Research topic addressed lsh-2005 1-2 Pharmacogenomics for individualised medicines Proposal abstract




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CONFIDENTIAL Integrated Project

[PGHEART]



Integrated Project on


Pharmacogenomics for Hypertension: Evaluation of Adverse Drug Reactions and Response to Treatment


PG HEART


Table of Contents


Project abstract 4


B 1 Scientific and technological objectives of

the project and state of the art 5


B 2 Relevance to the objectives of the specific

programme 7


B 3 Potential Impact 9

5.1 Contributions to standards 9

5.2 Contribution to policy developments 9

5.3 Risk assessment and related communication strategy 10


B 4 Outline implementation plan 10

4.1 RTD and innovation 11

4.2 Demonstration activities 15

4.3 Training activities 15

4.4 Management activities 15

B 5 Description of the consortium 15

5.1 New participants 24

5.2 Sub-contracting 24

5.3 Other countries 24


B 6 Description of project management 24


B 7 Project resources 27

Integrated Project Management: justification of 27

resources and budget


B 8 Detailed 18 month implementation plan 28

8.1 Work planning Gantt 29

8.2 IP interdependence chart 30

8.3 Work Package list 31

8.4 Deliverables list 32

8.5 Work Package descriptions 33


B 9 Ethical Issues 38


B 10 Gender issues 41


Proposal summary page


Pharmacogenomics in Hypertension: Evaluation of Adverse Drug Reactions

and Response to Treatment


PG HEART

Research topic addressed




LSH-2005-1.2.1-2 Pharmacogenomics for individualised medicines


Proposal abstract

Heart attack and stroke are major burdens on populations and health economies in the European Union and worldwide. Effective control of high blood pressure is a key component of programmes aimed at preventing these and other important disorders of the circulation. However this requires long term treatment which is complicated by the occurrence of adverse drug reactions. These may lead to poor concordance with treatment and increased pressures on primary and secondary care services.


A major opportunity to improve therapeutic management arises from the fact that occurrence of adverse drug reactions (ADRs) can be associated with genetic polymorphisms linked to poor drug metabolism by cytochrome enzymes. Reduced efficacy of treatment and increased ADRs may also occur in response to genetic differences in drug transporters and in metabolic pathways influenced by drug treatments. Pharmacogenetic profiling thus carries the potential both to reduce incidence of ADRs and to reduce pressures on acute medical services. Reduced frequency of development of subtle as well as more serious side effects associated with long term preventive treatment could also improve efficacy of cardiovascular risk factor management.

Little is known about the benefits of pharmacogenetic profiling in clinical practice. There is great need for prospective studies to evaluate evidence for the clinical value of pharmacogenetic profiling. We aim, with joint Academic, Health Service and Industry involvement, to study prospective pharmacogenetic testing in the context of management of chronic cardiovascular disease. We shall use cohort studies of blood pressure therapeutic control and associated adverse drug reactions to test proof of concept. We shall also assess ethical, legal, patients’ and health service users’ and industry perspectives on pharmacogenetic testing and explore health economic aspects of this challenging new technology.


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