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Cardiovascular DiseasesCardiovascular Diseases2 ry Prevention2 ry Prevention

Cardiovascular DiseasesCardiovascular Diseases2 ry Prevention2 ry Prevention

Dr. Shanthi Mendis Coordinator, Cardiovascular Diseases

World Health Organization

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•Magnitude of CVD burden•Potential of 2 ry prevention •FDC ; scaling up 2 ry Prevention

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Deaths due to CVD

CVD 16.3 m (29%) CVD 1.8M (42%)

World Europe (25)

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Disease Burden due to CVD

CVD 9 % CVD 22%

World Europe (25)

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Number of Cardiovascular Deaths Projected to 2020

Number of Cardiovascular Deaths Projected to 2020

Millions 2002

2020

2002 2020

02000000400000060000008000000

100000001200000014000000160000001800000020000000

LowerIncome

HigherIncome

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Commonality of interest between Commonality of interest between Europe and the WorldEurope and the World

Commonality of interest between Commonality of interest between Europe and the WorldEurope and the World

IHD and stroke are two leading causes of death in Europe and the world

Closing pharmaceutical gaps in Europe has benefits for the world

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Prevention and Control of CVDPrevention and Control of CVDPrevention and Control of CVDPrevention and Control of CVD

Primary prevention

Secondary prevention

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The potential of secondary preventionThe potential of secondary prevention The potential of secondary preventionThe potential of secondary prevention

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%

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Joint effects of BP / TC lowering and antiplatelet therapy

0

5

10

15

20

25

Baseline Aspirin add BPRx

addstatin

10 yr CV risk

RR reduction 20% 40% 55%

10

63

43

84

66

0 20 40 60 80 100

Statins

BB

ACEI

Aspirin

Overall Percentage on Rx

EUROASPIRE Survey EUROASPIRE Survey

Lancet 2001;357:996-1001Percentage

Drugs

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2357

4034

4643

5660

4747

36

0 20 40 60 80 100

BelgiumFinlandFrance

GermanyIreland

ItalyNetherlands

SpainSweden

UKGreece

Percentage of patients with BC goals achieved

EUROASPIRE II Survey EUROASPIRE II Survey

Countries

Percentage

12

5550

4436

5051

4936

554952

0 20 40 60 80 100

BelgiumFinlandFrance

GermanyIreland

ItalyNetherlands

SpainSweden

UKGreece

Percentage of patients with BP goals achieved

EUROASPIRE II Survey EUROASPIRE II Survey

Countries

Percentage

13

29

53

66

45

0 20 40 60 80 100

Statins

BB

ACEI

Aspirin

Overall Percentage in 10 countries

Secondary Prevention of CHD Secondary Prevention of CHD

WHO PREMISE 2003Percentage

Drugs

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Possible reasons for low uptakePossible reasons for low uptakePossible reasons for low uptakePossible reasons for low uptake

Provider not prescribingNot affordablePoor adherence; complexity of Rx Lack of access to servicesFragmented followup

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Added value of a Fixed Dose Added value of a Fixed Dose CombinationCombination

Added value of a Fixed Dose Added value of a Fixed Dose CombinationCombination

Improved adherenceReduced costs

(packaging/storage/distribution/low cost generic)

Less medication errors Improve access to effective treatment

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Drawbacks of a Fixed Dose Drawbacks of a Fixed Dose CombinationCombination

Drawbacks of a Fixed Dose Drawbacks of a Fixed Dose CombinationCombination

Reduced capacity of physician to tailor therapy/dose

Therapy cannot be individualizedSide effects of one result in

discontinuation of all

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FDC for Patients with CHDFDC for Patients with CHDFDC for Patients with CHDFDC 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 BB (atenolol 25 mg)

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FDC for Patients with CeVDFDC for Patients with CeVDFDC for Patients with CeVDFDC for Patients with CeVD

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)

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Potential for Europe Potential for Europe Potential for Europe Potential for Europe

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

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Key research issues in developmentKey research issues in developmentKey research issues in developmentKey research issues in development

Formulation Intellectual property Regulation Manufacture and quality assurance Bioequivalence and stability Comparability of pharmaco-dynamics and pharmaco-

kinetics

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FDC;Clinical researchFDC;Clinical researchFDC;Clinical researchFDC;Clinical research

Effects on intermediate outcomes

Enhanced adherence

Prospective metanalysis

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Europe; CVD projected to increaseEurope; CVD projected to increase Europe; CVD projected to increaseEurope; CVD projected to increase

Scaling up 2ry prevention is a key strategyPoor uptake of effective medications

Innovative strategy FDC;modest investment

No incentives for pharma/ No tradition

Who should step in ? public sector? EU?