk Factor for Cardiovascular Disease- a Review of the Recent Literature
Current Cardiology Reviews Recent Patents on Body Weight Support Training Devices for Spinal Cord Injury
Recent Patents on Biomedical Engineering (Discontinued) Production of Retroviral Vectors: Review
Current Gene Therapy Protease-Activated Receptor-2 Antagonists and Agonists
Current Medicinal Chemistry - Cardiovascular & Hematological Agents Modulators of Networks: Molecular Targets of Arterial Calcification Identified in Man and Mice
Current Pharmaceutical Design Structure-Based Virtual Screening to Identify Negative Allosteric Modulators of NMDA
Medicinal Chemistry New Oral Anticoagulation after Heart Valve Replacement
Cardiovascular & Hematological Disorders-Drug Targets Recent Advancement in the Field of Anticonvulsants: A Review
Letters in Drug Design & Discovery Sustained Delivery of Interferons by Micro- and Nanosystems
Recent Patents on Materials Science Experimental and Theoretical Advances in Functional Understanding of Flavonoids as Anti-Tumor Agents
Anti-Cancer Agents in Medicinal Chemistry Latest Results for Anti-Angiogenic Drugs in Cancer Treatment
Current Pharmaceutical Design Editorial (Thematic Issue: Endocrine Disorders and Cognitive Function in the Elderly)
Recent Patents on Endocrine, Metabolic & Immune Drug Discovery Epigenetic Control of Hypertension by DNA Methylation: A Real Possibility
Current Pharmaceutical Design