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Dr. Shanthi Mendis Coordinator, Cardiovascular Diseases World Health Organization. Cardiovascular Diseases 2 ry Prevention. Magnitude of CVD burden Potential of 2 ry prevention FDC ; scaling up 2 ry Prevention. Deaths due to CVD. World. Europe (25). CVD 16.3 m (29%).
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Dr. Shanthi Mendis Coordinator, Cardiovascular Diseases World Health Organization Cardiovascular Diseases2 ry Prevention
Magnitude of CVD burden • Potential of 2 ry prevention • FDC ; scaling up 2 ry Prevention
Deaths due to CVD World Europe (25) CVD 16.3 m (29%) CVD 1.8M (42%)
Disease Burden due to CVD World Europe (25) CVD 9 % CVD 22%
IHD and stroke are two leading causes of death in Europe and the world • Closing pharmaceutical gaps in Europe has benefits for the world Commonality of interest between Europe and the World
Primary prevention • Secondary prevention Prevention and Control of CVD
RR reduction 2-year event rate • None ----- 8.0% • Aspirin 25% 6.0% • B B 25% 4.5% • Statin 30% 3.0% • ACEI 25% 2.3% The potential of secondary prevention
Joint effects of BP / TC lowering and antiplatelet therapy 10 yr CV risk RR reduction 20% 40% 55%
EUROASPIRE Survey Overall Percentage on Rx Drugs Percentage Lancet 2001;357:996-1001
EUROASPIRE II Survey Percentage of patients with BC goals achieved Countries Percentage
EUROASPIRE II Survey Percentage of patients with BP goals achieved Countries Percentage
Secondary Prevention of CHD Overall Percentage in 10 countries Drugs Percentage WHO PREMISE 2003
Provider not prescribing • Not affordable • Poor adherence; complexity of Rx • Lack of access to services • Fragmented followup Possible reasons for low uptake
Improved adherence • Reduced costs (packaging/storage/distribution/low cost generic) • Less medication errors • Improve access to effective treatment Added value of a Fixed Dose Combination
Reduced capacity of physician to tailor therapy/dose • Therapy cannot be individualized • Side effects of one result in discontinuation of all Drawbacks of a Fixed Dose Combination
Low dose antiplatelet (aspirin 75 mg) • Full dose of a statin (simvastatin 40 mg) • Full dose of an ACEI (lisinopril 10 mg) • Half dose of a BB (atenolol 25 mg) FDC for Patients with CHD
Low dose antiplatelet (aspirin 75 mg) • Full dose of a statin (simvastatin 40 mg) • Full dose of an ACEI (lisinopril 10 mg) • Half dose of a diuretic (HCT 12.5 mg) FDC for Patients with CeVD
If there are 40 million individuals with a 10 year CV risk of 25% • In the absence of treatment every year there will be 1 million strokes and HA • About half these could be averted (10 year CV risk 11.25%) • Treat 70 over 1 year to avert 1 attack Potential for Europe
Formulation • Intellectual property • Regulation • Manufacture and quality assurance • Bioequivalence and stability • Comparability of pharmaco-dynamics and pharmaco-kinetics Key research issues in development
Effects on intermediate outcomes • Enhanced adherence • Prospective metanalysis FDC;Clinical research
Scaling up 2ry prevention is a key strategy • Poor uptake of effective medications • Innovative strategy FDC;modest investment • No incentives for pharma/ No tradition • Who should step in ? public sector? EU? Europe; CVD projected to increase